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

NCT ID: NCT04887103

Last Updated: 2021-05-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

29 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-10-16

Study Completion Date

2019-04-08

Brief Summary

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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.

Detailed Description

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Conditions

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Restless Legs Syndrome Pregnancy Related

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

pretest-posttest randomized controlled study
Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Participants

Study Groups

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hot water application

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

Group Type EXPERIMENTAL

Hot water application

Intervention Type OTHER

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

Control group

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Hot water application

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

Intervention Type OTHER

Eligibility Criteria

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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
Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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TC Erciyes University

OTHER

Sponsor Role lead

Responsible Party

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Ozlem Kaplan

Reserch Asistant

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Erciyes University

Kayseri, Talas, Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Other Identifiers

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Kaplan O-Erciyes University

Identifier Type: -

Identifier Source: org_study_id

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