The aim of this study was to Comparative effect of Warm and Cold Foot bath on Severity of Restless Legs Syndrome and sleep quality in pregnant women. Inclusions criteria included: Pregnancy age was 34-20 weeks; mental health; ability to read and write. Exclusion criteria included: cold or heat sensitivity; use sleep medication; Pregnancy illness; ulcer and lower limb pain.This is a randomized clinical trial study. 80 pregnant women with restless leg syndrome were randomly divided into two intervention groups (1 and 2).Each night, for group 1 was asked to wash their legs for 2 weeks with Cold water at 20 to 25 degrees for 10 minutes. Each night, for the group 2 was asked to wash their legs for 2 weeks with warm water at 40 to 45 degrees for 10 minutes.At baseline and at the end of the study, the severities of restless leg syndrome and sleep quality were measured.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2017072414229N6
Registration date:2017-08-13, 1396/05/22
Registration timing:prospective
Last update:
Update count:0
Registration date
2017-08-13, 1396/05/22
Registrant information
Name
Hadi Jafari manesh
Name of organization / entity
Arak University of Medical Science
Country
Iran (Islamic Republic of)
Phone
+98 86 3417 3503
Email address
jafarimanesh@arakmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Arak University of Medical Sciences
Expected recruitment start date
2017-09-23, 1396/07/01
Expected recruitment end date
2018-09-23, 1397/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of Warm and Cold Foot bath on Severity of Restless Legs Syndrome and sleep quality
Public title
Comparative effect of Warm and Cold Footbath on Severity of Restless Legs Syndrome and sleep quality in pregnant women
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusions criteria included: Pregnancy age was 34-20 weeks; mental health; ability to read and write. Exclusion criteria included: cold or heat sensitivity; use sleep medication; Pregnancy illness; ulcer and lower limb pain.
Age
From 18 years old to 60 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Arak University of Medical Sciences
Street address
Basij Sq. Arak
City
Arak
Postal code
3819693345
Approval date
2017-08-23, 1396/06/01
Ethics committee reference number
IR.ARAKMU.REC.1396
Health conditions studied
1
Description of health condition studied
Normal pregnancy
ICD-10 code
z34.8
ICD-10 code description
Supervision of other normal pregnancy
Primary outcomes
1
Description
Restless Leg Syndrome
Timepoint
Before and after 2 weeks
Method of measurement
Restless Leg Syndrome Questionnaires
Secondary outcomes
1
Description
Quality of Sleep
Timepoint
Before and after 2 weeks
Method of measurement
Petersburg Sleep Quality Questionnaire
Intervention groups
1
Description
Foot bath for 2 weeks with
Cold water at 20 to 25 degrees for 10 minutes
Category
Other
2
Description
Foot bath for 2 weeks with
warm water at 40 to 45 degrees for 10 minutes
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Taleghani Hospital
Full name of responsible person
Hadi Jafari Manesh
Street address
City
Arak
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Dr Mohammad Rafiei
Street address
Deputy of Research and Technology, Arak University of Medical Sciences, Basij Square, Sardasht, Arak, Iran
City
Arak
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Arak University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Hadi Jafari Manesh
Position
Master of Nursing
Other areas of specialty/work
Street address
Basij Sq. Arak
City
Arak
Postal code
Phone
+98 86 3417 3503
Fax
Email
hadijafarimanesh@arakmu.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Hadi Jafari Manesh
Position
Master of Nursing
Other areas of specialty/work
Street address
Basij Sq. Arak
City
Arak
Postal code
Phone
+98 86 3417 3503
Fax
Email
nurse_science@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Hadi Jafari Manesh
Position
Master of Nursing
Other areas of specialty/work
Street address
Basij Sq. Arak
City
Arak
Postal code
Phone
+98 86 3417 3503
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)