- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04412122
The Effect of Kinesio Taping and Breathing Exercises on Pain Management
The Effect of Kinesio Taping and Breathing Exercises on Pain Management Applied After Benign Gynecological Abdominal Operation: A Randomized Controlled Study
Study Overview
Status
Intervention / Treatment
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).
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Center
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Çankırı, Center, Turkey, 18200
- Çankırı Karatekin Univesity
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: PREVENTION
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: SINGLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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EXPERIMENTAL: Kinesio Taping
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).
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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.
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EXPERIMENTAL: Breathing Exercise
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).
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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.
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EXPERIMENTAL: Kinesio Taping and Breathing Exercise
According to the application protocols, two applications were made together.
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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.
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OTHER: Control Group
No intervention was performed to reduce pain in the control group.
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No intervention was performed to reduce pain in the control group.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Visual Analog Scale (VAS)
Time Frame: 11 MONTHS
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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).
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11 MONTHS
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Postoperative follow-up form
Time Frame: 11 MONTHS
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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).
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11 MONTHS
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Discharge risk assessment form
Time Frame: 11 MONTHS
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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.
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11 MONTHS
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Sakine Yılmaz, Asistant Prof, Çankırı Karatekin University
- Study Director: Füsun Terzioğlu, Professor, Atılım University
Publications and helpful links
General Publications
- Jensen MP, Chen C, Brugger AM. Interpretation of visual analog scale ratings and change scores: a reanalysis of two clinical trials of postoperative pain. J Pain. 2003 Sep;4(7):407-14. doi: 10.1016/s1526-5900(03)00716-8.
- 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.
- 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.
- Szczegielniak, J., Krajczy, M., Bogacz, K., Luniewski, J., & Sliwinski, Z. (2007). Kinesiotaping in physiotherapy after abdominal surgery. Medsportpress, 3(4), 299-307.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- Yaray O, Akesen B, Ocaklioglu G, Aydinli U. Validation of the Turkish version of the visual analog scale spine score in patients with spinal fractures. Acta Orthop Traumatol Turc. 2011;45(5):353-8. doi: 10.3944/AOTT.2011.2528.
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Ethic No: 2016/12/131
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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