NCT05483413

Brief Summary

The population of the study will be postmenopausal women who applied to the KETEM unit of a hospital in western Turkey for examination. This study is a two-group randomized controlled study.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
63

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2022

Shorter than P25 for not_applicable

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 15, 2022

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 15, 2022

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

July 19, 2022

Completed
14 days until next milestone

First Posted

Study publicly available on registry

August 2, 2022

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 15, 2022

Completed
Last Updated

February 16, 2023

Status Verified

June 1, 2022

Enrollment Period

4 months

First QC Date

July 19, 2022

Last Update Submit

February 14, 2023

Conditions

Keywords

postmenopausal periodfatiguesleep qualityprogressive relaxation exercise

Outcome Measures

Primary Outcomes (2)

  • Change in fatugue

    At the end of 8 weeks of progressive relaxation exercises, change in fatigue

    8-week process.

  • Change in sleep quality

    At the end of 8 weeks of progressive relaxation exercises, change in sleep quality

    8-week process.

Study Arms (2)

Progressive Relaxation Exercises

EXPERIMENTAL

Progressive relaxation exercises will be applied to this group for 8 weeks.

Behavioral: progressive relaxation exercises

Standard of Care

NO INTERVENTION

This group will continue their routine coping habits against sleep and fatigue problems in the postmenopausal period for 8 weeks.

Interventions

Progressive relaxation exercises are a cognitive behavioral technique that provides relaxation in the muscles that individuals can do alone.

Progressive Relaxation Exercises

Eligibility Criteria

Age40 Years - 65 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Being in the postmenopausal period,
  • Agreeing to participate in the research,
  • Being able to read and write,
  • Those experiencing high levels of fatigue
  • Women with poor sleep quality

You may not qualify if:

  • Experiencing menopause due to surgery, pharmacological reasons,
  • Not being willing to participate in the study,
  • Presence of any communication problems,
  • Being in premenopause and perimenopause period.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kütahya Health Science University

Kütahya, 43000, Turkey (Türkiye)

Location

MeSH Terms

Conditions

FatigueSleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Signs and SymptomsPathological Conditions, Signs and SymptomsSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System DiseasesMental Disorders

Study Officials

  • Elif Tuğçe ÇİTİL, PhD

    Kütahya Health Science University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: randomized controlled
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 19, 2022

First Posted

August 2, 2022

Study Start

February 15, 2022

Primary Completion

June 15, 2022

Study Completion

September 15, 2022

Last Updated

February 16, 2023

Record last verified: 2022-06

Locations