Clinical trial NCT04412122: The Effect of Kinesio Taping and Breathing Exercises on Pain Management
Official title: The Effect of Kinesio Taping and Breathing Exercises on Pain Management Applied After Benign Gynecological Abdominal Operation: A Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Postoperative Pain
Gas Bloat Syndrome
Defecation Disorders
Keywords: Benign gynecological changes
Postoperative pain
Kinesio taping
Breathing exercise
Nursing
Lead sponsor: Çankırı Karatekin University
Sponsor class: OTHER
First posted: 2020-06-02
Enrollment: 132
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: After abdominal surgery, kinesio taping and breathing exercise were applied.

Intervention Protocol of the Study Kinesio Taping (KT) Group In the study, kinesio taping method was applied immediately after the surgical operation. The tape was applied on one centimeter above and one centimeter below the incision site with a 25% tension in web cutting technique. In order to facilitate gas passing and defecation, the tape was applied around the navel in the Y shape with a 25% tension. No tension was applied to the starting and ending points of the tape. Kinesio tape remained on women for 72 hours.

Breathing Exercises (BE) Group Before the surgery, researchers informed the women about the purpose and benefits of breathing exercises and showed the how to perform them. Breathing exercises were performed 3 times a day for 30 minutes on the first, second and third days. 15 minutes of exercises were done while sitting and in a comfortable position and 15 minutes while mobilizing.
Primary purpose: PREVENTION

Brief summary: A randomised clinical trial in a single centre.The aim of this study is to evaluate the effect of kinesio taping and breathing exercises on pain management applied after benign gynecological abdominal operations. A total of 132 women, divided into 4 groups of 33 subjects each, were included.Women underwent gynecological abdominal operation were assigned to the groups randomly, depending on the application of two different methods of kinesio taping and breathing exercise.In randomization, a table of numbers was created, and an equal number of women were assigned to groups with four block patterns. Using kinesio taping and breathing exercise, 33 women were included in kinesio taping group (1st Group), 33 in breathing exercise group (2nd Group), and 33 in kinesio taping + breathing exercise group (3rd Group). No intervention was applied to the women in the control group (4th Group). Pain levels of women were evaluated with Visual Analog Scale (VAS) before and after administration of the interventions.

Detailed description: Aim: The aim of this study is to evaluate the effect of kinesio taping and breathing exercises on pain management applied after benign gynecological abdominal operations.

Design-Setting: This was an experimental, randomized controlled trial. This study was conducted at the Gynecology Service of Oncology Training and Research Hospital.

Participants: A total of 132 women, divided into 4 groups of 33 subjects each, were included.

Methods: The sampling size was calculated with G\*Power Ver.3.1.9.2 computer software. A total of 132 women, 33 of whom were in kinesio taping group, 33 in breathing exercise group, 33 in kinesio taping + breathing exercise group, and 33 in the control group, who matched the sampling selection criteria, were included in the study. In randomization, a table of numbers was created, and an equal number of women were assigned to groups with four block patterns. Women underwent gynecological abdominal operation were assigned to the groups randomly, depending on the application of two different methods of kinesio taping and breathing exercise. No intervention was applied to the women in the control group.

The personal information form was filled for each individual, who agreed to participate in the study, before the procedure.

Outcome Measures Pain scores of the women in all groups before, and after the procedure were evaluated by the researcher independent from each other using Visual Analog Scale (VAS).

Eligibility criteria: Inclusion criteria

* Women, had an abdominal operation with pfannenstiel incision due to gynecological benign changes,
* At least 18 years of age,
* Without any dermatological disease,
* Without migraines or similar chronic pain,
* Without any intestinal problem,
* Without mental disability and communication difficulties were included in the study.

Exclusion criteria

* Women, had abdominal operation due to gynecological benign changes but with a median incision,
* Had active cellulite or any other dermatological problems,
* Had deep vein thrombosis, open wounds or skin irritation, and previously had intestinal problems were excluded from the study.

Primary outcomes:
measure: Visual Analog Scale (VAS)
timeFrame: 11 MONTHS
measure: Postoperative follow-up form
timeFrame: 11 MONTHS
measure: Discharge risk assessment form
timeFrame: 11 MONTHS
Secondary outcomes:
Other outcomes:
Locations:
city: Çankırı
country: Turkey
facility: Çankırı Karatekin Univesity
state: Center
Study officials:
affiliation: Çankırı Karatekin University
name: Sakine Yılmaz, Asistant Prof
role: PRINCIPAL_INVESTIGATOR
affiliation: Atılım University
name: Füsun Terzioğlu, Professor
role: STUDY_DIRECTOR
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