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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04412122
Other study ID # Ethic No: 2016/12/131
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date June 1, 2017
Est. completion date June 1, 2018

Study information

Verified date May 2020
Source Çankiri Karatekin University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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).


Recruitment information / eligibility

Status Completed
Enrollment 132
Est. completion date June 1, 2018
Est. primary completion date May 1, 2018
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years and older
Eligibility 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 Design


Intervention

Other:
Kinesio Taping
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.
Breathing Exercise
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.
Kinesio Taping+Breathing Exercise
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.
Control Group
No intervention was performed to reduce pain in the control group.

Locations

Country Name City State
Turkey Çankiri Karatekin Univesity Çankiri Center

Sponsors (1)

Lead Sponsor Collaborator
Çankiri Karatekin University

Country where clinical trial is conducted

Turkey, 

References & Publications (13)

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.

Gürsen 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. — View Citation

Hadi N, Hanid AA. Lavender essence for post-cesarean pain. Pak J Biol Sci. 2011 Jun 1;14(11):664-7. — View Citation

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. — View 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. — View Citation

Kamali F, Sinaei E, Taherkhani E. Comparing spinal manipulation with and without Kinesio Taping(®) 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. — View Citation

Kelle B, Güzel 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. Epub 2015 Aug 27. — View Citation

Rakel B, Herr K. Assessment and treatment of postoperative pain in older adults. J Perianesth Nurs. 2004 Jun;19(3):194-208. Review. — View 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. — View Citation

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. Review. — View Citation

Szczegielniak, J., Krajczy, M., Bogacz, K., Luniewski, J., & Sliwinski, Z. (2007). Kinesiotaping in physiotherapy after abdominal surgery. Medsportpress, 3(4), 299-307.

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. — View Citation

* Note: There are 13 references in allClick here to view all references

Outcome

Type Measure Description Time frame Safety issue
Primary 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 & Aydinli, 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). 11 MONTHS
Primary 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 (Gürsen, Inanoglu, Kaya, Akbayrak & Baltaci, 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). 11 MONTHS
Primary 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 (Gürsen, Inanoglu, Kaya, Akbayrak & Baltaci, 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. 11 MONTHS
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