Protocol summary

Study aim
Determining the Effect of Transactional Analysis on Marital Satisfaction and Resilience of Infertile Women
Design
The Clinical trials with control group, with parallel groups, randomized
Settings and conduct
Anrich's Marital Satisfaction Scale and the connor Davidon, Resilience scale were distributed and completed among all infertile women who came there and were willing to participate in the study. Subjects then use the table. Random numbers were selected randomly and divided into two groups: intervention and control. The sample size was considered as 15 in each group. In the next step, the Group therapy with Transactional Analysis was done twice a week and in group session in 8 sessions of 2 hours for the intervention group. Finally, after intervention, to investigate the effect of interpersonal behavior analysis, these questionnaires were presented to intervention and control groups.
Participants/Inclusion and exclusion criteria
Inclusion criteria: 1.Diagnosis of infertility by a specialist 2.Have at least reading and writing skills 3.Infertility experience for at least one year 4.Failure to receive of psychological interventions in the past year Exclusion criteria: 1.More than two absentee sessions 2.Unwillingness to continue cooperation at any time from the implementation of the research
Intervention groups
In this research, the subjects were divided into intervention and control groups and the questionnaires were filled in by both groups and then the treatment group sessions were conducted for the intervention group and no intervention was performed on the control group, and then the effect of the training before and after the intervention in The two groups were measured and compared.
Main outcome variables
Marital satisfaction, Resilliency

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20170917036229N2
Registration date: 2018-12-10, 1397/09/19
Registration timing: retrospective

Last update: 2018-12-10, 1397/09/19
Update count: 0
Registration date
2018-12-10, 1397/09/19
Registrant information
Name
Atefeh Haghighi Cheli
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 26 3452 0412
Email address
a.haghighi@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-07-23, 1397/05/01
Expected recruitment end date
2018-09-18, 1397/06/27
Actual recruitment start date
2018-07-23, 1397/05/01
Actual recruitment end date
2018-09-18, 1397/06/27
Trial completion date
2018-09-18, 1397/06/27
Scientific title
The Effect of group Therapy Based on Transactional Analysis on Marital Satisfaction and Resilience of Women with infertility
Public title
The effect of group therapy on marital satisfaction and resilience of infertile women
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Diagnosis of infertility by a specialist Have at least reading and writing skills Infertility experience for at least one year Failure to receive of psychological interventions in the past year and Failure to receive of diagnostic criteria for major psychiatric disorders such as major depression, obsessive-compulsive disorder Desire to tell the experience
Exclusion criteria:
More than two absentee sessions Unwillingness to continue cooperation at any time from the implementation of the research
Age
No age limit
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 30
Actual sample size reached: 30
Randomization (investigator's opinion)
Randomized
Randomization description
Individuals are randomly selected using random numbers and will be placed in two groups of intervention and control, and The control and intervention groups will not contact each other.
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 Shahid beheshti University of Medical Sciences
Street address
Valiasr St., in front of the Shahid Rajaee Heart Hospital, Shahid Beheshti Faculty of Nursing and Midwifery
City
Tehran
Province
Tehran
Postal code
1985717443
Approval date
2017-07-18, 1396/04/27
Ethics committee reference number
IR.SBMU.PHNM.1396.759

Health conditions studied

1

Description of health condition studied
Infertility
ICD-10 code
N97
ICD-10 code description
Female infertility

Primary outcomes

1

Description
Marital Satisfaction
Timepoint
Before the intervention and after the intervention is completed
Method of measurement
Four ENRICH Couple Scales

2

Description
Resilience
Timepoint
Before the intervention and after the intervention is completed
Method of measurement
the Connor Davidon, Resilience scale

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: For the intervention group, the Transactional Analysis was performed twice a week and In group was run in 8 sessions at 2 hours.
Category
Behavior

2

Description
Control group: For the control group, no intervention was taken and the routine measures were taken to treat infertility, and the training package was provided to the control group following the completion of the work.
Category
Behavior

Recruitment centers

1

Recruitment center
Name of recruitment center
Infertility department of Mahdieh hospital in Tehran
Full name of responsible person
Dr. Shahrzad zadeh Modares
Street address
Shahid Rajabnia Street, Alley shishegarkhane, Fadaiean eslam St, Shosh Square
City
Tehran
Province
Tehran
Postal code
1185817311
Phone
+98 21 5506 2628
Fax
Email
Mahdiyeh_hospital@Sbmu.ac.ir
Web page address
https://mmc.sbmu.ac.ir/index.jsp?fkeyid=&siteid=109&pageid=43052

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Dr. Afshin Zarghi
Street address
Shahid Arabi Street, Yaman street, Shahid chamran Highway
City
Tehran
Province
Tehran
Postal code
1985717443
Phone
+98 21 23871
Email
zarghi@sbmu.ac.ir
Web page address
https://www.sbmu.ac.ir/
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Beheshti 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
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Atefeh Haghighi Cheli
Position
Master student of psychiatric nursing
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
No26, Shahid aghimi Ave, Enghelab street, Hesarak
City
Karaj
Province
Alborz
Postal code
3198735834
Phone
+98 26 3452 0412
Email
Haghighi.Atefeh@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Atefeh Haghighi Cheli
Position
Master student of psychiatric nursing
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
No26, Shadid aghimi ave ,Enghelab Street, Hesarak
City
Karaj
Province
Alborz
Postal code
3198735834
Phone
+98 26 3452 0412
Email
Haghighi.Atefeh@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Atefeh Haghighi Cheli
Position
Master student of psychiatric nursing
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
No26, Shadid aghimi ave ,Enghelab Street, Hesarak
City
Karaj
Province
Alborz
Postal code
3198735834
Phone
+98 26 3452 0412
Email
Haghighi.Atefeh@gmail.com

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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