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

NCT ID: NCT04924439

Last Updated: 2021-06-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-01-01

Study Completion Date

2021-01-31

Brief Summary

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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

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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

Conditions

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Breast Feeding Fatigue Sleep Pain, Postoperative

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

randomized controlled trial
Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

DOUBLE

Participants Outcome Assessors
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.

Study Groups

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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.

Group Type EXPERIMENTAL

foot reflexology

Intervention Type OTHER

Foot reflexology was applied to the experimental group for 40 minutes once a week for postpartum 8 weeks. The control group was only watched.

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

19 Years

Maximum Eligible Age

35 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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University of Gaziantep

OTHER

Sponsor Role lead

Responsible Party

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Aysegul Kilicli

Nursing

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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simge zeyneloğlu, proffessor

Role: STUDY_DIRECTOR

GAZİANTEP UNİVERSİTY CLINICAL RESEARCH ETHICS COMMITTE

Locations

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Gaziantep University Health Sciences Enstitutes

Gaziantep, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Other Identifiers

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reflexology and cesarean

Identifier Type: -

Identifier Source: org_study_id

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