Clinical trial NCT04170842: Music During Paediatric Outpatient Wound Dressing Changes: Impact on Anxiety, Pain and Patient Satisfaction
Official title: Music During Paediatric Outpatient Wound Dressing Changes: Impact on Anxiety, Pain and Patient Satisfaction
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Wound Heal
Keywords: Wound dressing
Lead sponsor: KK Women's and Children's Hospital
Sponsor class: OTHER_GOV
First posted: 2019-11-20
Enrollment: 48
Sex: ALL
Minimum age (years): 9
Maximum age (years): 21
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: SUPPORTIVE_CARE

Brief 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.

Detailed description: Music intervention - The music intervention used in the study will be a patient selected list of songs or other music delivered to the participant by passive listening via in-ear or on-ear headphones. They will be given the choice of using their own personal headphones or use a pair provided by the hospital. If choosing to use a hospital device, the earphones provided will be disposable to minimise infection risk from re-use.

Patient preferred music has shown to be more effective than preselected, or prescriptive music. Prescriptive music, if not of the patient's preference, could cause further discomfort, distress or anxiety. Therefore, investigators will use streaming services to provide a bank of music containing a wide range of music and genres to suit the majority of music preferences. Music will also be curated based on feedback from age-appropriate sources to identify common and popular music in the target participant age group.

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.

Patients will be given the opportunity to look to music therapists for support in choosing or creating a playlist to accompany their procedure.Through a brief questionnaire the music therapists will gather pertinent information such as favourite styles, experience playing instruments, favourite artists/songs as well as the challenges related to their first experience. The music therapist will help to identify possible song choices/playlists for various parts of the procedure that may decrease their perception of pain by refocusing their attention.

Randomisation - This will be a randomised crossover study. Patients will be randomised into 2 groups:

Group 1: One dressing change or procedure after recruitment will be accompanied by music intervention. Subsequent dressing change or procedure will NOT be accompanied by music intervention.

Group 2: One dressing change or procedure after recruitment will NOT be accompanied by music intervention. Subsequent dressing change or procedure will be accompanied by music intervention.

With this crossover design, all recruited participants will have the opportunity to experience the music intervention.

Eligibility criteria: Inclusion Criteria:

1. Aged 9 years and above, male or female
2. Anticipated to require at least 2 further wound dressing changes or outpatient painful procedures (e.g. cryotherapy for skin lesions)
3. Already had at least one outpatient dressing change or painful outpatient procedure prior to recruitment
4. Able to communicate clearly, navigate simple technical software, be awake and alert
5. Not hearing impaired
6. Willing to use headphones
7. Able to read and communicate in English

Exclusion Criteria:

1. Hearing impaired
2. Abnormal anatomy of external ear (unable to use headphones)
3. Wound site prevents use of headphones - for example, on the ear

Primary outcomes:
measure: Self-assessment of pain
timeFrame: Immediately after intervention
measure: Anxiety score
timeFrame: Immediately after intervention
measure: Satisfaction survey
timeFrame: Immediately after intervention
Secondary outcomes:
measure: Heart rate
timeFrame: Before and immediately after intervention
measure: Blood pressure readings
timeFrame: Before and immediately after intervention
Other outcomes:
Locations:
Study officials:
References:
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