Mothers Who Have Babies Between 0-6 Months and Are Actively BreastfeedingNCT06151899
Effect of Kinesio Tape on Back Pain, Breastfeeding Success and Breastfeeding Self-Efficacy
A study testing Kinesio taping with angle and tension in people with Mothers Who Have Babies Between 0-6 Months and Are Actively Breastfeeding and Mothers Who Complain of Back Pain Due to Breastfeeding (Getting 6 Points or More on VAS in the Mothers' Own Evaluation), run by KTO Karatay University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- 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)
- What is being tested?
- Kinesio taping with angle and tension
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2025to 1 Jul 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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)
Who cannot join
- 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.)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- 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)
- Being tested
- Kinesio taping with angle and tension
- Keywords
- Pain, Breastfeeding, Breast milk, Nursing, Therapy
- Medical subject headings
- Pain, Breast Feeding
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Kinesio taping with angle and tensionOther
Kinesio taping by applying angle and tension to back muscle
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Kinesio taping with angle and tension |
| Control group | No intervention | The control group will receive placebo kinesio taping. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
- 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.
Measured: 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.
- 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.
Measured: Average 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Nov 2023
- Study start1 Jan 2025
- Primary completion1 May 2025
- Study completion1 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Mothers Who Have Babies Between 0-6 Months and Are Actively BreastfeedingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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 blind
- Who is masked
- Participant
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- KTO Karatay University
- Sponsor type
- University, hospital or other
- Collaborators
- Niğde Ömer Halisdemir University, Selcuk University
- Responsible party
- Principal investigator, Merve Arı, KTO Karatay University
- Investigators
- Hilal Kurt Sezer, Ph.D., Study director, Nigde Omer Halisdemir UniversitySibel Kucukoglu, Ph.D., Study chair, Selcuk UniversityB. Sonmez Unuvar, Ph.D., Study director, KTO Karatay UniversityMerve A. Ceran, Study director, KTO Karatay University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06151899
- Sponsor's protocol ID
- ari1
- Status last verified
- Jul 2025
- First submitted
- 26 Oct 2023
- Last updated
- 3 Jul 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 31140258Admasu 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.
PubMed 35720173Schafer 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.
PubMed 28879823Kucukoglu 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.
PubMed 36323075Lambrinou 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.
PubMed 31577639Lockyer 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.
PubMed 34836103Milinco 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.
PubMed 32248838Anderson 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.
PubMed 31135656
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Applying Kinesio Tape on Back Pain, Breastfeeding Success and Breastfeeding Self-Efficacy Levels in Mothers: Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06151899
- Acronym / sponsor ID
- ari1
- 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
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- KTO Karatay UniversityUniversity, hospital or other
- Collaborators
- Niğde Ömer Halisdemir University, Selcuk University
- Study start
- 1 Jan 2025 (actual)
- Primary completion
- 1 May 2025 (actual)
- Study completion
- 1 Jul 2025 (actual)
- First posted
- 30 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Kinesio tape applying group | Experimental | Other: Kinesio taping with angle and tensionTo 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. |
| Control group | No intervention | –The control group will receive placebo kinesio taping. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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)
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Kinesio taping with angle and tensionKinesio taping by applying angle and tension to back muscle | Other | Kinesio tape applying group |
Primary outcome
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.
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.
2 secondary outcomes
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jul 2025.
- Results publication: PubMed 31140258Hay 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.
- Results publication: PubMed 35720173Admasu 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.
- Results publication: PubMed 28879823Schafer 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.
- Results publication: PubMed 36323075Kucukoglu 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.
- Results publication: PubMed 31577639Lambrinou 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.
- Results publication: PubMed 34836103Lockyer 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.
- Results publication: PubMed 32248838Milinco 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.
- Results publication: PubMed 31135656Anderson 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.
- WHOLink provided by the sponsor.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hilal Kurt Sezer, Ph.D. study director
Nigde Omer Halisdemir University
Sibel Kucukoglu, Ph.D. study chair
Selcuk University
B. Sonmez Unuvar, Ph.D. study director
KTO Karatay University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Kinesio taping with angle and tension in people with Mothers Who Have Babies Between 0-6 Months and Are Actively Breastfeeding and Mothers Who Complain of Back Pain Due to Breastfeeding (Getting 6 Points or More on VAS in the Mothers' Own Evaluation), run by KTO Karatay University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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. (time frame: Average 2 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06151899, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jul 2025.