NCT04268589

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
14

participants targeted

Target at below P25 for not_applicable pain

Timeline
Completed

Started May 2019

Shorter than P25 for not_applicable pain

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2019

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2019

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

January 21, 2020

Completed
23 days until next milestone

First Posted

Study publicly available on registry

February 13, 2020

Completed
Last Updated

February 17, 2020

Status Verified

February 1, 2020

Enrollment Period

2 months

First QC Date

January 21, 2020

Last Update Submit

February 13, 2020

Conditions

PainDepression

Keywords

geriatric paingeriatric depression

Outcome Measures

Primary Outcomes (2)

  • 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

    nine days

  • 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

    nine days

Study Arms (2)

control group

NO INTERVENTION

routine study

virtual reality group

EXPERIMENTAL

Three days a week, 2 times a day, 15 minutes in the morning and in the evening for 9 days in total

Other: virtual reality game

Interventions

virtual reality gameOTHER

routine

Also known as: routine
virtual reality group

Eligibility Criteria

Age65 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • Pependent patients
  • Patients with psychiatric illness
  • Patients with joint pain disease diagnosis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Osmangazi University

Eskişehir, Turkey (Türkiye)

Location

MeSH Terms

Conditions

PainDepression

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsBehavioral SymptomsBehavior

Study Officials

  • Gamze Unver

    Kutahya University of Health Sciences

    PRINCIPAL INVESTIGATOR

  • Halil Ibrahim Tuna

    Selcuk University

    PRINCIPAL INVESTIGATOR

  • Guler Balci Alparslan

    Osmangazi University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
CARE PROVIDER
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director

Study Record Dates

First Submitted

January 21, 2020

First Posted

February 13, 2020

Study Start

May 1, 2019

Primary Completion

June 30, 2019

Study Completion

June 30, 2019

Last Updated

February 17, 2020

Record last verified: 2020-02

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)