Back to resultsVirtual Reality Effect in Geriatric Individuals
Primary Purpose
Pain, Depression
Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
virtual reality game
Sponsored by
About this trial
This is an interventional supportive care trial for Pain focused on measuring geriatric pain, geriatric depression
Eligibility Criteria
Inclusion Criteria:
- Suffering from musculoskeletal pain in the last 3 years,
- Being energetic (Being independent in the daily life activities),
- Being able to stand up without help before 30 seconds and walk at least six meters without help,
- Individuals with blood sugar ranging between 90-200 mg/dl prior to the application,
- Individuals with blood pressure ranging between 130-70 mm/Hg prior to the application,
- Not having neurological and psychiatric diseases,
- No history of fall,
- Being literate,
- Not being visually-hearing impaired,
- Being able to communicate verbally.
Exclusion Criteria:
- Pependent patients
- Patients with psychiatric illness
- Patients with joint pain disease diagnosis
Sites / Locations
- Osmangazi University
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
control group
virtual reality group
Arm Description
routine study
Three days a week, 2 times a day, 15 minutes in the morning and in the evening for 9 days in total
Outcomes
Primary Outcome Measures
The visual analog scale (VAS)
This form includes numbers and is used in the assessment of pain severity. Patients mark their pain severity on a 10 cm ruler which is written no pain on one side and the most severe pain as possible on the other side. It has been stated that VAS is more sensitive and reliable in the measurement of pain severity than one sized scales
Geriatric Depression Scale
The scale was developed by Yesavage with the aim of assessing the depression symptoms of old persons and consists of 15 questions in total. In the assessment, 1 point is given to each "no" answer in the positive questions and to each "yes" answer in the negative questions. A score of 6 and higher in the scale is accepted as meaningful for the diagnosis of depression. Reliability and validity tests were performed in our country and Chronbach alpha internal consistency coefficient was found to be 0.92
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04268589
Brief Title
Virtual Reality Effect in Geriatric Individuals
Official Title
Effect of Virtual Reality Application on Pain, Functional Independence and Depression in Geriatric Individuals
Study Type
Interventional
2. Study Status
Record Verification Date
February 2020
Overall Recruitment Status
Completed
Study Start Date
May 1, 2019 (Actual)
Primary Completion Date
June 30, 2019 (Actual)
Study Completion Date
June 30, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Selcuk University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
This study aimed to determine the effect of a virtual reality experience on pain, depression and functional adequacy in geriatric individuals living in a nursing home.
A virtual reality video with dance moves has been applied to the experimental group participants. Each video takes 3 minutes, and the elderly person has been put into practice at least 30 minutes after having breakfast in 3-minute periods and at least 30 minutes after dinner. In the morning and evening, 15 minutes, 2 times a day, a total of 9 days were applied for 3 weeks. The application lasted a total of 3 weeks. Scales were applied 1 week after the virtual reality application was completed and 1 month after the experimental group. The scales were filled in the control group at the same time.
Detailed Description
It is recommended that the future studies be conducted with larger samples on pain, depression, life quality and functionality.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Depression
Keywords
geriatric pain, geriatric depression
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
Care Provider
Allocation
Non-Randomized
Enrollment
14 (Actual)
8. Arms, Groups, and Interventions
Arm Title
control group
Arm Type
No Intervention
Arm Description
routine study
Arm Title
virtual reality group
Arm Type
Experimental
Arm Description
Three days a week, 2 times a day, 15 minutes in the morning and in the evening for 9 days in total
Intervention Type
Other
Intervention Name(s)
virtual reality game
Other Intervention Name(s)
routine
Intervention Description
routine
Primary Outcome Measure Information:
Title
The visual analog scale (VAS)
Description
This form includes numbers and is used in the assessment of pain severity. Patients mark their pain severity on a 10 cm ruler which is written no pain on one side and the most severe pain as possible on the other side. It has been stated that VAS is more sensitive and reliable in the measurement of pain severity than one sized scales
Time Frame
nine days
Title
Geriatric Depression Scale
Description
The scale was developed by Yesavage with the aim of assessing the depression symptoms of old persons and consists of 15 questions in total. In the assessment, 1 point is given to each "no" answer in the positive questions and to each "yes" answer in the negative questions. A score of 6 and higher in the scale is accepted as meaningful for the diagnosis of depression. Reliability and validity tests were performed in our country and Chronbach alpha internal consistency coefficient was found to be 0.92
Time Frame
nine days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
65 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Suffering from musculoskeletal pain in the last 3 years,
Being energetic (Being independent in the daily life activities),
Being able to stand up without help before 30 seconds and walk at least six meters without help,
Individuals with blood sugar ranging between 90-200 mg/dl prior to the application,
Individuals with blood pressure ranging between 130-70 mm/Hg prior to the application,
Not having neurological and psychiatric diseases,
No history of fall,
Being literate,
Not being visually-hearing impaired,
Being able to communicate verbally.
Exclusion Criteria:
Pependent patients
Patients with psychiatric illness
Patients with joint pain disease diagnosis
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gamze Unver
Organizational Affiliation
Kutahya University of Health Sciences
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Halil Ibrahim Tuna
Organizational Affiliation
Selcuk University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Guler Balci Alparslan
Organizational Affiliation
Osmangazi University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Osmangazi University
City
Eskişehir
Country
Turkey
12. IPD Sharing Statement
Plan to Share IPD
No
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Virtual Reality Effect in Geriatric Individuals
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