Effect of Progressive Muscle Relaxation Exercises in Menopausal Women Experiencing RLS.

NCT06156007 | Completed DMC

• 1 other identifier: menopause
• Study Type: interventional
• Target: 62
• Locations: 1 country
• Sites: 1

Brief Summary

Restless legs syndrome is a symptom that can be seen in all stages of a woman's life, but its frequency and severity increases with menopause. Restless legs syndrome is a neurological problem that occurs usually at night with an irresistible urge to move the legs. It is a progressive muscle relaxation exercise. Progressive muscle relaxation exercise is a systematic practice aimed at providing deep relaxation by exercising large muscle groups in the body along with breathing techniques. This study aims to evaluate the effect of progressive muscle relaxation exercise on the severity of restless legs syndrome, quality of life and sleep quality related to restless legs syndrome in menopausal women with restless legs syndrome.

Conditions

Restless Legs Syndrome

Keywords

restless legs syndrome; menopause; progressive muscle relaxation exercises

Outcome Measures

Primary Outcomes (3)

• Restless Legs Syndrome Severity

  Measurements will be made using the RLS Severity Rating Scale. A total score is obtained, with the entire score range varying between 0 and 40; A score between 1-10 indicates mild disease, a score between 11-20 indicates moderate disease, a score between 21-30 indicates severe disease, and a score between 31-40 indicates very severe disease.

  Change from Baseline RLS Severity at 8 weeks

• Quality of life associated with restless legs syndrome

  Measurements will be made using the Johns Hopkins Restless Leg Syndrome Quality of Life Scale. The lowest score from the scale is 0 and the highest score is 100. As the score obtained from the scale decreases, it indicates that the quality of life associated with restless legs syndrome is poor.

  Change from Baseline Quality of Life at 8 weeks

• Quality of sleep associated with restless legs syndrome

  Measurements will be made using the Pittsburg Sleep Quality Index.A high total score indicates poor sleep quality. Total score is between 0-21. The index does not indicate the presence or frequency of sleep disturbances. However, a PSQI total score of 5 or above indicates poor sleep quality. The cut-off score indicating poor sleep quality is accepted as 5.

  Change from Baseline Quality of Life at 8 weeks

Study Arms (2)

progressive muscle relaxation exercises

EXPERIMENTAL

Women will be given one-time progressive muscle relaxation exercise training prepared by the researcher. In the training, the exercise will be demonstrated through demonstration method. Following training, women will be asked to perform progressive relaxation exercise at least 3 times a week (every other day). Women will be followed for 8 weeks with a progressive muscle relaxation exercise daily follow-up chart prepared by the researcher, and weekly reminders will be made (via WhatsApp® or text message). The final test will be administered to women online at the end of 8 weeks. RLS Severity Rating Scale form, Johns Hopkins Restless Legs Syndrome Quality of Life Scale and Pittsburg Sleep Quality Index will be used in the pre-test and post-test applications.

Behavioral: progressive muscle relaxation exercises

no intervention

NO INTERVENTION

No intervention will be applied to women. Posttest application to women; It will be conducted online 8 weeks after the pre-test application. RLS Severity Rating Scale form, Johns Hopkins Restless Legs Syndrome Quality of Life Scale and Pittsburg Sleep Quality Index will be used in the pre-test and post-test applications.

Interventions

progressive muscle relaxation exercises BEHAVIORAL

Progressive muscle relaxation exercises (PKGE); 16 large muscles (right hand and forearm, right upper arm, left hand and forearm of left arm, left upper arm, forehead, upper cheek and nose, chin, neck, abdomen, upper right arm, which people can do on their own after learning) leg, right calf, right foot, left upper leg, left thigh and left foot), followed by the contraction and then relaxation and accompanied by deep breathing, is a preferred method for reducing pain, anxiety and depression in individuals.The relaxation will be required to take 10-20 before stretching the next muscle group. In this way, the muscle groups in the hands, arms, neck, shoulder, chest, abdomen, hips, feet and fingers, face and the whole body will be voluntarily stretched and relaxed, and pregnant women will be relieved.

progressive muscle relaxation exercises

Eligibility Criteria

• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Having entered natural menopause
• At least 1 year has passed since the last menstrual period
• Not having any psychiatric disease
• Not having any communication problems (mental, auditory, visual, etc.)

You may not qualify if:

• Women not performing post-test applications
• Not doing progressive muscle relaxation exercises twice in a row.
• Wants to quit the research.
• The woman is hospitalized
• Inability to reach women during follow-ups

Sponsors & Collaborators

• Gazi University: lead

Study Sites (1)

Karabük Training and Research Hospital

Karabük, Karabük Province, 78050, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Restless Legs Syndrome

Condition Hierarchy (Ancestors)

Nervous System Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Parasomnias; Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: assistant professor doctor

Model Details: The research was planned as a single-center, parallel randomized controlled experimental study with stratified randomization (mild-moderate, severe-very severe) and pretest-posttest control group.

Study Record Dates

• First Submitted: November 26, 2023
• First Posted: December 5, 2023
• Study Start: December 25, 2023
• Primary Completion: May 30, 2024
• Study Completion: May 30, 2024
• Last Updated: September 26, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR

Locations

TU (1)