NCT04467645

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
72

participants targeted

Target at P75+ for not_applicable healthy

Timeline
Completed

Started May 2018

Typical duration for not_applicable healthy

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2018

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2018

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 28, 2019

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

June 24, 2020

Completed
19 days until next milestone

First Posted

Study publicly available on registry

July 13, 2020

Completed
Last Updated

July 13, 2020

Status Verified

July 1, 2020

Enrollment Period

8 months

First QC Date

June 24, 2020

Last Update Submit

July 8, 2020

Conditions

Keywords

Nursepostmenopausal womensleepreflexologyfatigue

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

EXPERIMENTAL

Reflexology Application: A total of twelve 30-minute reflexology sessions (2 per week)were administered to each patient.

Other: reflexology

No intervention

NO INTERVENTION

No 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.

Reflexology

Eligibility Criteria

Age50 Years - 65 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

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

Study Sites (1)

Leyla ZENGİN AYDIN

Diyarbakır, Sur, 21280, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Fatigue

Interventions

Musculoskeletal Manipulations

Condition Hierarchy (Ancestors)

Signs and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Complementary TherapiesTherapeuticsPhysical Therapy ModalitiesRehabilitation

Study Officials

  • Leyla ZENGİN AYDIN

    Dicle University, Diyarbakır, Turkey. 21100/Diyarbakır

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
CARE PROVIDER
Purpose
SUPPORTIVE CARE
Intervention Model
CROSSOVER
Model Details: 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
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

Locations