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

Sponsor
Gazi University (Other)
Overall Status
Recruiting
CT.gov ID
NCT06156007
Collaborator
(none)
62
1
2
9.2
6.8

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: progressive muscle relaxation exercises
N/A

Detailed Description

Menopause, which is a natural part of women's life; It is a condition that occurs between the ages of 45-52 on average and is characterized by hormonal changes and cessation of the menstrual cycle. Many symptoms are observed during menopause, such as hot flashes, sleep problems, mood disorders, sexual dysfunction, weight gain, and decline in cognitive functioning. Restless legs syndrome is another symptom that can be seen in all periods 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. There are studies reporting that sleep problems, which are a common problem during the menopausal period, worsen with the addition of restless legs syndrome. Restless legs syndrome and sleep problems are two important factors that negatively affect the quality of life of women in the menopausal period. Alternative and complementary therapies are frequently used among the methods used to cope with menopausal symptoms and symptoms triggered by menopause. These methods include hypnosis, body-mind techniques, cognitive behavioral therapies, aromatherapies, and herbal supplements. It is stated that these techniques reduce the stress of women in the menopausal period and are effective in improving their quality of life. One of these methods is progressive muscle relaxation exercise. Progressive muscle relaxation exercise is a systematic practice that aims to provide deep relaxation by exercising large muscle groups in the body along with breathing techniques. There are studies reporting that PCGE is used effectively in coping with menopausal symptoms. 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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
62 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
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.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.
Masking:
Single (Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Effect of Progressive Muscle Relaxation Exercise on RLS Severity, Quality of Life and Sleep Quality in Menopausal Women With Restless Legs Syndrome (RLS): A Randomized Controlled Study
Actual Study Start Date :
Aug 25, 2023
Anticipated Primary Completion Date :
May 30, 2024
Anticipated Study Completion Date :
May 30, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: progressive muscle relaxation exercises

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
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.

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.

Outcome Measures

Primary Outcome Measures

  1. Restless Legs Syndrome Severity [Change from Baseline RLS Severity at 8 weeks]

    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.

  2. Quality of life associated with restless legs syndrome [Change from Baseline Quality of Life at 8 weeks]

    Measurements will be made using the Johns Hopkins Restless Leg Syndrome Quality of Life Scale. Lower scores indicate worse quality of life.

  3. Quality of sleep associated with restless legs syndrome [Change from Baseline Quality of Life at 8 weeks]

    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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A and Older
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:

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.)

Exclusion Criteria:
  • 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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Karabük Training and Research Hospital Karabük Turkey 78050

Sponsors and Collaborators

  • Gazi University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Pinar Akbas, assistant professor doctor, Gazi University
ClinicalTrials.gov Identifier:
NCT06156007
Other Study ID Numbers:
  • menopause
First Posted:
Dec 5, 2023
Last Update Posted:
Dec 5, 2023
Last Verified:
Nov 1, 2023
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Pinar Akbas, assistant professor doctor, Gazi University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Dec 5, 2023