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The effect of performing technique emotionol relesse on stress, anxiety and depression in women with recurrently miscarriage

Protocol summary

Study aim
Comparing the stress, anxiety, and depression levels of women with repeated abortions before, immediately after, and four weeks after the intervention
Design
The clinical trial has a control group, an intervention group, no blinding, and each group has 47 people. Randomized using www.random.org.
Settings and conduct
Iranian women aged 25-49 with a history of two consecutive miscarriages will be included in the study, according to Shahid Akbarabadi Hospital in Tehran. A pre-test will be administered to both experimental and control groups in this research, and then the experimental group will be trained for eight sessions, one two-hour session every week, on mind release techniques, which will be taught by the researcher for each subject.
Participants/Inclusion and exclusion criteria
Reading and writing skills,The spouse does not smoke,Having multiple sexual partners,there is no inflammation or pelvic mass,Not suffering from severe stress, anxiety, or depression,Has not participated in mind liberation classes in the past,The couple does not suffer from mental illness,The couple has not suffered any stressful events in the last three months, ,Not using medicinal,and non-medicinal methods to improve stress, anxiety, and depression in the period of 6 months before the study until the end of the study ,miscarriages in the early stages of pregnancy
Intervention groups
As part of this research, the control and intervention groups will participate in the pre-test. Then only the experimental group will receive eight sessions of mind liberation training, one session each week for two hours. The therapist performs this method on each patient.
Main outcome variables
Stress; anxiety; depression

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20220822055777N1
Registration date: 2022-12-06, 1401/09/15
Registration timing: registered_while_recruiting

Last update: 2022-12-06, 1401/09/15
Update count: 0
Registration date
2022-12-06, 1401/09/15
Registrant information
Name
Raana Mozafarifar
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 8888 2885
Email address
raanamoozafari@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-09-22, 1401/06/31
Expected recruitment end date
2023-09-22, 1402/06/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of performing technique emotionol relesse on stress, anxiety and depression in women with recurrently miscarriage
Public title
effect of technique emotionol relesse in women with recurrently miscarriage
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Reading and writing skills Having multiple sexual partners Recurrence of miscarriages in the early stages of pregnancy (more than two miscarriages)
Exclusion criteria:
From 6 months before the study to the end of the study, medicinal or non-medicinal methods were used to boost stress, anxiety or depression. In the last 3 months, the couple has experienced any stressful experiences, such as the death of a loved one The couple does suffer from mental illness having attended a mind liberation class in the past suffering from severe stress, anxiety, or depression At the time of entering the study, the attending physician diagnosed inflammation or pelvic masses. tobacco abuse by the spouse
Age
From 25 years old to 40 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 94
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization is such that the participants were assigned to two control and intervention groups using the www.random.org site and through random block design with a block size of 4. Blocking was done by a person not involved in data sampling and analysis. The person is asked to write any number of 4-digit letters from the letters A and B, for example, AAAA, BBBB, etc. Then the researcher numbers these letters. The random site is used to assign random numbers. The output of this site is numbers. In order to hide the allocation, the type of intervention will be written on a sheet of paper and placed inside opaque envelopes numbered consecutively
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
Research Ethics Committees of Iran University of Medical Sciences
Street address
Floor 13, Block A, Ministry of Health & Medical Education Headquarters, Between Zarafashan & South Falamak, Qods Town, Tehran, Iran.
City
Tehran
Province
Tehran
Postal code
0000000000
Approval date
2022-10-23, 1401/08/01
Ethics committee reference number
IR.IUMS.REC.1401.604

Health conditions studied

1

Description of health condition studied
recurrently miscarriage
ICD-10 code
O03
ICD-10 code description
Spontaneous abortion

Primary outcomes

1

Description
stress
Timepoint
4 weeks after the educational intervention
Method of measurement
Stress, anxiety and depression questionnaire (DASS-21)

2

Description
anxiety
Timepoint
4 weeks after the educational intervention
Method of measurement
Stress, anxiety and depression questionnaire (DASS-21)

3

Description
depression
Timepoint
4 weeks after the educational intervention
Method of measurement
Stress, anxiety and depression questionnaire (DASS-21)

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: In the intervention group, in this research, a pre-test will be taken from both the test and control groups, and after that, the experimental group will be trained in mind release techniques for 8 sessions, one two-hour session every week, and this method will be taught by the therapist. Individual subjects are executed. Training and implementation of the IFT technique will be done using Craig's instructions (2017) under the title "Golden Standard of IFT".
Category
Behavior

2

Description
Control group:they will take a pre-test at the beginning of the study. During the study and implementation of the intervention, they will not receive any training and after 4 weeks the post-test will take place. At the end of the study, after obtaining the results, during a 2-hour session for The control group is briefly explained about the technique of freeing the mind and its effects based on the obtained results.
Category
Behavior

Recruitment centers

1

Recruitment center
Name of recruitment center
Akbarabadi Hospital
Full name of responsible person
Masoomeh Kheirkhah
Street address
School of Nursing & Midwifery, Rashid Yasemi st., Valiasr St., Tehran, 1996713883, Iran
City
Tehran
Province
Tehran
Postal code
۱۹۹۶۷۱۳۸۸۳
Phone
+98 912 478 7691
Email
kheirkhah.m@iums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Masoomeh Kheirkhah
Street address
Iran University of Medical Sciences, Shahid Hemmat Highway, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
۱۴۴۹۶۱۴۵۳۵
Phone
+98 21 86701
Email
info@iums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Iran 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
Iran University of Medical Sciences
Full name of responsible person
Masoomeh Kheirkhah
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Education
Street address
School of Nursing & Midwifery, Rashid Yasemi st., Valiasr St., Tehran, 1996713883, Iran
City
Tehran
Province
Tehran
Postal code
۱۹۹۶۷۱۳۸۸۳
Phone
+98 21 4365 1707
Email
kheirkhah.m@iums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Masoomeh Kheirkhah
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Education
Street address
School of Nursing & Midwifery, Rashid Yasemi st., Valiasr St., Tehran, 1996713883, Iran
City
Tehran
Province
Tehran
Postal code
۱۹۹۶۷۱۳۸۸۳
Phone
002143651707
Fax
Email
kheirkhah.m@iums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Masoomeh Kheirkhah
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Education
Street address
School of Nursing & Midwifery, Rashid Yasemi st., Valiasr St., Tehran, 1996713883, IRAN
City
Tehran
Province
Tehran
Postal code
۱۹۹۶۷۱۳۸۸۳
Phone
+98 21 4365 1707
Email
kheirkhah.m@iums.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
No - There is not a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
Not applicable
Title and more details about the data/document
The results obtained from the research will be reflected to the University of Medical Sciences and the Vice-Chancellor of Health
When the data will become available and for how long
After printing the results
To whom data/document is available
Deputy health and research
Under which criteria data/document could be used
In order to be used in various educational, clinical, research and economic fields.
From where data/document is obtainable
Name: Masoomeh Kheirkhah Email: kheirkhah.m@iums.ac.ir Name: Rana Moozafari Email: raanamoozafari@gmail.com
What processes are involved for a request to access data/document
Contact the corresponding author by email and register the request
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