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

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: Healthy; Nursing Caries
• Intervention / Treatment: Other: reflexology

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

Study Locations

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

Participation Criteria

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

How is the study designed?

Design Details

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

Number of Arms

2

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).	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

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

Study record dates

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: Nurse; fatigue; sleep; postmenopausal women; reflexology
• Additional Relevant MeSH Terms: Fatigue
• 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