The Effect of Health Education and Progressive Muscle Relaxation Exercise on Vasomotor Symptoms and Sleep Problems With Perimenopausal Women

NCT04808232 | Completed

• 1 other identifier: 168846
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to determine the effect of health education and progressive muscle relaxation exercise (PMRE) on vasomotor symptoms and sleep problems in women with perimenopausal period; a randomized, pretest-posttest is a randomized controlled, factorial group experimental study. The research was conducted in a family health center. The required institutional permission and ethics committee approval was received. The sample consisted of 90 women totally, 30 of whom in the PMRE + health education group, 30 of whom in the PMRE group and 30 of whom in the control group. The data was collected using personal information form, Visual Analog Scale for Vasomotor Symptoms (VAS), Women's Health Initiative Insomnia Rating Scale-WHIIRS, vasomotor symptom diary, progressive muscle relaxation exercise follow-up schedule, and health education practice follow-up schedule. The data were stored in the SPSS 24 program. In the analysis of the data, ANOVA test, Repeated Measures test, Kruskal-Wallis H test, Friedman test and χ2 test statistics were used.

Conditions

Vasomotor Symptoms; Hot Flashes; Sleep Problem

Keywords

Vasomotor symptoms,; sleep problems,; health education,; progressive muscle relaxation exercise

Outcome Measures

Primary Outcomes (6)

• daily night sweats frequency

  daily night sweats frequency

  9 weeks

• daily hot flashes frequency

  daily hot flashes frequency

  9 weeks

• mean VAS score for hot flashes and night sweats

  mean VAS score for hot flashes and night sweats

  9 weeks

• the mean sweating VAS score

  the mean sweating VAS score

  9 weeks

• mean daily hot flash and night sweats severity score

  mean daily hot flash and night sweats severity score

  9 weeks

• Women's Health Initiative Insomnia Scale mean score

  Women's Health Initiative Insomnia Scale mean score

  9 weeks

Study Arms (3)

health education and progressive muscle relaxation exercise

EXPERIMENTAL

Health education and progressive muscle relaxation exercise training was given to women in this group.

Behavioral: progressive muscle relaxation exercise

progressive muscle relaxation exercise

EXPERIMENTAL

Progressive muscle relaxation exercise training was given to women in this group.

Behavioral: progressive muscle relaxation exercise

Control group

NO INTERVENTION

women in this group were not intervened.

Interventions

progressive muscle relaxation exercise BEHAVIORAL

We used "the muscle relaxation audio CD" produced by the Turkish Psychologists Association. The CD consists of three parts; the 10-min first part includes definition and purpose of relaxation, and points to take into consideration during relaxation, the 30-min second part includes instructions with river sounds, and the 30-min third part includes only relaxing music without instructions. We used the second part of the audio record in this study. Following the instructions on the CD, the students tensed each muscle group from hands to feet, and then, all muscles in their face and body for approximately 10 s. The women breathed in, tensed a specific muscle group, and then relaxed it while breathing out. The relaxation step took 10-20 s before tensing the next muscle group. Thus, the women relaxed by tensing and relaxing the muscle groups in hands, arms, neck, shoulder, chest, stomach, hips, foot and fingers, and all muscles in the face and body.

Also known as: health education

health education and progressive muscle relaxation exercise; progressive muscle relaxation exercise

Eligibility Criteria

• Age: 40 Years - 55 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Being in the perimenopausal period according to the Staging of Reproductive Aging in Women (STRAW) criteria,
• Women in the early menopause transition phase (STRAW -2). In these women, there is a variation in the duration of the cycles for 7 days or more.
• Women in the late menopausal transition phase (STRAW -1). These women have amenorrhea that lasts 60 days or longer.
• Having entered natural menopause,
• Not receiving hormone replacement therapy in the past and / or currently,
• Not having a diagnosed psychiatric disease,
• Not using alcohol,
• Not using sleeping pills,
• Not doing any other body-mind based practice (meditation, hypnosis, yoga, mindfulness techniques-minfulness, guided imagery technique), Not having a disease that may cause sleep problems and vasomotor symptoms and not receiving medical treatment (thyroid diseases, heart failure, neurological disorders),
• Women health initiative insomnia scale score above 10,
• VAS severity score above 3 for vasomotor synptomes,
• Number of moderate and severe hot flashes over 3 a day,
• To have a smart mobile phone (IOS and Android) and to be using it effectively

You may not qualify if:

• Failure to communicate by calling 3 times on different days during the follow-up and the woman not returning to the phone call
• Woman not applying PMRE and health education at most 3 times a week
• The woman leaves the research voluntarily.

Sponsors & Collaborators

• Sidika Pelit Aksu: lead

Study Sites (1)

Sıdıka PELİT AKSU

Ankara, Turkey/Ankara, 06500, Turkey (Türkiye)

Location

Related Publications (1)

• Pelit Aksu S, Senturk Erenel A. Effects of health education and progressive muscle relaxation on vasomotor symptoms and insomnia in perimenopausal women: A randomized controlled trial. Patient Educ Couns. 2022 Nov;105(11):3279-3286. doi: 10.1016/j.pec.2022.07.015. Epub 2022 Jul 28.

  PMID: 35961801 DERIVED

MeSH Terms

Conditions

Hot Flashes; Parasomnias; Health Education

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders; Adherence Interventions; Medication Adherence; Patient Compliance; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Research asistant (RN)

Study Record Dates

• First Submitted: March 13, 2021
• First Posted: March 22, 2021
• Study Start: February 17, 2019
• Primary Completion: January 23, 2020
• Study Completion: April 2, 2020
• Last Updated: May 11, 2021

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)