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The Effect of Reflexology Massage and Passive Music Therapy Intervention Before Burn Dressing

Primary Purpose

Burn Degree Second, Burn Degree Third

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Reflexology massage
Reflexology massage and passive music
Sponsored by
Saglik Bilimleri Universitesi
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Burn Degree Second focused on measuring burn, reflexology, music, pain, anxiety, sleep

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Over 18 years,
  • illiterate,
  • without any mental and psychological disease and able to communicate with the assessor
  • no hearing problems,
  • moderate or severe burns,
  • 2 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.

Exclusion Criteria:

  • Patients who do not meet the inclusion criteria.

Sites / Locations

  • Ayse Kabuk

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

No Intervention

Arm Label

Reflexology massage

Reflexology massage and passive music

Control

Arm Description

Reflexology massage

Reflexology massage and passive music

Control

Outcomes

Primary Outcome Measures

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.
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
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

Secondary Outcome Measures

Full Information

First Posted
November 21, 2019
Last Updated
April 22, 2022
Sponsor
Saglik Bilimleri Universitesi
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1. Study Identification

Unique Protocol Identification Number
NCT04200053
Brief Title
The Effect of Reflexology Massage and Passive Music Therapy Intervention Before Burn Dressing
Official Title
The Effect of Reflexology Massage and Passive Music Therapy Intervention Before Burn Dressing on Pain, Anxiety Level and Sleep Quality
Study Type
Interventional

2. Study Status

Record Verification Date
April 2022
Overall Recruitment Status
Completed
Study Start Date
August 12, 2019 (Actual)
Primary Completion Date
March 7, 2020 (Actual)
Study Completion Date
March 7, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Saglik Bilimleri Universitesi

4. Oversight

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

5. Study Description

Brief Summary
Reflexology massage applied before burn dressing reduces pain, anxiety and sleep problems
Detailed Description
Reflexology massage regulates blood circulation and energy, gives a feeling of relaxation and provides homeostasis. During reflexology massage, relaxation music is recommended because it contributes to the relaxation of the individual. In the literature, reflexology massage and music therapy are used in different pain management, and these methods reduce anxiety and improve sleep quality. However, there is no study in which reflexology massage and passive music therapy are used to reduce pain, anxiety and sleep problems associated with dressing of burn individuals. It is thought that reflexology massage and passive music therapy will reduce pain, anxiety and sleep problems in dressing changes of burned individuals.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Burn Degree Second, Burn Degree Third
Keywords
burn, reflexology, music, pain, anxiety, sleep

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Grup 1: Reflexology massage group Grup 2: Reflexology massage and pasiive music group Grup 3: Control group
Masking
None (Open Label)
Allocation
Randomized
Enrollment
36 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Reflexology massage
Arm Type
Experimental
Arm Description
Reflexology massage
Arm Title
Reflexology massage and passive music
Arm Type
Experimental
Arm Description
Reflexology massage and passive music
Arm Title
Control
Arm Type
No Intervention
Arm Description
Control
Intervention Type
Other
Intervention Name(s)
Reflexology massage
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Reflexology massage and passive music
Intervention Description
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.
Primary Outcome Measure Information:
Title
Pain level
Description
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.
Time Frame
4 days
Title
Anxiety level
Description
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
Time Frame
4 days
Title
Sleep quality
Description
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
Time Frame
4 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Over 18 years, illiterate, without any mental and psychological disease and able to communicate with the assessor no hearing problems, moderate or severe burns, 2 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. Exclusion Criteria: Patients who do not meet the inclusion criteria.
Facility Information:
Facility Name
Ayse Kabuk
City
Istanbul
ZIP/Postal Code
34668
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
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.
Citations:
PubMed Identifier
25414869
Citation
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.
Results Reference
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PubMed Identifier
30312157
Citation
Rohilla 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.
Results Reference
background
PubMed Identifier
24767806
Citation
Rafii 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.
Results Reference
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The Effect of Reflexology Massage and Passive Music Therapy Intervention Before Burn Dressing

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