To determine the effects of virtual reality on burden, quality of life and satisfaction and to find out the association between caregiver burden and quality of life in informal caregivers of stroke survivors
Design
Randomized, parallel groups
Settings and conduct
Rawal General Hospital
Participants/Inclusion and exclusion criteria
Inclusion Criteria:
Both Genders of 20 to 40 years
Taking care of a stroke patient ≥ 3 months.
Exclusion Criteria:
Caregivers taking care of more than one patient
Caregivers who are suffering from a Neurological or Orthopedic disease.
Included caregiver was no longer the primary caregiver.
Intervention groups
Group A: Virtual reality therapy applied, every subject will be treated individually. Before the intervention, there will be a 5-minute warm-up time, and after the session there will also a 5-minute cool-down time. The virtual reality time will be 25 to 30 minutes periods, 3 days per week for 4 weeks.
Group B: Undergo the psychotherapy using Cognitive Behavioral therapy. The therapy will be 25 to 30 minutes periods per day, 3 days per week, for 4 weeks.
Group C: Provided with both cognitive behavioral therapy and virtual therapy training for 25 to 30minutes per day, 3 days per week for 4 consecutive weeks.
Main outcome variables
1. Caregiver Strain Index
2. 36-Item Short Form Health Survey
3. Adult Carer- Quality of Life
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20211123053152N1
Registration date:2021-11-25, 1400/09/04
Registration timing:retrospective
Last update:2021-11-25, 1400/09/04
Update count:0
Registration date
2021-11-25, 1400/09/04
Registrant information
Name
Mirza Obaid Baig
Name of organization / entity
Riphah International University
Country
Pakistan
Phone
+92 51 5166813
Email address
obaid.baig@riphah.edu.pk
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-08-01, 1399/05/11
Expected recruitment end date
2020-12-15, 1399/09/25
Actual recruitment start date
2020-08-13, 1399/05/23
Actual recruitment end date
2021-01-15, 1399/10/26
Trial completion date
2021-02-25, 1399/12/07
Scientific title
Effects of Virtual Reality on burden, quality of life and satisfaction in informal caregivers of stroke survivors.
Public title
VR and Informal Caregivers
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Taking care of a stroke patient ≥ 3 months
Exclusion criteria:
Caregivers taking care of more than one patient
Caregivers who are suffering from a Neurological or Orthopedic disease.
Included caregiver was no longer the primary caregiver
Age
From 20 years old to 40 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
66
Actual sample size reached:
66
Randomization (investigator's opinion)
Randomized
Randomization description
Total sixty six envelops (twenty two for each group) has designed and after taking consent from the individual to enter in the trial, the one envelope is being drawn to allocate a treatment group.
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
Research Ethical Committee, Riphah International University
Street address
Westridge Campus, Potohar Tower, Near Nisar Hospital, Lane 5,Peshawar Road, Rawalpindi
City
Islamabad
Postal code
46000
Approval date
2020-08-13, 1399/05/23
Ethics committee reference number
RIPHAH/RCRS/REC/Letter-00753
Health conditions studied
1
Description of health condition studied
ICD-10 code
ICD-10 code description
2
Description of health condition studied
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
The Caregiver Strain İndex (CSI) made up of 13 items was developed by Robinson (1983) and assesses the subjective care load of the caregiver. The CSI can be used to quickly identify families with potential caregiving concerns. There is at least one item for each of the following major domains: Employment, Financial, Physical, Social and Time. Positive responses to 7 or more items on the index indicate a greater level of strain. This instrument can be used to assess individuals of any age who have assumed the role of carer for an older adult. It was developed with a sample of 132 carers providing assistance to recently hospitalized older adults. Validity of the index was found to be 0.41 and test-retest reliability 0.75
Timepoint
Before intervention and 4 weeks after intervention
Method of measurement
subjective method by CSI
2
Description
The 36-Item Short Form Health Survey (SF-36) is widely validated and popularly used in assessing the subjective quality of life (QOL) of patients and the general public. And it includes eight domains. The aim of the study is to assess the psychometric properties of the 36-Item Short Form Health Survey (SF-36) in medical students in mainland of China. SF-36 questionnaire reliability was >0.7, Where as the validity of SF-36 is >0.5
Timepoint
Before intervention and 4 weeks after intervention
Method of measurement
subjectively by SF-36
Secondary outcomes
1
Description
Adult Carer-Quality of Life: A simple instrument for use with adult carers that measures quality of life in eight separate domains: support for caring; caring choice; caring stress; money matters; personal growth; sense of value; ability to care; and carer satisfaction. The AC-QoL's internal consistency/reliability is 0.94, indicating that the AC-QoL is a useful tool to assess the QoL of adult caregivers whereas the validity is ranging from 0.78 to 0.89.
Timepoint
Before intervention and 4 weeks after intervention
Method of measurement
Subjectively through AC-QOL
Intervention groups
1
Description
Intervention group: Virtual reality, The procedures will be explained to the subjects, and a demonstration of games will be given by the therapist before starting the intervention. Before the intervention, there will be a 5-minute warm-up time, and after the session there will also a 5-minute cool-down time. The Kinect training time will be 25 to 30 minutes periods interspersed with 5-minute rest, 3 days per week for 4 consecutive weeks.
Category
Treatment - Other
2
Description
Intervention group: Cognitive behavioral therapy, will be 25 to 30 minutes periods per day, 3 days per week, for 4 consecutive weeks.
Category
Treatment - Other
3
Description
Intervention group: Virtual reality and cognitive behavioral therapy, for 25 to 30minutes per day, 3 days per week for 4 consecutive weeks.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Rawal General Hospital
Full name of responsible person
Marrium Batool
Street address
Lehtrar Road, Islamabd
City
Islamabad
Postal code
42200
Phone
+92 51 2617381
Email
marriumbatool25@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Riphah International University
Full name of responsible person
Mirza Obaid Baig
Street address
House 29, Street 108
City
Islamabad
Postal code
46000
Phone
+92 51 5166813
Email
obaid.baig@riphah.edu.pk
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Riphah International University
Proportion provided by this source
100
Public or private sector
Private
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
Riphah International University
Full name of responsible person
Research Ethical Committee, Riphah International University
Position
Assistant Professor
Latest degree
Master
Other areas of specialty/work
Physiotherapy
Street address
Westridge Campus, Potohar Tower, Near Nisar Hospital, Lane 5,Peshawar Road, Rawalpindi
City
Islamabad
Province
Islamabad
Postal code
46000
Phone
+92 51 5166813
Fax
Email
obaid.baig@riphah.edu.pk
Person responsible for scientific inquiries
Contact
Name of organization / entity
Riphah International University
Full name of responsible person
Mirza Obaid Baig
Position
Assistant Professor
Latest degree
Master
Other areas of specialty/work
Physiotherapy
Street address
Westridge Campus, Peshawar Road
City
Rawalpindi
Province
Islamabad
Postal code
46000
Phone
+92 51 5166813
Email
dxo3@hotmail.com
Person responsible for updating data
Contact
Name of organization / entity
Riphah International University
Full name of responsible person
Research Ethical Committee, Riphah International University
Position
Assistant Professor
Latest degree
Master
Other areas of specialty/work
Physiotherapy
Street address
Westridge Campus, Potohar Tower, Near Nisar Hospital, Lane 5,Peshawar Road, Rawalpindi
City
Islamabad
Province
Islamabad
Postal code
46000
Phone
+92 51 5166813
Fax
Email
obaid.baig@riphah.edu.pk
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
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
Title and more details about the data/document
The data of participants who are undergone in the virtual realty group will be shared.
When the data will become available and for how long
The data will be available from March 2022 till December 2022.
To whom data/document is available
People working in academic, research institutes and clinical sites
Under which criteria data/document could be used
Advance analysis of the data, future prospects of research and clinical in this area of interest
From where data/document is obtainable
marriumbatool25@gmail.com
What processes are involved for a request to access data/document