The Effect of Hot Water Application in Pregnant Women With Restless Legs Syndrome: A Randomised Controlled Study

Backgraund and Purpose: The prevalance of restless legs syndrome (RLS) in pregnants varies between 15.4-26.0 percent. As well as pharmacological methods, there are studies reporting that non-pharmacological methods reduce RLS symptoms but the number of studies conducted with pregnants is limited. This study was conducted to determine the effect of hot water application to the legs of pregnants with RLS on their complaints.

Materials and methods: The study is a pretest-posttest randomised controlled. Among the pregnants whose IRLS score was more than 11, 13 people to the intervention group and 16 people to the control group were randomised. The data were collected using Personal Information Form, International RLS Study Group Diagnostic Criteria, and the International RLS Rating Scale (IRLS). Hot water application was made of intervention group. The application was made for 20 minutes before bedtime for seven days. No application was made in the control group other than routine care and follow-up. Chi-square test, descriptive statistics and dependent/independent samples t tests were used to assess the data. The value of p<0.05 was accepted as significant.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Restless Legs Syndrome Dyssomnias Mental Disorders Nervous System Diseases Parasomnias Pregnancy Related Sleep Disorders, Intrinsic Sleep Wake Disorders

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Erciyes University

Kayseri, Talas, 38380, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

in the gestation age of 28-32 weeks,
literate,
according to RLS Diagnostic Criteria and had 11 and higher severity according to International RLS Rating Scale (IRLS)

Exclusion criteria

risky pregnancies,
communication problems,
any chronic and psychiatric disease
were using antipsychotic, antidepressant, antihistaminic, and antiemetic drugs,
had history of deep vein thrombosis

Treatment and study plan

hot water application

Other

Pregnant women will apply hot water to their legs before going to sleep for a week.

Primary outcomes

RLS Severity Rating Scale

Time frame: change from baseline score at the end of one week

The RLS Severity Rating Scale was developed in 2003 by the International Restless Legs Syndrome Study Group. The scale was applied in the selection of patients and in the weekly evaluation of RLS severity. The scale comprised ten questions; each question was scored between 0 and 4. Questions 1, 2, 4, 6, 7, and 8 were related to RLS symptoms, questions 5, 9, and 10 were related to the effect of the disease on the mental state and daily social activities of patients with RLS, and question 3 was about the diagnostic criteria of RLS. The overall score indicated the RLS severity. A minimum score of 0 and a maximum score of 40 could be obtained. A score between 1 and 10 corresponded to "mild," 11-20 "moderate," 21-30 "severe," and 31-40 "very severe" RLS.

Sponsors and collaborators

Lead sponsor

TC Erciyes University

Other

Registry information

Important dates

Study start: 2018
Primary completion: 2019
Study completion: 2019
First posted: May 14, 2021
Registry last updated: May 14, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed