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

Primary Purpose

Wound Heal

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Music intervention
Sponsored by
KK Women's and Children's Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Wound Heal focused on measuring Wound dressing

Eligibility Criteria

9 Years - 21 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    Music intervention

    Control

    Arm Description

    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.

    Wound dressing procedure conducted according to clinical practice

    Outcomes

    Primary Outcome Measures

    Self-assessment of pain
    Using the numeric rating score, which is standard pain score used in the institution ranging from 0-10 where a score of 10 indicates 'worst possible pain' and 0 indicates 'no pain'.
    Anxiety score
    Spielberger State-Trait Anxiety Inventory Score for Children (STAIC) which is a validated anxiety score in children, or the Spielberger STAI Score which is a validated anxiety score in adolescents and adults. This score allows adjustment for the different scores that may be produced for a given situation in individuals who may vary in baseline anxiety levels.
    Satisfaction survey
    A modified version of the patient satisfaction survey currently used by KK Hospital to assess patient satisfaction with outpatient services

    Secondary Outcome Measures

    Heart rate
    Physiological observations before and after dressing changes
    Blood pressure readings
    Physiological observations before and after dressing changes

    Full Information

    First Posted
    November 3, 2019
    Last Updated
    November 18, 2019
    Sponsor
    KK Women's and Children's Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04170842
    Brief Title
    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

    2. Study Status

    Record Verification Date
    October 2019
    Overall Recruitment Status
    Completed
    Study Start Date
    December 23, 2016 (Actual)
    Primary Completion Date
    March 25, 2019 (Actual)
    Study Completion Date
    March 28, 2019 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    KK Women's and Children's Hospital

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Wound Heal
    Keywords
    Wound dressing

    7. Study Design

    Primary Purpose
    Supportive Care
    Study Phase
    Not Applicable
    Interventional Study Model
    Crossover Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    48 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Music intervention
    Arm Type
    Experimental
    Arm Description
    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.
    Arm Title
    Control
    Arm Type
    No Intervention
    Arm Description
    Wound dressing procedure conducted according to clinical practice
    Intervention Type
    Other
    Intervention Name(s)
    Music intervention
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    Self-assessment of pain
    Description
    Using the numeric rating score, which is standard pain score used in the institution ranging from 0-10 where a score of 10 indicates 'worst possible pain' and 0 indicates 'no pain'.
    Time Frame
    Immediately after intervention
    Title
    Anxiety score
    Description
    Spielberger State-Trait Anxiety Inventory Score for Children (STAIC) which is a validated anxiety score in children, or the Spielberger STAI Score which is a validated anxiety score in adolescents and adults. This score allows adjustment for the different scores that may be produced for a given situation in individuals who may vary in baseline anxiety levels.
    Time Frame
    Immediately after intervention
    Title
    Satisfaction survey
    Description
    A modified version of the patient satisfaction survey currently used by KK Hospital to assess patient satisfaction with outpatient services
    Time Frame
    Immediately after intervention
    Secondary Outcome Measure Information:
    Title
    Heart rate
    Description
    Physiological observations before and after dressing changes
    Time Frame
    Before and immediately after intervention
    Title
    Blood pressure readings
    Description
    Physiological observations before and after dressing changes
    Time Frame
    Before and immediately after intervention

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    9 Years
    Maximum Age & Unit of Time
    21 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Aged 9 years and above, male or female Anticipated to require at least 2 further wound dressing changes or outpatient painful procedures (e.g. cryotherapy for skin lesions) Already had at least one outpatient dressing change or painful outpatient procedure prior to recruitment Able to communicate clearly, navigate simple technical software, be awake and alert Not hearing impaired Willing to use headphones Able to read and communicate in English Exclusion Criteria: Hearing impaired Abnormal anatomy of external ear (unable to use headphones) Wound site prevents use of headphones - for example, on the ear

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    18301816
    Citation
    Stinson J, Yamada J, Dickson A, Lamba J, Stevens B. Review of systematic reviews on acute procedural pain in children in the hospital setting. Pain Res Manag. 2008 Jan-Feb;13(1):51-7. doi: 10.1155/2008/465891.
    Results Reference
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    PubMed Identifier
    26452308
    Citation
    Hyland EJ, D'Cruz R, Harvey JG, Moir J, Parkinson C, Holland AJA. An assessment of early Child Life Therapy pain and anxiety management: A prospective randomised controlled trial. Burns. 2015 Dec;41(8):1642-1652. doi: 10.1016/j.burns.2015.05.017. Epub 2015 Oct 6.
    Results Reference
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    PubMed Identifier
    26526331
    Citation
    Wilson-Smith EM. Procedural Pain Management in Neonates, Infants and Children. Rev Pain. 2011 Sep;5(3):4-12. doi: 10.1177/204946371100500303.
    Results Reference
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    PubMed Identifier
    18036465
    Citation
    Stouffer JW, Shirk BJ, Polomano RC. Practice guidelines for music interventions with hospitalized pediatric patients. J Pediatr Nurs. 2007 Dec;22(6):448-56. doi: 10.1016/j.pedn.2007.04.011.
    Results Reference
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    PubMed Identifier
    21897507
    Citation
    George S, Ahmed S, Mammen KJ, John GM. Influence of music on operation theatre staff. J Anaesthesiol Clin Pharmacol. 2011 Jul;27(3):354-7. doi: 10.4103/0970-9185.83681.
    Results Reference
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    PubMed Identifier
    23052506
    Citation
    Moris DN, Linos D. Music meets surgery: two sides to the art of "healing". Surg Endosc. 2013 Mar;27(3):719-23. doi: 10.1007/s00464-012-2525-8. Epub 2012 Oct 6.
    Results Reference
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    PubMed Identifier
    20498613
    Citation
    Tan X, Yowler CJ, Super DM, Fratianne RB. The efficacy of music therapy protocols for decreasing pain, anxiety, and muscle tension levels during burn dressing changes: a prospective randomized crossover trial. J Burn Care Res. 2010 Jul-Aug;31(4):590-7. doi: 10.1097/BCR.0b013e3181e4d71b.
    Results Reference
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    PubMed Identifier
    20360454
    Citation
    Protacio J. Patient-directed music therapy as an adjunct during burn wound care. Crit Care Nurse. 2010 Apr;30(2):74-6. doi: 10.4037/ccn2010250. No abstract available.
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    PubMed Identifier
    26247769
    Citation
    van der Heijden MJ, Oliai Araghi S, van Dijk M, Jeekel J, Hunink MG. The Effects of Perioperative Music Interventions in Pediatric Surgery: A Systematic Review and Meta-Analysis of Randomized Controlled Trials. PLoS One. 2015 Aug 6;10(8):e0133608. doi: 10.1371/journal.pone.0133608. eCollection 2015.
    Results Reference
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    16030507
    Citation
    DeLoach Walworth D. Procedural-support music therapy in the healthcare setting: a cost-effectiveness analysis. J Pediatr Nurs. 2005 Aug;20(4):276-84. doi: 10.1016/j.pedn.2005.02.016.
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    Music During Paediatric Outpatient Wound Dressing Changes: Impact on Anxiety, Pain and Patient Satisfaction

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