Progressive Relaxation Exercise, Menopausal Symptoms and Working Performance

NCT07085078 | Enrolling By Invitation

• 1 other identifier: 18/17
• Study Type: interventional
• Target: 106
• Locations: 1 country
• Sites: 2

Brief Summary

Women typically enter menopause between the ages of 40 and 47, and they spend approximately one-third of their lives in this phase. During menopause, many experience hot flashes due to decreased estrogen levels, along with vasomotor changes such as altered heart rhythms and sleep disturbances. These issues may accompany or occur independently of hot flashes. Additionally, psychological changes can arise, including tension, sudden mood swings, anxiety, stress, and depression. Physiological concerns may include vaginal atrophy and stress incontinence.

Conditions

Menopause; Menopause Related Conditions

Keywords

menophose; work performance; progressive relaxation; menopausal symptoms

Outcome Measures

Primary Outcomes (3)

• Personal information form before intervention

  Evaluation of women using personal information. This tool includes questions on women's sociodemographic characteristics

  Day 1 (During recruitment)

• Before intervention, menopausal symptoms

  Evaluation of menopausal symptoms with Menopause Rating Scale (MRS). It is a Likert-type scale consisting of 11 items, including menopausal complaints. For each item, there are options of "0= None", "1= Mild", "2= Moderate", "3= Severe", and "4= Very severe". The lowest possible score is 0, the highest score is 44. An increase in the total score obtained from the scale indicates an increase in the severity of the complaints experienced.

  Day 1 (during recruitment)

• Before intervention, Individual work performance

  Before intervention, participants are evaluated with the "Individual Work Performance Questionnaire"The scale was designed to measure job performance perception. It consists of 18 Likert-type items. A high score on the scale indicates that job performance perception has increased.

  Day 1 (During recruitment)

Secondary Outcomes (2)

• After intervention, menopausal symptoms

  Ten days after the conclusion of the five-week training program.

• After intervention, Individual work performance

  Ten days after the conclusion of the five-week training program.

Study Arms (2)

Education

EXPERIMENTAL

Progressive relaxation exercis

Behavioral: progressive relaxation exercises

Control

NO INTERVENTION

Participants with menopausal symptoms assigned to the control group will not receive any intervention. They are expected to answer the scale questions used in the study.

Interventions

progressive relaxation exercises BEHAVIORAL

Participants with menopausal symptoms received progressive relaxation exercise training, led by the responsible researcher who assigned them to the experimental group.

Education

Eligibility Criteria

• Age: 45 Years - 65 Years
• Gender Eligibility Details: Female participants are eligible as menopausal symptoms will be assessed
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Being a woman between the ages of 45-65
• Being able to read and understand Turkish
• Being at least a primary school graduate
• Not having menstruation for a year

You may not qualify if:

• Having a disability in maintaining communication (such as hearing and speaking)
• Having entered early menopause (no menstruation) through surgery or natural means,
• Being on hormone therapy
• Filling out forms incompletely

Sponsors & Collaborators

• Aydin Adnan Menderes University: lead
• Uludag University: collaborator

Study Sites (2)

Bursa Uludağ Üniversitesi

Nilufer, Bursa, 16059, Turkey (Türkiye)

Location

Bursa Uludag University

Bursa, 16059, Turkey (Türkiye)

Location

Related Publications (2)

• O'Neill MT, Jones V, Reid A. Impact of menopausal symptoms on work and careers: a cross-sectional study. Occup Med (Lond). 2023 Sep 29;73(6):332-338. doi: 10.1093/occmed/kqad078.

  PMID: 37542726 RESULT

• Koopmans L, Bernaards CM, Hildebrandt VH, Lerner D, de Vet HC, van der Beek AJ. Cross-cultural adaptation of the Individual Work Performance Questionnaire. Work. 2015;53(3):609-19. doi: 10.3233/WOR-152237.

  PMID: 26835864 RESULT

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assoc. Prof.

Study Record Dates

• First Submitted: June 26, 2025
• First Posted: July 25, 2025
• Study Start: April 30, 2025
• Primary Completion: September 30, 2025
• Study Completion: December 30, 2025
• Last Updated: July 25, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: I have a plan to make IPD available. A data dictionary (a description of the variables or types of data collected for each individual) will be provided so that the data can be fully interpreted.
• Access Criteria: IPD and information will be accessible to researchers and institutional auditors who are assisting with the information. The types of analyses and methods for these analyses that are appropriate for data sharing do not need to be approved by independent review.

Locations

TU (2)