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

Pain, Postoperative Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04924439
• Other study ID #: reflexology and cesarean
• Status: Completed
• Phase: N/A
• Start date: January 1, 2020
• Est. completion date: January 31, 2021

Study information

• Verified date: June 2021
• Source: University of Gaziantep
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: January 31, 2021
• Est. primary completion date: January 31, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 19 Years to 35 Years

Eligibility

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

Related Conditions & MeSH terms

• Breast Feeding
• Fatigue
• Pain, Postoperative
• Sleep

Intervention

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.

Locations

Country	Name	City	State
Turkey	Gaziantep University Health Sciences Enstitutes	Gaziantep

Sponsors (1)

Lead Sponsor	Collaborator
University of Gaziantep

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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. ]
Primary	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. ]
Primary	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 Agargün et al. (1996), Cronbach's a 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. ]
Primary	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. ]