Effect of positive thinking counseling and cognitive restructuring versus control group on the perceived stress caused by the repeated failure of in vitro fertilization (IVF) among infertile women: a randomized clinical trial
To assess the effect of positive thinking counseling and cognitive restructuring versus control group on the perceived stress caused by the repeated failure of in vitro fertilization (IVF) among infertile women
Design
This is a randomized clinical trial with control group, in which eligible patients will be randomly assigned through the block randomization to the intervention and control groups
Settings and conduct
This study will be performed in the Fatemieh Hospital in Hamadan city on 60 eligible infertile women. The patients will be randomly assigned to the intervention and control groups through the block randomization. This trial will be Blinding is not possible in this study.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Age 20 to 45 years
Perceived high stress
Primary infertility
A history of two failed IVFs
Normal body mass index
Exclusion criteria:
Mental disorder
History of endometriosis
Addiction
Intervention groups
Intervention group:
Routine treatment plus positive thinking and cognitive restructuring counseling sessions for 45 to 60 minutes twice a week for 4 weeks (including familiarity with types of female infertility, positive and negative emotions, stress and quality of life; positive effect of healthy nutrition, exercise, and meditation on reproductive health; teaching behavioral methods such as talking about stress, calming and postponing the reaction; the effect of positive emotions on the quality of married life and sexual performance of couples)
Control group:
Just routine treatment
Main outcome variables
Primary outcome:
Perceived stress
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20120215009014N474
Registration date:2023-05-15, 1402/02/25
Registration timing:prospective
Last update:2023-05-15, 1402/02/25
Update count:0
Registration date
2023-05-15, 1402/02/25
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
2023-06-22, 1402/04/01
Expected recruitment end date
2024-01-21, 1402/11/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of positive thinking counseling and cognitive restructuring versus control group on the perceived stress caused by the repeated failure of in vitro fertilization (IVF) among infertile women: a randomized clinical trial
Public title
Effect of positive thinking counseling and cognitive restructuring versus control group on the perceived stress caused by the repeated failure of in vitro fertilization (IVF) among infertile women
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age 20 to 45 years
Perceived high stress
Primary infertility
A history of two failed IVFs
Normal body mass index
Exclusion criteria:
Mental disorder
History of endometriosis
Addiction
Age
From 20 years old to 45 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
The patients will be randomly assigned to intervention and control groups using block randomization. For this purpose, we will prepare four sheets of paper, writing on two sheets the name of the intervention and on the other two sheets the name of the control. The paper sheets will be pooled, placed in a container, and randomly drawn one at a time for each patient without replacement until all four sheets are drawn. The four paper sheets will be then placed back into the container, and this action repeated until the 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, Shahid Fahmideh Ave
City
Hamadan
Province
Hamadan
Postal code
6517838695
Approval date
2023-05-06, 1402/02/16
Ethics committee reference number
IR.UMSHA.REC.1402.103
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
Perceived stress
Timepoint
Before the intervention and 4 weeks later
Method of measurement
Using Cohen's perceived stress scale
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Routine treatment plus positive thinking and cognitive restructuring counseling sessions for 45 to 60 minutes twice a week for 4 weeks (including familiarity with types of female infertility, positive and negative emotions, stress and quality of life; positive effect of healthy nutrition, exercise, and meditation on reproductive health; teaching behavioral methods such as talking about stress, calming and postponing the reaction; the effect of positive emotions on the quality of married life and sexual performance of couples)
Category
Treatment - Other
2
Description
Control group: Just routine treatment plus
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Fatemieh Hospital in Hamadan city
Full name of responsible person
Sara Abdoli
Street address
Fatemieh Hospital, Pasdaran Ave.
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3828 3939
Email
sara.abdoli.m96@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Dr. Reza Shokoohi
Street address
Hamadan University of Medical Sciences, Shahid 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
Sara Abdoli
Position
Midwifery Student
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
School of Nursing and Midwifery, Hamadan University of Medical Sciences, Shahid Fahmideh Ave.
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0572
Email
sara.abdoli.m96@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Dr. Seyedeh Zahra Masoumi
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, Shahid Fahmideh Ave.
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0572
Email
zahramid2001@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, Shahid 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