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

Study Overview
=================
Brief Summary
-----------------
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.

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.

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

Conditions
-----------------
Mothers Who Have Babies Between 0-6 Months and Are Actively Breastfeeding, Mothers Who Complain of Back Pain Due to Breastfeeding (Getting 6 Points or More on VAS in the Mothers' Own Evaluation)

Intervention / Treatment
-----------------
* Other: Kinesio taping with angle and tension


Participation Criteria
=================
Eligibility Criteria
-----------------
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.)

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: After the study is explained to mothers who meet the inclusion criteria and agree to participate in the study, their signatures on informed consent forms will be taken. Randomization will be random assignment to a control group or two intervention groups (1:1) with sequentially numbered, sealed, opaque envelopes containing randomly generated numbers after mothers have obtained informed consent. Randomization will be carried out via www.random.org using a table of random numbers.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Kinesio tape applying group<br>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<br>* Kinesio taping by applying angle and tension to back muscle<br>|
| No Intervention: Control group<br>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. | 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 | 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. | 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. | 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Pain, Breastfeeding, Breast milk, Nursing, Therapy