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The Effect of Kinesio Taping and Breathing Exercises on Pain Management

Primary Purpose

Postoperative Pain, Gas Bloat Syndrome, Defecation Disorders

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Kinesio Taping
Breathing Exercise
Kinesio Taping+Breathing Exercise
Control Group
Sponsored by
Çankırı Karatekin University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Postoperative Pain focused on measuring Benign gynecological changes, Postoperative pain, Kinesio taping, Breathing exercise, Nursing

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleAccepts Healthy Volunteers

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.

Sites / Locations

  • Çankırı Karatekin Univesity

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Other

Arm Label

Kinesio Taping

Breathing Exercise

Kinesio Taping and Breathing Exercise

Control Group

Arm Description

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).

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).

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

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

Outcomes

Primary Outcome Measures

Visual Analog Scale (VAS)
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).
Postoperative follow-up form
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).
Discharge risk assessment form
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 Outcome Measures

Full Information

First Posted
May 25, 2020
Last Updated
May 28, 2020
Sponsor
Çankırı Karatekin University
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1. Study Identification

Unique Protocol Identification Number
NCT04412122
Brief Title
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

2. Study Status

Record Verification Date
May 2020
Overall Recruitment Status
Completed
Study Start Date
June 1, 2017 (Actual)
Primary Completion Date
May 1, 2018 (Actual)
Study Completion Date
June 1, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Çankırı Karatekin University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Pain, Gas Bloat Syndrome, Defecation Disorders
Keywords
Benign gynecological changes, Postoperative pain, Kinesio taping, Breathing exercise, Nursing

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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.
Masking
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.
Allocation
Randomized
Enrollment
132 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Kinesio Taping
Arm Type
Experimental
Arm Description
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).
Arm Title
Breathing Exercise
Arm Type
Experimental
Arm Description
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).
Arm Title
Kinesio Taping and Breathing Exercise
Arm Type
Experimental
Arm Description
According to the application protocols, two applications were made together.
Arm Title
Control Group
Arm Type
Other
Arm Description
No intervention was performed to reduce pain in the control group.
Intervention Type
Other
Intervention Name(s)
Kinesio Taping
Intervention Description
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 (Figure 1.). In order to facilitate gas passing and defecation, the tape was applied around the navel in the Y shape with a 25% tension (Figure 2). No tension was applied to the starting and ending points of the tape. Pain level was evaluated with VAS before and after 45 minutes of tape application. Pain level was evaluated by VAS on the 1st, 2nd and 3rd postoperative day. Kinesio tape remained on women for 72 hours.
Intervention Type
Other
Intervention Name(s)
Breathing Exercise
Intervention Description
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. Pain levels of women were evaluated with VAS before and after 30 minutes of breathing exercises.
Intervention Type
Other
Intervention Name(s)
Kinesio Taping+Breathing Exercise
Intervention Description
In the study, kinesio taping method was applied immediately after the surgical operation. . Pain level was evaluated with VAS before and after 45 minutes of tape application.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. Pain levels of women were evaluated with VAS before and after 30 minutes of breathing exercises.
Intervention Type
Other
Intervention Name(s)
Control Group
Intervention Description
No intervention was performed to reduce pain in the control group.
Primary Outcome Measure Information:
Title
Visual Analog Scale (VAS)
Description
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).
Time Frame
11 MONTHS
Title
Postoperative follow-up form
Description
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).
Time Frame
11 MONTHS
Title
Discharge risk assessment form
Description
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.
Time Frame
11 MONTHS

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
All participants are women.
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sakine Yılmaz, Asistant Prof
Organizational Affiliation
Çankırı Karatekin University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Füsun Terzioğlu, Professor
Organizational Affiliation
Atılım University
Official's Role
Study Director
Facility Information:
Facility Name
Çankırı Karatekin Univesity
City
Çankırı
State/Province
Center
ZIP/Postal Code
18200
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
Citation
El-Refayea, G.E., El Nahasa, E.M., & Ghareebb, H.O. (2016). Effect of kinesio taping therapy combined with breathing exercises on childbirth duration and labor pain: a randomized controlled trial. Bulletin of Faculty of Physical Therapy, 21(1), 23-31.
Results Reference
background
PubMed Identifier
29861263
Citation
Kamali F, Sinaei E, Taherkhani E. Comparing spinal manipulation with and without Kinesio Taping(R) in the treatment of chronic low back pain. J Bodyw Mov Ther. 2018 Apr;22(2):540-545. doi: 10.1016/j.jbmt.2017.07.008. Epub 2017 Jul 26.
Results Reference
background
Citation
Szczegielniak, J., Krajczy, M., Bogacz, K., Luniewski, J., & Sliwinski, Z. (2007). Kinesiotaping in physiotherapy after abdominal surgery. Medsportpress, 3(4), 299-307.
Results Reference
background
PubMed Identifier
26492435
Citation
Kafa N, Citaker S, Omeroglu S, Peker T, Coskun N, Diker S. Effects of kinesiologic taping on epidermal-dermal distance, pain, edema and inflammation after experimentally induced soft tissue trauma. Physiother Theory Pract. 2015;31(8):556-61. doi: 10.3109/09593985.2015.1062943.
Results Reference
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PubMed Identifier
24093737
Citation
Rejeh N, Heravi-Karimooi M, Vaismoradi M, Jasper M. Effect of systematic relaxation techniques on anxiety and pain in older patients undergoing abdominal surgery. Int J Nurs Pract. 2013 Oct;19(5):462-70. doi: 10.1111/ijn.12088. Epub 2013 May 28.
Results Reference
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PubMed Identifier
15195278
Citation
Rakel B, Herr K. Assessment and treatment of postoperative pain in older adults. J Perianesth Nurs. 2004 Jun;19(3):194-208. doi: 10.1016/j.jopan.2004.03.005.
Results Reference
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PubMed Identifier
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Citation
Kelle B, Guzel R, Sakalli H. The effect of Kinesio taping application for acute non-specific low back pain: a randomized controlled clinical trial. Clin Rehabil. 2016 Oct;30(10):997-1003. doi: 10.1177/0269215515603218. Epub 2015 Aug 27.
Results Reference
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PubMed Identifier
26329802
Citation
Gursen C, Inanoglu D, Kaya S, Akbayrak T, Baltaci G. Effects of exercise and Kinesio taping on abdominal recovery in women with cesarean section: a pilot randomized controlled trial. Arch Gynecol Obstet. 2016 Mar;293(3):557-65. doi: 10.1007/s00404-015-3862-3. Epub 2015 Sep 2.
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Hadi N, Hanid AA. Lavender essence for post-cesarean pain. Pak J Biol Sci. 2011 Jun 1;14(11):664-7. doi: 10.3923/pjbs.2011.664.667.
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Sahai Sharma, A., Yadav, D., & Bindal, J. (2015). A study to compare healing in postoperative wounds with occlusive gauze dressing and after omitting the dressing. Journal of Medical Science and Clinical Research, 3(5), 5734-5741.
Results Reference
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Stanirowski PJ, Wnuk A, Cendrowski K, Sawicki W. Growth factors, silver dressings and negative pressure wound therapy in the management of hard-to-heal postoperative wounds in obstetrics and gynecology: a review. Arch Gynecol Obstet. 2015 Oct;292(4):757-75. doi: 10.1007/s00404-015-3709-y. Epub 2015 Apr 12.
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The Effect of Kinesio Taping and Breathing Exercises on Pain Management

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