Comparison of the efficacy of the intervention with Puttolazan method and the method of sensitization with eye movements and its rehabilitation on post traumatic stress disorder in children in the stricken cities of Kermanshah.
Design
15 patients were randomly assigned to the experimental group, the intervention with trembling blanket, and 15 subjects received the intervention in the orther experimental group, who received eye drops and retardation, and 15 were assigned.
All study samples randomly assigned to three groups are blind.
Settings and conduct
The research site is Kermanshah. The study samples were divided into two experimental groups, one receiving petulsarine intervention group and the other experimental group with EMDR and one control group receiving no intervention. All samples in this study, randomly assigned to three equal groups, are blind study groups.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Age range 7 to 10 years.
Being male.
Acquiring a score from the post traumatic stress disorder check-list based on the fifth edition of the diagnostic and statistical manual disorder (PCL-5)
The consent of the subject to participate in the research. (written consent)
The subject has the ability to follow eye movements.
Lack of intervention, psychotherapy and medication simultaneousy.
Exclusion criteria:
Dissatisfaction and cooperation The research sample.
Get treatment at the same time.
Family history of earthquakes.
There is a disorder at the same time.
Intervention groups
* The intervention group (1) consists of 15 subjects who receive interventional eye sensitization and retardation.
* The intervention group 2 consists of 15 subjects who receive the intervention by the petuleran method.
* The control group includes 15 subjects who do not receive any interventions.
Main outcome variables
The percentage of people who have a PTSD score list is above 33.
General information
Reason for update
Acronym
PTSD & EMDR
IRCT registration information
IRCT registration number:IRCT20181217042027N1
Registration date:2019-08-14, 1398/05/23
Registration timing:prospective
Last update:2019-08-14, 1398/05/23
Update count:0
Registration date
2019-08-14, 1398/05/23
Registrant information
Name
Hossein Maleki
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 25 3261 1141
Email address
psy.h.maleki@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-08-18, 1398/05/27
Expected recruitment end date
2019-09-01, 1398/06/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of Effectiveness of Intervention with the Methods of Trembling Blanket and EMDR, on PTSD
Public title
The effect of trembling blankets and eye movements desensitization on post-traumatic stress
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age range 7 to 10 years.
Being male.
Acquiring a score from the post traumatic stress disorder check-list based on the fifth edition of the diagnostic and statistical manual disorder (PCL-5).
The consent of the subject to participate in the research. (written consent)
The subject has the ability to follow eye movements.
Lack of intervention, psychotherapy and medication simultaneousy.
Exclusion criteria:
Dissatisfaction and cooperation The research sample.
Get treatment at the same time.
Family history of earthquakes.
There is a disorder at the same time.
Age
From 7 years old to 10 years old
Gender
Male
Phase
N/A
Groups that have been masked
Participant
Sample size
Target sample size:
45
Randomization (investigator's opinion)
Randomized
Randomization description
A simple randomization will be used using the lottery.
Blinding (investigator's opinion)
Triple blinded
Blinding description
It is explained to the participants that they participate in a pilot study, but they do not describe how the implementation of them will be different from the method of implementation on the other group, nor will they be aware of the information of other groups. Relationship between groups is controlled by the end of the experiment.
Placebo
Not used
Assignment
Parallel
Other design features
One of the treatments used in the research is trembling blanket exposure treatment, which is a researcher's innovative technique, and is the first to be scientifically examined
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Biomedical Sciences of Islamic Azad University of Qom
Street address
15th Khordad Avenue, Islamic Azad University of Qom
City
Qom
Province
Ghoum
Postal code
۳۷۱۴۹۶۳۷۴۴
Approval date
2019-07-08, 1398/04/17
Ethics committee reference number
IR.IAU.QOM.REC.1398.008
Health conditions studied
1
Description of health condition studied
Post traumatic stress disorder
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
The percentage of people who have a post-traumatic stress disorder score list is above 33.
Timepoint
Measuring the rate of post-traumatic stress disorder before intervention and 7, 14 and 21 days after intervention.
Method of measurement
Structured diagnostic interview based on the fifth Diagnostic and Statistical Manual of Psychiatric Disorders and the Post Traumatic Stress Disorder Checklist questionnaire are based on the fifth edition of the Diagnostic and Statistical Manual of Psychiatric Disorders (PCL-5).
Secondary outcomes
1
Description
Score of post traumatic stress disorder
Timepoint
Measurement of post-traumatic stress disorder before intervention, 7, 14 and 21 days after intervention.
Method of measurement
The Post Traumatic Stress Disorder Checklist is also based on the fifth edition of the PCL-5 Diagnostic and Statistical Manual of Mental Disorders.
Intervention groups
1
Description
The first intervention group: intervention using eye degradation and retardation; the intervention group's interventional group with sensory degeneration with eye movements and rehabilitation included: 1- Acquiring the necessary information 2- Preparing the therapist 3- Evaluation 4. Sensitization 5. Brokerage 6- Checking Physical 7. Closing 8. Re-evaluation.
Category
Treatment - Other
2
Description
Intervention group: the intervention by the trembling blanket method; the intervention stages include: 1) an effective and intimate relationship between the therapist (therapeutic communication) and the therapist; 2) the logic of this technique is explained, so that the treatment acquaints with the treatment model 3. Creating mutual trust between the therapist and the therapist in order to facilitate the process of treatment; 4- Preparing a therapist for participation in treatment; and Finally, arranging for a blanket and treatment.
Category
Treatment - Other
3
Description
Control group: no interventions are performed.
Category
Diagnosis
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Khomeini Relief Committee
Full name of responsible person
Heydar Bahrami
Street address
sarpolezahab, next to the governorate.
City
sarpolezahab
Province
Kermanshah
Postal code
6771953163
Phone
+98 83 4223 0636
Email
Emdad_sarpolezahab@chaparmail.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Islamic Azad University
Full name of responsible person
Ali Forghaniha
Street address
Iran - Markazi Province - Ashtian - Imam Khomeini Blvd (RA) - Islamic Azad University, Ashtian Branch
City
Ashtian
Province
Markazi
Postal code
3961813347
Phone
+98 86 3722 2500
Fax
+98 86 3722 2500
Email
aiau.ac@gmail.com
Web page address
http://www.aiau.ac.ir/
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Islamic Azad University
Proportion provided by this source
1
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
UN agencies and international organizations
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Hossein Maleki
Position
Member of Young and Elite Research Club of Islamic Azad University, Ashtian
Latest degree
Bachelor
Other areas of specialty/work
Psychology
Street address
Iran-Qom Province- Boulevard Republic-Alley 42- Teachers Building 1- Unit 145
City
Qom
Province
Ghoum
Postal code
3716749994
Phone
+98 25 3261 1141
Email
psy.h.maleki@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Hossein Maleki
Position
A member of the Young Researchers Club of the Islamic Azad University of Ashtian
Latest degree
Bachelor
Other areas of specialty/work
Psychology
Street address
Iran - Qom - Republic Blvd - Teachers Building 1 - Unit 145
City
qom
Province
Ghoum
Postal code
371679994
Phone
+98 252611141
Email
psy.h.maleki@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Hossein Maleki
Position
Member of Young and Elite Research Club of Islamic Azad University, Ashtian
Latest degree
Bachelor
Other areas of specialty/work
Psychology
Street address
Iran - Qom - Republic Blvd - Teachers Building 1 - Unit 145
City
Qom
Province
Ghoum
Postal code
3716749994
Phone
+98 252611141
Fax
Email
psy.h.maleki@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is 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
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
Part of the data, such as information on the main implications and effectiveness, and the comparison of the two interventions, are published.
When the data will become available and for how long
Three months after printing results.
To whom data/document is available
Researchers and therapists in the field of health, medical sciences universities, the Welfare Organization, the Committee for Psychosocial Interventions of Academic Societies and the Red Crescent Society.
Under which criteria data/document could be used
Observing professional and ethical principles in research. Like mentioning the source.
From where data/document is obtainable
Email the researcher to:
psy.h.maleki@gmail.com
What processes are involved for a request to access data/document
In an email, let us know about the scope and use of the results. After review, a maximum of two weeks will be answered.