Clinical trial NCT03686319: The Effect of Reflexology on Lactation and Postpartum Comfort for Cesarean-delivery Primiparous Mothers
Official title: The Effect of Reflexology on Lactation and Postpartum Comfort for Cesarean-delivery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breastfeeding
Lactation Failure
Nursing Caries
Postpartum
Reflexology
Lead sponsor: Selcuk University
Sponsor class: OTHER
First posted: 2018-09-26
Enrollment: 100
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 41
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Immediately after cesarean birth, many women suffer from breastfeeding problems due to pain, fatigue, activity intolerance, anesthesia, and delayed onset of lactation. Because of these avoidable problems, the baby cannot get enough breast milk, and mothers' postpartum comfort decreases.

This study aimed to investigate the effect of reflexology on lactation and postpartum comfort in primiparas giving births through cesarean section.

Detailed description: Methods: This randomized controlled trial was conducted with 100 women with first birth through cesarean section were investigated between May 2016 and May 2017. Expectant mothers were randomly included into an intervention and a control group. The intervention group consisted of mothers for whom reflexology was performed three times per day for 30 min every eight hours.

With face-to-face interviews, all participants were informed about the design, content and methods to be used in the study, and the sociodemographic data obtained self-reportingly from the primiparas were recorded. The data were collected between May 2016 and May 2017. In collecting the data related to primiparas and infants, a questionnaire structured by the researchers in light of literature was used, as well as The breastfeeding charting system (LATCH), The visual analogue scale (VAS) for signs of onset of lactation and The postpartum comfort questionnaire (PPCQ).

Eligibility criteria: Inclusion Criteria:

* primiparas delivering through CS,
* at the age of 18 and over,
* at ≤37 gestational weeks
* with one-fetus birth,
* with stable vital signs,
* those delivering under general anesthesia,
* except for CS and spinal/epidural anesthesia,
* with ability of communication in Turkish, and those accepting to participate into the study voluntarily.

Exclusion Criteria:

* primiparas with infectious diseases such as shingles, fungus, eczema, warts and callus in the intervention group,
* those with local infections like abscess,
* open lesion/wound, scar tissue, edema, hematoma, thrombophlebitis, deep vein thrombosis, coagulopathy, mass, varicosis, deformities on toes, recent fractures or dislocations, tearing of fascia and tendons,
* and with psychiatric disorders such as anxiety and depression, were excluded out of the study.

Primary outcomes:
measure: The breastfeeding charting system (LATCH)
timeFrame: Change from The breastfeeding charting system (LATCH) scores at first, second and third days after cesarean.
measure: The visual analogue scale (VAS) for signs of onset of lactation
timeFrame: Change from The visual analogue scale (VAS) for signs of onset of lactation scores at first, second and third days after cesarean
measure: The postpartum comfort questionnaire (PPCQ)
timeFrame: At the end of 3rd day, The postpartum comfort questionnaire (PPCQ) was performed for all mothers.
Secondary outcomes:
Other outcomes:
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