Effects of Reflexology on Postpartum Pain, Fatigue, Sleep Quality and Lactation

Effects Reflexology on Postpartum Pain, Fatigue, Sleep Quality and Lactation

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.

Study Overview

• Status: Completed
• Conditions: Pain, Postoperative; Fatigue; Sleep; Breast Feeding
• Intervention / Treatment: Other: foot reflexology

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

• Study Type: Interventional
• Enrollment (Actual): 80
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Gaziantep, Turkey, 27000
    • Gaziantep University Health Sciences Enstitutes

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 35 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: experimental group (foot reflexology group); Primiparas appropriate for the criteria, admitted to the clinic due to CS and accepting to participate in the study were randomly placed into groups. Reflexology was performed in the intervention group mothers, and the questionnaires and scales were self-reportingly filled in by the lead researcher (SC). Different rooms were allocated for the participants in the intervention and control groups not to affect each other. Foot reflexology was applied to the experimental group for 40 minutes once a week for postpartum 8 weeks.	Other: foot reflexology; Foot reflexology was applied to the experimental group for 40 minutes once a week for postpartum 8 weeks. The control group was only watched.
No Intervention: control group; Primiparas appropriate for the criteria, admitted to the clinic due to CS and accepting to participate in the study were randomly placed into groups. Reflexology was performed in the intervention group mothers, and the questionnaires and scales were self-reportingly filled in by the lead researcher (SC). Different rooms were allocated for the participants in the intervention and control groups not to affect each other.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Visual Analogue Scale (VAS)	The scale developed by Huskisson (1974) is used for pain assessment in musculoskeletal system and other clinical assessments. VAS is used to convert some values that cannot be measured numerically to numeric. It is a frequently used measurement tool because it is easy and safe to apply. The words "I have no pain" on the left end of the 10 cm long horizontal line and "I have pain" on the right end. The individual is asked to mark the point on this horizontal line that best expresses the severity of pain in his body. The distance from the point marked by the individual to the left end is measured and the pain score is determined. It is evaluated that the severity of the pain increases as the VAS value approaches 10, and decreases as it approaches 0. The lowest 0 and the highest 10 points are taken from the scale.	Change from Visual Analogue Scale (VAS) scores at first, second, third, fourth, fifth, sixth, seventh and eighth week after cesarean. ]
Visual Similarity Scale for Fatigue (YSSF)	It is in the form of a 10 cm ruler with the most positive statements on one end of the scale and the most negative statements on the other. The most positive expression of the fatigue sub-dimension is 0, the most negative expression is 10, the most negative expression of the energy sub-dimension is 0, and the most positive expression is 10. A high score of the fatigue sub-dimension and a low score of the energy sub-dimension indicate a high severity of fatigue. The calculation method of the scale is determined by adding up all the scores obtained from the scale items. The lowest score for YSSF is 0, and the highest score is 180. The lowest score for the YSSF fatigue sub-dimension is 0, and the highest score is 130. The lowest score is 0 for the energy sub-dimension of YSSF and the highest score is 50. The scale does not have a cut-off point.	Change from Visual Similarity Scale for Fatigue (YSSF) scores at first, second, third, fourth, fifth, sixth, seventh and eighth week after cesarean. ]
Pittsburg Sleep Quality Index (PSQI)	In order to evaluate the sleep quality in the last month, Buysse et al. (1989) is a quantitative measure of sleep quality as good and bad sleep. Its Turkish adaptation was done by Ağargün et al. (1996), Cronbach's α internal consistency coefficient is 0.80. It consists of a total of 24 questions and 7 sub-components. 18 items and 7 sub-components are included in the scoring. Each item is evaluated as 0-3 points and the sum of 7 sub-components forms the PSQI score. The lowest score of the scale is 0 and the highest score is 21. A total PSQI score of ≤5 indicates good sleep, and >5 indicates poor sleep.	Change from Pittsburg Sleep Quality Index (PSQI) scores at first, fourth and eighth week after cesarean. ]
Bristol Breastfeeding Assessment Tool (BBAT)	Each item in the scoring of the scale is between 0-2 points. The calculation method is the sum of all scores obtained from the scale items. The lowest score obtained from the scale is 0, and the highest score is 8. The scale does not have a breakpoint. A low score indicates that breastfeeding is ineffective, and a high score indicates that breastfeeding is effective.	Change from Bristol Breastfeeding Assessment Tool (BBAT) scores at first, second, third, fourth, fifth, sixth, seventh and eighth week after cesarean. ]

Collaborators and Investigators

• Sponsor: University of Gaziantep
• Investigators: Study Director: simge zeyneloğlu, proffessor, GAZİANTEP UNİVERSİTY CLINICAL RESEARCH ETHICS COMMITTE

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2020
• Primary Completion (Actual): January 31, 2021
• Study Completion (Actual): January 31, 2021

Study Registration Dates

• First Submitted: June 3, 2021
• First Submitted That Met QC Criteria: June 6, 2021
• First Posted (Actual): June 14, 2021

Study Record Updates

• Last Update Posted (Actual): June 14, 2021
• Last Update Submitted That Met QC Criteria: June 6, 2021
• Last Verified: June 1, 2021

More Information

Terms related to this study

• Keywords: pain; fatigue; postpartum; lactation; sleep quality; reflexology
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative; Fatigue
• Other Study ID Numbers: reflexology and cesarean

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No