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

NCT04887103 | Completed

• 1 other identifier: Kaplan O-Erciyes University
• Study Type: interventional
• Target: 29
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Restless Legs Syndrome; Pregnancy Related

Keywords

Restless legs syndrome; pregnancy; hot water application; nursing

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

hot water application

EXPERIMENTAL

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

Other: Hot water application

Control group

NO INTERVENTION

There will be no intervention other than routine follow-up and maintenance.

Interventions

Hot water application OTHER

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

hot water application

Eligibility Criteria

• Gender Eligibility Details: Pregnant women
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

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

Sponsors & Collaborators

• TC Erciyes University: lead

Study Sites (1)

Erciyes University

Kayseri, Talas, 38380, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Restless Legs Syndrome

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Reserch Asistant

Model Details: pretest-posttest randomized controlled study

Study Record Dates

• First Submitted: May 12, 2021
• First Posted: May 14, 2021
• Study Start: October 16, 2018
• Primary Completion: April 8, 2019
• Study Completion: April 8, 2019
• Last Updated: May 14, 2021

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)