Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR201505000906290 Date of Registration: 08/10/2014
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Music therapy for anxiety and pain after change of dressings in pediatric burn patients
Official scientific title The effects of music therapy on anxiety and pain in pediatric burn patients after change of dressing: a randomized controlled trial
Brief summary describing the background and objectives of the trial Debridement and change of dressing procedures are painful and stressful. Many pediatric burn patients suffer from high levels of anxiety and pain before, during and after the procedures. Apart from analgesics and sedatives, complementary therapies such as music therapy might give support. Studies that evaluate the effect of music to reduce anxiety and pain in children show promising results, but the effects of music on children with burns have not been studied extensively. The aim of this study is to determine the effects of music therapy on anxiety and pain in pediatric burn patients after change of dressing. This study is a randomised assessor-blind controlled trial (music intervention and control group) in 140 patients in the burn unit of the Red Cross War Memorial Children's Hospital. Anxiety is measured by the Observational Score of Behavioural Distress-revised, and the Wong-Baker FACES for children older than 4 years. Pain is measured by the COMFORT Behaviour Scale-B, and the Faces Pain Scale-revised. A music intervention may be beneficial in reducing anxiety and pain in the patient. If this study finds this to be true, this non-invasive intervention can be implemented in burn units.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Burns, anxiety, pain,Injury, Occupational Diseases, Poisoning,Paediatrics
Sub-Disease(s) or condition(s) being studied
Purpose of the trial music intervention
Anticipated trial start date 20/10/2014
Actual trial start date
Anticipated date of last follow up 19/10/2015
Actual Last follow-up date
Anticipated target sample size (number of participants) 140
Actual target sample size (number of participants)
Recruitment status Not yet recruiting
Publication URL
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Factorial: participants randomly allocated to either no, one, some or all interventions simultaneously Randomised simple randomisation using a computer software programme Sealed opaque envelopes Masking/blinding used Outcome Assessors
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Music therapy For 5 minutes after change of dressing procedure One time When the child comes out of change of dressings, the music therapist will engage the child in music therapy, he will sing accompanied by the guitar. 70 Active-Treatment of Control Group
Control Group Control For 5 minutes after change of dressing One time When the child comes out of change of dressings, they will be observed for 5 minutes 70 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
All newly admitted patients to the burns unit undergoing change of dressings Patients from all age groups who are admitted to the pediatric burn unit Children with a hearing impairment Children with an altered level of consciousness Children may be excluded at the discretion of the attending staff if they feel the study interferes with a treatment or if it would be too delicate to ask for consent Those not giving consent 1 Day(s) 13 Year(s) Both
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 29/08/2014 University of Cape Town Human Research Ethics Committee
Ethics Committee Address
Street address City Postal code Country
Old Main Building, Groote Schuur Hospital Observatory 7700 Cape Town South Africa
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 07/10/2014 Institutional Ethics Committee Red Cross Children's Hospital
Ethics Committee Address
Street address City Postal code Country
Klipfontein Road Rondebosch 7700 Cape Town South Africa
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Anxiety 1. Before change of dressings (2 minutes) 2. After change of dressings: during intervention (5 minutes) 3. After change of dressings: after intervention (2 minutes)
Secondary Outcome Pain 1. Before change of dressings (2 minutes) 2. After change of dressings: during intervention (5 minutes) 3. After change of dressings: after intervention (2 minutes)
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Red Cross War Memorial Children's Hospital Klipfontein Road Rondebosch 7700 Cape Town South Africa
FUNDING SOURCES
Name of source Street address City Postal code Country
Erasmus Medical Center - Sophia Children's Hospital 's Gravendijkwal 230 Rotterdam 3015 CE Netherlands
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Erasmus Medical Center - Sophia Children's Hospital 's Gravendijkwal 230 Rotterdam 3015 CE Netherlands Hospital
COLLABORATORS
Name Street address City Postal code Country
Red Cross War Memorial Children's Hospital Klipfontein Road Rondebosch 7700 Cape Town South Africa
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Sharon Cox Sharon.cox@uct.ac.za 0216585342 Klipfontein Road
City Postal code Country Position/Affiliation
Rondebosch 7700 Cape Town South Africa Pediatric Surgery
Role Name Email Phone Street address
Public Enquiries Marianne van der Heijden m.j.e.vanderheijden@erasmusmc.nl +27828657308 Klipfontein Road
City Postal code Country Position/Affiliation
Rondebosch 7700 Cape Town South Africa Pediatric surgery
Role Name Email Phone Street address
Scientific Enquiries Monique van Dijk m.vandijk.3@erasmusmc.nl +3110 7037091 's Gravendijkwal 230
City Postal code Country Position/Affiliation
Rotterdam 3015 CE Netherlands Pediatric Surgery
REPORTING
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