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The effect of Physical and mental relaxation on gestational hypertension

Protocol summary

Summary
(1) Objectives: This study aims to determine the effect of physical and mental relaxation on gestational hypertension, (2) Design: This is a single blind, randomized clinical trial will be conducted in 80 pregnant women with hypertension referring to Qazvin Kosar hospitals, (3) Setting and conduction: Eligible Subjects will be selected by a convenience sampling method. Then they will be randomly assigned into two groups of 40 subjects one an intervention group (green balls) and the other a control group (blue balls), (4) Participants including major eligibility criteria: BP ≥140/90 mmHg; Singleton pregnancy; gestational age of 20-30. And the main exclusion criteria are twin pregnancy; preeclampsia; eclampsia; HELLP syndrome; Cardiovascular; kidney, brain, blood or liver disorders, (5) Interventions: Beside the usual medical care, the intervention group should participate in advanced muscle relaxation and mental imagery classes, each session 30 minute, twice a week and for 8 weeks. The blood pressures will be measured before and after the intervention. In control group, in addition to the usual medical cares, the blood pressures will be measured twice a week, before and after a 15-min rest, (6) The main outcome measures: The Systolic and diastolic blood pressure will be assessed before and after the intervention.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201604181113N4
Registration date: 2016-08-07, 1395/05/17
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2016-08-07, 1395/05/17
Registrant information
Name
Fatemeh Ranjkesh
Name of organization / entity
Qazvin University Of Medical Scienes, Nursing & Midwifery school
Country
Iran (Islamic Republic of)
Phone
+98 28 1335 9501
Email address
franjkesh@qums.ac.ir
Recruitment status
Recruitment complete
Funding source
Investigator
Expected recruitment start date
2016-04-20, 1395/02/01
Expected recruitment end date
2016-07-22, 1395/05/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of Physical and mental relaxation on gestational hypertension
Public title
Effect of relaxation on Gestational hypertension
Purpose
Treatment
Inclusion/Exclusion criteria
Including criteria: BP ≥140/90 mmHg; Singleton pregnancy; gestational age of 20-30 week exclusion criteria: Twin pregnancy; preeclampsia; eclampsia; HELLP syndrome; Cardiovascular, kidney, brain, blood or liver disorders.
Age
No age limit
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)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
randomized clinical trial

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Qazvin University of Medical Sciences
Street address
Bahonar boulevar, Qazvin University of Medical Sciences
City
Qazvin
Postal code
Approval date
2016-03-09, 1394/12/19
Ethics committee reference number
ir.qums.rec.1394.839

Health conditions studied

1

Description of health condition studied
Gestational hypertension
ICD-10 code
013
ICD-10 code description
Gestational [pregnancy-induced] hypertension without significant proteinuria

Primary outcomes

1

Description
Systolic and Diastolic blood pressure
Timepoint
Before and after intervention
Method of measurement
According to mmhg

Secondary outcomes

empty

Intervention groups

1

Description
Intervention:The intervention group should participate in advanced muscle relaxation and mental imagery classes, each session 30 minute, twice a week and for 8 weeks. The blood pressures will be measured before and after the intervention
Category
Treatment - Other

2

Description
Intervention: In control group the blood pressures will be measured twice a week, before and after a 15-min rest
Category
Treatment - Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Kosar haspital
Full name of responsible person
Fatemeh Ranjkesh
Street address
City
Qazvin

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Investigator
Full name of responsible person
Fatemeh Ranjkesh
Street address
Bahonar Boulevar, Qazvin University of Medical Sciences,Vice chancellor for research
City
Qazvin
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Investigator
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
Qzvin University of Medical Sciences
Full name of responsible person
Fatemeh Ranjkesh
Position
Iinstructor, Msc in midwifery
Other areas of specialty/work
Street address
Bahonar Boulevar, Qazvin University of Medical Sciences
City
Qazvin
Postal code
Phone
+98 28 3323 7268
Fax
Email
fatemehranjkesh@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Fatemeh Ranjkesh
Position
Instructor, Msc in midwifery
Other areas of specialty/work
Street address
Bahonar Boulevar, Qazvin University of Medical Sciences
City
Qazvin
Postal code
Phone
+98 28 3323 7268
Fax
Email
fatemehranjkesh@yahoo.c0m
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Fatemeh Ranjkesh
Position
Instructor, Msc in midwifery
Other areas of specialty/work
Street address
Bahonar boulivar, Qazvin University of Medical Sciences
City
Qazvin
Postal code
Phone
Fax
Email
fatemehranjkesh@yahoo.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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