Effect of Kinesio Tape on Back Pain, Breastfeeding Success and Breastfeeding Self-Efficacy

November 21, 2023 updated by: Merve Arı, KTO Karatay University

The Effect of Applying Kinesio Tape on Back Pain, Breastfeeding Success and Breastfeeding Self-Efficacy Levels in Mothers: Randomized Controlled Trial

Back pain caused by posture changes and increased weight on the breasts during breastfeeding may negatively affect breastfeeding success and self-efficacy. Kinesio tape application, which is an effective and cost-effective method, can provide a more comfortable breastfeeding experience by controlling this pain.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Despite the universality of these globally valid recommendations for the promotion of breastfeeding, the frequency and prevalence of breastfeeding rates vary from country to country and even between regions within certain countries. Planning and successful implementation of interventions to promote breast milk is possible by controlling both positive and negative factors that affect the success and duration of breastfeeding. In order to control the physical problems associated with breastfeeding, existing approaches in the literature for pain management such as fullness of the breasts due to increased lactation, poor positioning during breastfeeding, backaches. Kinesio taping is one of these methods, and since it does not have any pharmacological content, it is a practice that does not have side effects on breastfeeding and lactation.

Study Type

Interventional

Enrollment (Estimated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Mothers who have babies between 0-6 months and are actively breastfeeding
  • Primiparous mothers
  • Mothers who complain of back pain due to breastfeeding (Getting 6 points or more on VAS in the mothers' own evaluation)

Exclusion Criteria:

  • Mothers with premature babies or babies with congenital anomalies
  • Mothers taking painkillers
  • Mothers diagnosed with posture disorders or skeletal system disorders
  • Mothers whose breastfeeding is contraindicated
  • Mothers whose breast milk has stopped
  • Mothers who have other pain complaints in addition to back pain (such as nipple cracks, mastitis pain, etc.)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Kinesio tape applying group
To the mothers in the experimental group; Kinesio tape application will be performed by two experienced physiotherapists, one of whom is an expert and the other has a doctorate degree, with a kinesio tape certificate.
Other: Kinesio taping with angle and tension
Kinesio taping by applying angle and tension to back muscle
No Intervention: Control group
The control group will receive placebo kinesio taping.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The first outcome measure of the study is to examine the effect of Kinesio tape application on back pain in the mothers in the experimental group.
Time Frame: Average 2 weeks
The VAS pain scale will be used for this.Visual Analog Scale (VAS): The scale is used to measure pain intensity. The scale consists of a 10 cm or 100 mm long horizontal or vertical ruler showing "no pain" at one end and "the most severe pain" possible at the other end. At the left end of the line is the expression "No pain" or "Pain is completely gone", while at the right end is the expression "Unbearable pain" or "There is no decrease in pain". A score of 6 and above indicates that the pain level has increased.
Average 2 weeks
Mother Introduction Form
Time Frame: Average 2 weeks
This form was prepared by the researchers in line with the literature. The form consists of 9 questions that question about breastfeeding process and her baby' demographics.
Average 2 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The second outcome measure of the study is to determine the effect of the interventions on the breastfeeding success perception of the mothers in the experimental group.
Time Frame: Average 2 weeks
1. LATCH Breastfeeding Diagnosis and Evaluation Scale: LATCH Breastfeeding Diagnosis Scale: L; Latch on the breast A; seeing/hearing the baby's swallowing movement (Audible swallowing) T; Type of the nipple C; comfort of the mother's breast and nipple (Comfort breast/nipple) H; It is the holding position of the baby (Hold/Help). A Turkish reliability study of the tool was conducted by Yenal and Okumuş, and it was found to be a suitable and reliable diagnostic tool for use. Each item is worth 0-2 points and the total score is a maximum of 10 points. A lower score indicates a need for support in breastfeeding.
Average 2 weeks
The second outcome measure of the study is to determine the effect of the interventions on the breastfeeding self-efficacy of the mothers in the experimental group.
Time Frame: Average 2 weeks
2. Breastfeeding Self-Efficacy Scale (EÖS): The minimum score that can be obtained from the scale is 14 and the maximum score is 70. A higher score indicates higher breastfeeding self-efficacy. The Turkish validity and reliability study of the scale was conducted by Tokat and Okumuş.
Average 2 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

KTO Karatay University

Collaborators

Selcuk University
Nigde Omer Halisdemir University

Investigators

  • Study Director: Hilal Kurt Sezer, Ph.D., Nigde Omer Halisdemir University
  • Study Chair: Sibel Kucukoglu, Ph.D., Selcuk University
  • Principal Investigator: B. Sonmez Unuvar, Ph.D., KTO Karatay University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

January 30, 2024

Primary Completion (Estimated)

July 30, 2024

Study Completion (Estimated)

December 30, 2024

Study Registration Dates

First Submitted

October 26, 2023

First Submitted That Met QC Criteria

November 21, 2023

First Posted (Actual)

November 30, 2023

Study Record Updates

Last Update Posted (Actual)

November 30, 2023

Last Update Submitted That Met QC Criteria

November 21, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ari1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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