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

April 22, 2022 updated by: Ayse Kabuk, RN, PhD, Saglik Bilimleri Universitesi

The Effect of Reflexology Massage and Passive Music Therapy Intervention Before Burn Dressing on Pain, Anxiety Level and Sleep Quality

Reflexology massage applied before burn dressing reduces pain, anxiety and sleep problems

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

36

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Istanbul, Turkey, 34668
        • Ayse Kabuk

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control
Experimental: Reflexology massage
Other: Reflexology massage
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.
Experimental: Reflexology massage and passive music
Other: Reflexology massage and passive music
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain level
Time Frame: 4 days
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
Time Frame: 4 days
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
Time Frame: 4 days
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Saglik Bilimleri Universitesi

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 12, 2019

Primary Completion (Actual)

March 7, 2020

Study Completion (Actual)

March 7, 2020

Study Registration Dates

First Submitted

November 21, 2019

First Submitted That Met QC Criteria

December 12, 2019

First Posted (Actual)

December 16, 2019

Study Record Updates

Last Update Posted (Actual)

April 26, 2022

Last Update Submitted That Met QC Criteria

April 22, 2022

Last Verified

April 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

IPD 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.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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