Back to resultsThe Effect of Reflexology on Sleep Quality and Fatigue in Postmenopausal Women
Primary Purpose
Healthy, Nursing Caries
Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
reflexology
Sponsored by
About this trial
This is an interventional supportive care trial for Healthy focused on measuring Nurse, postmenopausal women, sleep, reflexology, fatigue
Eligibility Criteria
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
Sites / Locations
- Leyla ZENGİN AYDIN
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Reflexology
No intervention
Arm Description
Reflexology Application: A total of twelve 30-minute reflexology sessions (2 per week)were administered to each patient.
No intervention was applied to the postmenopausal women in the control group.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04467645
Brief Title
The Effect of Reflexology on Sleep Quality and Fatigue in Postmenopausal Women
Official Title
The Effect of Reflexology on Sleep Quality and Fatigue in Postmenopausal Women: A Randomized Control Trial
Study Type
Interventional
2. Study Status
Record Verification Date
July 2020
Overall Recruitment Status
Completed
Study Start Date
May 1, 2018 (Actual)
Primary Completion Date
December 30, 2018 (Actual)
Study Completion Date
September 28, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Dicle University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Introduction: This study was conducted to determine the effect of reflexology on sleep quality and fatigue in postmenopausal women.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Healthy, Nursing Caries
Keywords
Nurse, postmenopausal women, sleep, reflexology, fatigue
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
This study was conducted as a pretest-posttest trial model with a control group in order to determine the effect of reflexology applications on sleep quality and fatigue in postmenopausal women
Masking
Care Provider
Allocation
Randomized
Enrollment
72 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Reflexology
Arm Type
Experimental
Arm Description
Reflexology Application: A total of twelve 30-minute reflexology sessions (2 per week)were administered to each patient.
Arm Title
No intervention
Arm Type
No Intervention
Arm Description
No intervention was applied to the postmenopausal women in the control group.
Intervention Type
Other
Intervention Name(s)
reflexology
Intervention Description
Reflexology is the stimulation of the reflex points in the hands and feet by massage, designed to provide relaxation and relief in the body.
Primary Outcome Measure Information:
Title
Reflexology Application, Pre-tests applied Pittsburgh Sleep Quality Index (PSQI), and Fatigue Severity Scale (FSS).
Description
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.
Time Frame
first week
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Leyla ZENGİN AYDIN
Organizational Affiliation
Dicle University, Diyarbakır, Turkey. 21100/Diyarbakır
Official's Role
Principal Investigator
Facility Information:
Facility Name
Leyla ZENGİN AYDIN
City
Diyarbakır
State/Province
Sur
ZIP/Postal Code
21280
Country
Turkey
12. IPD Sharing Statement
Learn more about this trial
The Effect of Reflexology on Sleep Quality and Fatigue in Postmenopausal Women
We'll reach out to this number within 24 hrs