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

Pregnancy Related Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04887103
• Other study ID #: Kaplan O-Erciyes University
• Status: Completed
• Phase: N/A
• Start date: October 16, 2018
• Est. completion date: April 8, 2019

Study information

• Verified date: May 2021
• Source: TC Erciyes University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 29
• Est. completion date: April 8, 2019
• Est. primary completion date: April 8, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Pregnancy Related
• Psychomotor Agitation
• Restless Legs Syndrome
• Syndrome

Intervention

Other:
• Hot water application
Pregnant women will apply hot water to their legs before going to sleep for a week.

Locations

Country	Name	City	State
Turkey	Erciyes University	Kayseri	Talas

Sponsors (1)

Lead Sponsor	Collaborator
TC Erciyes University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	RLS Severity Rating Scale	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.	change from baseline score at the end of one week