Kinesio Taping Application After Cesarean Section

NCT05213975 | Unknown

• 1 other identifier: Kinesio Taping
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief Summary

The study was planned in a randomized controlled study design to determine the effect of kinesio taping applied to women who gave birth by cesarean section on acute pain, comfort level and breastfeeding behavior. The study will be carried out at Hacettepe University Adult Hospital. The universe of the research will be women who gave birth by cesarean section at Hacettepe University Hospital during the study. Women who are planned for a cesarean section, meet the inclusion criteria and volunteer, will be informed about the practice and will be included in the sample of the research. There will be two groups assigned by the randomization method in the study. It is planned that 24 women will be formed in one of them, 48 women in total. In addition to routine treatment and care, kinesio taping will be applied to women in the intervention group; the control group will receive only routine treatment and care.

Conditions

Pain; Breastfeeding; Caesarean Section;Stillbirth

Keywords

kinesio tape; pain; comfort; breastfeeding

Outcome Measures

Primary Outcomes (4)

• pain level

  Pain level between 0 and 100 will be determined by scoring using the VAS scale.

  4 months

• The Breastfeeding Self-Efficacy Scale

  The Breastfeeding Self-Efficacy Scale was first developed by Dennis and Faux (1999) as a 33-item scale. This scale assesses how competent mothers feel about breastfeeding. All items in the scale have positive meaning. The Turkish adaptation of the scale was made by Alush-Tokat and Okumuş (2010). The cronbach's alpha value of the scale was found to be 0.86, and it was found to be a reliable scale. The Breastfeeding Self-Efficacy Scale consists of 14 items assessing breastfeeding self-efficacy. The scale is a 5-point Likert type scale and is evaluated as I am never sure (1 point) and I am always sure (5 points). The minimum score that can be obtained from the scale is 14, and the maximum score is 70. The scale has no cut-off point and an increase in the score means higher breastfeeding self-efficacy (Dennis \& Faux, 1999; Dennis, 2003).

  4 months

• Postpartum Comfort Scale

  Developed by Karakaplan and Yıldız (2010) in line with the comfort theory developed by Katharine Kolcaba in 1994, the Postpartum Comfort Scale consists of 34 items. The scale can evaluate postpartum comfort in 3 dimensions (physical, psychospiritual, sociocultural). The scale is evaluated using a 5-point Likert-type scale scoring system, ranging from "strongly agree" (5 points), to "strongly disagree" (1 point) for each item. In positive sentences, I completely agree indicates the best comfort (5 points), and negative sentences indicate low comfort (1 point). The total score obtained from the scale is divided by the number of items to determine an average of 18 values, and the result is shown in the 1-5 distribution. Accordingly, the lowest score to be taken from the scale is 34, and the highest score is 170 (Karakaplan \& Yildiz, 2010).

  4 months

• Breastfeeding Diagnostic and Evaluation Measurement Tool (LATCH)

  The scale was developed by Jensen, Wallace and Kelsay in 1994 by analogy with the APGAR score system. It was created to make the diagnosis of breastfeeding objectively, to determine breastfeeding problems and to make a training plan, to create a common language among healthcare professionals about breastfeeding and to use it in research (Jensen et al., 1994). The Turkish validity of the Measurement Tool was found to be between 0.94 and 0.96 in studies (Demirhan, 1997; Küçükoğlu, 2011). For each criterion that makes up the LATCH Breastfeeding Diagnostic and Evaluation Scale, 0, 1, 2 points are given. Breastfeeding success is evaluated by summing the scores. The highest score that can be obtained from the scale is 10 and the lowest score is 0. A score below 10 points for mothers indicates that they need support in breastfeeding, and as the score decreases, mothers' need for breastfeeding support increases (Jensen et al., 1994; Demirhan, 1997; Küçükoğlu, 2011).

  4 months

Study Arms (2)

intervention group

EXPERIMENTAL

kinesio taping group

Device: Kinesio tape

control group

NO INTERVENTION

Standard of care

Interventions

Kinesio tape DEVICE

Kinesio taping

intervention group

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Agreeing to participate in the research,
• Between the ages of 18- 45,
• At term, delivered by cesarean section and transverse incision applied,
• In the postoperative 8th hour (in the first 6 hours after the operation, hypotension and fatigue due to the effect of the surgery and anesthesia, headache, dizziness, nausea, vomiting, low back pain due to dural puncture are frequently observed, mobilization is delayed \[postoperative 6. Hour\], in order to have numbness in the extremities, to keep women under the influence of anesthesia cognitively, and to perform measurement tools and taping effectively, the application will be started from the 8th postoperative hour.),
• Having a single and healthy baby,
• Do not have a breast problem that prevents milk secretion (such as undergoing breast augmentation/reduction surgery, mass, endocrine disease, etc.),
• Not having nipple problems that may affect breastfeeding (nipple turned inward, flat, numerous and drooping at the size of a bottle head, etc.),
• No history of breast cancer,
• Does not have a dermatological disease,
• No migraine or similar chronic pain,
• Women who do not have intellectual disability or perception problems and do not have communication difficulties will be included in the research.

You may not qualify if:

• Having a diagnosis of allergic disease on the skin,
• Developing postpartum complications (bleeding, infection, fever, etc.),
• Women whose babies were taken to the neonatal intensive care unit will not be included in the study.

Sponsors & Collaborators

• Hacettepe University: lead

Study Sites (1)

Hacettepe University Hospital

Ankara, 06010, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Pain; Breast Feeding

Interventions

Athletic Tape

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Feeding Behavior; Behavior

Intervention Hierarchy (Ancestors)

Bandages; Equipment and Supplies; Orthotic Devices; Orthopedic Equipment; Surgical Equipment

Study Officials

• Ozgür Ozyüncü

  Hacettepe University

  STUDY DIRECTOR

Central Study Contacts

Pınar Uzunkaya Oztoprak

CONTACT

+90 (312) 305 15 80; pinaru09@gmail.com

Gülten Koç

CONTACT

+90 (312) 305 15 80; gultenko@hacettepe.edu.tr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 24, 2021
• First Posted: January 28, 2022
• Study Start: September 1, 2021
• Primary Completion: March 1, 2022
• Study Completion: March 1, 2022
• Last Updated: January 28, 2022

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, CSR
• Time Frame: january 2023
• Access Criteria: Statistical analyzes of the study will be made by an expert. The data will be shared with the expert by providing statistical blinding. The results of the study will be published in an international journal.

Locations

TU (1)