Clinical trial NCT06151899: Effect of Kinesio Tape on Back Pain, Breastfeeding Success and Breastfeeding Self-Efficacy
Official title: The Effect of Applying Kinesio Tape on Back Pain, Breastfeeding Success and Breastfeeding Self-Efficacy Levels in Mothers: Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
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)
Keywords: Pain
Breastfeeding
Breast milk
Nursing
Therapy
Lead sponsor: KTO Karatay University
Sponsor class: OTHER
Collaborators: name: Niğde Ömer Halisdemir University
name: Selcuk University
First posted: 2023-11-30
Enrollment: 60
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: OTHER

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.

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.)

Primary outcomes:
measure: 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.
timeFrame: Average 2 weeks
measure: Mother Introduction Form
timeFrame: Average 2 weeks
Secondary outcomes:
measure: 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.
timeFrame: Average 2 weeks
measure: 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.
timeFrame: Average 2 weeks
Other outcomes:
Locations:
city: Konya
country: Turkey
facility: KTO Karatay University
Study officials:
affiliation: Nigde Omer Halisdemir University
name: Hilal Kurt Sezer, Ph.D.
role: STUDY_DIRECTOR
affiliation: Selcuk University
name: Sibel Kucukoglu, Ph.D.
role: STUDY_CHAIR
affiliation: KTO Karatay University
name: B. Sonmez Unuvar, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
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citation: Milinco M, Travan L, Cattaneo A, Knowles A, Sola MV, Causin E, Cortivo C, Degrassi M, Di Tommaso F, Verardi G, Dipietro L, Piazza M, Scolz S, Rossetto M, Ronfani L; Trieste BN (Biological Nurturing) Investigators. Effectiveness of biological nurturing on early breastfeeding problems: a randomized controlled trial. Int Breastfeed J. 2020 Apr 5;15(1):21. doi: 10.1186/s13006-020-00261-4.
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