Hypnosis before diagnostic or therapeutic medical procedures: a systematic review.

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Hypnosis Before Diagnostic or Therapeutic Medical Procedures: A Systematic Review a

a

Nicole Cheseaux , Alix Juillet de Saint Lager & Bernhard a

Walder a

University Hospitals of Geneva, Switzerland Published online: 01 Aug 2014.

To cite this article: Nicole Cheseaux, Alix Juillet de Saint Lager & Bernhard Walder (2014) Hypnosis Before Diagnostic or Therapeutic Medical Procedures: A Systematic Review, International Journal of Clinical and Experimental Hypnosis, 62:4, 399-424, DOI: 10.1080/00207144.2014.931170 To link to this article: http://dx.doi.org/10.1080/00207144.2014.931170

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Intl. Journal of Clinical and Experimental Hypnosis, 62(4): 399–424, 2014 Copyright © International Journal of Clinical and Experimental Hypnosis ISSN: 0020-7144 print / 1744-5183 online DOI: 10.1080/00207144.2014.931170

HYPNOSIS BEFORE DIAGNOSTIC OR THERAPEUTIC MEDICAL PROCEDURES: A Systematic Review


Nicole Cheseaux, Alix Juillet de Saint Lager, and Bernhard Walder University Hospitals of Geneva, Switzerland

Abstract: The aim of this systematic review was to estimate the efficiency of hypnosis prior to medical procedures. Different databases were analyzed to identify randomized controlled trials (RCTs) comparing hypnosis to control interventions. All RCTs had to report pain or anxiety. Eighteen RCTs with a total of 968 patients were included; study size was from 20 to 200 patients (14 RCTs ≤ 60 patients). Fourteen RCTs included 830 adults and 4 RCTs included 138 children. Twelve of 18 RCTs had major quality limitations related to unclear allocation concealments, provider’s experience in hypnosis, patient’s adherence to hypnotic procedures, and intention-to-treat design. This systematic review observed major methodological limitations in RCTs on hypnosis prior to medical procedures.

Hypnosis is an altered state of consciousness in which patients are guided by a therapist who helps them to focus their attention on a personal experience, a pleasant memory, or with suggestions of relaxation (Erickson, Rossi, & Rossi, 1976). A session of hypnotherapy comprises an induction to enter a state of hypnosis, the trance itself during which treatment is performed, and finally coming out of hypnosis back to a normal state of awareness (Green, Barabasz, Barrett, & Montgomery, 2005). Hypnotic treatment can be used before and/or during a medical procedure. Hypnosis may be performed alone as a treatment or in combination with sedation or local anesthesia (Lucas-Polomeni, 2004). The hypnotic state can be reached either by listening to the instructions of a trained therapist, by oneself spontaneously, or after training with a therapist to perform self-hypnosis. Hypnosis is associated with

Manuscript submitted December 28, 2012; final revision accepted August 29, 2013. Address correspondence to Nicole Cheseaux, Division of Anesthesiology, University Hospitals of Geneva, Rue Gabrielle-Perret-Gentil 4, CH-1211 Geneva 14, Switzerland. E-mail: [email protected] Color versions of one or more of the figures in the article can be found online at www. tandfonline.com/nhyp. 399


400

NICOLE CHESEAUX ET AL.

alterations of the cerebral metabolic activity and cerebral perfusion in different parts of the brain (Faymonville, Boly, & Laureys, 2006). Hypnotic treatment is widely used in medicine for pain management (Montgomery, DuHamel, & Redd, 2000) or for diagnostic or therapeutic medical procedures to reduce anxiety or pain (Faymonville et al., 1997; Hammond, 2010; Lang et al., 2000). It was suspected that reducing anxiety may decrease intraoperative anesthetic requirements (Maranets & Kain, 1999), procedure time (Schupp, Berbaum, Berbaum, & Lang, 2005), postoperative pain, and behavioral disorders (Ip, Abrishami, Peng, Wong, & Chung, 2009; Kain, Mayes, Caldwell-Andrews, Karas, & McClain, 2006). In some studies, hypnosis was a rapid, cost-effective, and safe therapy (Lang et al., 2000; Lang & Rosen, 2002). Different systematic reviews on hypnosis in the medical setting were published in the last few years (Accardi & Milling, 2009; De Jong, Middelkoop, Faber, & Van Loey, 2007; Richardson, Smith, McCall, & Pilkington, 2006; Stinson, Yamada, Dickson, Lamba, & Stevens, 2008; Stoelb, Molton, Jensen, & Patterson, 2009; Uman, Chambers, McGrath, & Kisely, 2008). These systematic reviews were focused on a specific population with a specific medical procedure and included hypnotic interventions at unspecified time points in relation to a medical procedure. The efficacy of hypnosis before a medical procedure has never been investigated systematically. This estimation of efficacy, however, is important because this type of treatment may be less time consuming and can be performed, for instance, with an audiotape (Enqvist, von Konow, & Bystedt, 1995). Therefore, this systematic review aimed to estimate the efficacy of hypnosis before diagnostic or therapeutic medical procedures. An effort was made to estimate the quality of the included trials.

Method Data Sources and Systematic Search Studies were identified through electronic searches in the following databases: Pub Med, PsycInfo, Cinhal, Embase, Cochrane Collaboration, and AlternMed. We conducted a broad-based search on all databases, and we included the combination of the following keywords: (hypnosis OR hypnotic OR self-hypnosis OR active cognitive OR cognitive behavioral OR drug-free psychotherapeutic OR ericksonian OR hypnosedation OR hypnotherapeutic OR hypnotherapy OR non-pharmacological) AND (dental OR dentis∗ OR radiolog∗ OR invasive OR medical OR non-surgical OR operation OR surgery OR surgical OR sedation OR pain OR analges∗ OR interventional OR percutaneous OR biopsy OR needle puncture OR cardio∗ OR cardia∗ OR gastrointestinal OR endoscop∗ ). The last study search was performed in October

HYPNOSIS BEFORE MEDICAL PROCEDURES

401


2012. Reference lists from collected reports, reviews, systematic reviews, and meta-analyses (Accardi & Milling, 2009; Bongarzt, 2002; De Jong et al., 2007; Montgomery, David, Winkel, Silverstein, & Bovbjerg, 2002; Richardson et al., 2006; Stinson et al., 2008; Stoelb et al., 2009; Uman, Chambers, McGrath, & Kisely, 2006; Uman et al., 2008) were examined to identify additional studies. Articles in all languages were considered. Unpublished studies were not taken into consideration. Study Selection We only included full publications of randomized controlled trials of patients undergoing a medical diagnostic or therapeutic procedure. Meeting abstracts, letters, and publications on hypnosis by volunteers were excluded. Trials had to compare any technique of hypnosis or selfhypnosis before the medical procedure (active intervention) with no intervention (inactive control) or with another method of psychological intervention (active control). The trials had to report on the assessment of pain or anxiety. The intervention (hypnosis or control) had to take place only before and outside the medical procedure suite. Therefore, we excluded studies where hypnosis was used during or after medical procedure. The titles of all papers were independently screened by three authors (N. C., A. J. S. L., and B. W.) to identify reports that would potentially meet our inclusion criteria. The same three authors first read the abstracts of all reports that were selected for inclusion independently. If the study methods could not be identified from the abstract, the full text of the paper was examined. Disagreements among the reviewers regarding inclusion or exclusion were resolved by consensus. The full texts of all studies meeting our inclusion criteria were then retrieved and reviewed. Data Extraction Two authors (N. C.; A. J. S. L.) extracted data independently from each report using a standardized summary datasheet that included the following items: study population, sample size, publication date, journal, type of intervention, outcome measures, and medical procedures. For interventions, that is, hypnosis and active control, we analyzed the type of support and content, duration, and number of sessions. Methods of hypnosis were also analyzed. We searched baseline data (before nonpharmacological intervention) and outcome data (postnonpharmacological intervention or postmedical procedure). One investigator checked all data independently. Disagreements among the investigators regarding the extracted data were verified in the original full report and resolved by consensus.

402



Definition of Efficacy and Validity of Outcome Assessment The efficiency of the interventions was estimated on the basis of the outcomes difference. We considered differences in postintervention self-reported pain and anxiety between groups. We assessed the validity of these outcome measures. For each study, we looked for validation studies on the use of outcome measures to appraise the potential risk of bias. Assessment of Study Quality Regarding the general methodological appraisal of RCT, we assessed the method of randomization for each study, the degree of blinding, and the presence of comprehensive follow-up (Jadad score; Jadad et al., 1996); the maximum score is 5 points and the minimum score is 1. All quality assessments were checked; in case of disagreement, consensus was reached by discussion. In addition, we investigated the presence of a priori power calculation. Regarding the specific methodological evaluation of nonpharmacological studies, we independently assessed each study for the method of allocation, the description of nonpharmacological intervention, the experience of provider, the adherence to nonpharmacological intervention, the blinding, the follow-up, and the intention to treat analysis (Checklist to evaluate a report of a nonpharmacological trial [CLEAR NPT]; Boutron et al., 2005). Data Synthesis The data from the different RCTs were not pooled because they used heterogeneous outcome measures. This systematic review was reported according the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) Statement (Moher, Liberati, Tetzlaff, & Altman, 2009).

Results Description of the Studies We identified 7053 articles from our electronic searches; 18 RCTs were included in this systematic review (see Figure 1). All 18 included RCTs (Ashton et al., 1997; Enqvist, Bjorklund, Engman, & Jakobsson, 1997; Enqvist & Fischer, 1997; Everett, Patterson, Burns, Montgomery, & Heimbach, 1993; Ghoneim, Block, Sarasin, Davis, & Marchman, 2000; Goldmann, Ogg, & Levey, 1988; Hart, 1980; Katz, Kellerman, & Ellenberg, 1987; Lambert, 1996; Liossi & Hatira, 1999; Montgomery et al., 2007; Montgomery, Weltz, Seltz, & Bovbjerg, 2002; Patterson, Everett, Burns, & Marvin, 1992; Patterson & Ptacek, 1997; Saadat et al., 2006; Schnur et al., 2008; Slack et al., 2009; Wall &



403

Figure 1. Flow chart of included randomized controlled trials (RCTs).

Womack, 1989) were published in peer-reviewed journals in English: five in a specialized journal in hypnosis, five in a journal of anesthesia, three in a psychological journal, and five in other journals. The publication dates ranged between 1980 and 2009 (see Table 1). The 18 RCTs included 1005 randomized patients whereof the data of 968 patients was analyzed; 608 patients were female (gender was not reported in two RCTs containing a total of 50 patients) (Patterson et al., 1992; Wall & Womack, 1989). Six RCTs with 458 patients specified the ethnicity of the patients. Four hundred and forty-nine patients were treated with hypnosis, and 464 had a control intervention: 267 with active and 197 with inactive control. For 55 patients, no group attribution could be identified (Patterson & Ptacek, 1997). Study sizes were less than 100 patients in all studies except one (Montgomery et al., 2007) and 60 or less in 14 studies. The median study size was 48 patients (range: 20–200 patients). Mean age was reported in 13 studies; mean age was between 8 to 64 years (range: 5–78 years). Five studies with 211 patients

200 women

76

20 women

60

Montgomery et al. (2007)

Saadat et al. (2006)

Montgomery, Weltz, et al. (2002)

Ghoneim et al. (2000)

adults

adults

90 women

Schnur et al. (2008)

adults

Type

26

n

Slack et al. (2009)

Author (year of publication)

n/a n/a 22.8∗ 2.3 18–35

1.9 19–77 48.73∗ 12.88 n/a n/a n/a 18–65 n/a

electromyography

11.7 30–78 46.4∗

third molar surgery

breast biopsy

surgery

breast surgery

breast biopsy

needle

Medical Procedure

53.6

Age§

Patients

Table 1 Description and Design of Included RCTs

n/a

10

30

15

15

20

several

1

1

1

1

1

audio

live

live

live

live

audio

Duration (min) Number Support

inactive

inactive

activeinactive

active

active

active

Control

a, p

p

a

p

a

a, p

Outcome

Hypnotic session


Anesthesia & Analgesia

International Journal of Clinical and Experimental Hypnosis


Journal of the National Cancer Institute


American Journal of Physical Medicine & Rehabilitation

Journal

404 NICOLE CHESEAUX ET AL.

48 women

69

32

55

52 children

32

Enqvist et al. (1997)

Enqvist & Fischer (1997)

Ashton et al. (1997)

Patterson & Ptacek (1997)

Lambert (1996)

Everett et al. (1993)

adults

adults

adults

adults

30 children

Liossi & Hatira (1999)

6.23 n/a 64∗ 3 n/a n/a n/a 18–60 13 3 7–19 37.3 12.3 18–60

2.5 5–15 39∗ n/a 22–63 27.7∗

8

burn injury treatment

surgery


coronary artery bypass surgery

third molar surgery

breast surgery

bone marrow aspiration inactive

25

30

25

n/a

20

20

30

1

1

1

several

several

n/a

2

live

live

live

live

audio

audio

live

active

active

active

inactive

inactive

inactive

active


a, p

a, p

p

a

a, p

a, p

a, p

(Continued)

Journal of Burn Care & Rehabilitation

Journal of Developmental & Behavioral Pediatrics

Journal of Consulting and Clinical Psychology

Journal of Cardiovascular Surgery


Acta Anaesthesiologica Scandinavica

International Journal of Clinical and Experimental Hypnosis HYPNOSIS BEFORE MEDICAL PROCEDURES 405

52 women

36 children

40

Goldmann et al. (1988)

Katz et al. (1987)

Hart (1980)

n/a n/a

34.1 9.1 18–60 n/a n/a 5–18 24.6 n/a n/a 8.3 1.68 6–11 n/a

Age§

Medical Procedure

heart surgery

bone marrow aspiration

bone marrow aspiration and lumbar puncture gynaecological day case surgery


Patients

20

20–30

3

n/a

25

5

2

1

2

1

audio

live

live

live

live

Duration (min) Number Support

Note. a = anxiety; p = pain; n/a= not available. § Mean, standard deviation, or range. ∗ Data for hypnosis intervention group.

adults

20 children

Wall & Womack (1989)

adults

Type

30

n

Patterson et al. (1992)

Author (year of publication)

(Continued)

Table 1

inactive

inactive

active

active

Active inactive

Control

a

p

a

a, p

p

Outcome

Hypnotic session



Journal of Pediatric Psychology

Anaesthesia

American Journal of Clinical Hypnosis

Journal of Consulting and Clinical Psychology

Journal




407

did not report mean age (Hart, 1980; Montgomery, Weltz, et al., 2002; Patterson & Ptacek, 1997; Saadat et al., 2006; Wall & Womack, 1989), two with 60 patients gave no information about age (see Table 1) (Hart, 1980; Montgomery, Weltz, et al., 2002). Fourteen RCTs included 830 adult patients (mean age: 23 to 64 years; range: 18–78 years). Four RCTs with 138 patients examined a pediatric population (mean age: 8–13 years; range: 5–19 years). Five RCTs investigated 410 female adult patients only (mean age: 25–49 years; range: 19–77 years) (see Table 1). Seven RCTs with 500 patients were performed before surgery, three RCTs with 117 patients on treatments of burns, three RCTs with 86 patients on bone marrow aspiration and/or lumbar puncture, two RCTs with 129 patients on dental procedures, two RCTs with 110 patients on breast biopsy, and one RCT with 26 patients on needle electromyography (see Table 1). In three RCTs, hypnotizability was tested, of which two assessed hypnotizability with the Stanford Hypnotic Clinical Scale for Children (Liossi & Hatira, 1999; Wall & Womack, 1989) and one with the Hypnotic Induction Profile (Ashton et al., 1997). Ten RCTs utilized a treatment manual and five of these RCTs used hypnosis played on an audiotape for support (Enqvist et al., 1997; Enqvist & Fischer, 1997; Ghoneim et al., 2000; Hart, 1980; Slack et al., 2009). In seven RCTs, hypnosis was performed in more than one session (Ashton et al., 1997; Enqvist & Fischer, 1997; Ghoneim et al., 2000; Hart, 1980; Katz et al., 1987; Liossi & Hatira, 1999; Wall & Womack, 1989). In one RCT, the number of sessions was not available (Enqvist et al., 1997). The duration of hypnotic sessions ranged between 3 and 30 minutes. In three RCTs, the duration of the session was not available (Ashton et al., 1997; Ghoneim et al., 2000; Wall & Womack, 1989). The following methods of hypnosis were used: Barber’s (1977) hypnotic procedure in four RCTs; Rhue’s (Rhue, Lynn, & Kirsch, 1993) in three; Erickson’s (1970) in one; Enqvist’s (Enqvist & Fischer, 1997) in one; Elman’s (J. R. Hilgard & Lebaro, 1984) in one; and Olness and Gardner’s (1988) in one. In seven RCTs, the method of hypnosis was described in detail and not based on a particular published method.

Assessment of Study Quality Three RCTs had a Jadad score of 5 points (Montgomery et al., 2007; Patterson & Ptacek, 1997; Schnur et al., 2008), four studies had 4 points (Everett, Patterson, Burns, Montgomery, & Heimbach, 1993; Liossi & Hatira, 1999; Patterson et al., 1992; Slack et al., 2009), three RCTs had a score of 3 (Enqvist et al., 1997; Katz et al., 1987; Saadat et al., 2006), five had a score of 2 (Ashton et al., 1997; Enqvist & Fischer, 1997; Goldmann et al., 1988; Hart, 1980; Wall & Womack, 1989), and three had a score of


408


1 (Ghoneim et al., 2000; Lambert, 1996; Montgomery et al., 2002). Five RCTs reported on a priori power test (Hart, 1980; Montgomery et al., 2007; Saadat et al., 2006; Schnur et al., 2008; Slack et al., 2009). The methodological evaluation of nonpharmacological studies (CLEAR NPT) showed that the randomization was adequate in four RCTs (Montgomery et al., 2007; Patterson & Ptacek, 1997; Saadat et al., 2006; Schnur et al., 2008) and the treatment allocation was not concealed in any RCT. The details of the interventions administered to each group were available in 16 RCTs. The provider’s experience in hypnosis was reported as trained, advanced, or extensive in six RCTs (Ghoneim et al., 2000; Katz et al., 1987; Lambert, 1996; Liossi & Hatira, 1999; Montgomery et al., 2007; Schnur et al., 2008). No description of patients’ adherence was available in any RCT. The patients were blinded in 10 RCTs, the care providers of medical procedure were blinded in 11, and the outcome assessors were blinded in 10. All RCTs had the same follow-up for each group. One RCT was analyzed according to the intention to treat (Montgomery et al., 2007). Most RCTs have methodological limitations and potential bias (see Table 2). Table 2 Summary of Methodological Limitations and Potentials Bias of Included RCTs Authors (year of publication) Slack et al. (2009)

Schnur et al. (2008)

Montgomery et al. (2007) Saadat et al. (2006)

Montgomery, Weltz, et al. (2002)

Methodological limitations very small study size no reporting on concealment allocation no reporting on intention-to-treat analysis no reporting on provider’s experience no reporting on patient’s quality of adherence no reporting on ethnicity no reporting on concealment allocation no reporting on intention-to-treat analysis no reporting on patient’s quality of adherence no reporting on concealment allocation no reporting on patient’s quality of adherence no reporting on drop-outs no reporting on concealment allocation no reporting on intention-to-treat analysis no reporting on provider’s experience no reporting on patient’s quality of adherence no detailed age reporting no reporting on ethnicity no reporting on standardized treatment manual very small study size (Continued)


409

Table 2 (Continued)


Authors (year of publication)

Ghoneim et al. (2000)

Liossi & Hatira (1999)

Enqvist et al. (1997)

Enqvist & Fischer (1997)

Ashton et al. (1997)

Methodological limitations no reporting on blinding no reporting on drop-outs no reporting on concealment allocation no reporting on intention-to-treat analysis no reporting on provider’s experience no reporting on patient’s quality of adherence no detailed age reporting no power calculation no reporting on blinding no reporting on drop-outs no reporting on concealment allocation no reporting on intention-to-treat analysis no reporting on patient’s quality of adherence no detailed age reporting no power calculation very small study size no reporting on concealment allocation no reporting on intention-to-treat analysis no reporting on patient’s quality of adherence no reporting on ethnicity no power calculation very small study size no reporting on concealment allocation no reporting on intention-to-treat analysis no reporting on provider’s experience no reporting on patient’s quality of adherence no reporting on ethnicity no power calculation no detailed reporting on blinding no reporting on concealment allocation no reporting on intention-to-treat analysis no reporting on provider’s experience no reporting on patient’s quality of adherence no reporting on ethnicity no power calculation very small study size no reporting on drop-outs no reporting on concealment allocation no reporting on intention-to-treat analysis no reporting on provider’s experience no reporting on patient’s quality of adherence no reporting on ethnicity (Continued)

410


Table 2 (Continued) Authors (year of publication)


Patterson & Ptacek (1997)

Lambert (1996)


Patterson et al. (1992)

Methodological limitations no reporting on standardized treatment manual no power calculation no details of the intervention administered very small study size no reporting on concealment allocation no reporting on intention-to-treat analysis no reporting on provider’s experience no reporting on patient’s quality of adherence no detailed age reporting no reporting on ethnicity no reporting on standardized treatment manual no power calculation very small study size no reporting on blinding no reporting on drop-outs no reporting on concealment allocation no reporting on intention-to-treat analysis no reporting on patient’s quality of adherence no reporting on standardized treatment manual no power calculation very small study size no reporting on concealment allocation no reporting on intention-to-treat analysis no reporting on provider’s experience no reporting on patient’s quality of adherence no reporting on ethnicity no reporting on standardized treatment manual no power calculation very small study size no reporting on concealment allocation no reporting on intention-to-treat analysis no reporting on provider’s experience no reporting on patient’s quality of adherence no reporting on gender no reporting on ethnicity no reporting on standardized treatment manual no power calculation (Continued)


411

Table 2 (Continued) Authors (year of publication)


Wall & Womack (1989)

Goldmann et al. (1988)

Katz et al. (1987)

Hart (1980)

Methodological limitations very small study size no reporting on drop-outs no reporting on concealment allocation no reporting on intention-to-treat analysis no reporting on provider’s experience no reporting on patient’s quality of adherence no reporting on gender no detailed age reporting no reporting on ethnicity no power calculation no details of the intervention administered very small study size no reporting on blinding no reporting on concealment allocation no reporting on intention-to-treat analysis no reporting on provider’s experience no reporting on patient’s quality of adherence no reporting on ethnicity no reporting on standardized treatment manual no power calculation very small study size no reporting on drop-outs no reporting on concealment allocation no reporting on intention-to-treat analysis no reporting on patient’s quality of adherence” no reporting on standardized treatment manual no power calculation very small study size no reporting on blinding no reporting on concealment allocation no reporting on intention-to-treat analysis no reporting on provider’s experience no reporting on patient’s quality of adherence no detailed age reporting no reporting on ethnicity no power calculation


412


Validity of Outcome Measurements For postintervention pain assessment, three different assessment instruments were used: the visual analog scale (VAS) in 10 RCTs, the numeric-rating scale (NRS) in two, and the face rating scale (FRS) in one (see Table 3). All of these instruments were validated (Gagliese, Weizblit, Ellis, & Chan, 2005; Hicks, von Baeyer, Spafford, van Korlaar, & Goodenough, 2001; Kremer, Atkinson, & Ignelzi, 1981). For postintervention anxiety assessment, five different assessment instruments were used: the visual analog scale (VAS) in five RCTs, the State-Trait Anxiety Inventory (STAI) in five, the Short Version of Profile of Mood States (SV-POMS) in one, the Profile of Mood States (POMS) in one, and the face rating scale (FRS) in one (see Table 4). The first four were validated (Bringuier et al., 2009; Crandall, Lammers, Senders, Savedra, & Braun, 2007; Shacham, 1983; Spielberger, 1983). No validation data were found for one study (face rating scale) (Liossi & Hatira, 1999). Outcomes In 13 RCTs, the outcome was pain and, in 12 RCTS, the outcome was anxiety (see Tables 3 and 4). Apart from pain and anxiety, 15 other outcomes were irregularly reported: quantity of drug use during and after the medical procedure, duration of procedure, duration of monitored surveillance, duration of hospitalization, satisfaction of the patient, postinterventional nausea and vomiting, relaxation, perioperative hemodynamic measures, postoperative complications, postoperative mortality, comfort of the patient, fatigue of the patient, other psychological assessments, comfort of the operator, and costs. Six out of 13 RCTs with the outcome as pain compared hypnosis with the active controls, which were psychological interventions like nondirective empathic listening, attention support, cognitive-behavioral therapy, or discussion about the medical procedure. Five RCTs compared hypnosis with inactive control (no intervention) and two with active and inactive controls. For pain, 10 of out 13 RCTs had quantitative data; six had pre- and postinterventional and four postinterventional results only. Eight of out 10 RCTs with quantitative, postinterventional results were in favor of hypnosis. Five had a large variability of results (SD > 50% of results); among these, two had significant results. The other three RCT had significant results without standard deviations available (see Table 3). Among the five RCTs with significant results, two measured pain during procedure, two measured postprocedural pain, and one did not indicate which pain was measured. Six out of 12 RCTs with the outcome as anxiety compared hypnosis with the active controls, which were psychological interventions

Enqvist & Fischer (1997) Ashton et al. (1997) Patterson & Ptacek (1997) Lambert (1996) Everett et al. (1993)

Slack et al. (2009) Schnur et al. (2008) Montgomery et al. (2007) Saadat et al. (2006) Montgomery, Weltz, et al. (2002) Ghoneim et al. (2000) Liossi & Hatira (1999) Enqvist et al. (1997)


NRS VAS

VAS

VAS

VAS FRS VAS

VAS

VAS

VAS

Instrument for assessments

56.3 (14.2)

15.8 (23.0) 4 No data exploitable No data exploitable Not measured 55.9 (21.4)

Not measured

Not measured

Hypnosis

69.8 (22.7)

66.0 (24.5)

4

Active control

14∗, §

22.4 (25.4)∗, §

27 (14)‡

Hypnosis

62.6 (60.2)§ 44§ 63.5 (28.1)§

48.5 (50.9)§ 39∗, § 49.6 (29.5)§

3

‡

47.8 (30.8)§

35 (26)‡

Active control

(Continued)

31.1 (17.8)§ 4‡

43§

Inactive control

During and after medical procedure

16.3 (25.4) 36.3 (18.3)§ 4 2∗∗, ‡ No data exploitable No data exploitable

Inactive control

Before medical procedure (baseline)

Pain intensity

Table 3 Instruments for Pain Assessments, Quantitative Pain Estimation (Mean [SD]), and Timing of Pain Assessment


HYPNOSIS BEFORE MEDICAL PROCEDURES 413

83 (20) No data exploitable Not measured 75.5 (23.8) Not measured

NRS

Hypnosis

VAS VAS

Instrument for assessments 79 (12)

Active control 45 (27)∗∗, ‡ No data exploitable

Hypnosis

66 (23)‡

Active control

51.8 (33.8)‡

69 (26)‡

Inactive control


80.6 (27.5) 55 (36.9)‡

80 (16)

Inactive control


Pain intensity

Note. VAS = Visual Analog Scale (0–100); FRS = Face rating scale (0–5); NRS = Numeric Rating Scale (0–100). ∗ Statistically significant different between hypnosis and control (active control or inactive control), based on the analyses of the original authors. ∗∗ Statistically significant different between hypnosis and both active and inactive control, based on the analyses of the original authors. ‡ Pain assessment during procedure pain. § Pain assessment after procedure.

Patterson et al. (1992) Wall & Womack (1989) Goldmann et al. (1988) Katz et al. (1987) Hart (1980)


(Continued)

Table 3



Liossi & Hatira (1999) Enqvist et al. (1997) Enqvist & Fischer (1997) Ashton et al. (1997)

Slack et al. (2009) Schnur et al. (2008) Montgomery et al. (2007) Saadat et al. (2006) Montgomery, Weltz, et al. (2002) Ghoneim et al. (2000)


30.8 (7.3)

STAI

POMS

VAS No data exploitable

4.5 Not measured 44

46 (10) Not measured

STAI

FRS

17 (13) 18.9 (3.9) Not measured

Hypnosis

BAI◦ , VAS† SV-POMS


49

5

44 (11)

15 (10) 17 (4.1)

Active control

4.5

32.9 (8.7)

42 (13)

Inactive control


No data exploitable

3.5‡

37 (9)#

31 (8)∗∗, #

No data exploitable 0.5∗∗, ‡

44 (41)‡ 10 (2)#

Active control

33 (25)‡ 5 (2.5)∗, #

Hypnosis

(Continued)

5‡

41 (11)#

Inactive control


Anxiety intensity

Table 4 Instruments for Anxiety Assessment, Quantitative Anxiety Estimation (Mean [SD]), and Timing of Anxiety Assessment


HYPNOSIS BEFORE MEDICAL PROCEDURES 415

Not measured

Not measured No data exploitable 23.9 (20.1)

No data exploitable 29.0 (26.9)

Not measured

Hypnosis

46.5 (27.9)

50.9 (32.7)

Active control

Inactive control


42.3 (10.5)∗, §

No data exploitable

No data exploitable 19.2 (17.6)‡

Hypnosis

36.8 (31.5)‡

Active control

50.5 (10.2)§

Inactive control


Anxiety intensity

Note. VAS = Visual Analog Scale (0–100); STAI = State-Trait Anxiety Inventory (20–80); SV-POMS = Short Version of Profile of Mood States (0–24); POMS = Profile of Mood States (0–232); FRS = Face rating scale (0–5); BAI = Beck Anxiety Inventory. ∗ Statistically significant different between hypnosis and control (active control or inactive control), based on the analyses of the original authors. ∗∗ Statistically significant different between hypnosis and both active and inactive control, based on the analyses of the original authors. # Anxiety assessment immediately before procedure. ‡ Anxiety assessment during procedure. § Anxiety assessment after procedure.

STAI

VAS

VAS, STAI

VAS


Patterson et al. (1992) Wall & Womack (1989) Goldmann et al. (1988) Katz et al. (1987) Hart (1980)

STAI


Patterson & Ptacek (1997) Lambert (1996)


(Continued)

Table 4





417

like nondirective empathic listening, attention support, cognitivebehavioral therapy, or discussion about the medical procedure. Four RCTs compared hypnosis with inactive controls and two with active and inactive controls. For anxiety, 9 out of 12 RCTs had quantitative data, five had preand postprocedural results, two had preprocedural results, and one had postprocedural results. The six RCTs with quantitative, postprocedural data were in favor of hypnosis. Two had a large variability without significant results, three had a low variability (SD < 50% of results) and significant results, and one had significant results without available standard deviations (see Table 4). Two out of the four RCTs with significant results measured preprocedural anxiety, one measured anxiety during procedure, and one measured postprocedural.

Discussion The main result of this systematic review on hypnosis before diagnostic or therapeutic medical interventions is the heterogeneity of the included RCTs concerning the studied populations, the hypnotic interventions, the comparators, and the outcome measurements. Furthermore, most studies had limitations related to small group sizes, reporting on allocation concealments, provider’s experience, reporting on patients’ adherence to hypnotic procedures and no intention-totreat study design. Therefore, the validity of the reported efficacy on decreased pain and anxiety is low. Hypnosis has been used in clinical practice for different therapeutic indications for many years. Hypnosis was considered an efficient therapy for pain and anxiety that occurs during surgery (Montgomery, David, et al., 2002), during invasive medical procedures in pediatric oncology patients (Richardson et al., 2006), and during labor preceding childbirth (Cyna, McAuliffe, & Andrew, 2004). To our knowledge this is the first systematic review of RCTs testing hypnosis for the management of pain and anxiety before a diagnostic or therapeutic medical procedure. Only randomized control trials were included in this review; therefore, the risk of overestimating the efficacy of hypnosis was decreased. In this particular domain, the use of randomization is even more important than in the settings with drug interventions because a positive attitude toward hypnosis is associated with higher hypnosis suggestibility (Spanos, Brett, Menary, & Cross, 1987) and potentially an overestimation of self-reported outcomes. Our results, that is, the low methodological quality of the existing literature in this setting, are in alignment with other recent systematic reviews in this domain. Similar to our systematic review, Accardi and Milling (2009) observed in a systematic review including children


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and young adults a major heterogeneity in hypnosis administration, in particular in the use of specified treatment manuals for hypnosis, the type of delivery, the hypnotic context, and the testing of hypnotic suggestibility (Accardi & Milling, 2009; Landolt & Milling, 2011). The same research group in a second systematic review on women in labor and delivery pain observed major limitations in random assignment, characterization of the population, and use of treatment manuals (Accardi & Milling, 2009; Landolt & Milling, 2011). Studies on a hypnotic intervention need highly standardized and written procedures to identify differences in validated outcomes, like other psychological interventions. Furthermore, power calculation, adequate randomization, allocations concealment, assessor blindness, and timing of outcome measurement are basic conditions for study validity (Boutron, Moher, Altman, Schulz, & Ravaud, 2008; Chambless & Hollon, 1998). Some supplementary conditions are necessary for high-quality studies in this particular setting: the assessment of patients’ adherence to the intervention and standardization of cointerventions (Marc, Pelland-Marcotte, & Ernst, 2011). All these methodological measures are necessary to detect and to avoid biases. For instance, expectations and motivations of patients and therapists can enhance hypnotic effect (Kirsch & Braffman, 1999). Gender and ethnicity can also affect hypnosis efficacy. Last but not least the labeling of the interventions can influence the response of the patient (Hendler & Redd, 1986). The impact of levels of hypnotizability (E. R. Hilgard & Hilgard, 1975; Lang, Joyce, Spiegel, Hamilton, & Lee, 1996; Patterson & Jensen, 2003; Richardson et al., 2006) and the dose-response effect of audiotape practice (Laidlaw & Willett, 2002; Liossi & Hatira, 2003; Montgomery et al., 2002; Patterson & Jensen, 2003) on hypnosis efficacy, however, are more controversial but should be assessed in a high-quality RCT. High care-provider experience may have a limited impact on hypnosis efficacy (Lang et al., 2006) but should be mentioned in a high-quality scientific report in this setting. Further weaknesses of the included studies in this systematic review were the use of different outcome measurements and different reporting on these outcomes. Researchers in this domain do not seem to have a consensus on what instrument should be used and how quantitative data should be described. However, most studies reporting on analgesia measured pain with the VAS, a well-validated method that may be used in future studies. Studies reporting on anxiety used different instruments of assessment; the oldest and best established instrument is the State-Trait Anxiety Inventory, which could be a potential standard instrument for future studies. This heterogeneous use of assessment instruments precludes meta-analyses. These weaknesses are in accordance with the results of a systematic review on psychological interventions for needle-related procedural pain and distress in children and adolescents (Uman et al., 2008), where similar limitations were observed.



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Self-reported and subjective outcome measurements such as pain and anxiety usually have a large variability in a described population and need a well-defined minimal important difference, for instance, a change of 30% to 40% on the VAS score (Myles & Christelis, 2011). The systematic review confirms the large variability of these outcome measurements and identifies only a few studies with a clinically minimal important difference for the investigated outcomes. Conducting hypnosis before medical interventions could be promising, because it may be less personal and time consuming than therapistguided hypnosis during intervention. However, large RCTs are required to estimate its efficacy and its limitations. The design of such RCTs should fully describe the following aspects: standardized manuals for hypnosis including type of delivery, the hypnotic context, the intensity of hypnosis and controls interventions, as well as patients’ adherence to these interventions, with blind valid assessments of outcomes, with a predefined minimal important differences, defined care-provider experience in hypnosis, and standardization of cointerventions. Before such well-designed, large RCTs are available, we can only speculate on the beneficial effect of hypnosis before medical procedures. However, the actual absence of evidence is not evidence of absence of benefit for hypnosis before medical procedures. Hypnosis has few adverse effects and therefore it may be performed on patients demanding it before a medical intervention. In conclusion, this systematic review reported major methodological limitations in most RCTs for the use of hypnosis before medical interventions.

Acknowledgments The authors thank Mrs. Nicole Cuddy Pierrehumbert for the English editing of this manuscript and Mr. Ezra Bottequin, English editor, who revised this manuscript carefully.

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Hypnose vor diagnostischen oder therapeutischen medizinischen Behandlungen: Ein systematischer Rückblick Nicole Cheseaux, Alix Juillet de Saint Lager und Bernhard Walder Abstrakt: Das Ziel dieses systematischen Reviews war, die Effizienz der Hypnose vor medizinischen Behandlungen abschätzen zu können. Es wurden unterschiedliche Datenbanken analysiert, um randomisierte kontrollierte Versuche (RCTs) herauszusuchen, die Hypnose mit Kontrollbehandlungen vergleichen. Alle RCTs sollten sich auf Schmerz oder Angst beziehen. 18 RCTs, insgesamt 968 Patienten, wurden eingeschlossen. Die Studiengröße lag zwischen 20 und 200 Patienten (14 RCTs ≤ 60 Patienten). 14 RCTs schlossen 830 Erwachsene und 4 RCTs 138 Kinder mit ein. 12 von 18 RCTs hatten größere Qualitätseinschränkungen, die durch unklare Finanzierungen, eingeschränkte Erfahrungen der Beteiligten mit Hypnose, die durch unklare Patientenzuordnungen, eingeschränkte Erfahrungen der Beteiligten mit Hypnose, die Einhaltung der hypnotischen Behandlung durch den Patienten und des intention-to-treat Design

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entstanden. Dieser systematische Review beobachtete grössere methodische Einschränkungen der RCTs im Bereich Hypnose vor medizinischen Behandlungen. Stephanie Reigel, MD


L’hypnotisme préalable à la thérapie ou au diagnostic médicaux: Une revue systématique Nicole Cheseaux, Alix Juillet de Saint Lager et Bernhard Walder Résumé: L’objectif de cette revue systématique consiste à estimer l’efficacité de hypnose pratiquée avant une intervention médicale. Les auteurs ont procédé à l’analyse de diverses bases de données en vue de déterminer les essais cliniques randomisés (ECR) au cours desquels les interventions sous hypnose sont comparées avec celles subies par des groupes témoins. Seuls les ECR qui rendent compte de la douleur ou de l’anxiété sont retenus. La revue a porté sur 18 ECR réalisés sur un total de 968 patients; la taille de chaque étude variait de 20 à 200 patients (14 ECR ≤ 60 patients). De ces 18 ECR, 14 ont été réalisés sur des adultes (830 au total) et 4 sur des enfants (138 au total). Douze des 18 ECR ont des limitations majeures en lien avec la dissimulation des répartitions, l’expérience de l’hypnothérapeute, l’adhésion des patients aux procédures hypnotiques et l’analyse de l’intention de traiter. Cet examen systématique a permis de constater d’importantes limitations méthodologiques dans les ECR portant sur la pratique de l’hypnose avant des procédures médicales. Johanne Reynault C. Tr. (STIBC) La hipnosis antes de procedimientos médicos de diagnóstico o terapéuticos: Una revisión sistemática Nicole Cheseaux, Alix Juillet de Saint Lager, y Bernhard Walder Resumen: El propósito de esta revisión sistemática fue estimar la eficacia de la hipnosis antes de un procedimiento médico. Se analizaron diferentes bases de datos para identificar ensayos controlados aleatorios (ECAs) comparando hipnosis con intervenciones control. Todos los ECAs debieron reportar dolor o ansiedad. Se incluyeron dieciocho ECAs con un total de 968 pacientes; el tamaño del estudio varió entre 20 y 200 pacientes (con 14 ECAs ≤ 60 pacientes). Catorce ECAs incluyeron 830 adultos y 4 ECAs 138 niños. Doce de los 18 ECAs tuvieron importantes limitaciones de calidad relacionadas con el cegamiento de la asignación, la experiencia con hipnosis del proveedor, la adherencia del paciente a los procedimientos hipnóticos, y diseños de intención de tratar. Esta revisión sistemática observó limitaciones metodológicas mayores en los ECAs de hipnosis antes de procedimientos médicos. Omar Sánchez-Armáss Cappello, PhD Autonomous University of San Luis Potosi, Mexico

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