The aim of this research is evaluation of the impact of implementing empowerment program on the quality of life and believes in infertile women. This is randomized clinical trial study. The sample size is 80 infertile woman in Imam khomeini and Mirza kouchak khan infertility clinics that 40 infertile women will be selected from each hospital and will be randomly assigned into two intervention (20 people) and control (20 people) groups . Participants Inclusion criteria: infertility due to female factors; primary infertility; literacy; being Iranian; Muslim; Lack of physical and mental illness; aged 18 to 40 years. Exclusion criteria: physical and mental illness identified; become pregnant during the study; not participate in all meetings of the intervention. Intervention based on empowerment programs in four structures of knowledge, self-efficacy, training participation and evaluation will be conducted including five sessions meeting groups for two hours each week until 5 weeks and two session individual meeting. The data will be collected using three questionnaires consisted of demographic characteristics, quality of life and irrational parenthood cognition scale will be completed before and three months after intervention. Main outcome variables is studying the effectiveness of empowerment program on the quality of life and believes in infertile women
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201410236284N9
Registration date:2015-10-24, 1394/08/02
Registration timing:retrospective
Last update:
Update count:0
Registration date
2015-10-24, 1394/08/02
Registrant information
Name
Maryam Modarres
Name of organization / entity
Tehran university of Medical sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 6656 8142
Email address
modarres@sina.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Tehran University of Medical Sciences
Expected recruitment start date
2015-04-19, 1394/01/30
Expected recruitment end date
2015-09-21, 1394/06/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The impact of the implementing of empowerment program on the quality of life and thoughts in infertile women
Public title
Education based on empowerment model on thinking and quality of life in infertile women
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: infertility due to female factore; primary infertility; literacy; Iranian; Muslim; Lack of physical and mental illness; aged 18 to 40 years. Exclusion criteria: physical and mental illness identified; become pregnant during the study; not participate in all meetings of the intervention .
Age
From 18 years old to 40 years old
Gender
Female
Phase
2
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 of Tehran University of Medical sciences
Street address
6th floor, Central organization of University, edge of Qods avenue, Keshavarz blvd, Tehran
City
Tehran
Postal code
Approval date
2015-03-04, 1393/12/13
Ethics committee reference number
9111373001-1
Health conditions studied
1
Description of health condition studied
Infertility
ICD-10 code
N97.9
ICD-10 code description
Female infertility, unspecified
Primary outcomes
1
Description
Quality of life
Timepoint
Pre test, 3 months after intervention
Method of measurement
Quality of life questionnare
2
Description
Irrational parentrhood cognitions
Timepoint
Pre test, 3 month after intervention
Method of measurement
Irrational parentrhood cognitions scale
Secondary outcomes
1
Description
Psychological aspect of the quality of life
Timepoint
Before intervention and 12 weeks after intervention
Method of measurement
Quality of life questionnaire
2
Description
Physical aspect of the quality of life
Timepoint
Before intervention and 12 weeks after intervention
Method of measurement
Quality of life questionnaire
3
Description
Social aspect of the quality of life
Timepoint
Before intervention and 12 weeks after intervention
Method of measurement
Quality of life questionnaire
4
Description
Sexual aspect of quality of life
Timepoint
Before intervention and 12 weeks after intervention
Method of measurement
Quality of life questionnaire
5
Description
Spirituality aspect of the quality of life
Timepoint
Before intervention and 12 weeks after intervention
Method of measurement
Quality of life questionnaire
6
Description
Economic aspect of the quality of life
Timepoint
Before intervention and 12 weeks after intervention
Method of measurement
Quality of life questionnaire
7
Description
Emotional aspect quality of life
Timepoint
Before intervention and 12 weeks after intervention
Method of measurement
Quality of life questionnaire
8
Description
Irrational parentrhood cognitions
Timepoint
Pre test and 12 weeks after intervention
Method of measurement
Irrational parentrhood cognitions scale
Intervention groups
1
Description
Intervention is based on empowerment model which has four steps: knowledge, self-efficacy, training participation and evaluation. The first step (perceived threat) empowerment program will try to increase awareness and understanding of the nature and consequences of the infertility. The first step is two hours instructive sessions with a week interval. The second step which is problem solving, is two hours group discussion sessions under the supervision of the researcher and a psychologist(Group discussions and choose the best solution). In the third step (educational participation), will try to increase the efficacy through educational participation. The fourth step is evaluation done in two stages. The first stage involve asking two questions orally at the beginning of each session and The second stage is the final evaluation that instruments will be completed again by the sample. The meeting will be held in the form of individual and group(5 sessions of group and 2 individual sessions). Group meetings are once a week and Individual sessions are times that women come to evaluate the fertility and the aims of Individual sessions is for basic familiarity with each women and answer demographic questionnaire and evaluation of basic capacity and quality of life.
Category
Other
2
Description
The control group only received the routine therapies and services of the fertility center. No counseling was included for this group.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Mirza Kouchak Khan hospital
Full name of responsible person
Maryam abunasri
Street address
Ostad Nejatollahi street, Karim Khan boulevard
City
Tehran
2
Recruitment center
Name of recruitment center
Imam Khomeini Hospital
Full name of responsible person
maryam abunasri
Street address
End of Keshavarz Blvd, Imam Khomeini Hospital
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. Masoud Yunesian
Street address
5th floor, Central building of Tehran University of Medical sciences, edge of Qods Av, Keshavarz blvd, Tehran
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
Name of organization / entity
Tehran University of Medical Science
Full name of responsible person
Dr. Modares Maryam
Position
Phd Medical education
Other areas of specialty/work
Street address
Faculty of Nursing & Midwifery Tehran University of Medical Science, Tohid square
City
Tehran
Postal code
1419733171
Phone
+98 21 6692 7171
Fax
Email
modarres@sina.tums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Science
Full name of responsible person
Dr. Modares Maryam
Position
Phd Medical education
Other areas of specialty/work
Street address
Faculty of Nursing & Midwifery Tehran University of Medical Science, Tohid square
City
Tehran
Postal code
1419733171
Phone
+98 212166927171
Fax
Email
modarres@sina.tums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Mirza Kouchak Khan hospital
Full name of responsible person
Maryam Abunasri
Position
Master
Other areas of specialty/work
Street address
Ostad Nejatollahi street, Karim Khan boulevard
City
Tehran
Postal code
Phone
+98 71 4243 6621
Fax
Email
maryamabunasri.91@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)