The effect of foot bath on sleep disorder in menopausal women
Design
Blinded Randomized Clinical Trial
Settings and conduct
One-blind clinical trial will be performed on postmenopausal women referring to urban health centers in two groups of foot and control.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
1. Women who have been 1-4 years old since their menopause.
2. Reading and writing literacy
3. Non-use of psychiatric medications based on patient's statements
4. Lack of chronic diseases such as diabetes, hypertension, and medical illnesses.
5. Not having mental illness
Exclusion criteria:
1- Unwilling to participate in the study
2. Hormone therapy
3. Use of other complementary methods such as herbal medicine
Intervention groups
Footbath
Main outcome variables
Score of Sleep Quality
General information
Reason for update
Acronym
FBSQ
IRCT registration information
IRCT registration number:IRCT20190531043778N1
Registration date:2019-06-12, 1398/03/22
Registration timing:prospective
Last update:2019-06-12, 1398/03/22
Update count:0
Registration date
2019-06-12, 1398/03/22
Registrant information
Name
Khadijeh Nasiri
Name of organization / entity
Khalkhal University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 45 3243 2003
Email address
kh.nasiri@khalums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-06-21, 1398/03/31
Expected recruitment end date
2019-09-05, 1398/06/14
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effect of Footbath on Sleep Quality of the menopausal women: A BlindedRandomized Clinical Trial
Public title
Survay Footbath on Sleep Quality
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Women aged 1-4 years after menopause
Reading and writing skills
No psychiatric use based on the patient's own words
Lack of chronic diseases such as diabetes, hypertension and medical illnesses, etc.
Lack of mental illness
Exclusion criteria:
Unwillingness to participate in the study
Hormone Therapy
Use of other complementary therapies such as herbal remedies
Age
From 52 years old to 60 years old
Gender
Female
Phase
3
Groups that have been masked
Investigator
Sample size
Target sample size:
100
Randomization (investigator's opinion)
Randomized
Randomization description
Assignment in intervention and control groups will be randomized with a 1: 1 assignment ratio in blocks 4 and 6.
Blinding (investigator's opinion)
Single blinded
Blinding description
Sampling will be done by a colleague without the knowledge of the researcher
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethical Committee of Khalkhal ,Universitu of Medical science
Street address
Mozafar St
City
Khalkhal
Province
Ardabil
Postal code
1761351
Approval date
2019-02-22, 1397/12/03
Ethics committee reference number
IR.khalums.rec.1397.011
Health conditions studied
1
Description of health condition studied
Sleep Disorder
ICD-10 code
F51.8
ICD-10 code description
Other sleep disorders not due to a substance or known physiological condition
Primary outcomes
1
Description
Score of Sleep Quality
Timepoint
Before and After intervention
Method of measurement
PSQI questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Foot bath
Category
Lifestyle
Recruitment centers
1
Recruitment center
Name of recruitment center
Center of Health
Full name of responsible person
خدیجه نصیری
Street address
Mozafar St
City
Khalkhal
Province
Ardabil
Postal code
1761351
Phone
+98 45 3243 2002
Fax
+98 45 3242 1979
Email
Khadije.nasiri@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
دانشکده علوم پزشکی خلخال
Full name of responsible person
Khadijeh Nasiri
Street address
Mozafar St
City
Khalkhal
Province
Ardabil
Postal code
1761351
Phone
+98 45 3243 2002
Email
khadije.Nasiri@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
دانشکده علوم پزشکی خلخال
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
دانشکده علوم پزشکی خلخال
Full name of responsible person
khadijeh Nasiri
Position
faculty Member
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Mozafar St
City
Khalkhal
Province
Ardabil
Postal code
1761351
Phone
+98 45 3243 2002
Email
khadije.Nasiri@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Khalkhal University of Medical Science
Full name of responsible person
Khadijeh Nasiri
Position
Faculty Member
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Mozafar St
City
Khalkhal
Province
Ardabil
Postal code
1761351
Phone
+98 45 3243 2002
Email
khadije.Nasiri@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Khalkhal University of Medical Science
Full name of responsible person
khadijeh Nasiri
Position
Faculty Member
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Mozafar St
City
Khalkhal
Province
Ardabil
Postal code
1761351
Phone
+98 45 3243 2002
Email
khadije.Nasiri@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
It will be published in the form of the article
When the data will become available and for how long
2020
To whom data/document is available
free access
Under which criteria data/document could be used
All the conditions
From where data/document is obtainable
Khalkhal University of Medical Sciences
What processes are involved for a request to access data/document
Send a letter to Khalkhal Medical Sciences Research Vice-Chancellor