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The effect of relaxation technique on preeclampsia and its consequences in high risk pregnant mothers referred to Selected comprehensive Health centers of Isfahan

Protocol summary

Study aim
aim of investigating was the effect of body relaxation technique on PES
Design
Clinical trial with control group, randomized, on 100 high-risk pregnant mothers, randomized based on random number table and even and unit numbering
Settings and conduct
In this clinical trial, the effect of relaxation technique on preeclampsia investigated in Isfahan. These mothers were divided into intervention and control groups and were evaluated for preeclampsia at the end of the study.The statistical analyzer did not know the groups.
Participants/Inclusion and exclusion criteria
Inclusion criteria were as follows: pregnant mothers from 20-24 weeks of gestation, literacy, first or second pregnancy, PES background in previous pregnancy or chronic hypertension in previous pregnancy, lack of smoking, alcohol and psychotropic substances using history, high proteinuria up to Trace level, blood pressure less than 140/90 mm Hg, no psychiatric disorders and severe anxiety (person who scored above 26 on DASS21 questionnaire), having CD player, a computer or an Android mobile phone in order to listen to the audio of relaxation file at home. Exclusion criteria Exclusion criteria were as follows: absence of more than two consecutive sessions in relaxation sessions, failure to perform more than three consecutive relaxation sessions at home, lack of willingness to continue the study, symptoms of PES, eclampsia, HELLP syndrome or performing a preterm delivery or severe anxiety before completing 4 sessions of relaxation technique
Intervention groups
All high-risk pregnant women referred to selected comprehensive health centers in Isfahan.In the intervention group, they performed 16 relaxation sessions and in the control group, they received only clinical care.
Main outcome variables
stress score, preeclampsia, birth weight at delivery.

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20091219002889N11
Registration date: 2021-01-07, 1399/10/18
Registration timing: retrospective

Last update: 2021-01-07, 1399/10/18
Update count: 0
Registration date
2021-01-07, 1399/10/18
Registrant information
Name
Mahboubeh Valiani
Name of organization / entity
Isfahan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 31 3651 4640
Email address
valiani@nm.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-09-23, 1397/07/01
Expected recruitment end date
2018-11-22, 1397/09/01
Actual recruitment start date
2018-11-06, 1397/08/15
Actual recruitment end date
2019-02-04, 1397/11/15
Trial completion date
2020-02-10, 1398/11/21
Scientific title
The effect of relaxation technique on preeclampsia and its consequences in high risk pregnant mothers referred to Selected comprehensive Health centers of Isfahan
Public title
Body Relaxation techniques and Pre-eclampsia Syndrome
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
pregnant mothers from 20-24 weeks of gestation, literacy, first or second pregnancy, PES background in previous pregnancy or chronic hypertension in previous pregnancy, lack of smoking, alcohol and psychotropic substances using history, high proteinuria up to Trace level, blood pressure less than 140/90 mm Hg, no psychiatric disorders and severe anxiety (person who scored above 26 on DASS21 questionnaire), having CD player, a computer or an Android mobile phone in order to listen to the audio of relaxation file at home. Age range 16 to 43 years
Exclusion criteria:
Stress score obtained from the questionnaire is more than 26 Proteinuria over trace Blood pressure over than 140/90
Age
From 16 years old to 43 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 98
Actual sample size reached: 100
Randomization (investigator's opinion)
Randomized
Randomization description
The initial selection of pregnancy records of pregnant women was done randomly based on a table of random numbers. Samples were randomly divided into experimental (even numbers) and control (unit numbers) groups.This numbering was done up to 100.
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 Isfahan University of Medical Sciences
Street address
Hezar Jerib Avenue, Isfahan University of Medical Sciences, Faculty of Nursing and Midwifery .
City
Isfahan
Province
Isfehan
Postal code
81746-73461
Approval date
2018-11-18, 1397/08/27
Ethics committee reference number
IR.MUI.RESEARCH.REC.1397.312

Health conditions studied

1

Description of health condition studied
Preeclampsia
ICD-10 code
O10.412
ICD-10 code description
Pre-existing secondary hypertension complicating pregnancy, second trimester

Primary outcomes

1

Description
Blood pressure
Timepoint
Blood pressure was measured and recorded before and after the intervention in experimental and control group from the beginning and 36 weeks of pregnancy.
Method of measurement
Digital Blood Pressure Monitor

2

Description
stress score
Timepoint
stress score was measured and recorded before and after the intervention in experimental and control group from the beginning and 36 weeks of pregnancy.
Method of measurement
Dass21 Questionnaire,

3

Description
infant weight
Timepoint
After delivery, birth weight was measured and recorded.
Method of measurement
scales

4

Description
gestational age
Timepoint
After delivery, gestational age was measured and recorded.
Method of measurement
Gestational age based on LMP or the first sono of pregnancy

5

Description
proteinurine
Timepoint
proteinurine was measured and recorded before and after the intervention in experimental and control group from the beginning and 36 weeks of pregnancy.
Method of measurement
Roshe Laboratory Kit

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: the experimental group participated in 16 sessions(8 sessions in the class and 8 sessions at home) of 30-minute relaxation with the Jacobson and Benson methods.Thus, the first session was at 20 to 24 weeks of pregnancy. Next, at 24 to 34 weeks of pregnancy, there were five sessions every two weeks. Then, at 34 to 36 weeks of pregnancy, there were two sessions every a week. Mother blood pressure was recorded before and after each session using a microlife.digital device. Then each participant in the first session was given a CD and relaxation technique training. At the first 10 minutes of relaxation technique, the following actions were performed to physically relax. At first, the mother was in a relaxed position (Semi-prone position) and after concentration, deep breathing and abdominal breathing exercises were performed. BRT was performed with Jacobson's method of contraction (5 seconds) and then conscious muscle release (30 seconds) to consciously relieve muscle tension (14). Then, at the final 20 minutes, visualization and mind imagery were carried out (with Benson's method), which contained three fictional content and at each session, a story content was performed. As such, after three sessions, all three contents were performed.
Category
Prevention

2

Description
Control group: underwent routine medical care and Participate in PLC, the blood pressure, the Dass21 Stress Questionnaire, urine protein were measured once in the entrance to the study in the same manner as the experimental group, and re-examined at 36 weeks of pregnancy. Only Banson's relaxation was performed for 10 minutes with completely different content without Jackson's relaxation and deep relaxation. for the control group, by Perform a kind of Benson relaxation, is considered as a placebo for Body Relaxation technique. After 36 weeks of pregnancy, the mothers were followed up weekly by telephone. Furthermore, the researcher was present at the hospital during delivery and the mother was evaluated for gestational age, maternal hypertension, and PES. Maternal PES was diagnosed based on the approval of a gynecologist.
Category
Prevention

Recruitment centers

1

Recruitment center
Name of recruitment center
Navab Safavy Comperhensive Center
Full name of responsible person
Mahboubeh Valiani
Street address
Ahmadabad Square,Bozorgmehr Ave
City
Isfahan
Province
Isfehan
Postal code
8154785213
Phone
+98 31 3227 5358
Email
Valiani@nm.mui.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Shaghayegh Haghjo
Street address
Hezar Jerib Avenue, Isfahan University of Medical Sciences, Faculty of Nursing and Midwifery .
City
Isfahan
Province
Isfehan
Postal code
81746-73461
Phone
+98 31 3792 3060
Email
Haghjo@med.mui.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Esfahan 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
Esfahan University of Medical Sciences
Full name of responsible person
Mahboubeh Valiani
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Midwifery
Street address
Hezar Jerib Avenue, Isfahan University of Medical Sciences, Faculty of Nursing and Midwifery .
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3792 7538
Email
Valiani@nm.mui.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Mahboubeh Valiani
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Midwifery
Street address
Hezar Jerib Avenue, Isfahan University of Medical Sciences, Faculty of Nursing and Midwifery .
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3792 7538
Email
Valiani@nm.mui.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Mahboubeh Valiani
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Midwifery
Street address
Hezar Jerib Avenue, Isfahan University of Medical Sciences, Faculty of Nursing and Midwifery .
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3792 7538
Email
Valiani@nm.mui.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
The end result of the data is anonymously shared.
When the data will become available and for how long
After being published in the magazine
To whom data/document is available
Researcher
Under which criteria data/document could be used
Executors of research project
From where data/document is obtainable
Ministry of Health, Deputy Minister of Education
What processes are involved for a request to access data/document
Data will be sent via email and data request and consultation with the implementers of this project.
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