Clinical trial NCT04924439: Effects of Reflexology on Postpartum Pain, Fatigue, Sleep Quality and Lactation
Official title: Effects Reflexology on Postpartum Pain, Fatigue, Sleep Quality and Lactation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Feeding
Fatigue
Sleep
Pain, Postoperative
Keywords: fatigue
lactation
pain
postpartum
sleep quality
reflexology
Lead sponsor: University of Gaziantep
Sponsor class: OTHER
First posted: 2021-06-14
Enrollment: 80
Sex: FEMALE
Minimum age (years): 19
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: randomized controlled trial
Primary purpose: SUPPORTIVE_CARE

Brief summary: The aim of this research is to determine the effect of foot reflexology applied to primiparous women who had cesarean section in the postpartum period on pain, fatigue, sleep quality and lactation. This research is a randomized controlled trial. The study was conducted in Şanlıurfa, which has the highest fertility rate in Turkey.

Detailed description: The aim of this research is to determine the effect of foot reflexology applied to primiparous women who had cesarean section in the postpartum period on pain, fatigue, sleep quality and lactation. This research is a randomized controlled trial. The study was conducted in Şanlıurfa, which has the highest fertility rate in Turkey. The sample of the research consisted of 80 primiparous women (reflexology group: 40 and control group: 40). The data were collected between 01 January 2020 - 31 January 2021. "Introductory Information Form", "Visual Analogue Scale" for Pain, "Visual Analog Scale for Fatigue", "Pittsburg Sleep Quality Index" and "Bristol Breastfeeding Assessment Tool" were used as data collection tools. Foot reflexology was applied to the experimental group for 40 minutes (left foot 20 minutes and right foot 20 minutes) once a week for postpartum 8 weeks. The control group was only watched. In the intergroup comparison of the experimental and control groups, chi-square for categorical variables and independent groups t-test for numerical variables were used. Two-way repeated measures ANOVA test was performed in terms of time and group interaction in repeated measurements

Eligibility criteria: Inclusion Criteria:

* Caesarean section,
* Primipary,
* 19 and over and under 35
* Literate,
* 37 and above pregnancy week
* Giving birth singularly,
* Having spinal anesthesia
* No chronic disease or pregnancy complication,
* Have no breast-related health problems
* Have not had an operation related to the breast,
* Women who do not have any health problems in the feet of the mothers in the treatment group

Exclusion Criteria:

* The baby has died or is not present,
* Multiparous,
* Women with health problems in their feet

Primary outcomes:
measure: Visual Analogue Scale (VAS)
timeFrame: Change from Visual Analogue Scale (VAS) scores at first, second, third, fourth, fifth, sixth, seventh and eighth week after cesarean. ]
measure: Visual Similarity Scale for Fatigue (YSSF)
timeFrame: Change from Visual Similarity Scale for Fatigue (YSSF) scores at first, second, third, fourth, fifth, sixth, seventh and eighth week after cesarean. ]
measure: Pittsburg Sleep Quality Index (PSQI)
timeFrame: Change from Pittsburg Sleep Quality Index (PSQI) scores at first, fourth and eighth week after cesarean. ]
measure: Bristol Breastfeeding Assessment Tool (BBAT)
timeFrame: Change from Bristol Breastfeeding Assessment Tool (BBAT) scores at first, second, third, fourth, fifth, sixth, seventh and eighth week after cesarean. ]
Secondary outcomes:
Other outcomes:
Locations:
city: Gaziantep
country: Turkey
facility: Gaziantep University Health Sciences Enstitutes
Study officials:
affiliation: GAZİANTEP UNİVERSİTY CLINICAL RESEARCH ETHICS COMMITTE
name: simge zeyneloğlu, proffessor
role: STUDY_DIRECTOR
References: