The Effect of Reflexology on Sleep Quality and Fatigue in Postmenopausal Women
1 other identifier
interventional
72
1 country
1
Brief Summary
Introduction: This study was conducted to determine the effect of reflexology on sleep quality and fatigue in postmenopausal women.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable healthy
Started May 2018
Typical duration for not_applicable healthy
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 30, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
September 28, 2019
CompletedFirst Submitted
Initial submission to the registry
June 24, 2020
CompletedFirst Posted
Study publicly available on registry
July 13, 2020
CompletedJuly 13, 2020
July 1, 2020
8 months
June 24, 2020
July 8, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Study Arms (2)
Reflexology
EXPERIMENTALReflexology Application: A total of twelve 30-minute reflexology sessions (2 per week)were administered to each patient.
No intervention
NO INTERVENTIONNo intervention was applied to the postmenopausal women in the control group.
Interventions
Reflexology is the stimulation of the reflex points in the hands and feet by massage, designed to provide relaxation and relief in the body.
Eligibility Criteria
You may qualify if:
- able to communicate,
- aged 50 to 65,
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Dicle Universitylead
Study Sites (1)
Leyla ZENGİN AYDIN
Diyarbakır, Sur, 21280, Turkey (Türkiye)
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Leyla ZENGİN AYDIN
Dicle University, Diyarbakır, Turkey. 21100/Diyarbakır
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- CARE PROVIDER
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor
Study Record Dates
First Submitted
June 24, 2020
First Posted
July 13, 2020
Study Start
May 1, 2018
Primary Completion
December 30, 2018
Study Completion
September 28, 2019
Last Updated
July 13, 2020
Record last verified: 2020-07