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

NCT06151899 | Completed DMC

• 1 other identifier: ari1
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• 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.

  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.

  Average 2 weeks

Study Arms (2)

Kinesio tape applying group

EXPERIMENTAL

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

Control group

NO INTERVENTION

The control group will receive placebo kinesio taping.

Interventions

Kinesio taping with angle and tension OTHER

Kinesio taping by applying angle and tension to back muscle

Kinesio tape applying group

Eligibility Criteria

• Age: 18 Years - 40 Years
• Gender Eligibility Details: Active breastfeeding women
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• 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.)

Sponsors & Collaborators

• KTO Karatay University: lead
• Niğde Ömer Halisdemir University: collaborator
• Selcuk University: collaborator

Study Sites (1)

KTO Karatay University

Konya, Turkey (Türkiye)

Location

Related Publications (8)

• Hay G, Baerug AB. The benefits of exclusive breastfeeding up to six months. Tidsskr Nor Laegeforen. 2019 May 3;139(9). doi: 10.4045/tidsskr.19.0105. Print 2019 May 28. No abstract available. English, Norwegian.

  PMID: 31140258 RESULT

• Admasu J, Egata G, Bassore DG, Feleke FW. Effect of maternal nutrition education on early initiation and exclusive breast-feeding practices in south Ethiopia: a cluster randomised control trial. J Nutr Sci. 2022 May 30;11:e37. doi: 10.1017/jns.2022.36. eCollection 2022.

  PMID: 35720173 RESULT

• Schafer EJ, Campo S, Colaizy TT, Mulder PJ, Breheny P, Ashida S. First-time mothers' breast-feeding maintenance: role of experiences and changes in maternal perceptions. Public Health Nutr. 2017 Dec;20(17):3099-3108. doi: 10.1017/S136898001700221X. Epub 2017 Sep 7.

  PMID: 28879823 RESULT

• Kucukoglu S, Sezer HK, Dennis CL. Validity and reliability of the Turkish version of the paternal breastfeeding self-efficacy scale - Short form for fathers. Midwifery. 2023 Jan;116:103513. doi: 10.1016/j.midw.2022.103513. Epub 2022 Oct 22.

  PMID: 36323075 RESULT

• Lambrinou CP, Karaglani E, Manios Y. Breastfeeding and postpartum weight loss. Curr Opin Clin Nutr Metab Care. 2019 Nov;22(6):413-417. doi: 10.1097/MCO.0000000000000597.

  PMID: 31577639 RESULT

• Lockyer F, McCann S, Moore SE. Breast Milk Micronutrients and Infant Neurodevelopmental Outcomes: A Systematic Review. Nutrients. 2021 Oct 28;13(11):3848. doi: 10.3390/nu13113848.

  PMID: 34836103 RESULT

• 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.

  PMID: 32248838 RESULT

• Anderson L, Kynoch K, Kildea S, Lee N. Effectiveness of breast massage for the treatment of women with breastfeeding problems: a systematic review. JBI Database System Rev Implement Rep. 2019 Aug;17(8):1668-1694. doi: 10.11124/JBISRIR-2017-003932.

  PMID: 31135656 RESULT

Related Links

• WHO

MeSH Terms

Conditions

Pain; Breast Feeding

Condition Hierarchy (Ancestors)

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

Study Officials

• Hilal Kurt Sezer, Ph.D.

  Nigde Omer Halisdemir University

  STUDY DIRECTOR

• Sibel Kucukoglu, Ph.D.

  Selcuk University

  STUDY CHAIR

• B. Sonmez Unuvar, Ph.D.

  KTO Karatay University

  STUDY DIRECTOR

• Merve A. Ceran

  KTO Karatay University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Single (Participant)
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M.Sc.

Model Details: 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.

Study Record Dates

• First Submitted: October 26, 2023
• First Posted: November 30, 2023
• Study Start: January 1, 2025
• Primary Completion: May 1, 2025
• Study Completion: July 1, 2025
• Last Updated: July 3, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)