The effect of foot reflexology on quality of sleep in High Risk pregnant Women
Design
For random allocation according to whether the two methods of therapy (massage the soles of the feet, care treatment, rutin) were from block 4 triad will be used. to block 4 triad six different modes , there are (AAaa , aaAA , AaAa , AaaA , aAaA , aAAa ) this way , the scenarios on the six cards written and in the inside of abag , thrown will to choose 72 people card , from the bag out and arrange it on a tab will be written .at the time of sampling to arrange the writhen samples in the control group and the intervention amy.
Settings and conduct
Hospital Cosar, Unit Preneotal
Participants/Inclusion and exclusion criteria
معیارهای ورود به مطالعه
1.Having literacy of reading and writing
2.Gestation age 28-32 week pregnancy
3.The ability to access and track
عدم تمایل به شرکت در مطالعه
1.The lack of desire to participate in the study
2.There in nervous and mental diseases known to said patient
3.There are diseases that cause paresthesia of the lower extremities be
4.A history of diabetes, more than 10 years
5.The consumption of drugs, psychotropics and hypnotics
6.Restless leg syndrome
Intervention groups
Gestation age 28-32 week pregnancy
Main outcome variables
Sleep quality
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180514039650N1
Registration date:2018-06-09, 1397/03/19
Registration timing:registered_while_recruiting
Last update:2018-06-09, 1397/03/19
Update count:0
Registration date
2018-06-09, 1397/03/19
Registrant information
Name
Masumeh Nasiri
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 28 3366 0805
Email address
m.nasiri@qums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2017-11-24, 1396/09/03
Expected recruitment end date
2018-06-20, 1397/03/30
Actual recruitment start date
2017-11-24, 1396/09/03
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of foot reflexology on quality of sleep in High Risk pregnant Women
Public title
The effect of foot reflexology on quality of sleep in High Risk pregnant Women
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Having literacy of reading and writing
Gestation age 28-32 week
The ability to access and track
Exclusion criteria:
The lack of desire to participate in the study
There in nervous and mental diseases known
There are diseases that cause paresthesia of the lower extremities be
A history of diabetes, more than 10 years
The consumption of drugs, psychotropics and hypnotics
Restless leg syndrome
Age
From 18 years old to 40 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
72
Actual sample size reached:
72
Randomization (investigator's opinion)
Randomized
Randomization description
For random allocation according to whether the two methods of therapy (massage the soles of the feet, care treatment, rutin) were from block 4 triad will be used. to block 4 triad six different modes , there are (AAaa , aaAA , AaAa , AaaA , aAaA , aAAa ) this way , the scenarios on the six cards written and in the inside of abag , thrown will to choose 72 people card , from the bag out and arrange it on a tab will be written .at the time of sampling to arrange the writhen samples in the control group and the intervention amy.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Qazvin University of Medical Sciences
Street address
Qazvin University of Medical Sciences, Bahonar Blvd.
City
Qazvin
Province
Qazvin
Postal code
34197-59811
Approval date
2017-11-04, 1396/08/13
Ethics committee reference number
IR.QUMS.REC.1396.305
Health conditions studied
1
Description of health condition studied
Check the sleep disorder in pregnant women high risk
ICD-10 code
G47.9
ICD-10 code description
Sleep disorder, unspecified
Primary outcomes
1
Description
Pregnant women high risk that the score questionnaire sleep Espine Coline under 19.
Timepoint
En Before and after intervention
Method of measurement
Questionnaire sleep ESpie Coline
Secondary outcomes
1
Description
The quality of sleep of pregnant women high risk
Timepoint
En After intervention
Method of measurement
Questionnaire sleep Espie Coline
Intervention groups
1
Description
Intervention group: The intervention group additionally received the usual Care, Medical weeks, 2 to 4 weeks reflexology foot will receive, So that, was asked in a comfortable position used, then the hands to a moisturizing cream, dipped and duration 15 minute massage each foot by the researcher was done(for both feet 30 minutes), the instrument to measure the quality of sleep four weeks after the first intervention(immediately after the last session), the intervention re measured.
Category
Prevention
2
Description
Control group: only routine Care Medical was done without the intervention, the quality of sleep at the end of the intervention, the re measured.
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Qazvin Cosar Hospital
Full name of responsible person
Zahra Hoseini Golafshani
Street address
Qazvin university of medical sciences, Bahonar Blvd., Qazvin city
City
Qazvin
Province
Qazvin
Postal code
3453675845
Phone
+98 28 3369 8799
Fax
+98 28 3323 7268
Email
z.hoseinigolafshani@qums.ac.ir
Web page address
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Dr. Amir Peymani
Street address
Qazvin University of Medical Sciences Shahid Beheshti, Ave' 3415613911 Qazvin' IRAN
City
Qazvin
Province
Qazvin
Postal code
3453675845
Phone
+98 28 3333 7006
Fax
Email
apeymani@qums.ac.ir
Web page address
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Qazvin University of Medical Sciences
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
Qazvin University of Medical Sciences
Full name of responsible person
Zahra Hoseini Golashani
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Qazvin University of Medical Sciences, Bahonar Blvd., Qazvin City
City
Qazvin
Province
Qazvin
Postal code
3453675845
Phone
+98 28 3369 8799
Fax
+98 28 3323 7268
Email
z.hoseinigolafshani@qums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Zahra Hoseini Golafshani
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Qazvin University of Medical Ssciences, Bahonar Blvd., Qazvin City
City
Qazvin
Province
Qazvin
Postal code
3453675845
Phone
+98 28 3369 8799
Fax
+98 28 3323 7268
Email
z.hoseinigolafshani@qums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Zahra Hoseini Golafshani
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Qazvin University of Medical Sciences, Bahonar Blvd., Qazvin City
City
Qazvin
Province
Qazvin
Postal code
3453675845
Phone
+98 28 3369 8799
Fax
+98 28 3323 7268
Email
z.hoseinigolafshani@qums.ac.ir
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
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is 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
En All the data have code to identify.
When the data will become available and for how long
2018
To whom data/document is available
En Qazvin University of Medical Sciences
Under which criteria data/document could be used
En By confirmation of Qazvin University of Medical Sciences
From where data/document is obtainable
En Qazvin University of Medical Sciences
What processes are involved for a request to access data/document
En Refer to Qazvin University of Medical Sciences or sending email to z.hoseinigolafshani@qums.ac.ir