Determining the effectiveness of psychological interventions in the treatment of patients with tocophobia in Imam Khomeini hospital in 2022
Design
This clinical trial has a parallel, non-randomized intervention and control group with a sample size of 30 patients.
Settings and conduct
The duration of the study will be 12 months and the study environment will be Imam Khomeini Hospital. The target group of the study is pregnant women referring to the obstetrics and gynecology clinic of Imam Khomeini Hospital.
Participants/Inclusion and exclusion criteria
Inclusion criteria: pregnant women 20-40 years old; tocophobia. Exclusion criteria: accompanying physical or psychiatric illness; unwillingness to participation
Intervention groups
The intervention includes cognitive-behavioral psychotherapy sessions and is performed for the control group of other prenatal care
Main outcome variables
Tokophobia
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20220411054496N1
Registration date:2022-05-16, 1401/02/26
Registration timing:registered_while_recruiting
Last update:2022-05-16, 1401/02/26
Update count:0
Registration date
2022-05-16, 1401/02/26
Registrant information
Name
Sahar Ansari
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 6119 2421
Email address
sansari@sina.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-04-24, 1401/02/04
Expected recruitment end date
2023-04-24, 1402/02/04
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effectiveness of psychological intervention(CBT) in the treatment of patients with tocophobia in Imam Khomeini Hospital in 2022
Public title
Effectiveness of psychological intervention(CBT) in the treatment of patients with tocophobi
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Pregnant, gestational age 6-12 weeks
Existence of tokophobia based on screening with WDEQ-A (Wijma Delivery Questionnaire) by trained midwife and positive evaluation score.
Primary tokophobia
Exclusion criteria:
Comorbidity with another psychiatric disorder
Comorbidity with another physical disorder
Age
From 20 years old to 40 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
30
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
Ethics Committee of Imam Khomeini Hospital, Tehran University of Medical Sciences
Street address
Keshavarz Boulevard, Imam Khomeini hospital
City
Tehran
Province
Tehran
Postal code
1419733141
Approval date
2022-03-15, 1400/12/24
Ethics committee reference number
IR.TUMS.IKHC.REC.1400.496
Health conditions studied
1
Description of health condition studied
Tokophobia
ICD-10 code
F40.9
ICD-10 code description
Phobic anxiety disorder, unspecified
Primary outcomes
1
Description
Tokophobia
Timepoint
Before and at the end of intervention and at the gestational age of 35 weeks
Method of measurement
Interview and Questionnaire (Wijma)
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Cognitive-behavioral psychotherapy intervention will be performed in this group. Interventions will be performed face to face or virtually, once a week for 10 sessions of 2 hours.
Category
Treatment - Other
2
Description
Control group: This group will receive routine pregnancy care.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Obstetrics and Gynecology Clinic, Imam Khomeini hospitals complex
Full name of responsible person
Dr Sahar Ansari
Street address
Keshavarz Blvd
City
Tehran
Province
Tehran
Postal code
1419733141
Phone
+98 21 6690 1414
Email
sansari@sina.tums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr Akbar Fotouhi
Street address
Keshavarz Blvd
City
Tehran
Province
Tehran
Postal code
1418653761
Phone
+98 21 81631
Email
afotouhi@tums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr Sahar Ansari
Position
Assistant Professor
Latest degree
Subspecialist
Other areas of specialty/work
Psychiatrics
Street address
Psychosomatic department, Imam Khomeini Complex Hospital, the end of Keshavarz Blvd,
City
Tehran
Province
Tehran
Postal code
1419733141
Phone
+98 21 6119 2421
Email
sansari@tums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr Sahar Ansari
Position
Assistant professor
Latest degree
Subspecialist
Other areas of specialty/work
Psychiatrics
Street address
Imam Khomeini hospital, Keshavarz Boulevard, Tehran
City
Tehran
Province
Tehran
Postal code
1419733141
Phone
+98 21 6119 2421
Email
sansari@sina.tums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr Sahar Ansari
Position
Assistant professor
Latest degree
Subspecialist
Other areas of specialty/work
Psychiatrics
Street address
Imam Khomeini hospital, Keshavarz Boulevard, Tehran
City
Tehran
Province
Tehran
Postal code
1419733141
Phone
+98 21 6119 2421
Email
sansari@sina.tums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available