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Music During Paediatric Outpatient Wound Dressing Changes: Impact on Anxiety, Pain and Patient Satisfaction

NCT04170842 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 48

Last updated 2019-11-20

No results posted yet for this study

Summary

Background: Wound dressing changes can be painful and distressing for children and the consequences of poorly managed pain and anxiety can be lifelong. Multiple sessions are usually required, and recurrent painful episodes can trigger significant anxiety and behavioural changes with subsequent escalation on re-exposure. Music has been shown to improve relaxation and reduce autonomic activity in paediatric oncology outpatients and have significant positive effect on postoperative pain, anxiety and distress.

Aims: The investigators propose using music listening as a complement to alleviate anxiety, reduce pain and improve the experience of surgical outpatients undergoing wound dressing changes. Investigators will also evaluate the impact on physiological parameters, such as heart rate and blood pressure.

Hypothesis: That pain and anxiety are significantly reduced and patient satisfaction is significantly improved when wound dressings are accompanied by music intervention.

Methodology: A prospective crossover randomised controlled trial recruiting 88 surgical outpatients aged 9 years and above undergoing multiple wound dressing changes. Patients will be randomised to receive music intervention either during the first or subsequent dressing change, with the alternate dressing change not accompanied by music. Patient selected music will be chosen with the input of a trained music therapist. Participants will complete post session self-assessment questionnaires on pain, anxiety and satisfaction. Physiological parameters will be measured pre and post session.

Importance: If proven feasible and effective, this intervention may improve patient experience by reducing pain and anxiety associated with outpatient wound dressing changes, improve patient satisfaction by taking advantage of the relaxing and calming effects of music listening, and improve clinical efficiency by using a cost-effective method for alleviating pain and anxiety

Risks/benefits: There is minimal risk as usual standard treatment protocols for wound management continues. Patients may benefit from the soothing effects of music.

Conditions

  • Wound Heal

Interventions

OTHER

Music intervention

Participants will work with the music therapist to make their selections. Music therapists will provide input on how best to synchronise type, tempo and genre of music to the wound dressing procedure. As musical preference is very personal, the choice of music provided will try to strike a balance of providing what is acceptable to patients while not exposing them to music with known stimulatory effects.

Sponsors & Collaborators

  • KK Women's and Children's Hospital

    lead OTHER_GOV

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
9 Years
Max Age
21 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-12-23
Primary Completion
2019-03-25
Completion
2019-03-28

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04170842 on ClinicalTrials.gov