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The Effect of Virtual Reality On Anxiety, Depression, Stress and Death Anxiety in Elderly

Protocol summary

Study aim
General Objective: Determining the effect of virtual reality on anxiety, depression, stress, and death anxiety in elderly
Design
Experimental study, with a control group, without blinding, on 60 elderly people, randomization with four blocks
Settings and conduct
The study design is an experimental one, which includes a control group and does not involve blinding. The participants will consist of 60 elderly individuals who meet the inclusion criteria and have be randomly assigned to either the intervention or control group using a four-block randomization process. The intervention involves placing participants in a virtual reality environment that includes natural landscapes, pilgrimage sites, tourist sites, flight, and deep sea, which they can interact with for six 15-minute sessions, twice a week for three weeks. The intervention will take place in a quiet room to ensure privacy. The control group will not receive any intervention during this period. This study is conducting in Ramsar city
Participants/Inclusion and exclusion criteria
Inclusion criteria: Individuals aged 60 and above experiencing symptoms of anxiety, depression, stress, and death anxiety. Non-entry criteria: History of mental disorders. History of epilepsy or seizures.
Intervention groups
The intervention group is exposed to a virtual reality environment consisting of natural landscapes, pilgrimage sites, tourist sites, flight, and deep sea scenarios. Participants can interact with and navigate through any of these environments under the researcher's supervision. The intervention takes place in a private, quiet room. Participants receive six 15-minute sessions, twice a week, for a total of three weeks. There is no intervention in the control group during this period.
Main outcome variables
Anxiety؛ Depression؛ stress؛ Death anxiety

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20221130056669N1
Registration date: 2023-03-06, 1401/12/15
Registration timing: registered_while_recruiting

Last update: 2023-03-06, 1401/12/15
Update count: 0
Registration date
2023-03-06, 1401/12/15
Registrant information
Name
Mohammadamin Shahrbaf
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 28 3335 6985
Email address
mohammadaminshahrbaf@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-03-06, 1401/12/15
Expected recruitment end date
2023-06-05, 1402/03/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effect of Virtual Reality On Anxiety, Depression, Stress and Death Anxiety in Elderly
Public title
Effect of Virtual Reality on Anxiety, Depression, Stress and Death anxiety in Elderly
Purpose
Health service research
Inclusion/Exclusion criteria
Inclusion criteria:
Individuals aged 60 years and older Reading and writing literacy in Persian language Interest and informed consent to participate in the study Absence of visual, auditory, or tactile impairments Achieving a score of eight or above on the Abbreviated Mental Test (AMT) Absence of psychological disorders as determined by both file records and self-reported measures Absence of current use of psychiatric medications or narcotics as determined by both file records and self-reported measures. Absence of medical history pertaining to conditions such as epilepsy, dizziness, and convulsions, as confirmed by both file records and self-reported measures. Absence of self-reported prior participation in comparable programs Achieving a score of 14 or greater on the depression subscale of the Depression Anxiety Stress Scale-21 (DASS-21). Achieving a score of 10 or greater on the Anxiety subscale of the Depression Anxiety Stress Scale-21(DASS-21) Achieving a score 19 or greater on the Stress subscale of the Depression Anxiety Stress Scale-21(DASS-21) Achieving a score 7 and above in the Tampler Death anxiety Scale (DAS)
Exclusion criteria:
Sensory impairments in vision, hearing, and tactile Suffering from psychological disorders, according to the file and self-report Taking psychiatric medicine and narcotics according to the file and self-report Having a history of diseases such as epilepsy, dizziness and convulsions according to the file and self-report
Age
From 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 60
Randomization (investigator's opinion)
Randomized
Randomization description
The sampling procedure involves the use of cluster sampling to select health centers. Once the clusters are identified, a random sample is selected from them, with the number of clusters chosen based on the desired sample size. Health centers within each selected cluster are then included in the sample. Eligible elderly participants from these health centers are then randomly allocated into blocks of four and assigned to either the control or intervention group. This is done after they have met the entry criteria for the study. Random allocation into blocks of four means that for every four eligible elderly participants, two are randomly assigned to the intervention group and two to the control group. The randomization process is done using a computer-generated random number sequence. The blocks of four ensure that there are an equal number of participants in each group, which can help to reduce the risk of chance imbalances between the groups.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Other
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Babol University of Medical sciences
Street address
Nursing and Midwifery School., Imam Sajjad Hospital., Shahid Motahari St
City
Ramsar
Province
Mazandaran
Postal code
۴۶۹۱۷۱۴۱۴۱
Approval date
2022-11-27, 1401/09/06
Ethics committee reference number
IR.MUBABOL.HRI.REC.1401.168

Health conditions studied

1

Description of health condition studied
Depression
ICD-10 code
F32.8
ICD-10 code description
Other depressive episodes

2

Description of health condition studied
Anxiety
ICD-10 code
F41
ICD-10 code description
Other anxiety disorders

3

Description of health condition studied
Stress
ICD-10 code
F43.8
ICD-10 code description
Other reactions to severe stress

4

Description of health condition studied
Death anxiety
ICD-10 code
F41
ICD-10 code description
Other anxiety disorders

Primary outcomes

1

Description
Score from depression subscale, short form of depression, anxiety and stress scale
Timepoint
Before and after the intervention
Method of measurement
Short form of depression, anxiety and stress scale(DASS-21)

2

Description
Score from َanxiety subscale, short form of depression, anxiety and stress scale
Timepoint
Before and after intervention
Method of measurement
Short form of depression, anxiety and stress scale(DASS-21)

3

Description
Score from َstress subscale, short form of depression, anxiety and stress scale
Timepoint
Before and after intervention
Method of measurement
Short form of depression, anxiety and stress scale (DASS-21)

4

Description
Score from َTampler Death anxiety scale
Timepoint
Before and after intervention
Method of measurement
Tampler Death anxiety scale (DAS)

Secondary outcomes

empty

Intervention groups

1

Description
The intervention group will be using Samsung VR devices to be placed in a virtual reality environment. The virtual reality environment will consist of different settings, including natural landscapes, pilgrimage sites, historical sites, tourist sites, and deep sea or flight scenarios. The participants in the intervention group will interact with the virtual environment, which will be under the control of the researcher, and the intervention will take place in a quiet room that respects the privacy of the participants. The intervention will consist of six 15-minute sessions, conducted twice a week for three weeks, and will be held in the health centers.
Category
Other

2

Description
Control group: No intervention is done
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Health centers
Full name of responsible person
Mohammadaminshahrbaf
Street address
South 35, Imam khomeini Blvd, Ramsar Health Center
City
Ramsar
Province
Mazandaran
Postal code
4691844447
Phone
+98 11 5525 6683
Email
Mohammadaminshahrbaf@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Dr. Mehdi Rajabnia
Street address
Ganj Afrooz St
City
Babol
Province
Mazandaran
Postal code
۴۷۱۷۶-۴۷۷۵۴
Phone
+98 11 3219 0558
Email
research@mubabol.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Babol 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
Babol University of Medical Sciences
Full name of responsible person
Mohammadamin Shahrbaf
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
No. 19, Farzmahdi Alley., Padegan Ave.,
City
Qazvin
Province
Qazvin
Postal code
3413843686
Phone
+98 28 3335 6985
Email
Mohammadaminshahrbaf@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Mohammadamin Shahrbaf
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
No. 19, Farzmahdi Alley., Padegan Ave.,
City
Qazvin
Province
Qazvin
Postal code
3413843686
Phone
+98 28 3335 6985
Email
Mohammadaminshahrbaf@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Mohammadamin Shahrbaf
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
No. 19, Farzmahdi Alley., Padegan Ave.,
City
Qazvin
Province
Qazvin
Postal code
3413843686
Phone
+98 28 3335 6985
Email
Mohammadaminshahrbaf@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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