The effect of counseling with the method of happiness training based on cognitive behavioral model on the stress of infertile women: a randomized controlled trial
Determining the effect of counseling on the stress of infertile women will be done with the method of teaching happiness program based on cognitive behavioral model
Design
A controlled, parallel-group, single-blind, randomized, phase 3 clinical trial on 60 infertile women. The stratified random block method will be used for randomization
Settings and conduct
The location of the research in this study is the infertility clinic of Al-Zahra educational and therapeutic center in Tabriz and the time of the research is 1403. In this study, a group as an intervention group will participate in counseling sessions with the method of teaching happiness based on the cognitive behavioral model. The control group will not participate in the counseling session. Of course, both groups will receive their routine infertility treatment according to the doctor's opinion
Participants/Inclusion and exclusion criteria
Infertile women who will refer to the infertility clinic of Al-Zahra Medical Training Center in Tabriz for treatment
Intervention groups
In this study, a group as an intervention group will participate in counseling sessions with the method of teaching happiness based on the cognitive behavioral model, and the control group will not participate in the counseling session. Of course, both groups will receive their routine infertility treatment according to the doctor's opinion
Main outcome variables
Infertility stress score
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20240809062706N1
Registration date:2024-08-23, 1403/06/02
Registration timing:prospective
Last update:2024-08-23, 1403/06/02
Update count:0
Registration date
2024-08-23, 1403/06/02
Registrant information
Name
Khadije Hajizadeh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 41 3479 6770
Email address
hajizade_k@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-09-20, 1403/06/30
Expected recruitment end date
2025-02-19, 1403/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of counseling with the method of happiness training based on cognitive behavioral model on the stress of infertile women: a randomized controlled trial
Public title
The effect of counseling with the method of happiness training on the stress of infertile women: a randomized controlled trial
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Infertile women with at least one year of primary infertility and treated with IVF
Having at least middle school literacy
Obtaining a minimum score of 184 in the infertility stress questionnaire
Exclusion criteria:
Suffering from nervous and mental diseases according to the patient herself
Suffering from chronic diseases (kidney and liver failure, etc.)
Taking psychiatric drugs according to the patient's own statement
Visiting a psychologist in the past few months due to infertility
Uncertainty that she can participate in all counseling sessions
Age
No age limit
Gender
Female
Phase
3
Groups that have been masked
Outcome assessor
Data analyser
Sample size
Target sample size:
60
More than 1 sample in each individual
Number of samples in each individual:
1
Infertile women who will refer to the infertility clinic of Al-Zahra Medical Training Center in Tabriz for treatment
Randomization (investigator's opinion)
Randomized
Randomization description
The participants who completed the pre-test questionnaires were randomly selected using the website www.random.org and by blocking with blocks of four and six with an allocation ratio of 1:1. They will be assigned to two intervention groups (receiving counseling) and control group (not receiving counseling).
Blinding (investigator's opinion)
Single blinded
Blinding description
The person supervising the completion of the post-test questionnaires, the outcome evaluator, and the data analyst will be a person not involved in sampling
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
کمیته اخلاق دانشگاه علوم پزشکی تبریز
Street address
Reaserch department, third floor, central construction number 2, Tabriz university of medical sciences, Golgasht street, Azadi avenue
City
Tabriz
Province
East Azarbaijan
Postal code
5138947977
Approval date
2024-08-21, 1403/05/31
Ethics committee reference number
IR.TBZMED.REC.1403.404
Health conditions studied
1
Description of health condition studied
Infertility
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Average infertility stress score
Timepoint
Before and after the intervention
Method of measurement
The Fertility problem Inventory(FPI)
Secondary outcomes
1
Description
Average infertility self-efficacy score
Timepoint
Before and after the intervention
Method of measurement
Infertility self-efficacy scale(ISE)
Intervention groups
1
Description
Intervention group: This group will participate in counseling sessions with the method of teaching happiness based on the cognitive-behavioral model during 8 sessions
Category
Treatment - Other
2
Description
Control group: No counseling session will be held for the control group
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
بیمارستان آموزشی درمانی الزهرا
Full name of responsible person
خدیجه حاجی زاده
Street address
Alzahra Hospital, Artesh street
City
Tabriz
Province
East Azarbaijan
Postal code
5138947977
Phone
+98 41 3553 9161
Email
nursing@tbzmed.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr Parviz Shahabi
Street address
Research department, third floor, central construction number 2,Tabriz University of Medical Sciences, Golgasht Street, Azadi Avenue, Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
5138947977
Phone
+98 41 3335 7310
Email
iro@tbzmed.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tabriz 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
Tabriz University of Medical Sciences
Full name of responsible person
Fereshteh Shaker
Position
Student of master's degree in Counselling in Midwifery
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
Faculty of Nursing and Midwifery, South Shariati St
City
Tabriz
Province
East Azarbaijan
Postal code
5138947977
Phone
+98 41 3447 2966
Email
Frsh319@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Khadijeh Hajizadeh
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Midwifery
Street address
Faculty of Nursing and Midwifery, South Shariati Street
City
Tabriz
Province
East Azarbaijan
Postal code
5138947977
Phone
+98 41 3447 2699
Email
hajizade_k@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Fereshteh Shaker
Position
Student of master's degree in Counselling in midwifery
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
Faculty of Nursing and Midwifery, South Shariati Street
City
Tabriz
Province
East Azarbaijan
Postal code
5415933739
Phone
+98 41 3447 2966
Email
Frsh319@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD