Protocol summary

Study aim
Determining the effect of online training on perceived stress and increased self - efficacy in women undergoing ivf treatment .
Design
This clinical trial was a randomized controlled study with parallel groups.
Settings and conduct
The statistical population of the study consisted of women undergoing IVF treatment who attended infertility centers in Birjand. Participants meeting the inclusion and exclusion criteria were recruited through convenience sampling and were randomly allocated into intervention and control groups using the block randomization method.
Participants/Inclusion and exclusion criteria
Inclusion Criteria:married women aged 20 to 40 years, diagnosed with infertility and currently undergoing an IVF treatment cycle, reading and writing skills, having access to a smartphone with the proficiency to utilize the Eita messaging application, and providing signed informed consent. Exclusion Criteria: having a diagnosis of severe psychiatric disorders, current use of psychotropic medications, receiving concurrent psychotherapy
Intervention groups
Intervention Group:The intervention group will participate in a 4 week online resilience training program conducted via the Eitaa messenger. The training content, provided in both text and video formats, consists of eight sessions. The curriculum covers the following topics: Introduction of resilience,Stress management,Cognitive restructuring, Emotion regulation,Effective communication and social support,Meaning-making and growth through challenges,Problem-solving and flexibility, and Consolidation and future planning.The control group received only routine care provided by the infertility center and did not participate in the online resilience training sessions.
Main outcome variables
Perceived Stress, Self-Efficacy

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20251228068473N1
Registration date: 2026-05-27, 1405/03/06
Registration timing: retrospective

Last update: 2026-05-27, 1405/03/06
Update count: 0
Registration date
2026-05-27, 1405/03/06
Registrant information
Name
Mina Salmanpour
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 41 2293 0470
Email address
slmnprmina@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2026-02-07, 1404/11/18
Expected recruitment end date
2026-02-19, 1404/11/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effect of Online Resilience Training on Stress Reduction and Self-Efficacy Enhancement in Women Undergoing IVF Treatment
Public title
Investigating the Effect of Online Resilience Training on Stress and Self-Efficacy
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Having a diagnosis of infertility and being in an IVF treatment cycle Having at least basic literacy in reading and writing Having access to a smartphone and the ability to use the Eita messenger application
Exclusion criteria:
Suffering from severe psychiatric disorders Taking psychiatric medications Receiving concurrent psychotherapy
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: 74
Randomization (investigator's opinion)
Randomized
Randomization description
Eligible subjects were selected via convenience sampling from patients attending infertility clinics in Birjand. To achieve balanced allocation and control for potential confounders, a permuted block randomization technique was applied. Fixed-size blocks of four were defined, ensuring an equal distribution of participants between the intervention group (A) and the control group (B) within each block. The randomization process involved six possible block arrangements (AABB, ABAB, BBAA, BABA, ABBA, and BAAB). The specific sequence of these blocks was determined using the RANDBETWEEN(1,6) command in Microsoft Excel, tailored to the study’s required sample size. Following this generated sequence, participants were allocated to the two groups in a 1:1 ratio. This methodology was adopted to mitigate selection bias and ensure a balanced distribution of subjects, providing each participant with an equal and fair probability of assignment to either study arm.
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 Birjand University of Medical Sciences
Street address
Central Organization of Birjand University of Medical Sciences , Ghaffari Street ,Birjand ,South Khorasan
City
Birjand
Province
South Khorasan
Postal code
۹۷۱۷۸۵۳۰۷۶
Approval date
2026-01-28, 1404/11/08
Ethics committee reference number
IR.BUMS.REC.1404.463

Health conditions studied

1

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

Primary outcomes

1

Description
Perceived stress
Timepoint
Before and after the intervention
Method of measurement
Perceived Stress Scale

2

Description
Self - efficacy
Timepoint
Before and after the intervention
Method of measurement
Infertility Self Efficacy Scale

Secondary outcomes

empty

Intervention groups

1

Description
Intervention Group: The intervention group will participate in a four-week online resilience training program conducted via the Eitaa messenger application. The training content, provided in both text and video formats, consists of eight sessions held one hour twice weekly. The curriculum covers the following topics: Introduction and understanding of resilience, Stress and emotion management, Cognitive restructuring, self-care and emotion regulation, Effective communication and social support, Meaning-making and growth through challenges, Problem-solving and flexibility, and Consolidation and future planning. The intervention group will receive the training virtually and will be under supervision throughout the program.
Category
Lifestyle

Recruitment centers

1

Recruitment center
Name of recruitment center
Royesh Infertility Treatment Center of Birjand
Full name of responsible person
Vajihe Hazari
Street address
Valiasr Hospital (AJ) , Opposite the University of Medical Sciences , Zakariya Razi Street , Birjand Town
City
Birjand
Province
South Khorasan
Postal code
۹۷۱۷۸۵۳۰۷۶
Phone
+98 21 9109 4453
Email
iranfertility@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Birjand University of Medical Sciences
Full name of responsible person
Masoud Yousefi
Street address
Birjand University of Medical Sciences, Ghafari Street
City
Birjand
Province
South Khorasan
Postal code
9717853577
Phone
+98 56 3238 1200
Email
masoud.yousefi@bums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Birjand 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
Birjand University of Medical Sciences
Full name of responsible person
Mina Salmanpour
Position
Student
Latest degree
A Level or less
Other areas of specialty/work
Health Technology Assessment
Street address
The female dormitory of Hazrat zeinab, Imam Khomeini 7 Street, Ferdows Town
City
Ferdows
Province
South Khorasan
Postal code
۹۷۱۷۸۵۳۰۷۶
Phone
+98 41 2293 0470
Fax
Email
Slmnprmina@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Birjand University of Medical Sciences
Full name of responsible person
Mina Salmanpour
Position
Student
Latest degree
A Level or less
Other areas of specialty/work
Health Technology Assessment
Street address
The female dormitory of Hazrat zeinab, Imam Khomeini 7 Street, Ferdows Town
City
Ferdows
Province
South Khorasan
Postal code
9717853076
Phone
+98 41 2293 0470
Fax
Email
Slmnprmina@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Birjand University of Medical Sciences
Full name of responsible person
Mina Salmanpour
Position
Student
Latest degree
A Level or less
Other areas of specialty/work
Health Technology Assessment
Street address
The female dormitory of Hazrat zeinab, Imam Khomeini 7 Street, Ferdows Town
City
Ferdows
Province
South Khorasan
Postal code
9717853076
Phone
+98 41 2293 0470
Fax
Email
Slmnprmina@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
Yes - There is 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
Not applicable
Title and more details about the data/document
-
When the data will become available and for how long
-
To whom data/document is available
-
Under which criteria data/document could be used
-
From where data/document is obtainable
-
What processes are involved for a request to access data/document
-
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