Determining the efficacy of virtual reality software produced by Daj-scientific Corporation in acrophobia treatment
Design
Clinical trial with no control or parallel groups, no randomization and blinding, with only one intervention group
Settings and conduct
After diagnosis of acrophobia by a psychiatrist, 21 male and female patients referring to Ibn Sina hospital will be assigned to one group with an age range of 18 to 65. Treatment begins with the virtual reality technique using the software produced by Daj-scientific Corporation for eight 45-minute sessions once a week for 8 weeks. Before the treatment, on session 4, and at the end of the treatment, the State-Trait Anxiety Inventory (STAI) will be administered. There is no blinding in this study.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Patients who have acrophobia according to the diagnostic interview based on the checklist of symptoms in DSM-5; patients have symptoms of acrophobia for at least the past six months; patients are between18 to 65 years old. Exclusion criteria: Addiction to alcohol or drugs; major psychological disorder
Intervention groups
In the intervention group, after diagnosis of acrophobia by a psychiatrist, male and female patients are treated with a virtual reality technique using the software produced by Daj-scientific Corporation for eight 45-minute sessions once a week for 8 weeks. Before the treatment, on session 4, and at the end of the treatment, the State-Trait Anxiety Inventory (STAI) will be administered
Main outcome variables
Anxiety level
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20101130005280N40
Registration date:2021-08-25, 1400/06/03
Registration timing:registered_while_recruiting
Last update:2021-08-25, 1400/06/03
Update count:0
Registration date
2021-08-25, 1400/06/03
Registrant information
Name
Raheleh Nejati
Name of organization / entity
Mashhad University of Medical Scinces, Ibn-e- Sina Psychiatric Hospital
Country
Iran (Islamic Republic of)
Phone
+98 51 3711 2540
Email address
nejatir2@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-08-23, 1400/06/01
Expected recruitment end date
2021-10-23, 1400/08/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the efficacy of virtual reality in acrophobia treatment
Public title
Effect of virtual reality on acrophobia treatment
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients who have acrophobia according to the diagnostic interview based on the checklist of symptoms in DSM-5
Patients have symptoms of acrophobia for at least the past six months.
Patients arebetween 18 to 65 years old
Exclusion criteria:
Addiction to alcohol or drugs
Major psychological disorder
Age
From 18 years old to 65 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
21
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Mashhad University of Medical Sciences
Street address
Daneshgah street, Ghoreishi building
City
Mashhad
Province
Razavi Khorasan
Postal code
91778-99191
Approval date
2019-10-08, 1398/07/16
Ethics committee reference number
IR.MUMS.MEDICAL.REC.1398.793
Health conditions studied
1
Description of health condition studied
Acrophobia
ICD-10 code
F40.241
ICD-10 code description
Acrophobia
Primary outcomes
1
Description
Anxiety level
Timepoint
At the beginning of the intervention, week 4 , and at the end of the intervention
Method of measurement
The State-Trait Anxiety Inventory (STAI)
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: After diagnosis of acrophobia by a psychiatrist, male and female patients are treated with a virtual reality technique using the software produced by Daj-scientific Corporation for eight 45-minute sessions once a week for 8 weeks. Before the treatment, on session 4, and at the end of the treatment, the State-Trait Anxiety Inventory (STAI) will be administered. The topics covered in each session are as follows. Session 1: getting familiar with the goals and rules of treatment sessions, teaching relaxation techniques, showing photos taken from high locations. Session 2: showing videos of a glass elevator as if the patient is sitting in it and it is at the ground floor and teaching patients relaxation techniques such as breathing techniques. Sessions 3 to 7: showing videos of a glass elevator in which the person is sitting and it goes up to the upper floors of high-rise buildings. In each session according to the progress of treatment, the elevator goes higher and the patient is asked to look at the surroundings and look down and then the patient returns to the ground. Patients are taught relaxations techniques in each session. From the fourth or fifth session onwards, exercises at home such as going to the elevator, or different heights such as the first floor of the building, etc. are given to evaluate the treatment. Session 8: Combining the extremist forms of all the steps performed in the last 7 sessions, and calming the patient.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Ibn Sina Hospital
Full name of responsible person
Ali Talaei
Street address
Ibn Sinal Hospital, Horre Ameli boulevard, Bu Ali Square
City
Mashhad
Province
Razavi Khorasan
Postal code
91959 83134
Phone
+98 51 3711 2709
Email
talaeia@mums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Dr.Mohsen Tafaghodi
Street address
Central Building of Mashhad University of Medical Sciences (Ghorshi), Daneshgah 16, Daneshgah street
City
Mashhad
Province
Razavi Khorasan
Postal code
9177899191
Phone
+98 51 3841 2081
Email
ramresearch@mums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad 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
Mashhad University of Medical Sciences
Full name of responsible person
Sahar Saadat
Position
resident
Latest degree
Medical doctor
Other areas of specialty/work
Psychiatrics
Street address
Ibn Sinal Hospital, Horre Ameli boulevard, Bu Ali Square
City
Mashhad
Province
Razavi Khorasan
Postal code
91959 83134
Phone
+98 51 3711 2709
Email
sadats961@mums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Dr Ali Talaei
Position
Professor
Latest degree
Specialist
Other areas of specialty/work
Psychiatrics
Street address
Ibn-e-Sina psychiatric Hospital, Horre ameli avenue, Boo Ali square
City
Mashhad
Province
Razavi Khorasan
Postal code
9195983134
Phone
+98 51 3711 2721
Email
talaeia@mums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Sahar Saadat
Position
resident
Latest degree
Medical doctor
Other areas of specialty/work
Psychiatrics
Street address
Ibn Sinal Hospital, Horre Ameli boulevard, Bu Ali Square
City
Mashhad
Province
Razavi Khorasan
Postal code
91959 83134
Phone
+98 51 3711 2709
Email
saadats961@mums.ac.ir
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
All data can be shared after patients are made unidentifiable.
When the data will become available and for how long
Data can be accessible 6 months after results are published.
To whom data/document is available
Data will be available for researchers in universities and other scientific institutes.
Under which criteria data/document could be used
Carrying out analysis on data is permitted.
From where data/document is obtainable
Data can be accessible through an email to the corresponding author (Dr Sahar Saadat. Email:saadats961@mums.ac.ir).
What processes are involved for a request to access data/document
After sending a request email to the corresponding author, data will be sent in 1 month.