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Investigating the impact of midwifery counseling and mindfulness-based stress reduction on pregnancy outcomes in women with preeclampsia

Protocol summary

Study aim
Determining the effect of midwifery counseling with a mindfulness approach based on stress reduction on pregnancy outcomes in women with preeclampsia
Design
Clinical trial with a control group, with parallel groups, double-blind, randomized, phase 2 on 80 patients. The rand function of Excel software was used for randomization. The sample size in each group is 40 people. Block randomization method is used in this study. The blocks are placed in opaque white envelopes in the order of the generated sequence and are identified according to the registered names of the groups.
Settings and conduct
Place of performance: Kotsar and Razi Hospital Qazvin For the intervention group, a mindfulness counseling program based on stress reduction is provided. Before and after the intervention, Cohen's Perceived Stress Questionnaire (PSS-14) and Freiburg Mindfulness Questionnaire are completed by the groups. The outcome of pregnancy is checked in both groups. Because our intervention is based on counseling; People are aware of their groups and there is no possibility of blinding
Participants/Inclusion and exclusion criteria
admission criteria; suffering from preeclampsia; non-admission criteria; Suffering from chronic physical and mental diseases
Intervention groups
intervention and control group; Pregnant women 21-30 weeks with pre-eclampsia who meet the criteria to enter the study. In the control group of routine pregnancy care and in the intervention group, mindfulness counseling based on stress reduction is held as a program of 8 sessions of 90 minutes during 8 weeks, for groups of 10 people.
Main outcome variables
maternal consequences; changes in blood pressure and gestational age at delivery and neonatal outcomes; It includes Apgar, height, weight, birth weight.

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20240128060834N1
Registration date: 2024-04-07, 1403/01/19
Registration timing: registered_while_recruiting

Last update: 2024-04-07, 1403/01/19
Update count: 0
Registration date
2024-04-07, 1403/01/19
Registrant information
Name
Fateme Haji molaei
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 23 3239 1850
Email address
miss.n.h.6517@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-02-20, 1402/12/01
Expected recruitment end date
2024-06-30, 1403/04/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the impact of midwifery counseling and mindfulness-based stress reduction on pregnancy outcomes in women with preeclampsia
Public title
Investigating the effect of mindfulness on preeclampsia
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
1. Suffering from mild to moderate preeclampsia 2. Single and live fetus 3. Pregnancy age between 21 and 30 weeks (based on LMP and ultrasound of the first trimester of pregnancy) 4. Having minimum literacy in reading and writing 5. Consent to participate in the study 6. Living in Qazvin province
Exclusion criteria:
1. Suffering from chronic physical diseases (cardiovascular, renal, autoimmune, diabetes) 2. Obstetric problems other than preeclampsia (severe nausea and vomiting of pregnancy, placenta previa, etc.) 3. Drug addiction 4. Suffering or having a history of suffering from mental illnesses, psychological treatments, and the use of nerve drugs, the existence of a stressful situation for the participant in the past 6 months, such as (death of first-degree relatives, etc.) 5. Suffering from acute diseases during the fetal period (genetic problems, hydrocephalus, etc.)
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
Randomization method and description of each method: We will use block randomization method in this study. Blocking is usually used in order to balance the number of samples allocated to each of the studied groups. This feature helps the researchers so that the number of samples assigned to each of the studied groups is equal. The size of all the blocks is equal and we will use 4 blocks in this experiment. Randomization unit: individual, the size of all blocks is equal and we will use blocks of 4 in this experiment. Randomization tool: sealed envelope, statistical software How to make a random sequence: Using the website https://www.sealedenvelope.com/simple-randomiser/v1/lists and with the help of a statistical consultant, the allocation sequence was generated. Explanation about concealment: Since the study participants are from different hospitals, the central list method is used in such a way that the eligible people who are in each center are registered by one person in a central list and according to this list and are assigned to groups using random blocks. The blocks are placed in opaque white envelopes in the order of the generated sequence and are opened according to the registered names and the groups are identified.
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 Shahrood University of Medical Sciences
Street address
No. 11, Hekmat 8, First Bostan, Qazvin
City
Shahrood
Province
Semnan
Postal code
3416664731
Approval date
2024-01-10, 1402/10/20
Ethics committee reference number
IR.SHMU.REC.1402.170

Health conditions studied

1

Description of health condition studied
ذهن آگاهی٬ استرس٬ پره اکلامپسی
ICD-10 code
O14.0
ICD-10 code description
Mild to moderate pre-eclampsia

Primary outcomes

1

Description
Maternal outcomes
Timepoint
During pregnancy and after delivery
Method of measurement
Changes in systolic and diastolic blood pressure, gestational age at delivery,

2

Description
Neonatal outcomes
Timepoint
after delivery
Method of measurement
Apgar score of the baby at delivery, weight, head circumference and height of the baby at delivery

Secondary outcomes

1

Description
average stress score in women with preeclampsia
Timepoint
Before and after the intervention
Method of measurement
Cohen's Perceived Stress Questionnaire (PSS-14)

2

Description
average score of Mindfulness in women with preeclampsia
Timepoint
Before and after the intervention
Method of measurement
Freiburg Mindfulness Questionnaire

Intervention groups

1

Description
Intervention group: 21-30 weeks pregnant women suffering from pre-eclampsia who meet the criteria to enter the research and are referred to the selected medical centers of Qazvin city in 1402. The purpose of the research is explained to each person and written informed consent is obtained from him. A demographic checklist is used to collect information, and in terms of stress scores, Cohen's Perceived Stress Questionnaire (PSS-14) is completed by pregnant women. Eligible people are divided into two control and intervention groups based on the sequence of allocation. In the control group, routine pregnancy care was done and no intervention was done, and in the intervention group, in addition to routine pregnancy care, mindfulness counseling sessions based on stress reduction were held. The mindfulness counseling program based on stress reduction will be presented as a program of 8 sessions of 90 minutes during 8 weeks, once a week, in person by the researcher (for groups of 10 people). It should be noted that the Freiburg mindfulness questionnaire is completed before and after the implementation of mindfulness sessions by the intervention and control groups to measure their mindfulness and finally stress in women with pre-eclampsia using the questionnaire (PSS-14) for the intervention group. and the same is calculated for the control group. Pregnancy outcomes include neonatal and maternal outcomes. In the follow-ups, maternal outcomes including changes in systolic and diastolic blood pressure, gestational age at delivery, and neonatal outcomes including Apgar, height, weight, head circumference, will be examined using medical records and newborn care cards in both groups. It should be mentioned that medical centers that have a delivery department and high-risk pregnancy care are selected.
Category
Treatment - Other

2

Description
Control group: At the end of the study, in order to meet ethical considerations and not deprive the control group of the intervention, if they wish, an educational package with counseling content based on mindfulness based on stress reduction will be available to them in PDF file.
Category
Treatment - Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Kausar Hospital
Full name of responsible person
Fateme Haji Molaei
Street address
No. 9, Shahid Babaei St., Bostan 1, Heshmat 8
City
Qazvin
Province
Qazvin
Postal code
3416664731
Phone
+98 28 3368 9550
Email
miss.n.h.6517@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Shahroud University of Medical Sciences
Full name of responsible person
Dr. Behzad Garmabi
Street address
Shahrood, Haftam Tir Square-Shahrood University of Medical Sciences and Health Care Services
City
Shahrood
Province
Semnan
Postal code
36147-73943
Phone
+98 23 3239 1850
Email
miss.n.h.6517@gmail.com
Web page address
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahroud 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
Shahroud University of Medical Sciences
Full name of responsible person
Fateme Haji Moulaei
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
Shahrood, Haftam Tir Square-Shahrood University of Medical Sciences and Health Care Services
City
shahrood
Province
Semnan
Postal code
۳۶۱۴۷-۷۳۹۴۳
Phone
+98 23 3239 1850
Email
miss.n.h.6517@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shahroud University of Medical Sciences
Full name of responsible person
Fateme Haji molaei
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
Shahrood, Haftam Tir Square-Shahrood University of Medical Sciences and Health Care Services
City
Shahrood
Province
Semnan
Postal code
۳۶۱۴۷-۷۳۹۴۳
Phone
+98 23 3239 1850
Email
miss.n.h.6517@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Shahroud University of Medical Sciences
Full name of responsible person
Fateme Haji Moulai
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
Shahrood, Haftam Tir Square-Shahrood University of Medical Sciences and Health Care Services
City
Shahrood
Province
Semnan
Postal code
۳۶۱۴۷-۷۳۹۴۳
Phone
+98 23 3239 1850
Email
miss.n.h.6517@gmail.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
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
All data and research results will be provided to Shahrood University of Medical Sciences.
When the data will become available and for how long
It will be possible to access research documents six months after the final statistical analysis
To whom data/document is available
The data will be available only for the use of researchers of academic institutions.
Under which criteria data/document could be used
In order to conduct similar research
From where data/document is obtainable
In order to receive the data, people can refer to the main executive of the project, Dr. Khadijeh Abadian, a member of the faculty of Shahrood University of Medical Sciences.
What processes are involved for a request to access data/document
After obtaining the necessary permits from Shahrood University of Medical Sciences and the Research and Technology Vice-Chancellor of this university, the applicant can proceed to receive the documents.
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