NCT05202054

Brief Summary

Menopause is the longest life stage in a woman's life, in which psychological and social changes are experienced as well as physical changes and some health problems occur. The symptoms of menopause develop due to varying degrees of somatic and psychological changes that occur as a result of the gradual loss of function of the ovaries. One of the most common and disturbing symptoms of menopause is sleep problems. Sleep is seen as an important health variable that affects an individual's quality of life and well-being. The need for sleep is included among the basic care problems by nursing theorists, and sleep-related problems are included as a nursing diagnosis in the nursing literature. In the literature, it has been stated that mindfulness stress reduction program reduces menopausal symptoms. Nurses should have knowledge about menopause and coping methods in the field. Although the number of studies examining the effect of mindfulness stress reduction program on insomnia, which is one of the menopausal complaints, is very few in the literature.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
192

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 22, 2021

Completed
2 months until next milestone

First Posted

Study publicly available on registry

January 21, 2022

Completed
2 months until next milestone

Study Start

First participant enrolled

April 3, 2022

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 3, 2022

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 29, 2023

Completed
Last Updated

April 11, 2023

Status Verified

April 1, 2023

Enrollment Period

8 months

First QC Date

November 22, 2021

Last Update Submit

April 7, 2023

Conditions

Postmenopausal Symptoms

Keywords

MenopauseSleepQUALITY OF LIFENURSING

Outcome Measures

Primary Outcomes (1)

  • women's health initiative insomnia scale

    Levine et al. (2003) the validity and reliability study of the scale in our country was done by Timur and Şahin (2009). The scale is a Likert type scale consisting of 5 questions. In the study of Timur and Şahin (2009), the Cronbach Alpha value was found to be 0.85.

    UP TO 16 WEEKS

Secondary Outcomes (1)

  • Menopause-Specific Quality of Life Scale

    up to 16 weeks

Study Arms (2)

The Effect of mindfulness stress reduction program on slepness and quality of life

EXPERIMENTAL

Groups of 20 will be formed for the implementation of the mindfulness stress reduction program in the experimental group. The BFSAP day and time will be determined by taking into account the time zones where women are available. 150 minutes of BFSAP will be applied to the women in the experimental group once a week, lasting 8 weeks and consisting of 8 times in total. The women will then be given a midterm test. After the midterm, women will be asked to individually repeat the BFSAP application in their own home for 8 weeks (weeks 8-16).

Other: mindfulness stress reduction program

control group

NO INTERVENTION

THESE PARTICIPANTS HAVE NOT BEEN APPLIED

Interventions

mindfulness stress reduction programOTHER

Before the program is implemented, in case women forget, they will be called and reminded of the training time, and they will be invited to the program. The women in the experimental group will be administered 150 minutes of BFSAP once a week, lasting 8 weeks, and consisting of 8 times in total. Afterwards, the women will be given an intermediate test. After the midterm test, women will be asked to individually repeat their BFSAP administration in their own home for 8 weeks (weeks 8-16).

The Effect of mindfulness stress reduction program on slepness and quality of life

Eligibility Criteria

Age50 Years - 70 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility Detailsonly the menopausal period
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • being able to read and write,
  • Not having a period for at least a year,
  • Not having any diagnosed psychiatric disease or not using medication,
  • Not using or not using hormone replacement therapy.

You may not qualify if:

  • To have entered menopause with surgical methods,
  • Not participating in at least two group programs.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

NURDİLAN

Elâzığ, 23100, Turkey (Türkiye)

Location

Related Publications (1)

  • Sener Cetin N, Nacar G, Timur Tashan S. The effect of mindfulness-based stress reduction program applied to postmenopausal women on insomnia and quality of life. Women Health. 2024 Aug;64(7):573-583. doi: 10.1080/03630242.2024.2382420. Epub 2024 Jul 28.

    PMID: 39069644DERIVED

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Model Details: PRETEST POSTTEST EXPERIMENTAL RANDOMIZED STUDY
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
principal investigator

Study Record Dates

First Submitted

November 22, 2021

First Posted

January 21, 2022

Study Start

April 3, 2022

Primary Completion

December 3, 2022

Study Completion

January 29, 2023

Last Updated

April 11, 2023

Record last verified: 2023-04

Locations

TU(1)