The Effect of Progressive Muscle Relaxation Exercise Training Given to Pregnant Women With Restless Leg Syndrome

NCT04853771 | Completed DMC

• 1 other identifier: PAkbas
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

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 sleep.It is reported that pregnancy is an important risk factor in the onset and worsening of RLS.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. Individuals with RLS initially undertake a variety of non-pharmacological practices to relieve symptoms.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, decreasing pain by increasing endorphin levels, increasing coping with pain and stress, It has many benefits such as improving sleep and quality of life.This 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.

Conditions

Restless Legs Syndrome

Keywords

restless legs sendrome; progressive muscle relaxation exercise; quality of life; sleep hygiene

Outcome Measures

Primary Outcomes (3)

• Restless Legs Syndrome Severity

  Measurements will be made using the RLS Severity Rating Scale.

  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.

  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.

  Change from Baseline Quality of Sleep at 8 weeks

Study Arms (2)

experiment

EXPERIMENTAL

28-29. Between the weeks of gestation, one-time progressive muscle relaxation exercise training prepared by the researcher will be given to the pregnant women. Exercise will be demonstrated in training. Later, pregnant women will be asked to explain and practice the exercise. Women will be repeated until they do the exercise completely correctly (Check-list 1). After the training, pregnant women will be asked to do progressive relaxation exercises at least 3 times a week (every other day). With the progressive muscle relaxation exercise daily follow-up schedule prepared by the researcher, the pregnant women will be followed for 8 weeks and weekly reminders will be made (via whatsapp® or text message). The final test application (36-37 weeks) will be done online at the end of 8 weeks to the pregnant women. In pre-test and post-test applications, RLS Severity Rating Scale form, Johns Hopkins Restless Leg Syndrome Quality of Life Scale and Pittsburg Sleep Quality Index will be used.

Behavioral: progressive muscle relaxation exercise training

control

NO INTERVENTION

No intervention will be applied to pregnant women, other than the routine training given in the pregnancy school. In the maternity school, training is given on physiological and psychological changes that occur during pregnancy, baby care, postpartum period, family planning. However, pregnant women are not given any information about RLS, coping methods, creating a healthy lifestyle, and progressive muscle relaxation exercises. Final test application to pregnant women; 36-37. It will be held online between weeks. In pre-test and post-test applications, RLS Severity Rating Scale form, Johns Hopkins Restless Leg Syndrome Quality of Life Scale and Pittsburg Sleep Quality Index will be used.

Interventions

progressive muscle relaxation exercise training 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.

experiment

Eligibility Criteria

• Age: 20 Years - 34 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Being in the age range of 20-34
• days of her pregnancy. being in weeks of gestation
• Not having any chronic disease
• Not having any psychiatric illness
• Not being pregnant at risk
• Not having any communication problems (mental, auditory, visual, etc.)

You may not qualify if:

• Pregnancy does not do the post-test applications
• Failure to do progressive muscle relaxation exercises 2 times in a row
• Willing to leave research
• Other complications during pregnancy
• Hospitalization of the woman
• Early termination of pregnancy
• Not reaching pregnant woman during follow-up

Sponsors & Collaborators

• Gazi University: lead

Study Sites (1)

Karabük Training and Research Hospital

Karabük, 78050, Turkey (Türkiye)

Location

Related Publications (1)

• Akbas P, Yaman Sozbir S. The effect of progressive muscle relaxation exercise on the intensity of symptoms and quality of sleep and quality of life in pregnant women with restless leg syndrome. Patient Educ Couns. 2023 Aug;113:107768. doi: 10.1016/j.pec.2023.107768. Epub 2023 Apr 28.

  PMID: 37146530 DERIVED

MeSH Terms

Conditions

Restless Legs Syndrome; Sleep Hygiene

Condition Hierarchy (Ancestors)

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

Study Officials

• Şengül YAMAN SÖZBİR, PhD

  Gazi Universty

  PRINCIPAL INVESTIGATOR

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: Expert Nurse, Doctoral student

Model Details: Research, single -centered , stratified randomization (hafif-moderate, severe-very severe ) with a pre-test and post-test control group parallel randomized control with experimental was designed as an operation.

Study Record Dates

• First Submitted: April 4, 2021
• First Posted: April 21, 2021
• Study Start: April 6, 2021
• Primary Completion: December 24, 2021
• Study Completion: December 24, 2021
• Last Updated: April 1, 2022

Record last verified: 2022-03

Data Sharing

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

Locations

TU (1)