Protocol summary

Study aim
Determining the effect of virtual reality technology on anxiety caused by fear of heights (acrophobia) in Birjand University of Medical Sciences students
Design
Clinical trial with control group, with parallel groups , random, on 120 patients using randomizer software.
Settings and conduct
This study will be conducted in the summer of 2020 at Birjand University of Medical Sciences.
Participants/Inclusion and exclusion criteria
The criteria for entering a study for patients include: 1) Diagnosis of acrophobia based on the criteria for diagnosis of DSM V 2) A maximum of 6 months have elapsed since the onset of the disease. 3) Absence of any other mental illness in the patient. Medicine Criteria for not entering the study for patients are: 1) Pregnancy 2) Current drug or psychiatric treatment or within three months before the start of the study 3) Cardiovascular or neurological diseases 4) Stereoscopic visual impairment 5) Severe aphthous disorder 6) Severe psychiatric disorder. 7) Dissatisfaction with continuing to study.
Intervention groups
A number enter the study, and after a height encounter, through virtual reality glasses, the Beck Anxiety Questionnaire and the Fearful Height Questionnaire are performed as a pre-test on all of these individuals, and after collecting the questionnaires, the case group In 8 30-minute sessions over 4 weeks, panoramic virtual reality videos from high-altitude locations And the control group will complete the Beck Anxiety Inventory and the researcher-made Fear of Height Questionnaire at the beginning of the post-exposure to height through virtual reality glasses, and will complete the questionnaire once at the end of the study without intervention.
Main outcome variables
Fear of heights, acrophobia, anxiety

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20200619047830N1
Registration date: 2020-07-28, 1399/05/07
Registration timing: retrospective

Last update: 2020-07-28, 1399/05/07
Update count: 0
Registration date
2020-07-28, 1399/05/07
Registrant information
Name
Seyyedreza Sajjadi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 56 3239 5000
Email address
seyyedrezasajjadi@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-04-01, 1399/01/13
Expected recruitment end date
2020-06-21, 1399/04/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of virtual reality technology (VR) on reduction of anxiety caused by fear of Height (acrophobia) in students of Birjand University of Medical Sciences
Public title
The effect of virtual reality technology on reduction of anxiety caused by acrophobia
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Diagnosis of acrophobia based on DSM V diagnostic criteria At most 6 months have passed since the onset of the disease Absence of any other mental illness in the patient Lack of common pharmacological and non-pharmacological treatments
Exclusion criteria:
Pregnancy Current pharmacological or psychiatric treatment or within three months before the start of the study Cardiovascular or neurological diseases Stereoscopic vision impairment Severe hearing loss Severe psychiatric disorder Dissatisfaction with continuing to study
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 120
Randomization (investigator's opinion)
Randomized
Randomization description
Using a simple randomization method using randomizer software
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 Birjand University of Medical Sciences
Street address
Moallem Blvd,birjand university of medical sciences
City
Birjand
Province
South Khorasan
Postal code
9717953577
Approval date
2020-06-10, 1399/03/21
Ethics committee reference number
IR.BUMS.REC.1399.088

Health conditions studied

1

Description of health condition studied
acrophobia, anxiety
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Anxiety score in Beck questionnaire
Timepoint
Before the intervention, immediately after the intervention and one month after the intervention
Method of measurement
Beck Anxiety Questionnaire

2

Description
Height fear scores in the acrophobia questionnaire
Timepoint
Before the intervention, immediately after the intervention and one month after the intervention
Method of measurement
acrophobia questionnaire

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: In eight 30-minute sessions, the group will be confronted with eight panoramic virtual reality videos from high-altitude locations over four weeks, including the roofs of tall buildings, the balcony of the building, the flyover and the parachute flight via virtual reality glasses.
Category
Prevention

2

Description
Control group: They did not intervene.
Category
Prevention

Recruitment centers

1

Recruitment center
Name of recruitment center
Birjand University of Medical Sciences
Full name of responsible person
Seyyedreza sajjadi
Street address
Moallem Blvd
City
Birjand
Province
South Khorasan
Postal code
9717853577
Phone
+98 56 3239 5000
Email
seyyedrezasajjadi@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Birjand University of Medical Sciences
Full name of responsible person
tooba kazemi
Street address
Moallem Blvd
City
Birjand
Province
South Khorasan
Postal code
9717853577
Phone
+98 56 3239 5000
Email
drtooba.kazemi@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Birjand University of Medical Sciences
Proportion provided by this source
30
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
Birjand University of Medical Sciences
Full name of responsible person
Seyyedreza sajjadi
Position
medical student
Latest degree
Medical doctor
Other areas of specialty/work
General Practitioner
Street address
Moallem Blvd
City
Birjand
Province
South Khorasan
Postal code
9717853577
Phone
+98 56 3239 5000
Email
seyyedrezasajjadi@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Birjand University of Medical Sciences
Full name of responsible person
Seyyedreza sajjadi
Position
medical student
Latest degree
Medical doctor
Other areas of specialty/work
General Practitioner
Street address
Moallem Blvd
City
Birjand
Province
South Khorasan
Postal code
9717853577
Phone
+98 56 3239 5000
Email
seyyedrezasajjadi@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Birjand University of Medical Sciences
Full name of responsible person
Seyyedreza Sajjadi
Position
Student
Latest degree
Medical doctor
Other areas of specialty/work
General Practitioner
Street address
Ghaffari blvd,birjand university of medical science
City
Birjand
Province
South Khorasan
Postal code
9717853577
Phone
+98 56 3239 5000
Fax
Email
seyyedrezasajjadi@gmail.com

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
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