The Effect of Reflexology on Sleep Quality and Fatigue in Postmenopausal Women

July 8, 2020 updated by: Leyla ZENGİN AYDIN, Dicle University

The Effect of Reflexology on Sleep Quality and Fatigue in Postmenopausal Women: A Randomized Control Trial

Introduction: This study was conducted to determine the effect of reflexology on sleep quality and fatigue in postmenopausal women.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This study was conducted in Batıkent Family Health Center of the Ministry of Health between May-December 2018. The sample of the study consisted of 72 postmenopausal women. The data were collected by using the Introductory Information Form, Pittsburgh Sleep Quality Index and Fatigue Severity Scale. A total of 12 reflexology sessions were applied to the postmenopausal women by the researcher twice a week. No intervention was applied to the postmenopausal women in the control group.

Study Type

Interventional

Enrollment (Actual)

72

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
    • Sur
      • Diyarbakır, Sur, Turkey, 21280
        • Leyla ZENGİN AYDIN

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • able to communicate,
  • aged 50 to 65,

Exclusion Criteria:

  • taking hormone replacement therapy,
  • chronic diseases (such as diabetes, hypertension, and so on),
  • psychiatric disease,
  • diagnosed with a sleep disorder attributed to other cause
  • menstruation for more than one year
  • history of alcohol or drug addiction

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Reflexology
Reflexology Application: A total of twelve 30-minute reflexology sessions (2 per week)were administered to each patient.
Other: reflexology
Reflexology is the stimulation of the reflex points in the hands and feet by massage, designed to provide relaxation and relief in the body.
No Intervention: No intervention
No intervention was applied to the postmenopausal women in the control group.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Reflexology Application, Pre-tests applied Pittsburgh Sleep Quality Index (PSQI), and Fatigue Severity Scale (FSS).
Time Frame: first week
A PSQI score of 5 or higher indicates poor sleep quality. A mean total score on the FSS of four and above indicates chronic fatigue.
first week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Dicle University

Investigators

  • Principal Investigator: Leyla ZENGİN AYDIN, Dicle University, Diyarbakır, Turkey. 21100/Diyarbakır

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2018

Primary Completion (Actual)

December 30, 2018

Study Completion (Actual)

September 28, 2019

Study Registration Dates

First Submitted

June 24, 2020

First Submitted That Met QC Criteria

July 8, 2020

First Posted (Actual)

July 13, 2020

Study Record Updates

Last Update Posted (Actual)

July 13, 2020

Last Update Submitted That Met QC Criteria

July 8, 2020

Last Verified

July 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LZA2018/4

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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