Clinical trial NCT04200053: 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
Overall status: COMPLETED
Phase: NA
Conditions: Burn Degree Second
Burn Degree Third
Keywords: burn
reflexology
music
pain
anxiety
sleep
Lead sponsor: Saglik Bilimleri Universitesi
Sponsor class: OTHER
First posted: 2019-12-16
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Grup 1: Reflexology massage group Grup 2: Reflexology massage and pasiive music group Grup 3: Control group
Primary purpose: SUPPORTIVE_CARE

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.

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.

Primary outcomes:
measure: Pain level
timeFrame: 4 days
measure: Anxiety level
timeFrame: 4 days
measure: Sleep quality
timeFrame: 4 days
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Ayse Kabuk
Study officials:
References:
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.
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.
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.