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NCT04786314: RLS

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

Status unknown NA Last updated 12 March 2021
What this trial tests

NA trial testing Hot Water Application in Restless Legs Syndrome in 90 participants. Status unknown.

Timeline
30 September 2020
Primary endpoint
30 September 2021
30 September 2022

Quick facts

Lead sponsorTC Erciyes University
PhaseNA
StatusStatus unknown
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingnone
Primary purposesupportive care
Enrollment90
Start date30 September 2020
Primary completion30 September 2021
Estimated completion30 September 2022
Sites1 location across Turkey (Türkiye)

Drugs / interventions tested

Conditions studied

Sponsor

TC Erciyes University

Who can join

Eligibility, female only, with Restless Legs Syndrome or Pregnant. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

  1. THE EFFECT OF HOT WATER APPLICATION IN PREGNANT WOMEN WITH RESTLESS LEGS SYNDROME: A RANDOMISED CONTROLLED STUDY
    kaplan ö, Başer M, Müderris İ. · · 2021 · DOI 10.22541/au.162935801.10999591/v1

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Other recruiting trials for Restless Legs Syndrome

Currently open trials in the same condition.

Other TC Erciyes University trials

Trials by the same sponsor.

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Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04786314.

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