Implementing of coping strategies with infertility using couple-based approach for infertile couples
Design
The experimental study has two experimental and control groups, each of which will include 32 people. Individuals are grouped in a non-random way; people who refer on even days of the week will be in the intervention group and people who refer on odd days will be in the control group.The coping strategies program will be implemented for the intervention group.
Settings and conduct
Infertile couples referring to Shahid Beheshti Infertility Center which have inclusion criteria, are divided into two groups; case and control.The Depression Anxiety Stress Scale-21(DASS-21) and Fertility Adjustment Scale (FAS) are completed by two groups before the intervention. The program will be implemented for the case group.The questionnaires will be completed immediately and three months after the intervention. No intervention is performed for the control group.
Participants/Inclusion and exclusion criteria
Iranian infertile couples with informed consent to enter the study - at least three months have passed since their last infertility treatment failure and have no history of mental disorders.
Intervention groups
Anxiety, depression and stress of infertile couples are measured using the Depression Anxiety Stress Scale-21(DASS-21) and infertility adjustment using the Fertility Adjustment Scale (FAS) before implementing infertility coping strategies. Coping strategies based on interviews with infertile couples and fertility service providers are implemented for the case group. Questionnaires will be completed immediately and three months after the intervention. No intervention is performed for the control group.
Main outcome variables
Depression, stress, anxiety and infertility adjustment
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20191014045102N1
Registration date:2021-10-19, 1400/07/27
Registration timing:prospective
Last update:2021-10-19, 1400/07/27
Update count:0
Registration date
2021-10-19, 1400/07/27
Registrant information
Name
Marziye Reisi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 38 3224 8636
Email address
mrz.reisi@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-10-22, 1400/07/30
Expected recruitment end date
2022-11-21, 1401/08/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Implementing of coping strategies with infertility using couple-based approach for infertile couples
Public title
Coping strategies with infertility in infertile couples
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Infertile Iranian couples
At least three months have passed since the last failure in infertility treatment.
No history of hospitalization or use of medication because of mental disorders
Absence of stress, anxiety and severe depression
Exclusion criteria:
Unwillingness to participate in study
Infertile couples with history of mental disorders
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
64
Randomization (investigator's opinion)
Not randomized
Randomization description
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 Isfahan University of Medical Sciences
Street address
Building No. 4, Isfahan University of Medical Sciences and Health Services, Hezar Jerib St., Isfahan, Iran.
City
Isfahan
Province
Isfehan
Postal code
81746-73461
Approval date
2021-05-08, 1400/02/18
Ethics committee reference number
IR.MUI.NUREMA.REC.1400.019
Health conditions studied
1
Description of health condition studied
mental health
ICD-10 code
F34
ICD-10 code description
Persistent mood [affective] disorders
Primary outcomes
1
Description
Depression
Timepoint
before the intervention, immediately after the intervention and three months after the intervention.
Method of measurement
Depression, anxiety and stress DASS 21 Scale
2
Description
Anxiety
Timepoint
before the intervention, immediately after the intervention and three months after the intervention.
Method of measurement
Depression, anxiety and stress DASS 21 Scale
3
Description
Stress
Timepoint
before the intervention, immediately after the intervention and three months after the intervention.
Method of measurement
Depression, anxiety and stress DASS 21 Scale
4
Description
Adjustment to infertility
Timepoint
before the intervention, immediately after the intervention and three months after the intervention.
Method of measurement
Fertility Adjustment Scale
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Intervention is a program that will be done with the aim of improving the structures. It should be noted that the exact content of the program will be determined after interviewing key participants (infertile couples and fertility service providers).
Category
Prevention
2
Description
Control group: The control group will not receive any intervention.