This study was designed to examine the effect of collaborative infertility counseling on infertility perceived stress and coping strategies in infertile women undergoing In Vitro Fertilization in 2010 in Mashhad, Iran. In this clinical trial 60 women with primary infertility selected from Montaserieh Research Center and were randomly allocated to intervention (29) and control (31) groups. Women in intervention group were counseled in five meetings with the participation of midwife, gynecologist and clinical psychologist. Control group were counseled routinely. Perceived infertility-related stress and coping strategies were measured using Newton Fertility Problem Inventory and Folkman & Lazarous Ways of Coping questionnaire at the beginning and embryo transfer day. Results show that collaborative infertility counseling can decrease infertile women's perceived infertility-related stress. Thus it could be suggested as one of the stress management strategies in infertile women undergoing IVF.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201110267915N1
Registration date:2014-07-25, 1393/05/03
Registration timing:retrospective
Last update:
Update count:0
Registration date
2014-07-25, 1393/05/03
Registrant information
Name
Mahbobeh rasolzadeh Bidgoly
Name of organization / entity
Kashan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 315554002125
Email address
mehr232007@yahoo.com
Recruitment status
Recruitment complete
Funding source
Mashhad University of Medical Sciences
Expected recruitment start date
2009-10-23, 1388/08/01
Expected recruitment end date
2010-03-20, 1388/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of collaborative infertility counseling on perceived stress and coping strategies in infertile women undergoing IVF
Public title
The effect of collaborative counseling on psychological subsequent in infertile women
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: persian ethnicity; 20-45 aged; literate; have primary infertility; no recipient of donated oocyte or gestational carrier, no have adapted child; no smoker, drug and alcohol abuser; not have somatic or psychiatric problems; in basic sonogram ovaries was normal for beginning of treatment
Exclusion criteria: not responding to treatment; not completing the treatment period for any reason; did not participate in counseling sessions regularly and did not done assignment
Age
From 20 years old to 45 years old
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
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 Scienses
Street address
Ghorashy building, Daneshgah street, Mashhad
City
Mashhad
Postal code
91375-345
Approval date
2009-07-21, 1388/04/30
Ethics committee reference number
511/1388
Health conditions studied
1
Description of health condition studied
Primary Infertility
ICD-10 code
N97
ICD-10 code description
Female Infertility
Primary outcomes
1
Description
Infertility persieved stress
Timepoint
Pretest (beginning of cycle) and posttest (after embryo transfer)
Method of measurement
Fertility Problem Inventory
2
Description
Coping strategies
Timepoint
Pretest (beginning of cycle) and posttest (after embryo transfer)
Method of measurement
Ways of Coping Scale- Revised (WOC-R)
Secondary outcomes
1
Description
Marital Satisfaction
Timepoint
Pretest (beginning of cycle) and posttest (after embryo transfer)
Method of measurement
Index of Marital Satisfaction
2
Description
General Health
Timepoint
Pretest and posttest
Method of measurement
General Health Questionnaire-28
3
Description
Treatment success
Timepoint
posttest
Method of measurement
Pregnancy Test
Intervention groups
1
Description
Women in intervention group were counseled individually in 5 meetings with the participation of MSc in midwife, gynecologist and MSc in clinical psychologist. Intervention lasted almost 2 months (the time it take to complete a cycle of In Vitro Fertilization). The time of meeting was arranged as follow without incurring additional visit to subjects: 1. It was conducted by researchers on days 2 and 3 of cycle. 2. Around days 19 to 20 cycle that (after the sonography) was provided by psychologist and midwife. 3. The second day of the next cycle (approximately 10 days after the second session) and was conducted by psychologist and midwife. 4. 6-8 days of cycle (approximately one week after the third session) that was held by the midwife. 5. were conducted by gynecologist at 14 day of cycle.
Category
Behavior
2
Description
Control group received standard center care
Category
Behavior
Recruitment centers
1
Recruitment center
Name of recruitment center
Montaserieh Infertility Research Center
Full name of responsible person
Mahbobeh Rasolzadeh Bidgoly
Street address
City
Mashhad
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Doctor Mohammad Ramezany
Street address
Ghorashy building, Daneshgah street, Mashhad
City
Mashhad
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
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Kashan University of Medical Sciences.Kashan.I.R.Iran
Full name of responsible person
Mahbobeh Rasolzadeh Bidboly
Position
MSC, Faculty Membership
Other areas of specialty/work
Street address
Department of Midwifery, Nursing Midwifery Faculty, Kashan University of Medical Sciences, Qotbe Ravandi Blvd, Kashan, Iran
City
Kashan
Postal code
Phone
+98 31 5554 2125
Fax
Email
Rasolzadeh-ma@kaums.ac.ir, Mehr232007@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Mahbobeh Rasolzadeh Bidgoly
Position
Msc
Other areas of specialty/work
Street address
Department of Midwifery, Nursing Midwifery Faculty, Kashan University of Medical Sciences, Qotbe Ravandi Blvd, kashan, Iran
City
Kashan
Postal code
Phone
+98 315554002125
Fax
Email
Mehr232007@yahoo.com; Rasolzadeh-ma@kaums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Mahbobeh Rasolzadeh Bidgoly
Position
MSC
Other areas of specialty/work
Street address
Department of Midwifery, Nursing Midwifery Faculty, Kashan University of Medical Sciences, Qotbe Ravandi Blvd, Kashan, Iran
City
Kashan
Postal code
Phone
+98 315554002125
Fax
Email
Rasolzadeh-ma@kaums.ac.ir; Mehr232007@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)