The aim of this study is to evaluate the effect of group therapy based on positive psychology on patients anxiety and result of IVF/ICSI in infertile women candidate of IVF/ICSI. research community in this clinical trial is infertile women undergoing IVF/ICSI in Yas Hospital in Tehran.
Forty infertile women, candidate for IVF/ICSI, who referred by her infertility doctor and their high anxiety level needed psychological intervention are studied in two groups; control and case by non-randomized division. All The patients in the control and case group sign the informed consent and then will be tested by Beck anxiety questionnaire as pre-test questionnaire, first and before the intervention. These both groups are matched according to Beck anxiety test score, age, duration of infertility. Intervention in the case group is ten sessions of group therapy based on positive psychology. Each session is ninety-minutes weakly. During this period, the control group will be placed on the waiting list. At the end of the study, the researcher must conduct these sessions for the control group, if requested. The level of anxiety in both groups will be evaluated and compared again. ovarian stimulation therapy for IVF/ICSI is done according to the patients' age and ovarian reserve. Then embryo transferred adjusting the patient's age and embryo quality. The outcome of IVF/ICSI in control and experimental groups will be investigated by pregnancy test two weeks after embryo transfer and its relation to the anxiety will be evaluated.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201701242576N14
Registration date:2017-07-11, 1396/04/20
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2017-07-11, 1396/04/20
Registrant information
Name
Fatemeh Davari Tanha
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 8831 3955
Email address
fdavaritanha@sina.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Investigator
Expected recruitment start date
2017-07-11, 1396/04/20
Expected recruitment end date
2017-10-23, 1396/08/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of group therapy based on positive psychology on anxiety and result of IVF/ICSI in infertile women candidate of IVF/ICSI
Public title
The effect of group psychotherapy on anxiety and result of IVF/ICSI
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: Infertile women candidate of IVF/ICSI; infertile women with high anxiety who need psychological intervention.
Exclusion criteria: Any history of hospitalization or drug therapy for psychological disease; interest of patient to exit from study.
Age
From 18 years old to 50 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
40
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 University of Medical Sciences
Street address
Vice Chancellor for Medical Research, Tehran University of Medical Sciences, 6th floor, Central Building of Tehran University of Medical Sciences, Ghods Ave, keshavarz Blvd.
City
Tehran
Postal code
1597856511
Approval date
2017-04-23, 1396/02/03
Ethics committee reference number
IR.TUMS.MEDICINE.REC.1396.2111
Health conditions studied
1
Description of health condition studied
Pregnancy
ICD-10 code
Z35.0
ICD-10 code description
Supervision of pregnancy with history of infertility
2
Description of health condition studied
Anxiety
ICD-10 code
F41.9
ICD-10 code description
Anxiety disorder, unspecified
Primary outcomes
1
Description
Anxiety
Timepoint
before and after intervention
Method of measurement
Beck anxiety test
Secondary outcomes
1
Description
Pregnancy
Timepoint
Two weeks after embryo transfer
Method of measurement
BHCG Test
Intervention groups
1
Description
Intervention on case group is a weekly ten ninety-minute sessions of group therapy based on positive psychology. first session: introduction the members to each others and training them for proper feedback. second session: training the theory of building and spread of positive emotions (step 1). third session: training the theory of building and spread of positive emotions (step 2).
4th session: cognitive challenges.
5th session: challenge of emotions.
6th session: their progress and self-esteem.
7th session: effective communication.
8th session: challenge of beliefs and values.
9th session: self-actualization as a final purpose.
10th session: wrap and finishing.
Category
Lifestyle
2
Description
There is no intervention on control group except of routine care.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Yas Hospital
Full name of responsible person
Fatemeh Mehrabi
Street address
Yas Hospital, Ostad Nejatollahi Shomaly St.
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for Medical Research, Tehran University of Medical Sciences
Full name of responsible person
Dr. Yunesian
Street address
Vice Chancellor for Medical Research, Tehran University of Medical Sciences, Ghods Ave, Keshavarz Blvd.
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 Medical 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
Yas Hospital
Full name of responsible person
Fatemeh Mehrabi
Position
Fellowship of Infertility
Other areas of specialty/work
Street address
Yas Hospital, Ostad Nejatollahi Shomaly St.
City
Tehran
Postal code
1597856511
Phone
+98 21 4216 0000
Fax
Email
fmtums95@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Yas Hospital
Full name of responsible person
Fatemeh Mehrabi
Position
Fellowship of Infertility
Other areas of specialty/work
Street address
Yas Hospital, Ostad Nejatollahi Shomaly St.
City
Tehran
Postal code
1597856511
Phone
+98 21 4216 0000
Fax
Email
fmtums95@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Yas Hospital
Full name of responsible person
Fatemeh Mehrabi
Position
Fellowship of infertility
Other areas of specialty/work
Street address
Yas Hospital, Ostad Nejatollahi Shomaly St.
City
Tehran
Postal code
1597856511
Phone
+98 21 4216 0000
Fax
Email
fmtums95@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)