The Effect of Reflexology Massage and Passive Music Therapy Intervention Before Burn Dressing
interventional
36
1 country
1
Brief Summary
Reflexology massage applied before burn dressing reduces pain, anxiety and sleep problems
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Aug 2019
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 12, 2019
CompletedFirst Submitted
Initial submission to the registry
November 21, 2019
CompletedFirst Posted
Study publicly available on registry
December 16, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 7, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
March 7, 2020
CompletedApril 26, 2022
April 1, 2022
7 months
November 21, 2019
April 22, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Pain level
The effect of reflexology massage and passive music on pain before burn dressing. The scale used is a scale in which the individual can score himself / herself. "0" means no pain, "10" means pain as bad as can be. In the study, patients' pain will be evaluated for 4 days before and after dressing.
4 days
Anxiety level
The effect of reflexology massage and passive music on anxiety before burn dressing. Anxiety of patients will be measured with Visual analog scale, State-Trait Anxiety Inventory.The Anxiety Inventory consists of two different sections and contains a total of 40 items, 20 each. Each item is scored between 1 and 4. A high score indicates that anxiety level is high. In the study, patients' anxiety will be evaluated for 4 days before and after dressing
4 days
Sleep quality
The effect of reflexology massage and passive music on sleep qualty before burn dressing. Sleep quality of patients will be measured by Richard-Campbell Sleep Questionnaire.Each item of the scale is evaluated between 0-100. 0-25 points indicate "very bad sleep" and 76-100 points indicate "very good sleep". The higher the scale score, the higher the sleep quality of the patient. In the study, patients' sleep will be evaluated for 4 days before and after dressing
4 days
Study Arms (3)
Reflexology massage
EXPERIMENTALReflexology massage
Reflexology massage and passive music
EXPERIMENTALReflexology massage and passive music
Control
NO INTERVENTIONControl
Interventions
Before the burn dressing, a reflexology massage will be performed for 20 minutes on the right foot and 20 minutes on the left foot. This intervention will continue in the morning for 3 days.
Before the burn dressing, a reflexology massage and passive music will be performed for 20 minutes on the right foot and 20 minutes on the left foot. Instrumental music will be played during the massage. This intervention will continue in the morning for 3 days.
Eligibility Criteria
You may qualify if:
- Over 18 years,
- illiterate,
- without any mental and psychological disease and able to communicate with the assessor
- no hearing problems,
- moderate or severe burns,
- days or more after burn injury,
- proliferation phase of wound healing,
- No open wound, infection or circulatory problems in the area where reflexology will be applied.
- Not having diabetes,
- not using any pre-dressing complementary medicine,
- non-pregnant,
- having no pacemaker,
- agreeing to participate in the study.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Ayse Kabuk
Istanbul, 34668, Turkey (Türkiye)
Related Publications (3)
Molavi Vardanjani M, Masoudi Alavi N, Razavi NS, Aghajani M, Azizi-Fini E, Vaghefi SM. A randomized-controlled trial examining the effects of reflexology on anxiety of patients undergoing coronary angiography. Nurs Midwifery Stud. 2013 Sep;2(3):3-9. doi: 10.5812/nms.12167. Epub 2013 Sep 15.
PMID: 25414869BACKGROUNDRohilla L, Agnihotri M, Trehan SK, Sharma RK, Ghai S. Effect of Music Therapy on Pain Perception, Anxiety, and Opioid Use During Dressing Change Among Patients With Burns in India: A Quasi-experimental, Cross-over Pilot Study. Ostomy Wound Manage. 2018 Oct;64(10):40-46.
PMID: 30312157BACKGROUNDRafii F, Mohammadi-Fakhar F, Jamshidi Orak R. Effectiveness of jaw relaxation for burn dressing pain: randomized clinical trial. Pain Manag Nurs. 2014 Dec;15(4):845-53. doi: 10.1016/j.pmn.2013.11.001. Epub 2014 Apr 24.
PMID: 24767806BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Research Assistant
Study Record Dates
First Submitted
November 21, 2019
First Posted
December 16, 2019
Study Start
August 12, 2019
Primary Completion
March 7, 2020
Study Completion
March 7, 2020
Last Updated
April 26, 2022
Record last verified: 2022-04
Data Sharing
- IPD Sharing
- Will not share
The work is still underway and is being monitored by a committee. It is also a doctoral thesis. Necessary comments will be received and then shared.