The Effect of Hot Water Application in Pregnant Women With Restless Legs Syndrome: A Randomised Controlled Study
Primary Purpose
Restless Legs Syndrome, Pregnancy Related
Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Hot water application
Sponsored by
![TC Erciyes University](https://trials-media.s3.amazonaws.com/orgs/tc-erciyes-university.jpeg)
About this trial
This is an interventional supportive care trial for Restless Legs Syndrome focused on measuring Restless legs syndrome, pregnancy, hot water application, nursing
Eligibility Criteria
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
Sites / Locations
- Erciyes University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
hot water application
Control group
Arm Description
Pregnant women will apply hot water to their legs before going to sleep for a week.
There will be no intervention other than routine follow-up and maintenance.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04887103
Brief Title
The Effect of Hot Water Application in Pregnant Women With Restless Legs Syndrome: A Randomised Controlled Study
Official Title
The Effect of Hot Water Application in Pregnant Women With Restless Legs Syndrome: A Randomised Controlled Study
Study Type
Interventional
2. Study Status
Record Verification Date
May 2021
Overall Recruitment Status
Completed
Study Start Date
October 16, 2018 (Actual)
Primary Completion Date
April 8, 2019 (Actual)
Study Completion Date
April 8, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
TC Erciyes University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Restless Legs Syndrome, Pregnancy Related
Keywords
Restless legs syndrome, pregnancy, hot water application, nursing
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Model Description
pretest-posttest randomized controlled study
Masking
Participant
Allocation
Randomized
Enrollment
29 (Actual)
8. Arms, Groups, and Interventions
Arm Title
hot water application
Arm Type
Experimental
Arm Description
Pregnant women will apply hot water to their legs before going to sleep for a week.
Arm Title
Control group
Arm Type
No Intervention
Arm Description
There will be no intervention other than routine follow-up and maintenance.
Intervention Type
Other
Intervention Name(s)
Hot water application
Intervention Description
Pregnant women will apply hot water to their legs before going to sleep for a week.
Primary Outcome Measure Information:
Title
RLS Severity Rating Scale
Description
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.
Time Frame
change from baseline score at the end of one week
10. Eligibility
Sex
Female
Gender Based
Yes
Gender Eligibility Description
Pregnant women
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
Erciyes University
City
Kayseri
State/Province
Talas
ZIP/Postal Code
38380
Country
Turkey
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
It is thought to be shared after publication as an article.
Learn more about this trial
The Effect of Hot Water Application in Pregnant Women With Restless Legs Syndrome: A Randomised Controlled Study
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