Protocol summary

Summary
This research is Quasi-experimental study application that will done with the aim of evaluation of education based on implementing continuous care model on quality of life in infertile women. All women 20-45 years who detected their infertility by gynecologist and have clinical file in Health Centre ara Society of research and women eligible are samples of research.In this reaserch will be sampling by methods available.Willingness to cooperate and Company research, Minimum education of Reading and Writing,Final diagnosis of infertility based on doctor's diagnose and the contents of the clinical file ,Age of female : 20-45 , Duration of infertility up to 5 years, A female cause of infertility(primary or Secondary) are inclusion criteria and Pregnancy during research , Something bad happening and stress, Tail desire to continue cooperation in control and follow-up period are exclusion Criteria. Were consideredn 34 persion for intervention group and 34 persion for control group.The sample sizewas increased to 40 persion for compensate for the loss of samples.Beginning completed FertiQul international questionnaire for them . Women eligible who will see to Valiasr hospital will be in intervention group and women eligible who will see to Aarash hospital will be in control group and will be implemented model for intervention group.Continuous care model included 4 sections: Orientation,Sensitization,Control and Evaluation.At the end of follow-up and in evaluation stage be filled FertiQul international questionnaire by all participants( intervention group and control group) and will be compared the results of the two groups.It should be noted that control group will Received routine health care center.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2015051222241N1
Registration date: 2015-06-11, 1394/03/21
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2015-06-11, 1394/03/21
Registrant information
Name
Masoomeh Fadaee
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 7731 4786
Email address
m_fadaee@razi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Tehran University of Medical Sciences
Expected recruitment start date
2015-05-22, 1394/03/01
Expected recruitment end date
2015-06-21, 1394/03/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of education based on implementing continuous care model on quality of life in infertile women
Public title
Effect of education on quality of life in infertile women
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:Willingness to cooperate and Company research; Minimum education of Reading and Writing;Final diagnosis of infertility based on doctor's diagnose and the contents of the clinical file ;Age of female : 20-45; Duration of infertility up to 5 years; A female cause of infertility(primary or Secondary) Exclusion Criteria: Pregnancy during research ;Something bad happening and stress;Tail desire to continue cooperation in control and follow-up period
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)
Not 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
Tehran medical university
Street address
Tehran, enghelab square,16 Aazar st,Qods square,Tehran medical university
City
Tehran
Postal code
Approval date
2015-02-24, 1393/12/05
Ethics committee reference number
9111373030-135030

Health conditions studied

1

Description of health condition studied
Infertility
ICD-10 code
N97
ICD-10 code description
Female infertility

Primary outcomes

1

Description
Quality of life
Timepoint
Before intervention and end of control stage
Method of measurement
FertiQul international questionnaire

Secondary outcomes

1

Description
Quality of life
Timepoint
Befor intervention and end of control stage
Method of measurement
FertiQul international questionnaire

Intervention groups

1

Description
Intervention group: Applying continuous care model(Orientation,Sensitization,Control and Evaluation)
Category
Other

2

Description
Control Group: Receipttion routin care of treatment center
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Valiasr hospital
Full name of responsible person
Dr. Ensiyeh Shahrokh Teraninejad
Street address
Tehran,Chamran Expressway,Towhid Square, Emam khomeini hospital
City
Tehran

2

Recruitment center
Name of recruitment center
Aarash hospital
Full name of responsible person
Dr. Ashraf Moeni
Street address
Tehran Resalat highway after Shahid Bagheri autobahn Shahid Baghdarnia St Next to police station126 Alley162
City
Tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Tehran medical niversity
Full name of responsible person
Dr. Ziba Taghizadeh
Street address
Tehran Keshavarz blvd Qods St central organization of university
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran medical niversity
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 medical university , faculty of nursing and midwifery
Full name of responsible person
Rahimikian Fatemeh
Position
Coach faculty
Other areas of specialty/work
Street address
Tehran , chamran highway , Towhid scuare
City
Tehran
Postal code
1419733171
Phone
+98 21 6692 7171
Fax
+98 61054539
Email
rahimikian@tums.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Faculty of Nursing & Midwifery of Tehran medical university
Full name of responsible person
Fadaee Masoomeh
Position
Bachelor Degree
Other areas of specialty/work
Street address
Tehran tehranpars hakimiye sazmane aab St Alley 8 west bulding Sadaf unit 4
City
Tehran
Postal code
1658955787
Phone
+98 21 7731 4786
Fax
Email
m_fadaee@razi.tums.ac.irmfadaee06@gmail.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Faculty of nursing and midwifery of Tehran medical university
Full name of responsible person
Fadaee Masoomeh
Position
MSc Student of Midwifery
Other areas of specialty/work
Street address
Tehran Tehranpars Hakimiye Sazmane Aab St Alley 8 west Building Sadaf 4 Unit
City
Tehran
Postal code
1658955787
Phone
+98 21 7731 4786
Fax
Email
m_fadaee@razi.tums.ac.irmfadaee06@gmail.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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