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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04467645
Other study ID # LZA2018/4
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date May 1, 2018
Est. completion date September 28, 2019

Study information

Verified date July 2020
Source Dicle University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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


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.


Recruitment information / eligibility

Status Completed
Enrollment 72
Est. completion date September 28, 2019
Est. primary completion date December 30, 2018
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 50 Years to 65 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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.

Locations

Country Name City State
Turkey Leyla ZENGIN AYDIN Diyarbakir Sur

Sponsors (1)

Lead Sponsor Collaborator
Dicle University

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
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