Clinical trial NCT05213975: Kinesio Taping Application After Cesarean Section
Official title: Effect of Kinesio Taping on Acute Pain, Comfort Level and Breastfeeding Behavior After Cesarean Section: A Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Pain
Breastfeeding
Caesarean Section;Stillbirth
Keywords: kinesio tape
pain
comfort
breastfeeding
Lead sponsor: Hacettepe University
Sponsor class: OTHER
First posted: 2022-01-28
Enrollment: 48
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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. 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.

Eligibility criteria: Inclusion Criteria:

* 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.),
* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: pain level
timeFrame: 4 months
measure: The Breastfeeding Self-Efficacy Scale
timeFrame: 4 months
measure: Postpartum Comfort Scale
timeFrame: 4 months
measure: Breastfeeding Diagnostic and Evaluation Measurement Tool (LATCH)
timeFrame: 4 months
Secondary outcomes:
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Hacettepe University Hospital
Study officials:
affiliation: Hacettepe University
name: Ozgür Ozyüncü
role: STUDY_DIRECTOR
References: