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Clinical Trials/NCT04412122
NCT04412122CompletedNot Applicable

The Effect of Kinesio Taping and Breathing Exercises on Pain Management Applied After Benign Gynecological Abdominal Operation: A Randomized Controlled Study

Çankırı Karatekin University1 site in 1 country132 target enrollmentStarted: June 1, 2017Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
132
Locations
1
Primary Endpoint
Postoperative follow-up form

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Prevention
Masking
Single (Investigator)

Masking Description

The data of the research were collected with personal information, postoperative follow-up and discharge risk assessment forms and Visual Analog Scale by the researcher. Pain levels of women were evaluated with Visual Analog Scale (VAS) before and after administration of the analgesic or interventions by the researcher. Data were collected on the postoperative days 0, 1, 2 and 3 during the hospital stay.

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
Female
Accepts Healthy Volunteers
Yes

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.

Arms & Interventions

Kinesio Taping

Experimental

Kinesio taping is thought to remove the barriers that slow the healing process, activate neurological suppression and reduce pain (El-Refayea, El Nahasa & Ghareebb, 2016; Kamali, Sinaei & Taherkhan, 2018). Kinesio tape stimulates cutaneous mechanoreceptors. Mechanoreceptors decrease sympathetic nervous system activity and increase parasympathetic activity, which can improve intestinal control (Azam, 2017; Szczegielniak, Krajczy, Bogacz, Luniewski & Sliwinski, 2007). Kinesio taping changes skin contours and accelerates blood flow. Increased blood flow brings more oxygen and nutrients to the area. This phenomenon contributes to the natural healing process (Kafa et al., 2015).

Intervention: Kinesio Taping (Other)

Breathing Exercise

Experimental

Breathing exercise is accepted as a key to relaxation or cooling down (El-Refayea et al., 2016). It is stated that breathing exercises reduce anxiety by preventing the transmission of pain messages to the spinal cord (Rejeh et al., 2013), reducing the catecholamine response (Rakel & Herr, 2004) and muscle tension by distracting subjects (Kelle, Güzel & Sakallı, 2016).

Intervention: Breathing Exercise (Other)

Kinesio Taping and Breathing Exercise

Experimental

According to the application protocols, two applications were made together.

Intervention: Kinesio Taping+Breathing Exercise (Other)

Control Group

Other

No intervention was performed to reduce pain in the control group.

Intervention: Control Group (Other)

Outcomes

Primary Outcomes

Postoperative follow-up form

Time Frame: 11 MONTHS

Postoperative follow-up form in the study were developed by the researcher in line with the literature, and expert opinion was obtained (Gürşen, İnanoğlu, Kaya, Akbayrak \& Baltacı, 2016; Hadi \& Akbar Haind, 2011; Sahai Sharma, Yadav \& Bindal, 2015; Stanirowski, Wunk, Cendrowski \& Sawick, 2015). The postoperative follow-up form contains questions regarding the planned interventions following surgery (pain scores before and after kinesio taping and/or breathing exercises) and the postoperative recovery process (oral intake, mobilization, gas-passing, defecation time).

Visual Analog Scale (VAS)

Time Frame: 11 MONTHS

VAS, developed by Freyd, is a scale consisting of 100-millimeter lines and used in the assessment of pain (Yaray, Akesen, Ocakolu \& Aydınlı, 2011). For pain assessment using VAS, "no pain" on one end, "worst possible pain" is written on the other end of the scale and the individual shows or marks their current situation on the 100-millimeter line (Jensen, Chen, Brugger, 2003).

Discharge risk assessment form

Time Frame: 11 MONTHS

Discharge risk assessment form in the study were developed by the researcher in line with the literature, and expert opinion was obtained (Gürşen, İnanoğlu, Kaya, Akbayrak \& Baltacı, 2016; Hadi \& Akbar Haind, 2011; Sahai Sharma, Yadav \& Bindal, 2015; Stanirowski, Wunk, Cendrowski \& Sawick, 2015). Discharge risk assessment form includes questions regarding the improvement of the incision site (infection, wound color, tenderness, bleeding, ecchymosis, edema) and the individual's self-perception of healing on the day of discharge.

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Sakine Yılmaz

Assistant Professor Dr, PhD

Çankırı Karatekin University

Study Sites (1)

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