Effect of emotional self-regulation counseling versus control group on emotion regulation skills and anxiety in infertile women undergoing in vitro fertilization (IVF) treatment: a randomized clinical trial
To assess the effect of emotional self-regulation counseling versus control group on emotion regulation skills and anxiety in infertile women undergoing in vitro fertilization (IVF) treatment
Design
This is randomized clinical trial with a control group with parallel groups without blinding, in which eligible patients will be randomly assigned to the intervention and control groups using block randomization.
Settings and conduct
This study will be conducted at the Fatemieh Hospital in Hamadan city, involving 66 eligible infertile women. The patients will be randomly assigned to the intervention and control groups through the block randomization. Blinding is not feasible in this trial.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Age 20 to 40
Infertile women
Mild to moderate anxiety (score 20 to 42 on the Spielberger Anxiety Risk Scale)
Literacy
Exclusion criteria:
Mental disorder
Addiction
Candida treatment First time in vitro fertilization
Intervention groups
Intervention group:
Routine IVF treatment plus self-regulation counseling for 60 minutes once a week for 4 weeks
Control group:
Routine IVF treatment
Main outcome variables
Primary outcome:
Emotion score; Anxiety score
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20120215009014N551
Registration date:2025-03-07, 1403/12/17
Registration timing:prospective
Last update:2025-03-07, 1403/12/17
Update count:0
Registration date
2025-03-07, 1403/12/17
Registrant information
Name
Jalal Poorolajal
Name of organization / entity
Department of Epidemiology & Biostatistics Hamadan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 81 1838 0090
Email address
poorolajal@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2025-06-01, 1404/03/11
Expected recruitment end date
2025-09-02, 1404/06/11
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of emotional self-regulation counseling versus control group on emotion regulation skills and anxiety in infertile women undergoing in vitro fertilization (IVF) treatment: a randomized clinical trial
Public title
Effect of emotional self-regulation counseling versus control group on emotion regulation skills and anxiety in infertile women undergoing in vitro fertilization (IVF) treatment
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age 20 to 40
Infertile women
Mild to moderate anxiety (score 20 to 42 on the Spielberger Anxiety Risk Scale)
Literacy
Exclusion criteria:
Mental disorder
Addiction
Candida treatment First time in vitro fertilization
Age
From 20 years old to 40 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
66
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, random assignment of patients to the intervention and control groups will be carried out using block randomization. To achieve this, four sheets of paper will be prepared - two with the name of the intervention and two with the name of the control. These paper sheets will be pooled and placed in a container. Patients will be selected one at a time without replacement, and for each patient, a paper sheet will be randomly drawn from the container. After each draw, the paper sheets will be returned to the container, and the process will be repeated until the desired sample size is reached.
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 Hamadan University of Medical Sciences
Street address
Vice-chancellor for Research and Technology, Hamadan University of Medical Sciences, Fahmideh Ave
City
Hamadan
Province
Hamadan
Postal code
6517838695
Approval date
2025-03-01, 1403/12/11
Ethics committee reference number
IR.UMSHA.REC.1403.876
Health conditions studied
1
Description of health condition studied
Female infertility
ICD-10 code
N97
ICD-10 code description
Female infertility
Primary outcomes
1
Description
Emotion score
Timepoint
Before intervention and 4 weeks after
Method of measurement
Using the Emotion Regulation Skills Questionnaire (ERSQ)
2
Description
Anxiety score
Timepoint
Before intervention and 4 weeks after
Method of measurement
Using the Spielberger Anxiety Inventory (STAI)
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Routine IVF treatment plus self-regulation counseling for 60 minutes once a week for 4 weeks (including familiarization with the anatomy of the reproductive system and reproductive hormones, familiarization with the stages of treatment with assisted reproductive methods, possible consequences and complications of treatment, how anxiety and negative emotions affect hormonal and physiological changes in the reproductive system, sperm and egg enhancement strategies, expression of normal emotions and problematic emotions, how to differentiate between different emotions, identification of emotions in physical and psychological states, cognitive, physiological and behavioral consequences of emotional reactions during treatment, physical, behavioral and cognitive symptoms of emotional reactions caused by thoughts to the treatment process, awareness of the relationship between emotions and behavior and thought, breaking problematic core beliefs and replacing them with new beliefs)
Category
Treatment - Other
2
Description
Control group: Routine IVF treatment
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Fatemieh Hospital in Hamadan city
Full name of responsible person
Fariba Soltani
Street address
Fatemieh Hospital, Pasdaran Ave.
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3828 3939
Email
soltanifariba484@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Dr. Alireza Soltanian
Street address
Hamadan University of Medical Sciences, Fahmideh Ave
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0717
Email
info.research@umsha.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Hamedan 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
Hamedan University of Medical Sciences
Full name of responsible person
Fariba Soltani
Position
Midwifery Student
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
School of Nursing and Midwifery, Hamadan University of Medical Sciences, Fahmideh Ave.
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0572
Email
soltanifariba484@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Dr. Azita Tiznobeik
Position
Reproductive Health Specialist
Latest degree
Ph.D.
Other areas of specialty/work
Reproductive Health
Street address
School of Nursing and Midwifery, Hamadan University of Medical Sciences, Fahmideh Ave.
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0572
Email
azita.tizno@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Dr. Jalal Poorolajal
Position
Professor of Epidemiology
Latest degree
Ph.D.
Other areas of specialty/work
Epidemiology
Street address
School of Public Health, Hamadan University of Medical Sciences, Fahmideh Ave
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0090
Email
poorolajal@umsha.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