Objectives : the effect of infertility counseling on quality of life and emotional level of infertile couples.
Design : The present study is an interventional study with available sampling method for infertile couples referring to the Infertility Center.
Setting and conduct : In the even days of the first week ; intervention group samples and in the odd days ; control group samples will be selected and in the next week ; the sampling will be done in the opposite way. The sampling will be continued until the samples will be completed .
Major Inclusion Criteria : The first infertility ; first referring to infertility center.
Major Exclusion Criteria : Instinctive pregnancy during counseling sessions ; being absent in two sessions from six counseling sessions ; under treatment members of psychiatry and psychology.
" Intervention group : " Those who will participate in the study and have entry criteria ; will be given a written testimonial .
Then the group will be asked to answer the pretest questionnaire. The group counseling sessions for intervention group will be established by 6 sessions of 45 minutes.
At the end of the last session ; the post test was taken from this group .
" Control group : " The group will not be given counseling ; but because of complying ethical considerations ; after the post test ; a pamphlet including the summary of the counseling sessions will be given to the control group . Also ; the pretest and post test will be taken from this group .
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2017080124866N4
Registration date:2017-10-11, 1396/07/19
Registration timing:retrospective
Last update:
Update count:0
Registration date
2017-10-11, 1396/07/19
Registrant information
Name
Katayoun Alidousti
Name of organization / entity
Kerman University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 34 3132 5219
Email address
alidoosti@kmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research ; Kerman University of Medical Sciences
Expected recruitment start date
2016-10-22, 1395/08/01
Expected recruitment end date
2017-01-19, 1395/10/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effectiveness of infertility counselling on the quality of life and emotional level of infertile couples
Public title
The effectiveness of infertility counselling on the quality of life and emotional level of infertile couples
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion Criteria : The first infertility ; first referring to infertility center.
Exclusion Criteria : Instinctive pregnancy during counseling sessions ; being absent in two sessions from six counseling sessions ; under treatment members of psychiatry and psychology .
Age
From 20 years old to 50 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
120
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
It was used randomized numerical table for randomizing.
Secondary Ids
1
Registry name
not registered
Secondary trial Id
not registered
Registration date
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Kerman University of Medical Sciences
Street address
Kerman Campus University of Medical Sciences
City
Kerman
Postal code
7617694345
Approval date
2016-09-29, 1395/07/08
Ethics committee reference number
IR . KMU . REC . 1395 . 678
Health conditions studied
1
Description of health condition studied
Quality of life and emotional level in infertility
ICD-10 code
XXI
ICD-10 code description
Chapter XXI Factors influencing health status and contact with health services (Z00-Z99)
Primary outcomes
1
Description
Quality of life
Timepoint
Before intervention ; then At the end of the counseling last session during three mounth
Method of measurement
The questionnaire included demographic specification and Fertility Quality of Life Questionnaire (FertiQoL) .
2
Description
Emotional levels
Timepoint
Before intervention ; then At the end of the counseling last session during three mounth
Method of measurement
The questionnaire included demographic specification and the emotional level of infertile patients Questionnaire (Screenivf).
Secondary outcomes
empty
Intervention groups
1
Description
"Intervention group " : after coordinating with the head nurse ; the researcher will explain the research purpose to the units under research and they will be satisfied with participating in the study. Those who will participate in the study and will have entry criteria ; will be given a written testimonial .Then the group will be asked to answer the pretest questionnaire. The group counseling sessions for intervention group will be established by 6 sessions of 45 minutes.
At the end of the last session ; the post test will be taken from this group .
Category
Other
2
Description
Control group " : The group will not be given counseling ; but because of complying ethical considerations ; after the post test ; a pamphlet including the summary of the counseling sessions will be given to the control group . Also ; the pretest and post test will be taken from this group .
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Kerman’s Afzalipour hospital
Full name of responsible person
Kobra Alidoosti
Street address
Colleg of Nursing and Midwifery ; Kermam
City
Kerman
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research ; Kerman University of Medical Sciences
Full name of responsible person
Dr Pardakhti
Street address
Kerman ; University of Medical Sciences
City
Kerman
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 ; Kerman 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
Kerman University of Medical Sciences
Full name of responsible person
katayoun Alidoosti
Position
Master in Miwifery
Other areas of specialty/work
Street address
Kerman ; Afzalipour Hospital
City
Kerman
Postal code
Phone
+98 34 3132 5219
Fax
Email
alidoosti@kmu.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Katayoun Alidoosti
Position
Master in Midwifery
Other areas of specialty/work
Street address
Kerman ، Afzalipour Hospital
City
Kerman
Postal code
Phone
+98 34 3132 5219
Fax
Email
alidoosti@kmu.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Tayebeh Mokhtari Sorkhani
Position
Master's degree Student in Midwifery Counseling
Other areas of specialty/work
Street address
City
Postal code
Phone
+98 34 3252 6897
Fax
Email
arianmokhtari2@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)