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

Primary Purpose

Breast Feeding, Fatigue, Sleep

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
foot reflexology
Sponsored by
University of Gaziantep
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Breast Feeding focused on measuring fatigue, lactation, pain, postpartum, sleep quality, reflexology

Eligibility Criteria

19 Years - 35 Years (Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • Gaziantep University Health Sciences Enstitutes

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

experimental group (foot reflexology group)

control group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.
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.
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.
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.

Secondary Outcome Measures

Full Information

First Posted
June 3, 2021
Last Updated
June 6, 2021
Sponsor
University of Gaziantep
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1. Study Identification

Unique Protocol Identification Number
NCT04924439
Brief Title
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

2. Study Status

Record Verification Date
June 2021
Overall Recruitment Status
Completed
Study Start Date
January 1, 2020 (Actual)
Primary Completion Date
January 31, 2021 (Actual)
Study Completion Date
January 31, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Gaziantep

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Feeding, Fatigue, Sleep, Pain, Postoperative
Keywords
fatigue, lactation, pain, postpartum, sleep quality, reflexology

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
randomized controlled trial
Masking
ParticipantOutcomes Assessor
Masking Description
Small papers with 40 experiments and 40 controls were folded and put into closed, sealed, opaque envelopes, then all the envelopes were put in a bag and mixed. The women were asked to choose one envelope from the bag, and it was determined whether the experimental or control group they were included in before the application. The women in the study did not know which of the experimental and control groups they were included in, and the statistical analysis was planned double-blind, as an independent statistician apart from the researchers did it. Statistical analysis of the research was carried out independently by a statistician.
Allocation
Randomized
Enrollment
80 (Actual)

8. Arms, Groups, and Interventions

Arm Title
experimental group (foot reflexology group)
Arm Type
Experimental
Arm Description
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.
Arm Title
control group
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
foot reflexology
Intervention Description
Foot reflexology was applied to the experimental group for 40 minutes once a week for postpartum 8 weeks. The control group was only watched.
Primary Outcome Measure Information:
Title
Visual Analogue Scale (VAS)
Description
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.
Time Frame
Change from Visual Analogue Scale (VAS) scores at first, second, third, fourth, fifth, sixth, seventh and eighth week after cesarean. ]
Title
Visual Similarity Scale for Fatigue (YSSF)
Description
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.
Time Frame
Change from Visual Similarity Scale for Fatigue (YSSF) scores at first, second, third, fourth, fifth, sixth, seventh and eighth week after cesarean. ]
Title
Pittsburg Sleep Quality Index (PSQI)
Description
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.
Time Frame
Change from Pittsburg Sleep Quality Index (PSQI) scores at first, fourth and eighth week after cesarean. ]
Title
Bristol Breastfeeding Assessment Tool (BBAT)
Description
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.
Time Frame
Change from Bristol Breastfeeding Assessment Tool (BBAT) scores at first, second, third, fourth, fifth, sixth, seventh and eighth week after cesarean. ]

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
simge zeyneloğlu, proffessor
Organizational Affiliation
GAZİANTEP UNİVERSİTY CLINICAL RESEARCH ETHICS COMMITTE
Official's Role
Study Director
Facility Information:
Facility Name
Gaziantep University Health Sciences Enstitutes
City
Gaziantep
ZIP/Postal Code
27000
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No

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

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