The main goal: to determine the effect of supportive counseling on the resilience of infertile women after the failure of in vitro fertilization.
Design
A two-group clinical trial will be conducted on 60 infertile women immediately after the failure of in vitro fertilization. Research units will be randomly assigned to intervention and control groups.
Settings and conduct
This two-group clinical trial study will be conducted on 60 infertile women immediately after the failure of in vitro fertilization at the Milad Infertility Center in Mashhad. Research units will be randomly assigned to intervention and control groups. In the intervention group, in addition to the center's routine care, they will receive 4 individual support counseling sessions with an interval of 1 week. Data collection tools include the demographic profile questionnaire, the Connor and Davidson resilience questionnaire, and the DASS-21 stress-anxiety-depression questionnaire.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Being Iranian
Ability to read and write
No known medical disease
No known mental illness
Diagnosis of primary infertility based on the information in the patient's file
Negative pregnancy test after in vitro fertilization
Consent to participate in the study
No severe depression stress or anxiety according to the DASS-21 scale
Not having adopted children
Monogamous partner
Non-entry criteria:
Absence of stressful incidents during study
Participating in any of the counseling sessions or not answering the questionnaires
Not placing the resilience score in the last decile (i.e. score 90 and above)
Intervention groups
supportive counseling by a midwife (45 to 60 minutes) will be done in person and individually during 4 weekly sessions.
Main outcome variables
Determining the effect of supportive counseling on the resilience of infertile women after in vitro fertilization failure.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20230403057809N1
Registration date:2023-06-04, 1402/03/14
Registration timing:prospective
Last update:2023-06-04, 1402/03/14
Update count:0
Registration date
2023-06-04, 1402/03/14
Registrant information
Name
Aida Kabirian
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3767 9033
Email address
kabiriana992@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-06-13, 1402/03/23
Expected recruitment end date
2023-12-21, 1402/09/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of supportive counseling on resilience in infertile women after failure of in vitro fertilization(IVF)
Public title
The effect of supportive counseling on resilience in infertile women
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Being Iranian
Ability to read and write
No known medical disease
No known mental illness
Diagnosis of primary infertility based on the information in the patient's file
Negative pregnancy test after in vitro fertilization
Consent to participate in the study
No severe depression, stress or anxiety according to the DASS-21 scale
Not having adopted children
Monogamous partner
Exclusion criteria:
Absence of stressful incidents during study
Participating in any of the counseling sessions or not answering the questionnaires
Failure to place the resilience score in the last decile (i.e. score 90 and above).
Age
No age limit
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
Random assignment of eligible women to the two groups of supportive counseling and control will be simple randomly using a random sequence created by the random number table at randomization.com. It is written in small letters and kept in a sealed envelope. When each person is selected, the envelope door is opened and the person enters supportive counseling or controlgroup according to the code
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
Mashhad University of Medical Sciences
Street address
Khorasan Razavi - Mashhad - University Street - across from 18 University Street - Mashhad University of Medical Sciences - Research and Technology Vice-Chancellor of the University
City
Mashhad
Province
Razavi Khorasan
Postal code
9188667656
Approval date
2023-04-09, 1402/01/20
Ethics committee reference number
IR.MUMS.NURSE.REC.1402.001
Health conditions studied
1
Description of health condition studied
Resilience
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Resilience of infertility
Timepoint
Before, immediately after and 4 weeks after the end of the intervention.
Method of measurement
Connor and Davidson Resilience Questionnaire
Secondary outcomes
1
Description
Stress, anxiety, depression
Timepoint
Before, immediately after and 4 weeks after the end of the intervention
Method of measurement
DASS 21 stress-anxiety-depression questionnaire
Intervention groups
1
Description
Intervention group: supportive counseling by a midwife (45 to 60 minutes) will be done in person and individually during 4 weekly sessions. The stages of supportive counseling include creating a therapeutic alliance, clinical interview and talking about in vitro fertilization, the rate of failure and its effectiveness (first session), implementing the principle of reassurance, removing misunderstandings and doubts of the patient and pointing out his abilities and potentials, guiding, encouraging and persuasion (second and third sessions), Jobson's relaxation technique training and release for emotional discharge (fourth session).
Category
Behavior
2
Description
Control group: In the first session, the control group will complete the demographic characteristics questionnaire and the resilience questionnaire, and the center's routine care, which includes phone calls and explanations related to the continuation of assisted reproductive treatment, will be provided.
Category
Behavior
Recruitment centers
1
Recruitment center
Name of recruitment center
Milad Infertility Clinic, Mashhad
Full name of responsible person
Dr. Fatemeh zahra Karimi
Street address
Razi Sharghi Street
City
Mashhad
Province
Razavi Khorasan
Postal code
1355691359
Phone
+98 51 3853 4021
Email
karimifz@mums.ac.ir
Web page address
http://www.goums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Dr. Mohammad Hossein Bahreini
Street address
Khorasan Razavi - Mashhad - University St. - Qurashi Building, Khorasan Razavi University of Medical Sciences and Healthcare Services
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913199
Phone
+98 51 3859 1511
Email
kabirianA992@mums.ac.ir
Web page address
http://www.goums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad 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
Mashhad University of Medical Sciences
Full name of responsible person
Aida kabirian
Position
student
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
Faculty of Nursing and Midwifery, Doctor's intersection, Ibn Sina St.
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913199
Phone
+98 903 080 4369
Email
KabirianA992@mums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Fatemeh zahra Karimi
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Midwifery
Street address
Faculty of Nursing and Midwifery,Doctor's Crossroad, University Street,
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913199
Phone
+98 51 3859 1511
Email
Karimifz@mums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Aida kabirian
Position
student
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
Faculty of Nursing and Midwifery,Doctor's Crossroad, University Street,
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913199
Phone
+98 903 080 4369
Email
kabirianA992@mums.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