Australian Critical Care 28 (2015) 103–105

Contents lists available at ScienceDirect

Australian Critical Care journal homepage: www.elsevier.com/locate/aucc

Article Critique

Patient-directed music therapy reduces anxiety and sedation exposure in mechanically-ventilated patients: A research critique Janice G. Gullick RN, PhD a,∗ , Xiu Xian Kwan RN, BN b,c a

Master of Emergency and Intensive Care Nursing Programs, Sydney Nursing School, University of Sydney, Australia Sydney Nursing School, University of Sydney, Australia c Intensive Care Unit, Alexandra Hospital, Jurong Health Services, Singapore b

article information Article history: Received 16 February 2015 Accepted 5 March 2015 Keywords: Anxiety Research critique Critical care Music therapy Sedation Noise-cancelling headphones

a b s t r a c t This research appraisal, guided by the CASP Randomised Controlled Trial Checklist, critiques a randomised, controlled trial of patient-directed music therapy compared to either noise-cancelling headphones or usual care. This study recruited 373 alert, mechanically-ventilated patients across five intensive care units in the United States. The Music Assessment Tool, administered by a music therapist, facilitated music selection by participants in the intervention group. Anxiety was measured using the VAS-A scale. Sedation exposure was measured by both sedation frequency and by sedation intensity using a daily sedation intensity score. Context for the data was supported by an environmental scan form recording unit activity and by written comments from nurses about the patient’s responses to the protocol. Patient-directed music therapy allowed a significant reduction in sedation frequency compared to noise-cancelling headphones and usual care participants. Patient-directed music therapy led to significantly lower anxiety and sedation intensity compared to usual care, but not compared to noise-cancelling headphones. This is a robust study with clear aims and a detailed description of research methods and follow-up. While no participants were lost to follow-up, not all were included in the analysis: 37% did not have the minimum of two anxiety assessments for comparison and 23% were not included in sedation analysis. While some participants utilised the intervention or active control for many hours-per-day, half the music therapy participants listened for 12 min or less per day and half of the noise-cancelling headphone participants did not appear to use them. While the results suggest that patient-directed music therapy and noise-cancelling headphones may be useful and cost-effective interventions that lead to an overall improvement in anxiety and sedation exposure, these may appeal to a subset of ICU patients. The selfdirected use of music therapy and noise-cancelling headphones means these findings may not transfer to sedated or cognitively-impaired patients. © 2015 Australian College of Critical Care Nurses Ltd. Published by Elsevier Ltd. All rights reserved.

Research article for critique

1. Summary

Chlan LL, Weinert CR, Heiderscheit A, Tracy MF, Skaar DJ, Guttormson JL, Savik K. Effects of patient-directed music intervention on anxiety and sedative exposure in critically ill patients receiving mechanical ventilatory support: a randomized clinical trial. JAMA 2013;309(22):2335–44.

The aim of this study was to determine whether self-directed, self-initiated music therapy, compared to either noise-cancelling headphones or usual care reduced self-reported anxiety or sedation use in 373 mechanically-ventilated patients. Patient-directed music (PDM) therapy has been shown to divert attention from negative experiences or emotions, reducing the perception of emotional stress.1 PDM is selected with the assistance of a music therapist according to patient preference and thereafter is initiated by the direct action of the patient. This unblinded, randomised, controlled trial was conducted across 12 ICUs in five hospitals in the United States. Participation was offered to alert, patients who were

∗ Corresponding author at: A4:17 MO2, University of Sydney, NSW 2006, Australia. Tel.: +61 2 9351 0638. E-mail address: [email protected] (J.G. Gullick).

http://dx.doi.org/10.1016/j.aucc.2015.03.003 1036-7314/© 2015 Australian College of Critical Care Nurses Ltd. Published by Elsevier Ltd. All rights reserved.

104

J.G. Gullick, X.X. Kwan / Australian Critical Care 28 (2015) 103–105

mechanically ventilated for acute respiratory failure; were able to follow instructions and participate in their own care; had adequate vision and hearing; and were able to provide informed consent. Patients were excluded if they were receiving aggressive ventilatory support or vasopressors, were unresponsive, delirious or had a cognitive deficit. PDM participants reviewed a starter set of generic, relaxing tracks with the research nurse. Within 24-h of randomisation, a music therapist then compiled a list of music preferences with the participant using the Music Assessment Tool (MAT)2 : a 3page, yes/no music preference instrument designed for use with mechanically-ventilated patients. Questions elicited information on patient background, music preferences and dislikes related to music genres, individual artists and instrumental combinations. Anxiety was measured using the VAS-A; a ten-point measure assessed for concurrent validity and well-correlated with the Spielberger State Inventory.3,4 Those randomised to PDM were encouraged to listen to music therapy at least twice per day for relaxation or when feeling anxious. Those randomised to active control with noise-cancelling headphones (NCH) were encouraged to wear these when they wished to block out noise or have quiet time. The different indications for use of these devices should be noted. Usual care recipients received no study-directed music or NCH and were managed according to local unit protocols. NCH participants were in the ICU a median of one to two days longer than music therapy or usual care participants prior to enrolment. Fifty-two percent of subjects were female and mean age was 59 years. Participants had a wide range of APACHE III scores5 (mean 63, SD – 21.6) and follow-up occurred for a maximum period of 30 days or until extubation, with a mean study duration of 5.7 days. The PDM group listened to music for a mean of 79.8 min (median 12 min, range 0–796 min) per day. NCH were worn for a mean time of 34 min (median 0 min, range 0–916 min) per day. More PDM participants were extubated at the end of the study (p = .02). PDM participants recorded significantly lower VAS-A scores compared to usual care, and significantly larger decreases in sedation frequency compared to both NCH (p = 0.04) and usual care (p = .01). The authors concluded that among mechanicallyventilated ICU patients with respiratory failure, measures of anxiety, sedation frequency and sedation intensity are reduced for PDM patients compared to usual care, while sedation frequency only is reduced when compared to NCH. There was no difference between PDM and NCH in the reduction of anxiety or sedation intensity. The CASP Randomised Controlled Trial Checklist6 guided the following critique.

2. Critique These findings have relevance for Australian critical care practice. Given the high frequency of anxiety in the critical care environment7 and the known benefits of reducing sedative exposure in the ICU,8 research findings that support non-pharmacological interventions may both improve patient experience and facilitate patients’ participation in their own care. While others have explored the use of music therapy in the ICU, this is the first to use a patient-directed and initiated approach. This study demonstrated a role for PDM therapy in reducing anxiety, sedation frequency and intensity, but also demonstrated the efficacy of using noise-cancelling headphones with the only additional PDM benefit being a reduction in sedation frequency. This suggests that significant benefit may arise from noise reduction alone. There was a large discrepancy between the mean and median utilisation times for both PDM and NCH reflecting the negative skew in duration of utilisation practices. While average daily PDM

listening time was 79.8 min, half the participants listened to PDM for 12 min or less per day. The median use time for NCH was 0 suggesting it was not widely utilised among participants in that group. While the results suggest that PDM and NCH may lead to an overall improvement in anxiety and sedation exposure, these appear to be options that will appeal to a subset of ICU patients. The choice of a three-arm randomised, controlled trial is a robust approach to this research question; the use of an active control with NCH helped to differentiate which anxiety-reducing effects might arise from noise reduction compared to the therapeutic benefit of music. The trial addressed a clearly focused issue with a well-described population and clear study groups. Participants were randomised using computer-generated random numbers and the use of opaque envelopes ensured allocation concealment. A flow diagram demonstrates the screening, recruitment and randomisation numbers and process. No participants were lost to follow-up. Participants who discontinued (n = 8 PDM; n = 8 NCH) did so because of dislike of the equipment, family request, fatigue, worsening physiological status and protocol deviation but were included in the analysis. Explanation was provided when the interventions were not administered as randomised. Not all participants were included in the analysis: 37% did not have two anxiety assessments for comparison due to sedation, fatigue, absence from unit or inability to respond; 23% were not included in the sedation analysis without explanation. These threats to validity may reflect the difficulty in conducting such trials in critically ill populations. The inclusion of 95% confidence intervals strengthened the report. Reporting of effect sizes could further communicate the strength of observable effects. Pairwise comparisons revealed a significantly lower VAS-A score at baseline for the PDM group compared to those receiving usual care, however, when covariate analysis was used to adjust for this, significantly lower VAS-A scores remained for the PDM group. Use of sedatives was determined by calculating a daily sedative intensity score (a process explained in detail by the authors) and by calculating sedative frequency for administration of eight common sedative medications. There was no unit or study protocol in place for sedation, rather, these medications were administered as required by nurses within the parameters of a physician’s p.r.n. order. Each shift, a record of unit activity was collected using an environmental scan form. In addition, nurses were able to record a qualitative comment on their experience with the patients’ responses and the study protocol each shift. ICU patients are known to be a vulnerable cohort and special guidelines are available to inform an ethical approach to recruitment.9 In this study, participants were required to answer yes or no questions correctly to be eligible for enrolment, and enrolment could be revisited if cognitive function improved. Whereas many trials are conducted in the ICU using consent waivers or consent from close family members, the need for alert, cognitively intact participants in this study allowed full, informed participant consent and this was obtained by trained research nurses rather than nurses providing care, reducing any sense of coercion. The sample size of 373 participants was based on a power calculation allowing for at least 48-h of participant data and a 20% attrition rate, an alpha level of .05 and a power level of 80%. The sample exceeded the required 286 participants and is large compared to similar trials. While blinding of staff has been utilised in prior music therapy research,10 the nature of these participant-initiated therapies made patient blinding impossible. This self-directed intervention was only appropriate to those patients who were able to hear, see and follow commands. Results are not, therefore, transferrable to sedated or cognitively-impaired patients. A similar randomised, controlled trial from China11 also demonstrated a significant reduction in anxiety for their ICU

J.G. Gullick, X.X. Kwan / Australian Critical Care 28 (2015) 103–105

music-listening group and NCH group compared to controls. Other reports of music therapy during mechanical ventilation describe significant anxiety reduction in both non-sedated, alert patients12 and in sedated patients.13 In the randomised, controlled trial of To, et al. however, Mozart therapy failed to reduce anxiety in patients during sedation vacation.10 To’s population undergoing sedation lightening may have had higher baseline anxiety scores than the alert sample in the study under review. Qualitative studies describe the use of music therapy in facilitating weaning from mechanical ventilation14 and in inducing a sense of calm and comfort.15 Such findings are congruent with research that demonstrates a reduction in sedative exposure following music therapy,10,12 and improved sleep quality for ICU patients.16 While this study uses the active control of NCH, other reports have demonstrated the superiority of music therapy to uninterrupted rest periods.17,18 In conclusion this is a robust study that provides evidence for the place of both music therapy and noise-cancelling headphones in reducing anxiety among alert, mechanically-ventilated patients. The cost-effective and self-directed nature of patientdirected music therapy and noise-cancelling headphones provides an important potential avenue for both improved patient experience and the participation of patients in their own care. References 1. Särkämö T, Tervaniemi M, Laitinen S, Forsblom A, Soinila S, Mikkonen M, et al. Music listening enhances cognitive recovery and mood after middle cerebral artery stroke. Brain 2008;131(3):866–76. 2. Chlan L, Heiderscheit A. A tool for music preference assessment in critically ill patients receiving mechanical ventilation. Music Ther Perspect 2009;27(1): 42–7. 3. Chlan L. Relationship between two anxiety instruments in patients receiving mechanical ventilatory support. J Adv Nurs 2004;48(5):493–9.

105

4. Facco E, Stellini E, Bacci C, Manani G, Pavan C, Cavallin F, et al. Validation of visual analogue scale for anxiety (VAS-A) in preanesthesia evaluation. Minerva Anestesiol 2013;79(12):1389–95. 5. Knaus W, Wagner D, Draper E, Zimmerman J, Bergner M, Bastos P, et al. The APACHE III prognostic system. Risk prediction of hospital mortality for critically ill hospitalized adults. Chest 1991;100(6):1619–36. 6. Critical Appraisal Skills Programme (CASP). Randomised controlled trials checklist; 2013. Available from: http://media.wix.com/ugd/dded87 c7984187fdc74d25a3fba6c707383b15.pdf [cited 08.02.15]. 7. Chlan L, Savik K. Patterns of anxiety in critically ill patients receiving mechanical ventilatory support. Nurs Res 2011;60(3 (Suppl)):S50–7. 8. Reade M, Finfer S. Sedation and delirium in the intensive care unit. N Engl J Med 2014;370(5):444–54. 9. National Health Medical Research Council. National statement on ethical conduct in human research. Australian Government; 2007. p. 61. Available from: http://www.nhmrc.gov.au/ files nhmrc/publications/attachments/e72 national statement 140130.pdf [updated 2013/cited 08.02.15]. 10. To W, Bertolo T, Dinh V, Jichici D, Hamielec C. Mozart Piano Sonatas as a nonpharmacological adjunct to facilitate sedation vacation in critically ill patients. Music Med 2013;5(2):119–27. 11. Chlan L. Effectiveness of a music therapy intervention on relaxation and anxiety for patients receiving ventilatory assistance. Heart Lung 1998;27(3):169–76. 12. Dijkstra B, Gamel C, Van der Bijl J, Bots M, Kesecioglu J. The effects of music on physiological responses and sedation scores in sedated, mechanically ventilated patients. J Clin Nurs 2010;19:1030–9. 13. Stubbs T. Experiences & perceptions of music therapy in critical illness. Nursing Times; 2005. Available from: http://www.nursingtimes.net/Journals/ 2013/02/15/s/e/u/051108ResMusic.pdf [cited 08.02.15]. 14. Updike P. Music therapy results for ICU patients. Dimens Crit Care Nurs 1990;9(1):39–45. 15. Wong H, Lopez-Nahas V, Molassiotis A. Effects of music therapy on anxiety in ventilator-dependent patients. Heart Lung 2001;30(5):376–7. 16. Su CP, Lai HL, Chang ET, Yiin LM, Perng SJ, Chen PW. A randomized controlled trial of the effects of listening to non-commercial music on quality of nocturnal sleep and relaxation indices in patients in medical intensive care unit. J Adv Nurs 2013;69(6):1377–89. 17. Han L, Li JP, Sit J, Chung L, Jiao ZY, Ma WG. Effects of music intervention on physiological stress response and anxiety level of mechanically ventilated patients in China: a randomised controlled trial. J Clin Nurs 2010;19(7–8):978–87. 18. Sendelbach S, Halm M, Doran K, Miller E, Gaillard P. Effects of music therapy on physiological and psychological outcomes for patients undergoing cardiac surgery. J Cardiovasc Nurs 2006;21(3):194–200.

Patient-directed music therapy reduces anxiety and sedation exposure in mechanically-ventilated patients: a research critique.

This research appraisal, guided by the CASP Randomised Controlled Trial Checklist, critiques a randomised, controlled trial of patient-directed music ...
279KB Sizes 0 Downloads 8 Views