Determination and comparison of post-traumatic stress disorder before and after the intervention in two control and intervention groups
Design
A clinical trial type study with two control and intervention groups, with parallel groups, randomized on 41 mothers with premature babies.
Settings and conduct
Children's Medical Center Hospital, Shariati, Waliasr Imam Khomeini
Participants/Inclusion and exclusion criteria
Having a baby hospitalized in a special care unit, not having a history of premature baby hospitalization, not being abnormal, suffering from depression and anxiety during the study, and the mother's unwillingness to continue participating in the study.
Intervention groups
Mothers of premature babies do mandala coloring
Main outcome variables
Post-traumatic stress disorder
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20221025056293N1
Registration date:2022-11-18, 1401/08/27
Registration timing:prospective
Last update:2022-11-18, 1401/08/27
Update count:0
Registration date
2022-11-18, 1401/08/27
Registrant information
Name
Fatemeh Alimohammadi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 5583 3896
Email address
fatemehalimohammadi340@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-12-22, 1401/10/01
Expected recruitment end date
2023-05-22, 1402/03/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of mandala coloring meditation technique on PTSD of mothers of premature infants
Public title
The effect of mandala coloring on PTSD
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Having a baby hospitalized in a special care unit
Not having a history of hospitalization of a premature baby
The baby is not abnormal
Exclusion criteria:
Suffering from depression and anxiety during the study
Mother's unwillingness to continue participating in the study
Age
No age limit
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
41
Randomization (investigator's opinion)
Randomized
Randomization description
Selection is done by a simple random method. In this method of sampling, two groups (mandala and control) are written on a card and placed in closed envelopes, and the mothers select the envelopes from the box to determine which group they will fall under..
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 School of Nursing and Midwifery
Street address
Tawheed Square, Dr. Mirkhani St. (East Nusrat)
City
Tehran
Province
Tehran
Postal code
1419733171
Approval date
2022-10-24, 1401/08/02
Ethics committee reference number
IR.TUMS.FNM.REC.1401.085
Health conditions studied
1
Description of health condition studied
Post-traumatic stress disorder
ICD-10 code
F43.1
ICD-10 code description
Post-traumatic stress disorder (PTSD)
Primary outcomes
1
Description
Post-traumatic stress disorder in mothers of premature babies
Timepoint
Investigating post-traumatic stress disorder before the beginning of the stages and one month after mandala coloring
Method of measurement
Pernatal Post Traumatic Stress Questionnair
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Mothers of premature babies first completed the post-natal stress disorder questionnaire and then colored mandala designs from simple to complex for 11 sessions, each session lasting 20 minutes, and one month after the intervention, the stress disorder questionnaire was completed again. After the accident, they answer perinatal.
Category
Lifestyle
2
Description
Control group: mothers with premature babies hospitalized in the neonatal intensive care unit are selected, who only complete the post-traumatic stress disorder questionnaire one month later.
Category
Lifestyle
Recruitment centers
1
Recruitment center
Name of recruitment center
Children's Medical Center Hospital
Full name of responsible person
Fatemeh Ali Mohammadi
Street address
Children's Medical Center, No. 62, next to Imam Khomeini Hospital, Dr. Mohammad Gharib St., end of Keshavarz Blvd., Tehran
City
Tehran
Province
Tehran
Postal code
1419733151
Phone
+98 21 6147 2353
Email
cmcpr@tums.ac.ir
2
Recruitment center
Name of recruitment center
Shariati Hospital
Full name of responsible person
Fatemeh Ali Mohammadi
Street address
Tehran, North Kargar St., Jalal Al Ahmad Street, Shariati Hospital's Educational Research and Treatment Center
City
Tehran
Province
Tehran
Postal code
1411713135
Phone
+98 21 8490 1000
Email
shariatihosp@tums.ac.ir
3
Recruitment center
Name of recruitment center
Imam Khomeini's Waliasr complex
Full name of responsible person
Fatemeh Ali Mohammadi
Street address
Tehran, at the end of Keshavarz Boulevard, Dr. Gharib Street; Imam Khomeini Hospital Complex
City
Tehran
Province
Tehran
Postal code
۱۴۱۹۷۳۳۱۴۱
Phone
+98 21 6119 0000
Email
Imamhospital@tums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr. Mehrnaz Granmayeh
Street address
Tawheed Square, Dr. Mirkhani St. (East Nusrat)
City
Tehran
Province
Tehran
Postal code
1419733171
Phone
+98 21 6692 7171
Email
fnm@tums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Tehran School of Nursing and Midwifery
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
Batol Purabuli
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Tawheed Square, Dr. Mirkhani St. (East Nusrat)
City
Tehran
Province
Tehran
Postal code
1419733171
Phone
+98 21 6692 7171
Email
fnm@tums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Fatemeh Alimohammadi
Position
Nurse
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Tawheed Square, Dr. Mirkhani St. (East Nusrat)
City
Tehran
Province
Tehran
Postal code
1419733171
Phone
+98 21 6692 7171
Fax
Email
fatemehalimohammadi340@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Fatemeh Alimohammadi
Position
Nurse
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Tawheed Square, Dr. Mirkhani St. (East Nusrat)
City
Tehran
Province
Tehran
Postal code
1419733171
Phone
+98 21 6692 7171
Email
fatemehalimohammadi340@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is 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
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is 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
Title and more details about the data/document
Information about the main outcome can be shared.
When the data will become available and for how long
The access period starts 6 months after the results are published
To whom data/document is available
Only for researchers working in academic and scientific institutions
Under which criteria data/document could be used
Increasing information
From where data/document is obtainable
Tehran University School of Nursing and Midwifery Library
What processes are involved for a request to access data/document
Submit your application to Tehran University School of Nursing and Midwifery