NCT06508970

Brief Summary

The main purpose of this study is to determine the effect of Roy adaptation model-based virtual reality glasses application on adaptation difficulties, life satisfaction, and psychological well-being in the elderly using a randomized controlled experimental method. The hypotheses of the study are: H1: The Roy adaptation model-based virtual reality glasses application has an effect on adaptation difficulties in the elderly. H2: The Roy adaptation model-based virtual reality glasses application has an effect on life satisfaction in the elderly. H3: The Roy adaptation model-based virtual reality glasses application has an effect on psychological well-being in the elderly.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2024

Shorter than P25 for not_applicable

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2024

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2024

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2024

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

July 6, 2024

Completed
12 days until next milestone

First Posted

Study publicly available on registry

July 18, 2024

Completed
Last Updated

July 18, 2024

Status Verified

July 1, 2024

Enrollment Period

2 months

First QC Date

July 6, 2024

Last Update Submit

July 12, 2024

Conditions

Keywords

ElderlyRoy adaptation modeladaptation difficulty in the elderlypsychological well-beingvirtual reality glassesvirtual reality

Outcome Measures

Primary Outcomes (3)

  • Adaptation Difficulty Assessment Scale in the Elderly

    It is a 4-point Likert type scale consisting of 24 items, developed and validated by Şişman and Kutlu (2016) according to the Roy Adaptation Model, to determine the adequacy of elderly individuals in adapting to old age. Cronbach Alpha value is 0.93.The individual's compliance level is determined by adding up the total scores from the scale and dividing by the number of items. The lowest possible score is 0 and the highest is 3. It is seen that as the score obtained from the scale increases, the individual's adaptation level to old age decreases.

    one months

  • Life Satisfaction Scale for the Elderly

    It was developed by Altay and Çalmaz in 2022. It has 14 items and 3 subscales that question the participation of elderly individuals in the process related to life satisfaction. Cronbach Alpha value is 0.874. The subscales of the Scale are represented by factors 1, 2 and 3: Self-acceptance (Factor 1), Motivation (Factor 2), Peace of mind (Factor 3). Responses to the items on this 5-point Likert scale are "I strongly disagree" and "I strongly agree". Each item is scored between 1 and 5. The total possible minimum score from the scale is 14, and the highest score that can be obtained is 70. It is known that life satisfaction increases as the score obtained from the scale increases.

    one months

  • Psychological Well-Being Scale in the Elderly

    The scale developed by Gümüş Demir in 2022 consists of fifteen items. In line with the scoring of the scale, no cut-off score has been determined for the level of well-being in the elderly. The Cronbach's alpha internal consistency coefficient of the scale is 0.89. The scale was prepared using a 5-point Likert type response system and the score range varies between 15 and 75. High scores indicate an increase in the level of well-being.

    one months

Study Arms (2)

experimental group

EXPERIMENTAL

RAM-based virtual reality glasses were applied to the experimental group for 4 weeks.

Behavioral: Experimental RAM-based virtual reality glassesOther: pre-post test

Control group

OTHER

Nursing students will receive their regular semester courses; no additional intervention will be implemented.

Other: pre-post test

Interventions

RAM-based virtual reality glasses were applied to the experimental group for 4 weeks. Video contents: 1. week; 1st sub-dimension (physiological domain) 2. weeks; 2nd sub-dimension (self-space) Three weeks; 3rd sub-dimension (Role function/function area) week 4; 4th sub-dimension (Independence and interdependence/autonomy)

experimental group

Adaptation Difficulty Assessment Scale in the Elderly, Life Satisfaction Scale in the Elderly , and Psychological Well-Being Scale in the Elderly

Control groupexperimental group

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Those aged 60 and over
  • Residents of Kocaeli nursing home
  • Those who score 25 and above in the Standardized Mini Mental Test

You may not qualify if:

  • Not wanting to participate in the research voluntarily
  • Those who score 24 or below on the Standardized Mini Mental Test

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kafkas University Faculty of Health Sciences

Kars, 36500, Turkey (Türkiye)

Location

Related Publications (3)

  • Aydogdu O, Tastan S, Kublay G. The effects of the instrumental reminiscence therapy based on Roy's adaptation model on adaptation, life satisfaction and happiness in older people: A randomized controlled trial. Int J Nurs Pract. 2023 Jun;29(3):e13101. doi: 10.1111/ijn.13101. Epub 2022 Aug 24.

  • Barsasella D, Liu MF, Malwade S, Galvin CJ, Dhar E, Chang CC, Li YJ, Syed-Abdul S. Effects of Virtual Reality Sessions on the Quality of Life, Happiness, and Functional Fitness among the Older People: A Randomized Controlled Trial from Taiwan. Comput Methods Programs Biomed. 2021 Mar;200:105892. doi: 10.1016/j.cmpb.2020.105892. Epub 2020 Nov 29.

  • Skjaeret N, Nawaz A, Morat T, Schoene D, Helbostad JL, Vereijken B. Exercise and rehabilitation delivered through exergames in older adults: An integrative review of technologies, safety and efficacy. Int J Med Inform. 2016 Jan;85(1):1-16. doi: 10.1016/j.ijmedinf.2015.10.008. Epub 2015 Oct 28.

MeSH Terms

Conditions

Psychological Well-Being

Interventions

Evaluation Studies as Topic

Condition Hierarchy (Ancestors)

Personal SatisfactionBehavior

Intervention Hierarchy (Ancestors)

Investigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and Evaluation

Study Officials

  • Eda ERSARI ŞEN, Student

    Kafkas University-Kafkas University Faculty of Health Sciences

    PRINCIPAL INVESTIGATOR
  • Gönül GÖKÇAY, Asist. Prof.

    Bayan.

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
Participants were assigned to groups using the "simple randomization method." Participants were not informed about which group they were in. Unique 2-group columns were created with the registration numbers of elderly individuals in nursing homes by using the Random Integer Generator method under the numbers subheading on the Random.org website. The researcher was blind to all conditions until participants started the computer program and the intervention began. Participants were also unaware of whether the group they were assigned to was an experimental or control group. Additionally, researchers who coded and analyzed the data were blinded to randomization and interventions.
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: RAM-based virtual reality glasses were applied to the experimental group for 4 weeks.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Asist. Prof.

Study Record Dates

First Submitted

July 6, 2024

First Posted

July 18, 2024

Study Start

April 1, 2024

Primary Completion

May 31, 2024

Study Completion

June 30, 2024

Last Updated

July 18, 2024

Record last verified: 2024-07

Data Sharing

IPD Sharing
Will not share

Locations