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

TC Erciyes University

Status: Completed

Conditions: Pregnancy Related; Restless Legs Syndrome

Treatments: Other: Hot water application

Study type: Interventional

Funder types: Other

Identifiers

NCT04887103

Kaplan O-Erciyes University

Details and patient eligibility

About

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.

Enrollment: 29 patients

Sex: Female

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Single Blind

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29 participants in 2 patient groups

hot water application

Experimental group

Description:

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

Treatment:

Other: Hot water application

Control group

No Intervention group

Description:

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