PainNCT05213975
Kinesio Taping Application After Cesarean Section
A study testing Kinesio tape in people with Pain and Breastfeeding, run by Hacettepe University at 1 site in Turkey (Türkiye).
Trial summary
The study was planned in a randomized controlled study design to determine the effect of kinesio taping applied to women who gave birth by cesarean section on acute pain, comfort level and breastfeeding behavior. The study will be carried out at Hacettepe University Adult Hospital. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pain, Breastfeeding, Caesarean Section;Stillbirth
- What is being tested?
- Kinesio tape
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Sep 2021to 1 Mar 2022
- 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 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Agreeing to participate in the research,
- Between the ages of 18- 45,
- At term, delivered by cesarean section and transverse incision applied,
- In the postoperative 8th hour (in the first 6 hours after the operation, hypotension and fatigue due to the effect of the surgery and anesthesia, headache, dizziness, nausea, vomiting, low back pain due to dural puncture are frequently observed, mobilization is delayed [postoperative 6. Hour], in order to have numbness in the extremities, to keep women under the influence of anesthesia cognitively, and to perform measurement tools and taping effectively, the application will be started from the 8th postoperative hour.),
- Having a single and healthy baby,
- Do not have a breast problem that prevents milk secretion (such as undergoing breast augmentation/reduction surgery, mass, endocrine disease, etc.),
Show all 11Show fewer
- Not having nipple problems that may affect breastfeeding (nipple turned inward, flat, numerous and drooping at the size of a bottle head, etc.),
- No history of breast cancer,
- Does not have a dermatological disease,
- No migraine or similar chronic pain,
- Women who do not have intellectual disability or perception problems and do not have communication difficulties will be included in the research.
Who cannot join
- Having a diagnosis of allergic disease on the skin,
- Developing postpartum complications (bleeding, infection, fever, etc.),
- Women whose babies were taken to the neonatal intensive care unit will not be included in the study.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Hacettepe University Hospital
Ankara, 06010
Pınar Uzunkaya Oztoprak, ress. asst., +90 (312) 305 15 80 ext. 135, pinaru09@gmail.com
Ozgür Ozyüncü, Professor, +90 (312) 305 50 00 ext. 1998, ozgurozyuncu@hacettepe.edu.tr
About this study
Official title: Effect of Kinesio Taping on Acute Pain, Comfort Level and Breastfeeding Behavior After Cesarean Section: A Randomized Controlled Study
The study was planned in a randomized controlled study design to determine the effect of kinesio taping applied to women who gave birth by cesarean section on acute pain, comfort level and breastfeeding behavior. The study will be carried out at Hacettepe University Adult Hospital. The universe of the research will be women who gave birth by cesarean section at Hacettepe University Hospital during the study. Women who are planned for a cesarean section, meet the inclusion criteria and volunteer, will be informed about the practice and will be included in the sample of the research. There will be two groups assigned by the randomization method in the study. It is planned that 24 women will be formed in one of them, 48 women in total. In addition to routine treatment and care, kinesio taping will be applied to women in the intervention group; the control group will receive only routine treatment and care.
Read the detailed description
The study was planned in a randomized controlled study design to determine the effect of kinesio taping applied to women who gave birth by cesarean section on acute pain, comfort level and breastfeeding behavior. The study will be carried out at Hacettepe University Adult Hospital. The universe of the research will be women who gave birth by cesarean section at Hacettepe University Adult Hospital during the study. Women who are planned for a cesarean section, meet the inclusion criteria and volunteer, will be informed about the practice and will be included in the sample of the research. There will be two groups assigned by the randomization method in the study. The number of samples to be recruited into the control and intervention groups was determined by a statistician using the G*Power 3.1.9.4 package program, based on studies in Turkish culture and studies evaluating pain and breastfeeding in women who underwent kinesio taping on the abdominal and breast regions, and the sample size was determined by each of the kinesio taping and control groups. It is planned that 24 women will be formed in one of them, 48 women in total. In addition to routine treatment and care, kinesio taping will be applied to women in the intervention group; the control group will receive only routine treatment and care. The data of the research; "Information Form on Descriptive Characteristics", "Breastfeeding Diagnosis and Evaluation Measurement Tool (LATCH)", "Postpartum Breastfeeding Self-Efficacy Scale" and "Postpartum Comfort Scale", "Visual Analog Scale (Postpartum Breastfeeding Self-Efficacy Scale)" VAS)'' will be collected using the "Mother Follow-up Form". In the analysis of data; in qualitative variables according to descriptive statistics (mean, standard deviation, frequency) and normal distribution of data; Chi-square test, Fisher's exact test, numerical variables; Student's t test, Mann Whitney U test, one-way analysis of variance (ANOVA) and Kruskal Wallis Analysis will be used. Before and after repeated measurements, one-way analysis of variance or Wilcoxon t test will be used according to the normal distribution. At the end of the research, it is expected that the kinesio taping applied after the cesarean section will make a positive contribution to reducing the pain level of the mother, increasing the success of breastfeeding and improving the comfort level.
- Conditions
- Pain, Breastfeeding, Caesarean Section;Stillbirth
- Being tested
- Kinesio tape
- Keywords
- kinesio tape, pain, comfort, breastfeeding
- 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 tapeDevice
Kinesio taping
| Study group | Role | What they receive |
|---|---|---|
| intervention group | Experimental | kinesio taping group Receives: Device: Kinesio tape |
| control group | No intervention | Standard of care |
What is being measured
The primary outcome is the main question the study is designed to answer.
pain level
Pain level between 0 and 100 will be determined by scoring using the VAS scale.
Measured: 4 months
The Breastfeeding Self-Efficacy Scale
The Breastfeeding Self-Efficacy Scale was first developed by Dennis and Faux (1999) as a 33-item scale. This scale assesses how competent mothers feel about breastfeeding. All items in the scale have positive meaning. The Turkish adaptation of the scale was made by Alush-Tokat and Okumuş (2010). The cronbach's alpha value of the scale was found to be 0.86, and it was found to be a reliable scale. The Breastfeeding Self-Efficacy Scale consists of 14 items assessing breastfeeding self-efficacy. The scale is a 5-point Likert type scale and is evaluated as I am never sure (1 point) and I am always sure (5 points). The minimum score that can be obtained from the scale is 14, and the maximum score is 70. The scale has no cut-off point and an increase in the score means higher breastfeeding self-efficacy (Dennis \& Faux, 1999; Dennis, 2003).
Measured: 4 months
Postpartum Comfort Scale
Developed by Karakaplan and Yıldız (2010) in line with the comfort theory developed by Katharine Kolcaba in 1994, the Postpartum Comfort Scale consists of 34 items. The scale can evaluate postpartum comfort in 3 dimensions (physical, psychospiritual, sociocultural). The scale is evaluated using a 5-point Likert-type scale scoring system, ranging from "strongly agree" (5 points), to "strongly disagree" (1 point) for each item. In positive sentences, I completely agree indicates the best comfort (5 points), and negative sentences indicate low comfort (1 point). The total score obtained from the scale is divided by the number of items to determine an average of 18 values, and the result is shown in the 1-5 distribution. Accordingly, the lowest score to be taken from the scale is 34, and the highest score is 170 (Karakaplan \& Yildiz, 2010).
Measured: 4 months
Breastfeeding Diagnostic and Evaluation Measurement Tool (LATCH)
The scale was developed by Jensen, Wallace and Kelsay in 1994 by analogy with the APGAR score system. It was created to make the diagnosis of breastfeeding objectively, to determine breastfeeding problems and to make a training plan, to create a common language among healthcare professionals about breastfeeding and to use it in research (Jensen et al., 1994). The Turkish validity of the Measurement Tool was found to be between 0.94 and 0.96 in studies (Demirhan, 1997; Küçükoğlu, 2011).
For each criterion that makes up the LATCH Breastfeeding Diagnostic and Evaluation Scale, 0, 1, 2 points are given. Breastfeeding success is evaluated by summing the scores. The highest score that can be obtained from the scale is 10 and the lowest score is 0. A score below 10 points for mothers indicates that they need support in breastfeeding, and as the score decreases, mothers' need for breastfeeding support increases (Jensen et al., 1994; Demirhan, 1997; Küçükoğlu, 2011).
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2022
- Study start1 Sep 2021
- Primary completion1 Mar 2022 (estimated)
- Study completion1 Mar 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PainStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hacettepe University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pinar Uzunkaya Oztoprak, Hacettepe University
- Investigators
- Ozgür Ozyüncü, Study director, Hacettepe University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05213975
- Sponsor's protocol ID
- Kinesio Taping
- Status last verified
- Jan 2022
- First submitted
- 24 Dec 2021
- Last updated
- 28 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: There is a plan to make IPD and related data dictionaries available.
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Kinesio Taping on Acute Pain, Comfort Level and Breastfeeding Behavior After Cesarean Section: A Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT05213975
- Acronym / sponsor ID
- Kinesio Taping
- Conditions
- Pain, Breastfeeding, Caesarean Section;Stillbirth
- Keywords
- kinesio tape, pain, comfort, breastfeeding
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- Hacettepe UniversityUniversity, hospital or other
- Study start
- 1 Sep 2021 (actual)
- Primary completion
- 1 Mar 2022 (estimated)
- Study completion
- 1 Mar 2022 (estimated)
- First posted
- 28 Jan 2022 (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.
The study was planned in a randomized controlled study design to determine the effect of kinesio taping applied to women who gave birth by cesarean section on acute pain, comfort level and breastfeeding behavior. The study will be carried out at Hacettepe University Adult Hospital. The universe of the research will be women who gave birth by cesarean section at Hacettepe University Hospital during the study. Women who are planned for a cesarean section, meet the inclusion criteria and volunteer, will be informed about the practice and will be included in the sample of the research. There will be two groups assigned by the randomization method in the study. It is planned that 24 women will be formed in one of them, 48 women in total. In addition to routine treatment and care, kinesio taping will be applied to women in the intervention group; the control group will receive only routine treatment and care.
Detailed description
The study was planned in a randomized controlled study design to determine the effect of kinesio taping applied to women who gave birth by cesarean section on acute pain, comfort level and breastfeeding behavior. The study will be carried out at Hacettepe University Adult Hospital. The universe of the research will be women who gave birth by cesarean section at Hacettepe University Adult Hospital during the study. Women who are planned for a cesarean section, meet the inclusion criteria and volunteer, will be informed about the practice and will be included in the sample of the research. There will be two groups assigned by the randomization method in the study. The number of samples to be recruited into the control and intervention groups was determined by a statistician using the G*Power 3.1.9.4 package program, based on studies in Turkish culture and studies evaluating pain and breastfeeding in women who underwent kinesio taping on the abdominal and breast regions, and the sample size was determined by each of the kinesio taping and control groups. It is planned that 24 women will be formed in one of them, 48 women in total. In addition to routine treatment and care, kinesio taping will be applied to women in the intervention group; the control group will receive only routine treatment and care. The data of the research; "Information Form on Descriptive Characteristics", "Breastfeeding Diagnosis and Evaluation Measurement Tool (LATCH)", "Postpartum Breastfeeding Self-Efficacy Scale" and "Postpartum Comfort Scale", "Visual Analog Scale (Postpartum Breastfeeding Self-Efficacy Scale)" VAS)'' will be collected using the "Mother Follow-up Form". In the analysis of data; in qualitative variables according to descriptive statistics (mean, standard deviation, frequency) and normal distribution of data; Chi-square test, Fisher's exact test, numerical variables; Student's t test, Mann Whitney U test, one-way analysis of variance (ANOVA) and Kruskal Wallis Analysis will be used. Before and after repeated measurements, one-way analysis of variance or Wilcoxon t test will be used according to the normal distribution. At the end of the research, it is expected that the kinesio taping applied after the cesarean section will make a positive contribution to reducing the pain level of the mother, increasing the success of breastfeeding and improving the comfort level.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| intervention group | Experimental | Device: Kinesio tapekinesio taping group |
| control group | No intervention | –Standard of care |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (11 listed)
- Agreeing to participate in the research,
- Between the ages of 18- 45,
- At term, delivered by cesarean section and transverse incision applied,
- In the postoperative 8th hour (in the first 6 hours after the operation, hypotension and fatigue due to the effect of the surgery and anesthesia, headache, dizziness, nausea, vomiting, low back pain due to dural puncture are frequently observed, mobilization is delayed [postoperative 6. Hour], in order to have numbness in the extremities, to keep women under the influence of anesthesia cognitively, and to perform measurement tools and taping effectively, the application will be started from the 8th postoperative hour.),
- Having a single and healthy baby,
Key exclusion criteria (3 listed)
- Having a diagnosis of allergic disease on the skin,
- Developing postpartum complications (bleeding, infection, fever, etc.),
- Women whose babies were taken to the neonatal intensive care unit will not be included in the study.
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 tapeKinesio taping | Device | intervention group |
Primary outcome
pain level
Time frame: 4 months
Pain level between 0 and 100 will be determined by scoring using the VAS scale.
The Breastfeeding Self-Efficacy Scale
Time frame: 4 months
The Breastfeeding Self-Efficacy Scale was first developed by Dennis and Faux (1999) as a 33-item scale. This scale assesses how competent mothers feel about breastfeeding. All items in the scale have positive meaning. The Turkish adaptation of the scale was made by Alush-Tokat and Okumuş (2010). The cronbach's alpha value of the scale was found to be 0.86, and it was found to be a reliable scale. The Breastfeeding Self-Efficacy Scale consists of 14 items assessing breastfeeding self-efficacy. The scale is a 5-point Likert type scale and is evaluated as I am never sure (1 point) and I am always sure (5 points). The minimum score that can be obtained from the scale is 14, and the maximum score is 70. The scale has no cut-off point and an increase in the score means higher breastfeeding self-efficacy (Dennis \& Faux, 1999; Dennis, 2003).
Postpartum Comfort Scale
Time frame: 4 months
Developed by Karakaplan and Yıldız (2010) in line with the comfort theory developed by Katharine Kolcaba in 1994, the Postpartum Comfort Scale consists of 34 items. The scale can evaluate postpartum comfort in 3 dimensions (physical, psychospiritual, sociocultural). The scale is evaluated using a 5-point Likert-type scale scoring system, ranging from "strongly agree" (5 points), to "strongly disagree" (1 point) for each item. In positive sentences, I completely agree indicates the best comfort (5 points), and negative sentences indicate low comfort (1 point). The total score obtained from the scale is divided by the number of items to determine an average of 18 values, and the result is shown in the 1-5 distribution. Accordingly, the lowest score to be taken from the scale is 34, and the highest score is 170 (Karakaplan \& Yildiz, 2010).
Breastfeeding Diagnostic and Evaluation Measurement Tool (LATCH)
Time frame: 4 months
The scale was developed by Jensen, Wallace and Kelsay in 1994 by analogy with the APGAR score system. It was created to make the diagnosis of breastfeeding objectively, to determine breastfeeding problems and to make a training plan, to create a common language among healthcare professionals about breastfeeding and to use it in research (Jensen et al., 1994). The Turkish validity of the Measurement Tool was found to be between 0.94 and 0.96 in studies (Demirhan, 1997; Küçükoğlu, 2011). For each criterion that makes up the LATCH Breastfeeding Diagnostic and Evaluation Scale, 0, 1, 2 points are given. Breastfeeding success is evaluated by summing the scores. The highest score that can be obtained from the scale is 10 and the lowest score is 0. A score below 10 points for mothers indicates that they need support in breastfeeding, and as the score decreases, mothers' need for breastfeeding support increases (Jensen et al., 1994; Demirhan, 1997; Küçükoğlu, 2011).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2022.
- Individual participant dataSharing planned: Yes. There is a plan to make IPD and related data dictionaries available.
Related trials for Pain
Not yet recruiting
Effects of Adding Vagal Neuromodulation to Manual Therapy in Women With Fibromyalgia
Fibromyalgia (FM) OR Fibromyalgia Syndrome, Manuel Therapy
Not yet recruitingPhase 3
Veterans' Intervention Blending NeuRomodulation and YogA for Chronic Low BackPaiN Treatment: VIBRANT
Chronic Low Back Pain, Musculoskeletal Pain
Not yet recruiting
Testing the Timing and Application of Virtual Reality Distraction During Knee Injections in a VA Pain Clinic
Pain Management, Injection Pain Prevention
Not yet recruiting
The Effect of a Ginger Formula on Menstrual Health vs a Placebo
Painful Menstruation
Not yet recruitingEarly Phase 1
Pain Sensitivity, Alcohol-Induced Analgesia, and Heavy Drinking in Individuals With Opioid Use Disorder
Opioid Use Disorder, Alcohol Intoxication
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.
Ozgür Ozyüncü study director
Hacettepe 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 tape in people with Pain and Breastfeeding, run by Hacettepe 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 11 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 28 Jan 2022. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Pınar Uzunkaya Oztoprak (+90 (312) 305 15 80, pinaru09@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
pain level (time frame: 4 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 28 Jan 2022; AzTrials last refreshed its copy on 27 Oct 2026.