This study aims to evaluate the effect of An Educational package on self-efficacy and self-esteem of infertile women. This is a experimental study with two groups intervention (n=40) and control (n= 40). Sampling method is continuous and randomized controlled trial. In this study 80 Iranian infertile women who are able to read and write , age between 20-45, primary infertility with female factor for at least of 5 years and without known disease and history of psychiatry interventions after completion of demographic and self-esteem questionnaires and infertility self-efficacy scale, will be recruite . Exclusion criteria: pregnancy and women who withdrawal during the study. In the intervention group 40 infertile women ( in 4 groups) will be participated. An educational programs on reproductive system, definition and prevalence of infertility, causes, diagnose and treatment of infertility, assisted reproductive technology and coping with the stress of infertility in four sessions (one session a week, in 4 consecutive week and each session 60-90 minutes) will be provided by the researcher for women gregariously and then booklets will be delivered to the women to recall. The researcher will follow the women 15 days after fourth educational session by the phone. The infertility self-efficacy scale and self-esteem questionnaire will be completed by intervention group in 6 weeks after the last educational session. The infertility self-efficacy scale and self-esteem questionnaire will be completed by control group in 6 weeks after primary completion of them. The educational package’s effect will be measured by comparing the infertility self-efficacy and self-esteem scores.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201205073034N9
Registration date:2012-06-17, 1391/03/28
Registration timing:prospective
Last update:
Update count:0
Registration date
2012-06-17, 1391/03/28
Registrant information
Name
Mansoureh Jamshidimanesh
Name of organization / entity
Iran University Faculty of Nursing & Midwifery
Country
Iran (Islamic Republic of)
Phone
+98 21 4365 1811
Email address
delshad2@iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, School of Nursing and Midwifery, Tehran University of Medical Sciences
Expected recruitment start date
2012-06-21, 1391/04/01
Expected recruitment end date
2012-09-22, 1391/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of An Educational package on self-efficacy and self-esteem of infertile women
Public title
Effect of An Educational package on self-efficacy and self-esteem of infertile women
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: Iranian infertile women who are able to read and write; age between 20-45years old; primary infertility with female factor for at least of 5 years and have no known disease and history of psychiatry interventions. Exclusion criteria: pregnancy and women who withdrawal during the study.
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:
80
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
Ethics Committee School of Nursing and Midwifery, Tehran University of Medical Sciences
Street address
Tohid SQ, East Nosrat Ave
City
Tehran
Postal code
Approval date
2012-04-29, 1391/02/10
Ethics committee reference number
90/130/2719/د/
Health conditions studied
1
Description of health condition studied
Female infertility
ICD-10 code
N97
ICD-10 code description
inability to achieve a pregnancysterility, female NOS
Primary outcomes
1
Description
Infertility self-efficacy scores
Timepoint
Before intervention and 6 weeks after the end of intervention
Method of measurement
Infertility self-efficacy Questionnaire
2
Description
Eysenck self-esteem scores
Timepoint
Before intervention and 6 weeks after the end of intervention
Method of measurement
Eysenck self-esteem Questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Educational group will be implemented by the researcher in 4 sessions of 60-90 minutes, one session a week in 4 consecutive weeks. In the first session the women will be educated about reproductive system, definition and prevalence of infertility, causes, diagnose and treatment of infertility, assisted reproductive technology and coping with the stress of infertility. Then, a booklet, including discussed topics, delivered to recall the women and finally the women’ questions will be answered by the researcher. In the second, third and fourth sessions, the educational program will include more complete explanation of treatment of infertility, assisted reproductive technology and coping with the stress of infertility. The infertility self-efficacy scale and self-esteem questionnaire will be completed by intervention group at baseline and 6 weeks after the last educational session.
Category
Other
2
Description
In control group: The infertility self-efficacy scale and self-esteem questionnaire will be completed at baseline and in 6 weeks after primary completion of them.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Vali e Asr Reproductive Health Center
Full name of responsible person
Niloofar Alimanesh
Street address
Keshavarz Blvd, Imam Khomeini Hospital Complex, Vali e Asr Reproductive Health Center
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research,Tehran University of Medical Sciences
Full name of responsible person
Dr Mohammad Ali Cheraghi
Street address
School of Nursing and Midwifery, Tehran University of Medical Sciences Tohid SQ East Nosrat Ave Tehran, Iran
City
Tehran
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,Tehran 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
Person responsible for scientific inquiries
Contact
Name of organization / entity
School of Nursing and Midwifery, Tehran University of Medical Sciences
Full name of responsible person
Mansoureh Jamshidimanesh
Position
MSc Midwifery, Master of Science
Other areas of specialty/work
Street address
School of Nursing and Midwifery, Tehran University of Medical Sciences , Tohid SQ , East Nosrat Ave , Tehran, Iran
City
Tehran
Postal code
Phone
+98 21 6692 7171
Fax
Email
jamshidimanesh@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
School of Nursing and Midwifery, Tehran University of Medical Sciences
Full name of responsible person
Mansoureh Jamshidimanesh
Position
Midwifery, Master of Science
Other areas of specialty/work
Street address
School of Nursing and Midwifery, Tehran University of Medical Sciences, Tohid SQ , East Nosrat Ave ,Tehran, Iran
City
Tehran
Postal code
Phone
+98 21 6692 7171
Fax
Email
jamshidimanesh@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)