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Postoperative PainNCT04412122

The Effect of Kinesio Taping and Breathing Exercises on Pain Management

A study testing Kinesio Taping, Breathing Exercise and Kinesio Taping+Breathing Exercise in people with Postoperative Pain and Gas Bloat Syndrome, run by Çankırı Karatekin University at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 years and older, women onlyHealthy volunteers can take part
What is being tested?
Kinesio Taping, Breathing Exercise and Kinesio Taping+Breathing Exercise
Could I receive a placebo?
No, everyone receives an active treatment
How many people
132 participants
Where
1 siteTurkey (Türkiye)
Study dates
1 Jun 2017to 1 Jun 2018
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site
  • Çankırı Karatekin Univesity

    Çankırı, Center, 18200

Other trials in Turkey (Türkiye)

About this study

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

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.

Read the 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).

Being tested
Kinesio Taping, Breathing Exercise, Kinesio Taping+Breathing Exercise, Control Group
Keywords
Benign gynecological changes, Postoperative pain, Kinesio taping, Breathing exercise, Nursing
Medical subject headings
Pain, Postoperative, Gas bloat syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Kinesio TapingOther

    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 ExerciseOther

    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 ExerciseOther

    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 GroupOther

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

Study groups in NCT04412122
Study groupRoleWhat they receive
Kinesio TapingExperimentalKinesio 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).
Receives: Other: Kinesio Taping
Breathing ExerciseExperimentalBreathing 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).
Receives: Other: Breathing Exercise
Kinesio Taping and Breathing ExerciseExperimentalAccording to the application protocols, two applications were made together.
Receives: Other: Kinesio Taping+Breathing Exercise
Control GroupOtherNo intervention was performed to reduce pain in the control group.
Receives: Other: Control Group

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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).

    Measured: 11 MONTHS

  2. 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).

    Measured: 11 MONTHS

  3. 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.

    Measured: 11 MONTHS

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Jun 2020
  2. Study start1 Jun 2017
  3. Primary completion1 May 2018
  4. Study completion1 Jun 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
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
Single blind
Who is masked
Investigator
Enrolment
132 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04412122
Sponsor's protocol ID
Ethic No: 2016/12/131
Status last verified
May 2020
First submitted
25 May 2020
Last updated
2 Jun 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 29861263
  • 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.

    PubMed 26492435
  • 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.

    PubMed 24093737
  • 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.

    PubMed 15195278
  • 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.

    PubMed 26316553
  • 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.

    PubMed 26329802
  • 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.

    PubMed 22235509
  • 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.

    PubMed 25864095
  • 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.

    PubMed 22033000
  • 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.

    PubMed 14622683

Questions about this trial

What is this clinical trial studying?

A study testing Kinesio Taping, Breathing Exercise and Kinesio Taping+Breathing Exercise in people with Postoperative Pain and Gas Bloat Syndrome, run by Çankırı Karatekin University at 1 site in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 2 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Visual Analog Scale (VAS) (time frame: 11 MONTHS). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04412122, which also lists 13 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jun 2020.

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