The Effect of Hot and Cold Water Application on Pregnant Women With Restless Leg Syndrome

NCT04786314 | Unknown DMC

• 1 other identifier: TDK-2020-10628
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

This study was planned as a randomized controlled study to determine the effect of hot and cold water application on complaints and sleep quality in pregnant women with restless legs syndrome (RLS). Pregnant women with a total of 90 RLS, including 30 people in each group, will be included in the study. The data of this study will be collected by Personal Information Form, RLS Diagnosis Criteria Questionnaire, RLS Severity Rating Scale, Pittsburgh Sleep Quality Index, Post Application Follow-up Chart and Application Satisfaction Form. While hot and cold water is applied in the intervention groups in the study, no application other than routine maintenance and follow-up will be done to the control group.Data analysis obtained in the research will be performed in TURCOSA statistical software (Turcosa Analytics Ltd Co, Turkey, www.turcosa.com.tr).In comparisons, a value of p \<0.05 will be considered statistically significant.In order to conduct the study, the necessary Academic Committee decision, Ethics Committee approval (September 09, 2020 and number 2020/445) and institutional permission were obtained. The individuals included in the study will be informed about the purpose of the research, their verbal consent will be obtained and the participant's informed consent form will be signed.

Conditions

Restless Legs Syndrome; Pregnant; Sleep Disorder

Keywords

Restless legs syndrome; Pregnant; Cold Water Application; Hot Water Application; Quality of Sleep

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

Secondary Outcomes (1)

• Pittsburgh Sleep Quality Index

  change from baseline score at the end of one week

Study Arms (3)

Hot Water Application Group

EXPERIMENTAL

Pregnant women will apply hot water to their legs before going to sleep for a week, depending on the groups they are in.

Other: Hot Water Application

Cold Water Application Group

EXPERIMENTAL

Pregnant women will apply cold water to their legs before going to sleep for a week, depending on the groups they are in.

Other: Cold 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 Group

Cold Water Application OTHER

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

Cold Water Application Group

Eligibility Criteria

• Gender Eligibility Details: Since the study will be conducted with pregnant women with restless legs syndrome, only women were included in the study.
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Least literate
• between the weeks of gestation
• Having a single pregnancy
• The presence of RLS is detected according to the RLS Diagnostic Criteria Questionnaire
• Having RLS due to pregnancy
• Uses Iron, Vitamin D, Magnesium and Calcium
• Pregnant women who have a severity of 11 or more according to the RLS Severity Rating Scale will be included in the study

You may not qualify if:

• Those who have a communication disability,
• Risky pregnancy (Preterm labor risk, Cervical insufficiency, etc.),
• Chronic disease (Diabetes, Hypertension, Thyroid, Cardiovascular disease, epilepsy, etc.),
• With maternal obesity, BMI\> 30
• He has heirs in his legs,
• Pre-pregnancy sleep apnea,
• Having any psychiatric disease and using antipsychotic, antidepressant medication,
• Using antihistamine, antiepileptic, antiemetic, calcium channel blocker, dextromethorphan and decongestant type drugs,
• Using heparin,
• Pregnant women with a history of deep vein thrombosis, or atherosclerosis history or risk will not be included in the study.

Sponsors & Collaborators

• TC Erciyes University: lead

Study Sites (1)

Erciyes University

Melikgazi, Kayseri, 38260, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Restless Legs Syndrome; Sleep Wake Disorders; Sleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Nervous System Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Parasomnias; Mental Disorders; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Reserch Asistant

Study Record Dates

• First Submitted: March 1, 2021
• First Posted: March 8, 2021
• Study Start: September 30, 2020
• Primary Completion: September 30, 2021
• Study Completion: September 30, 2022
• Last Updated: March 12, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)