Viewing Study NCT04853771



Ignite Creation Date: 2024-05-06 @ 4:03 PM
Last Modification Date: 2024-10-26 @ 2:02 PM
Study NCT ID: NCT04853771
Status: COMPLETED
Last Update Posted: 2022-04-01
First Post: 2021-04-04

Brief Title: The Effect of Progressive Muscle Relaxation Exercise Training Given to Pregnant Women With Restless Leg Syndrome
Sponsor: Gazi University
Organization: Gazi University

Study Overview

Official Title: The Effect of Progressive Muscle Relaxation Exercise Training Given to Pregnant Women With Restless Leg Syndrome on Symptom Severity Sleep and Quality of Life
Status: COMPLETED
Status Verified Date: 2022-03
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief Summary: Restless Leg Syndrome RLS is a sensory-motor problem characterized by an uncomfortable and unpleasant feeling that causes a strong and overwhelming desire to move the legs usually during periods of inactivity during sleepIt is reported that pregnancy is an important risk factor in the onset and worsening of RLSIndividuals with RLS avoid social activities often experience psychiatric problems such as depression anxiety disorders and chronic sleep disorders Therefore restless leg syndrome significantly affects daily life and coping with these problems Individuals with RLS initially undertake a variety of non-pharmacological practices to relieve symptomsProgressive muscle relaxation exercises reducing the level of epinephrine and norepinephrine in the blood and heart rate reducing oxygen consumption regulating metabolic rate lowering blood pressure reducing muscle tension preventing fatigue and restlessness decreasing pain by increasing endorphin levels increasing coping with pain and stress It has many benefits such as improving sleep and quality of lifeThis study will be conducted to evaluate the effect of progressive muscle relaxation exercise training and follow-up given to pregnant women with restless leg syndrome on the severity of restless leg syndrome quality of life associated with restless legs syndrome and sleep quality
Detailed Description: Restless Leg Syndrome RLS is a sensory-motor problem characterized by an uncomfortable and unpleasant feeling that causes a strong and irresistible desire to move in the legs usually during periods of inactivity during sleep Depending on cultural environmental and genetic differences the prevalence of RLS is reported to be the highest in North America and Europe ranging from 55 to 116 and this prevalence is reported to be between 10 and 75 in Asia Turkey made society based on two studies in RLS prevalence of respectively 319 and 7 were found

HBS s with age e increases from and in women has been reported from two times higher than that seen in man The reason for its higher incidence in women has not been clearly explained but it has been thought to be related to hormonal changes during pregnancy menstruation and menopause In a systematic review and meta-analysis study it was reported that the prevalence of RLS in pregnant women worldwide is 21 and the symptoms are more common in the third trimester In our country g is reported to vary between midwives in HBS 19-26 incidence In the study conducted by Neyal et al 2015 in our country it was found that 156 in the first trimester of pregnancy 328 in the second trimester It is reported that RLS symptoms are observed with a rate of 388 in the third trimester and the symptoms continue at a rate of 348 after birth In the study conducted by Akbaş and Yaman Sözbir 2019 approximately half of the pregnant women 464 had RLS symptoms and the RLS severity mean score of pregnant women with RLS was found to be 2082 661 In the same study the HBS of 491 of women with severe and very Siddiqui has been determined that there is live meat that fell to the severity of RLS increases quality of life reported and un

Pregnancy is reported to be an important risk factor in the onset and worsening of RLS It has been proven that the dopaminergic system plays an important role in the pathogenesis of RLS Iron acts as a cofactor in the synthesis and formation of dopamine and normal dopamine production is impaired in iron deficiency It is reported that increased iron need and anemia during pregnancy triggers RLS and the problem gets worse in the third trimester of pregnancy In addition vitamin D and folate increase dopamine synthesis and are reported to be protective of dopaminargic neurons and the brain against metabolite toxins Studies have shown that iron folate and vitamin D deficiency cause restless leg syndrome In addition increasing estrogen progesterone and prolactin levels during pregnancy accelerate the appearance of symptoms especially in the third trimester It has been reported that estrogen inhibits the synthesis and release of dopamine during pregnancy and progesterone increases neuronal excitability leading to frequent hyper- reflexes and periodic leg movements and RLS during pregnancy After birth with the rapid increase of prolactin hormone symptoms begin to improve

Individuals with RLS avoid social activities often experience psychiatric problems such as depression anxiety disorders and chronic sleep disorders Therefore restless leg syndrome significantly affects daily life and coping with these problems HBS to relieve symptoms of various individuals who initially non-pharmacological located in the application s However it may be necessary to benefit from pharmacological treatment in cases with severe RLS However the use of drugs in pregnant women may be inconvenient A standard drug therapy has not been determined for the treatment of RLS in pregnant women and the number of drugs that can be used is limited Because most drugs have been used according to the evidence of non-pregnant patients and controlled studies in the treatment of RLS during pregnancy are insufficient Therefore GeBa steel during treatment of RLS in terms of drug therapy with the benefits of fetal compromise between the advantagesdisadvantages of evaluation and decision making in this regard is necessary However during the treatment of RLS in pregnancy the effect of drugs on the fetus especially putting njenital me lformasyo considering the possibility should be taken

The purpose of progressive relaxation exercises It is to learn to feel the difference between tension and looseness in our body and to relax by ourselves in our daily life For this purpose the most widely used muscle groups hands arms neck shoulders face chest abdomen hips feet and fingers were run This method which is applied in the form of stretching and relaxing the muscles enables people to learn where their muscles are what they have become during tension and the difference when this tension disappears

Progressive muscle relaxation exercises reducing the level of epinephrine and norepinephrine in the blood and heart rate reducing oxygen consumption regulating metabolic rate lowering blood pressure reducing muscle tension preventing fatigue and restlessness reducing pain by increasing endorphin levels increasing coping with pain and stress It has many benefits such as increasing the quality of sleep and life

RLS which increases in frequency during pregnancy disrupts sleep quality and affects the quality of life as it increases fatigue in pregnant women During the follow-up care and counseling process performed by nurses during pregnancy pregnant women should be evaluated for sleep disturbance fatigue anxiety and stress that may be caused by RLS and attempts should be made to increase the quality of life by solving problems in cases At this point it is especially important to teach how to deal with RLS or how to relieve symptoms In this context progressive muscle relaxation exercises which have many benefits and can be applied by nurses should be taught to pregnant women during the routine follow-up and care process and the use of relaxation exercises should be provided both at home and in clinics

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: False
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None