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Comparing The Effectiveness of Group training Based on Acceptance and Commitment with Transactional Analysis on Mother-Fetus Attachment, Ego Strength and Fear of Childbirth in Pregnant Women

Protocol summary

Study aim
Comparing The Effectiveness of Group training Based on Acceptance and Commitment with Transactional Analysis on Mother-Fetus Attachment, Ego Strength and Fear of Childbirth in Pregnant Women
Design
This research will be of the type of semi-experimental research (pre-test, post-test and follow-up test design with control group and parallel groups, unidirectional and without phase) and 45 participants will be randomly selected based on random allocation software. They will be placed in two experimental groups and one control group
Settings and conduct
The statistical population of the current study will include all women with their first pregnancy in the last quarter of the year 2023 , 1st district of Tehran, who will refer to the pregnancy care clinics and will be willing to participate in the research.
Participants/Inclusion and exclusion criteria
Inclusion criteria: primiparous women, Iranian nationality, literacy at least diploma, age 18 to 45 years, pregnancy age 12 weeks to 25 weeks, normal pregnancy, no psychological and personality diseases, no addiction. Exclusion criteria: participation in other educational and counseling programs Individual or drug therapy
Intervention groups
The first experimental group training based on commitment and acceptance, the second experimental group, training based on transactional analysis, and the control group will remain in the waiting list. The intervention protocol will be 8 weekly 90s sessions
Main outcome variables
Mother's attachment to the fetus, ego strength, fear of childbirth

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20230725058924N1
Registration date: 2023-09-24, 1402/07/02
Registration timing: prospective

Last update: 2023-09-24, 1402/07/02
Update count: 0
Registration date
2023-09-24, 1402/07/02
Registrant information
Name
Sara Langroudian
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2612 6417
Email address
s.langroudian@iau-tnb.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-10-23, 1402/08/01
Expected recruitment end date
2023-12-21, 1402/09/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing The Effectiveness of Group training Based on Acceptance and Commitment with Transactional Analysis on Mother-Fetus Attachment, Ego Strength and Fear of Childbirth in Pregnant Women
Public title
Comparing The Effectiveness of Group training Based on Acceptance and Commitment with Transactional Analysis on Mother-Fetus Attachment, Ego Strength and Fear of Childbirth in Pregnant Women
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Primiparous women Gestation age 12 to 25 weeks Having a literacy level of at least a diploma Age 18 to 45 years The normality of pregnancy Iranian nationality
Exclusion criteria:
Previous diagnosis of psychological and personality diseases Taking psychotropic drugs Participation in other psychology training programs Individual counseling Psychotherapeutic drugs
Age
From 18 years old to 45 years old
Gender
Female
Phase
N/A
Groups that have been masked
  • Participant
Sample size
Target sample size: 45
Randomization (investigator's opinion)
Randomized
Randomization description
The purpose-based sampling will be done based on the entry criteria and with random assignment based on the random allocation software, so that first the samples are selected based on the entry criteria and each sample will be given a number, and then the number and groups will be assigned to the software. is given and the software gives us a page that has randomly assigned each person in the corresponding group
Blinding (investigator's opinion)
Single blinded
Blinding description
In this research, the researcher is aware of the methods and interventions, but the subjects are not aware of the difference between interventions and work methods.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of slamic Azad University, North Tehran branch
Street address
Unit 111, No. 7,The third ally ,Shahid Sabari St., corner of Koche Som East
City
Tehran
Province
Tehran
Postal code
1957843434
Approval date
2023-07-16, 1402/04/25
Ethics committee reference number
IR.IAU.TNB.REC.1402.051

Health conditions studied

1

Description of health condition studied
Comparing the effectiveness of group training based on commitment and acceptance with transactional analysis on mother-child attachment, ego strength and fear of childbirth in pregnant women.
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Mother_fetus Attachment
Timepoint
before the start of the interventions, after the end of the interventions and three months after the end of the interventions
Method of measurement
Cranley Maternal Attachment Questionnaire (1981)

2

Description
Ego Strength
Timepoint
before the start of the interventions, after the end of the interventions and three months after the end of the interventions
Method of measurement
Markstrom's Strength Questionnaire (1997)

3

Description
Fear of childbirth
Timepoint
before the start of the interventions, after the end of the interventions and three months after the end of the interventions
Method of measurement
Harman Fear of Childbirth Questionnaire (1993)

Secondary outcomes

empty

Intervention groups

1

Description
The protocol of training sessions based on the acceptability and commitment for 90-minute on 8 sessions will be held during 8 weeks.
Category
Lifestyle

2

Description
Transactional analysis (TA): In this study, group training of Transactional analysis will be held during 8 sessions of 90 minutes and on a weekly
Category
Lifestyle

Recruitment centers

1

Recruitment center
Name of recruitment center
Clinic Didgaaheno
Full name of responsible person
Maryam Janfada
Street address
Unit 12, 3rd floor, plate 36, Chizer Square, Qaytarieh
City
Tehran
Province
Tehran
Postal code
1938963394
Phone
+98 21 2221 5352
Email
janfada@didgaaheno
Web page address

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Islamic Azad University
Full name of responsible person
Saied Malmasi
Street address
Shahid Babaei Highway, shahid Abbaspor, Shahid Sadoqi, North Tehran Branch, Islamic Azad University
City
Tehran
Province
Tehran
Postal code
1651153511
Phone
+98 21 7700 9848
Email
ravabet-omomi@iau-tnb.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Islamic Azad University
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
Islamic Azad University
Full name of responsible person
Sara Langroudian
Position
Consultant
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
Unit 11, No. 7, 3rd East Alley ,Shahid Sabari St
City
Tehran
Province
Tehran
Postal code
1957843434
Phone
+98 21 2612 6417
Email
S.langroudian@iau-tnb.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Sara Langroudian
Position
Consultant
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
Unit 11, No. 7, 3rd East Alley, Shahid Sabari St
City
Tehran
Province
Tehran
Postal code
11957843434
Phone
+98 21 2612 6417
Email
S.langroudian@iau-tnb.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Sara Langroudian
Position
Consultant
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
Unit 11, No. 7, 3rd East Alley, Shahid Sabari St
City
Tehran
Province
Tehran
Postal code
1957843434
Phone
+98 21 2612 6417
Email
S.langroudian@iau-tnb.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
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