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

NCT ID: NCT04200053

Last Updated: 2022-04-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-08-12

Study Completion Date

2020-03-07

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Burn Degree Second Burn Degree Third

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Grup 1: Reflexology massage group Grup 2: Reflexology massage and pasiive music group Grup 3: Control group
Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Reflexology massage

Reflexology massage

Group Type EXPERIMENTAL

Reflexology massage

Intervention Type OTHER

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.

Reflexology massage and passive music

Reflexology massage and passive music

Group Type EXPERIMENTAL

Reflexology massage and passive music

Intervention Type OTHER

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.

Control

Control

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type 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.

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Saglik Bilimleri Universitesi

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Ayse Kabuk, RN, PhD

Research Assistant

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Ayse Kabuk

Istanbul, , Turkey (Türkiye)

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Turkey (Türkiye)

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type BACKGROUND
PMID: 25414869 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 30312157 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 24767806 (View on PubMed)

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.