Protocol summary
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Study aim
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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
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Design
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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
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Settings and conduct
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The location of the research in this study is the infertility Center of Jahad Daneshgahi in Tabriz and the time of the research is 2024. 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
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Participants/Inclusion and exclusion criteria
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Infertile women who will refer to the infertility Center of Jahad Daneshgahi in Tabriz for treatment
Inclusion criteria:
1- Infertile women with at least one year of primary infertility and undergoing IVF treatment
2- Having at least basic literacy
3- Obtaining a minimum score of 184 on the Infertility Stress Questionnaire
Exclusion criteria:
1- Suffering from neurological and mental illnesses according to the patient's own statement
2- Suffering from chronic illnesses (kidney and liver failure, etc.)
3- Taking psychiatric medications according to the patient's own statement
4- Referral to a psychologist within the past few months due to infertility
5- Lack of confidence in being able to attend all counseling sessions
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Intervention groups
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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.
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Main outcome variables
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Infertility stress score
General information
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Reason for update
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After approval by the Research Council of the Tabriz Faculty of Nursing and Midwifery, the sampling center has been changed from Al-Zahra Tabriz Center to the Jahad Daneshgahi Infertility Center.
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20240809062706N1
Registration date:
2024-08-23, 1403/06/02
Registration timing:
prospective
Last update:
2025-11-12, 1404/08/21
Update count:
1
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Registration date
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2024-08-23, 1403/06/02
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2024-09-20, 1403/06/30
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Expected recruitment end date
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2025-02-19, 1403/12/01
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Actual recruitment start date
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empty
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Actual recruitment end date
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empty
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Trial completion date
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empty
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Scientific title
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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
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Public title
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The effect of counseling with the method of happiness training on the stress of infertile women
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Purpose
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Education/Guidance
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Inclusion/Exclusion criteria
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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
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Age
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No age limit
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Gender
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Female
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Phase
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3
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Groups that have been masked
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- Outcome assessor
- Data analyser
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Sample size
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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
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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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).
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Blinding (investigator's opinion)
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Single blinded
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Blinding description
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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
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Placebo
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Not used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2024-08-21, 1403/05/31
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Ethics committee reference number
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IR.TBZMED.REC.1403.404
Health conditions studied
1
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Description of health condition studied
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Infertility
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ICD-10 code
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F40-F48
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ICD-10 code description
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Anxiety, dissociative, stress-related, somatoform and other nonpsychotic mental disorders
Primary outcomes
1
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Description
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Average infertility stress score
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Timepoint
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Before and after the intervention
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Method of measurement
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The Fertility problem Inventory (FPI)
Secondary outcomes
1
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Description
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Average infertility self-efficacy score
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Timepoint
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Before and after the intervention
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Method of measurement
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Infertility self-efficacy scale (ISE)
Intervention groups
1
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Description
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Intervention group: This group will participate in counseling sessions with the method of teaching happiness based on the cognitive-behavioral model during 8 sessions
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Category
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Treatment - Other
2
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Description
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Control group: No counseling session will be held for the control group
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Category
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N/A
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Tabriz University of Medical Sciences
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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No - There is not a plan to make this available
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Justification/reason for indecision/not sharing IPD
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Confidentiality of participants' information
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Study Protocol
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No - There is not a plan to make this available
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Statistical Analysis Plan
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No - There is not a plan to make this available
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Informed Consent Form
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No - There is not a plan to make this available
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Clinical Study Report
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No - There is not a plan to make this available
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Analytic Code
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No - There is not a plan to make this available
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Data Dictionary
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No - There is not a plan to make this available