NCT04412122

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
132

participants targeted

Target at P75+ for not_applicable postoperative-pain

Timeline
Completed

Started Jun 2017

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2017

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2018

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2018

Completed
2 years until next milestone

First Submitted

Initial submission to the registry

May 25, 2020

Completed
8 days until next milestone

First Posted

Study publicly available on registry

June 2, 2020

Completed
Last Updated

June 2, 2020

Status Verified

May 1, 2020

Enrollment Period

11 months

First QC Date

May 25, 2020

Last Update Submit

May 28, 2020

Conditions

Keywords

Benign gynecological changesPostoperative painKinesio tapingBreathing exerciseNursing

Outcome Measures

Primary Outcomes (3)

  • 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).

    11 MONTHS

  • 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).

    11 MONTHS

  • 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.

    11 MONTHS

Study Arms (4)

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).

Other: Kinesio Taping

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).

Other: Breathing Exercise

Kinesio Taping and Breathing Exercise

EXPERIMENTAL

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

Other: Kinesio Taping+Breathing Exercise

Control Group

OTHER

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

Other: Control Group

Interventions

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.

Kinesio Taping

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.

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.

Kinesio Taping and Breathing Exercise

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

Control Group

Eligibility Criteria

Age18 Years+
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsAll participants are women.
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Çankırı Karatekin Univesity

Çankırı, Center, 18200, Turkey (Türkiye)

Location

Related 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.

    BACKGROUND
  • 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.

    PMID: 29861263BACKGROUND
  • Szczegielniak, J., Krajczy, M., Bogacz, K., Luniewski, J., & Sliwinski, Z. (2007). Kinesiotaping in physiotherapy after abdominal surgery. Medsportpress, 3(4), 299-307.

    BACKGROUND
  • 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.

    PMID: 26492435BACKGROUND
  • 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.

    PMID: 24093737BACKGROUND
  • 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.

    PMID: 15195278BACKGROUND
  • 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.

    PMID: 26316553BACKGROUND
  • 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.

    PMID: 26329802BACKGROUND
  • 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.

    PMID: 22235509BACKGROUND
  • 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.

    BACKGROUND
  • 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.

    PMID: 25864095BACKGROUND
  • 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.

    PMID: 22033000BACKGROUND
  • 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.

    PMID: 14622683BACKGROUND

MeSH Terms

Conditions

Pain, PostoperativeGas bloat syndrome

Interventions

Breathing ExercisesControl Groups

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Intervention Hierarchy (Ancestors)

Mind-Body TherapiesComplementary TherapiesTherapeuticsExercise Movement TechniquesPhysical Therapy ModalitiesEpidemiologic Research DesignEpidemiologic MethodsInvestigative TechniquesResearch DesignMethods

Study Officials

  • Sakine Yılmaz, Asistant Prof

    Çankırı Karatekin University

    PRINCIPAL INVESTIGATOR
  • Füsun Terzioğlu, Professor

    Atılım University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Masking Details
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.
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor Dr, PhD

Study Record Dates

First Submitted

May 25, 2020

First Posted

June 2, 2020

Study Start

June 1, 2017

Primary Completion

May 1, 2018

Study Completion

June 1, 2018

Last Updated

June 2, 2020

Record last verified: 2020-05

Data Sharing

IPD Sharing
Will not share

Locations