evaluating supportive intervention on attitude, treatment continuation intention and mental health of infertile couples
Design
Clinical trial with control group. No blinding, randomized, on 130 patients. A table of random numbers will be used for randomization.
Settings and conduct
This study is part of a larger study and at this stage an educational and counseling intervention will be conducted on infertile couples who have referred to the Jahad Infertility Center of Qom and do not intend to continue treatments. Samples will be randomly selected to participate in control and intervention groups. Then the designed intervention will be given to the experimental group (65 people). The control group is 65 people who will receive routine care.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
infertile women (18-42)
history of at least one unsuccessful IVF / ICSI and FET cycle
Having a file in the infertility center
Voluntary participation and written consent.
Having Iranian nationality (couple)
No addiction to drugs and psychotropic drugs
Fluency in Persian
Exclusion criteria:
get pregnant
Intervention groups
The educational and counseling intervention will be conducted on two groups (intervention and control). 4 1-hour online sessions (weekly) are provided to present the main issues of the intervention, and also some of the easier content will be presented in 6 sessions (twice a week) by forming a group in cyberspace. The content of the training sessions is based on a transtheoretical model and covers various areas such as identification and self-care about stress, depression, anxiety, social anxiety, coping skills, how to interact with others, anger management. The control group will also receive standard infertility center care.
Main outcome variables
Attitude, intention to continue treatment and mental health
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210516051315N1
Registration date:2021-05-30, 1400/03/09
Registration timing:prospective
Last update:2021-05-30, 1400/03/09
Update count:0
Registration date
2021-05-30, 1400/03/09
Registrant information
Name
Maryam Ghorbani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 23 3239 5054
Email address
maryam_ghorbany89@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-06-22, 1400/04/01
Expected recruitment end date
2021-08-06, 1400/05/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
providing and evaluation of a supportive educational intervention on treatment continuation of infertile couples
Public title
educational intervention for infertile couples
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Infertile women aged 42-18
Having a file in the infertility center
Voluntary participation and written consent
Having Iranian nationality (for both of couples)
No addiction to drugs and psychotropic drugs
Fluency in Persian
Perform at least one IVF / ICSI and FET cycle after the required time period to start treatment again. For this purpose, a follow-up period of at least 6 months, according to a study conducted by Moeini et al. In 2009, at Royan Infertility Center taken
Exclusion criteria:
geting pregnant
Age
From 18 years old to 42 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
130
Randomization (investigator's opinion)
Randomized
Randomization description
This randomized clinical trial will be performed at Jihad Infertility Center of Qom University . Among infertile couples who do not intend to continue infertility treatments and meet the inclusion criteria, after obtaining informed consent, samples are taken individually using a simple random method and using a random number table to participate in control group (n = 65) and intervention (n = 65). Thus, a number is first assigned to infertile couples who meet the criteria for entry into the intervention. Reading the numbers in the random table will be from bottom to top. Then even numbers will be selected to be in the intervention group and odd numbers will be selected to be in the control group. And this will continue until the required number of samples in each group is completed, and thus the researcher will not have the option to change the assignment status of individuals or predict it.
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 commitee of Shahroud University of Medical Sciences
Street address
7tir street
City
Shahroud
Province
Semnan
Postal code
3614773947
Approval date
2019-03-11, 1397/12/20
Ethics committee reference number
IR.SHMU.REC.1397.235
Health conditions studied
1
Description of health condition studied
infertility
ICD-10 code
N97
ICD-10 code description
Female infertility
Primary outcomes
1
Description
attitude to infertility treatments
Timepoint
one month after the end of intervention
Method of measurement
Attitude Questionnaire on Infertility Treatments
2
Description
Mental health
Timepoint
one month after the end of intervention
Method of measurement
GHQ28 questionaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: They will receive educational counseling intervention as follows. 4 1-hour online sessions per week are provided to present the main issues of the intervention, and also some of the easier content will be presented in 6 sessions (twice a week) by forming a group in cyberspace. The content of the training sessions is based on a transtheoretical model and covers various areas such as identification and self-care about stress, depression, anxiety, social anxiety, coping skills, how to interact with others, anger management.
Category
Behavior
2
Description
Control group: participants of control group will not receive any intervention from the research team during the study.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Jahad Infertility treatment center , Qom province
Full name of responsible person
Maryam Ghorbani
Street address
Jahad daneshgahi alley, Safashar street
City
Qom
Province
Ghoum
Postal code
3716986466
Phone
+98 25 3285 9856
Email
maryam_ghorbany89@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahroud University of Medical Sciences
Full name of responsible person
Mohammad Hasan Emamian
Street address
7street
City
Shahroud
Province
Semnan
Postal code
3614773947
Phone
+98 23 3239 5054
Email
pishgiri1@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahroud 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
Shahroud University of Medical Sciences
Full name of responsible person
Afsaneh Keramat
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Reproductive Health
Street address
7tir street
City
shahroud
Province
Semnan
Postal code
3614773947
Phone
+98 23 3239 5054
Email
keramat2222@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahroud University of Medical Sciences
Full name of responsible person
Afsaneh Keramat
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Reproductive Health
Street address
7tir street
City
Shahroud
Province
Semnan
Postal code
3614773947
Phone
+98 23 3239 5054
Email
keramat2222@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Shahroud University of Medical Sciences
Full name of responsible person
Maryam Ghorbani
Position
Student
Latest degree
Ph.D.
Other areas of specialty/work
Reproductive Health
Street address
7tir street
City
Shahroud
Province
Semnan
Postal code
3614773947
Phone
009832935054
Email
maryam_ghorbany89@yahoo.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
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