Protocol summary

Study aim
The effectiveness of exergame virtual reality interventions on occupational performance and life habits of depressed elderly people
Design
A single-blind, randomized, controlled and interventional clinical trial involving 98 participants. The online site www.sealedenvelope.com was used for randomization and was performed by an epidemiologist.
Settings and conduct
After receiving the written and oral consent form from the participants who meet the study entry criteria, before the start of the intervention, from the qualified participants of both groups, Beck Depression Questionnaire-II to determine the depression status before the intervention, MoCA test to determine their cognitive status, Canadian Occupational Performance Measure (COPM) to determine the status and performance satisfaction. Exergame virtual reality interventions are activities with specific scenarios that are implemented in the equipped virtual reality laboratory room at the National Center for Brain Mapping located in the technical faculty of Tehran University. Evaluations of the study variables are performed by an occupational therapy expert who is not a member of the research team, before and after the study.
Participants/Inclusion and exclusion criteria
Age range of 60 years and above • Diagnosis of depression by a trusted psychiatrist • Obtaining a score of 20 to 28 as suffering from moderate depression in Beck Depression Questionnaire II • Obtaining a score of 23 and above on the MoCA scale as healthy people in terms of cognitive items by all participants. • Be able to communicate verbally
Intervention groups
The intervention group, are subjected to exergame virtual reality interventions. In this study, the control group receives no intervention.
Main outcome variables
Occupational Performance - Life habits - Exergame Virtual Reality

General information

Reason for update
Acronym
VR
IRCT registration information
IRCT registration number: IRCT20240619062186N1
Registration date: 2024-08-03, 1403/05/13
Registration timing: registered_while_recruiting

Last update: 2024-08-03, 1403/05/13
Update count: 0
Registration date
2024-08-03, 1403/05/13
Registrant information
Name
Seyed Parsa Fallah Abbasi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 7768 4879
Email address
abbasiparsa2090@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-07-22, 1403/05/01
Expected recruitment end date
2024-08-24, 1403/06/03
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effectiveness of exergame virtual reality intervention on occupational performance and life habits of depressed elderly people
Public title
The effectiveness of exergame virtual reality intervention on occupational performance and life habits of depressed elderly people
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
• Age range of 60 years and above• Diagnosis of depression by a trusted psychiatrist• Obtaining a score of 20 to 28 as suffering from moderate depression in Beck Depression Questionnaire II• Obtaining a score of 23 and above on the MoCA scale as healthy people in terms of cognitive items by all participants.• Be able to communicate verbally
Exclusion criteria:
• People who have a neurological disorder (such as stroke, parkinsonism);• have a musculoskeletal or upper limb disorder;• have untreated medical conditions;• have vision, vestibular and hearing problems;• have active arthritis;• have arthroplasty or joint fusion;• Any amputation or surgery;• Suffering from mental problems other than depression or mental problems with depression
Age
From 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
  • Outcome assessor
Sample size
Target sample size: 98
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization and concealment are done by the epidemiologist and for this purpose the online site www.sealedenvelope.com is used. Regarding the method of randomization, at the beginning of the study, using the above site, a random sequence of n items is generated by the balanced block method with block sizes of 4 and 6, which included n intervention cases and n control cases, and this The list was kept with the epidemiologist colleague (advisor). After examining the entry criteria of each of the participants and their eligibility, in order to decide on the placement of that person in each of the groups, the student contacts the professor and makes a decision based on the randomization sequence list for that person. It will be This procedure was carried out for all participants (n people) until the end, which led to the division of people into two completely equal and random groups, and this work kept the random sequence hidden from the patient (student), which shows the concept of concealment in The allocation process is random. Since the participants are from different areas of Tehran, this population can be referred to the whole society.
Blinding (investigator's opinion)
Single blinded
Blinding description
Both control and intervention group participants were assessed in terms of the studied scales, which include work performance and life habits in depressed elderly people, and were measured by the Canadian Occupational Performance Measure and the Life-H, respectively, by an occupational therapist, who is not a member of the research team, is evaluated before and after the intervention.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Tehran University of Medical Sciences
Street address
Tehran University of Medical Sciences - School of Rehabilitation
City
Tehran
Province
Tehran
Postal code
1148965111
Approval date
2024-07-29, 1403/05/08
Ethics committee reference number
IR.TUMS.FNM.REC.1403.064

Health conditions studied

1

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

Primary outcomes

1

Description
Exergame Virtual reality, Occupational performance - Life habit
Timepoint
Measurement of occupational performance and life habits before intervention and six weeks after intervention
Method of measurement
Occupational performance using the Canadian Occupational Performance Measure. Life habits with Life-H.

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: Moderately depressed elderly people aged 60 years and older according to Beck depression II
Category
Treatment - Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Ziaeian Hospital
Full name of responsible person
Dr. Abolfazl Zendeh Del
Street address
Abouzar st.
City
Tehran
Province
Tehran
Postal code
13667 36511
Phone
+98 21 5517 6813
Email
ziaeian@tums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Hamid Dalvand
Street address
Enghelab
City
Tehran
Province
Tehran
Postal code
65111-11489
Phone
+98 21 7753 3939
Email
rehabilitation-lib@sina.tums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran 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
Tehran University of Medical Sciences
Full name of responsible person
Seyed Parsa Fallah Abbasi
Position
Master Student
Latest degree
Bachelor
Other areas of specialty/work
Occupational Therapy
Street address
Enghelab
City
Tehran
Province
Tehran
Postal code
65111-11489
Phone
77636041 -021
Email
abbasiparsa2090@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Hamid Dalvand
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Occupational Therapy
Street address
Enghelab
City
Tehran
Province
Tehran
Postal code
65111-11489
Phone
77636041 -021
Email
hamiddalvand@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Seyed Parsa Fallah Abbasi
Position
Master Student
Latest degree
Bachelor
Other areas of specialty/work
Occupational Therapy
Street address
Enghelab
City
Tehran
Province
Tehran
Postal code
65111-11489
Phone
77636041 -021
Email
abbasiparsa2090@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
There is no further information
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
No - There is not 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
Not applicable
Title and more details about the data/document
Researcher and guidance professors and consultant professors
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
Researcher and guidance professors and consultant professors
Under which criteria data/document could be used
Completion of intervention and publication of study results
From where data/document is obtainable
research fellow. To the email address abbasiparsa2090@gmail.com
What processes are involved for a request to access data/document
Submitting a request to the researcher's email, consulting the researcher with the supervisor, receiving a response from the researcher
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