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NCT04170842
Music During Paediatric Outpatient Wound Dressing Changes: Impact on Anxiety, Pain and Patient Satisfaction
NA trial testing Music intervention in Wound Heal in 48 participants. Completed in 28 March 2019.
25 March 2019
Quick facts
| Lead sponsor | KK Women's and Children's Hospital |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | crossover |
| Masking | none |
| Primary purpose | supportive care |
| Enrollment | 48 |
| Start date | 23 December 2016 |
| Primary completion | 25 March 2019 |
| Estimated completion | 28 March 2019 |
Drugs / interventions tested
- Music intervention — full drug profile →
Conditions studied
- Wound Heal — all drugs for Wound Heal →
Sponsor
KK Women's and Children's Hospital
Who can join
Adults 9 to 21, any sex, with Wound Heal. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
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Other recruiting trials for Wound Heal
Currently open trials in the same condition.
- NCT07261501 — An Exploratory Research on the Efficacy and Safety of Antibacterial Absorbable Dressing in Chronic Non-healing Wounds · NA · recruiting
- NCT07209358 — EDX110 Randomized Control Trial for Treatment of DFUs · NA · recruiting
- NCT06522438 — Hyaluronic Acid and Octenidine Gel as an Adjunct to Non-surgical Periodontal Treatment · NA · recruiting
- NCT06841237 — Randomized Controlled Trial on the Efficacy and Safety of Xiang Lei Ointment in Diabetic-related Ulcer Management · NA · recruiting
- NCT06563323 — Guselkumab in the Treatment of Adults With Pyoderma Gangrenosum (PG) · Phase 2 · recruiting
Other KK Women's and Children's Hospital trials
Trials by the same sponsor.
- NCT07534670 — Early Pregnancy Lifestyle and Glucose Patterns: A Substudy of TOFFFY · NA · not yet recruiting
- NCT07466797 — The eHealth Integrated Maternal Physical Activity Programme in Prenatal Care Trial (E-IMPACT) · NA · recruiting
- NCT06457750 — Anthropometric Outcomes of a Mobile Health Intervention for Eating Behaviour and Lifestyle in Infancy · NA · not yet recruiting
- NCT06481644 — Asia Pediatric Intensive Care Epidemiology and Outcomes Study · recruiting
- NCT06489834 — Group Drumming for Improving the Health of Community-Dwelling Elderly · NA · active not recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04170842 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by KK Women's and Children's Hospital
- Last refreshed: 20 November 2019
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