Clinical trial NCT06156007: Effect of Progressive Muscle Relaxation Exercises in Menopausal Women Experiencing RLS.
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Restless Legs Syndrome
Keywords: restless legs syndrome
menopause
progressive muscle relaxation exercises
Lead sponsor: Gazi University
Sponsor class: OTHER
First posted: 2023-12-05
Enrollment: 62
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Restless Legs Syndrome Severity
timeFrame: Change from Baseline RLS Severity at 8 weeks
measure: Quality of life associated with restless legs syndrome
timeFrame: Change from Baseline Quality of Life at 8 weeks
measure: Quality of sleep associated with restless legs syndrome
timeFrame: Change from Baseline Quality of Life at 8 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Karabük
country: Turkey
facility: Karabük Training and Research Hospital
Study officials:
References: