The Effect of Cognitive-Behavioral Stress Management Education on Infertility Related Stress, Marital Quality and Marital Satisfaction in Infertile Couples
Determining the effect of cognitive-behavioral education on infertility-related stress and marital quality and marital satisfaction in infertile couples
Design
Two parallel group randomized of infertile couples were selected to participate in this study (10 couples in intervention group and 10 couples in control group). This study was not blind.
Settings and conduct
This randomized study was conducted on 20 couples of Saboohi Infertility Center in Mahdieh Hospital of Tehran. The data collection tool was standard questionnaires of fertility problems, Enrich marital satisfaction and marital quality. At first, the primary test was performed in two groups (intervention and control) and then again, the test was performed immediately and two weeks after intervention with the same questionnaire in two groups.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Iranians, have reading and writing skills, live in Tehran, have no known psychological problems, have not experienced severe stressful events such as close relatives or job loss during the past 6 months, Initial infertility. Exclusion criteria: Non-cooperation
Intervention groups
In intervention group was performed 8 educational intervention sessions for 180 minutes using lecturing method, question answer method, focus group discussion and slideshows. The control group received only 2 infertility counseling sessions 180-minute.
Main outcome variables
Infertility related stress, marital quality, marital satisfaction
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20170807035540N3
Registration date:2018-07-20, 1397/04/29
Registration timing:retrospective
Last update:2018-07-20, 1397/04/29
Update count:0
Registration date
2018-07-20, 1397/04/29
Registrant information
Name
Hashemieh Chehreh
Name of organization / entity
School of Nursing & Midwifery,Shahid Beheshti University of Medical Science,
Country
Iran (Islamic Republic of)
Phone
+98 21 8865 5366
Email address
hashemieh_chehreh@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-05-05, 1397/02/15
Expected recruitment end date
2018-06-05, 1397/03/15
Actual recruitment start date
2018-05-10, 1397/02/20
Actual recruitment end date
2018-06-10, 1397/03/20
Trial completion date
empty
Scientific title
The Effect of Cognitive-Behavioral Stress Management Education on Infertility Related Stress, Marital Quality and Marital Satisfaction in Infertile Couples
Public title
The Effect of Education on Infertility Stress, Marital Quality and Marital Satisfaction
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Iranians couples
have reading and writing skills
live in Tehran
have no known psychological problems
have not experienced severe stressful events such as close relatives or job loss during the past 6 months
have primary infertility
Exclusion criteria:
Non-cooperation
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
40
Actual sample size reached:
40
Randomization (investigator's opinion)
Randomized
Randomization description
In the random sampling process of couples in two groups of intervention and control, random allocation software for clinical trails was used. Using this software, data about the number of samples, the number and names of the groups were given to Excel software, and the output was taken from the random list of the groups.
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 Shahid Beheshti University of Medical Sciences
Street address
Nursing and Midwifery School, Crossroads Valieaser with Niaiesh, Valieaser St.
City
Tehran
Province
Tehran
Postal code
1985717443
Approval date
2016-07-18, 1395/04/28
Ethics committee reference number
1395.500.IR-SBMU.PHNM
Health conditions studied
1
Description of health condition studied
Marital quality
ICD-10 code
ICD-10 code description
2
Description of health condition studied
Marital satisfaction
ICD-10 code
ICD-10 code description
3
Description of health condition studied
Infertility-related stress
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Marital quality
Timepoint
Before the intervention, immediately after the intervention and two weeks after the intervention
Method of measurement
Fertility Marital Quality Questionnaire
2
Description
Marital satisfaction
Timepoint
Before the intervention, immediately after the intervention and two weeks after the intervention
Method of measurement
Marital Satisfaction Questionnaire
3
Description
Infertility related stress
Timepoint
Before the intervention, immediately after the intervention and two weeks after the intervention
Method of measurement
Fertility problem or Infertility-related Stress Questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
The intervention included 8 training sessions 180-minute in the intervention group that it was carried out by question and answer method, focused group discussion and slideshow. The intervention included the Infertility counseling, Marital counseling, Problem solving and conflict resolution techniques, Social support, relaxation and breathing exercises.
Category
Other
2
Description
Control group: The control group received only 2 infertility counseling sessions 180-minute. This counseling was carried out by question and answer method, focused group discussion and slideshow. This consultation included definition of infertility and its causes, treatment methods, treatment costs and the impact of infertility on marital relationships.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Mahdiyeh Hospital, Saboohi Infertility Center
Full name of responsible person
Elaheh Mazaheri
Street address
Mahdiyeh Hospital, Fadaiyan Islam St.
City
Tehran
Province
Tehran
Postal code
1185817311
Phone
+98 21 5506 2628
Email
mazaheri_elaheh@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for research Shahid Beheshti University of Medical Sciences
Full name of responsible person
Dr. Afshin Zarghi
Street address
Shahid Beheshti University of Medical Sciences, beside the Taleqani hospital, Yaman St, Shahid Chamran highway
City
Tehran
Province
Tehran
Postal code
1983963113
Phone
+98 21 2243 9331
Email
zarghi@sbmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor for research Shahid Beheshti 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
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Hashemieh Chehreh
Position
Ph.D. student of reproductive health
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
Nursing and Midwifery School, Crossroads Valieaser with Niaiesh, Valieaser St.
City
Tehran
Province
Tehran
Postal code
1985717443
Phone
+98 21 8820 2518
Email
hashemieh_chehreh@sbmu.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Giti Ozgoli
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Reproductive Health
Street address
Nursing and Midwifery School, Crossroads Valieaser with Niaiesh, Valieaser St.
City
Tehran
Province
Tehran
Postal code
1985717443
Phone
+98 21 8820 2518
Email
g.ozgoli@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Hashemieh Chehreh
Position
PhD student
Latest degree
Master
Other areas of specialty/work
Reproductive Health
Street address
Nursing and Midwifery School, Crossroads Valieaser with Niaiesh, Valieaser St.
City
Tehran
Province
Tehran
Postal code
1985717443
Phone
+98 21 8820 2518
Email
hashemieh_chehreh@sbmu.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
Not applicable
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available