Protocol summary

Study aim
To assess the effect of couple counseling on stress and dyadic coping in infertile couples
Design
This is a randomized clinical trial, phase II, in which 70 eligible couple will be randomly assigned to the intervention and control groups
Settings and conduct
The eligible infertile couples referring to the Fatemieh Hospital in Hamadan city during the study period will be enrolled in the trial and will be randomly assigned to the intervention and control groups through the block randomization.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Age of 20 to 45 years, Primary infertility at least for one year, Stress in both couples, Literate, Exclusion criteria: Attending to other educational programs in the past, Any mental or neurological disorder
Intervention groups
Intervention group: Providing routine infertility services and care in addition to couple-centered counseling (including familiarity with stress, personal coping, marital coping and problem-solving skills, observance of fairness and justice in marital relationship, marital communication skills, increasing individual coping skills and marital coping skills and increasing solving skills) each session lasts 90 to 120 minutes, one session per week for 7 sessions Control group: Providing just routine infertility services and care
Main outcome variables
Primary outcome: Measuring stress, measuring dyadic coping

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20120215009014N367
Registration date: 2020-09-20, 1399/06/30
Registration timing: prospective

Last update: 2020-09-20, 1399/06/30
Update count: 0
Registration date
2020-09-20, 1399/06/30
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
2020-11-05, 1399/08/15
Expected recruitment end date
2021-11-06, 1400/08/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of couple counseling on stress and dyadic coping in infertile couples: a randomized clinical trial
Public title
Effect of couple counseling on stress and dyadic coping in infertile couples
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age of 20 to 45 years, Primary infertility at least for one year, Stress in both couples, Literate,
Exclusion criteria:
Attending to other educational programs in the past, Any mental or neurological disorder
Age
From 20 years old to 45 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 70
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
2020-08-22, 1399/06/01
Ethics committee reference number
IR.UMSHA.REC.1399.485

Health conditions studied

1

Description of health condition studied
Stress
ICD-10 code
F43.8
ICD-10 code description
Other reactions to severe stress

Primary outcomes

1

Description
Measuring stress
Timepoint
Before the intervention and 7 weeks after that
Method of measurement
Using Newton Infertility Stress Scale

2

Description
Measuring dyadic coping
Timepoint
Before the intervention and 7 weeks after that
Method of measurement
Using Standard Couple Coping Questionnaire

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: Providing routine infertility services and care in addition to couple-centered counseling (including familiarity with stress, personal coping, marital coping and problem solving skills, observance of fairness and justice in marital relationship, marital communication skills, increasing individual coping skills and marital coping skills and increasing solving skills) each session lasts 90 to 120 minutes, one session per week for 7 sessions
Category
Treatment - Other

2

Description
Control group: Providing just routine infertility services and care
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Fatemieh Hospital in Hamadan city
Full name of responsible person
Fahimeh Monirian
Street address
Fatemieh Hospital, Pasdaran Ave.
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3828 3939
Email
fahimehmoniriyan@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Dr. Saeid Bashirian
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
Fahimeh Monirian
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
fahimehmoniriyan@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Dr. Soodabeh Aghababaii
Position
Reproductive Health Specialist
Latest degree
Ph.D.
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
aghababii@yahoo.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
Loading...