NursingRAMNCT06508970
RAM-Based Virtual Reality Glasses and Adaptation, Satisfaction, Well-Being in the Elderly
A study testing Experimental RAM-based virtual reality glasses and pre-post test in people with Nursing and Evidence-Based Nursing, run by Kafkas University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Nursing, Evidence-Based Nursing
- What is being tested?
- Experimental RAM-based virtual reality glasses and pre-post test
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Apr 2024to 30 Jun 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Those aged 60 and over
- Residents of Kocaeli nursing home
- Those who score 25 and above in the Standardized Mini Mental Test
Who cannot join
- Not wanting to participate in the research voluntarily
- Those who score 24 or below on the Standardized Mini Mental Test
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Kafkas University Faculty of Health Sciences
Kars, 36500
About this study
Official title: The Effect of RAM-Based Virtual Reality Glasses Application on Adaptation, Life Satisfaction, and Psychological Well-Being in the Elderly
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.
Read the detailed description
In the 21st century, advances in science and technology have led to demographic changes, resulting in an increase in the elderly population. In this process, developments in the field of health such as increased preventive health services and early diagnosis and treatment of diseases played an important role. Aging is a natural process and can be defined as a decrease in an individual's physical and spiritual functions and an increase in external dependency. Adapting the elderly to this period supports psychological well-being by increasing functionality and life satisfaction. The Roy Adaptation Model aims for nurses to meet the needs of individuals to adapt, and this model can also be applied to the elderly. With technological advances, innovations such as virtual reality are used in the field of health and help improve the quality of life of the elderly. In the literature, studies examining the effects of Roy Adaptation Model and virtual reality glasses application on adaptation difficulties, life satisfaction and psychological well-being in the elderly are limited. This study aims to determine the effects of Roy Adaptation Model and virtual reality glasses application on adaptation difficulties, life satisfaction and psychological well-being in the elderly and to lay the foundation for evidence-based research. The thesis is a pre-posttest randomized controlled study with experimental and control groups. In the thesis study, data were collected as pre-post test from the elderly living in nursing homes using the Personal Information Form, Adaptation Difficulty Assessment Scale in the Elderly, Life Satisfaction Scale in the Elderly, and Psychological Well-Being Scale in the Elderly.In the thesis study, the experimental group was shown educational videos and nature videos with VR SHINECON 360 degree virtual reality glasses, based on the Roy adaptation model adaptation areas titles (physiological needs, self-concept area, role function area, interdependence area) twice a week for four weeks.
- Conditions
- Nursing, Evidence-Based Nursing
- Being tested
- Experimental RAM-based virtual reality glasses, pre-post test
- Keywords
- Elderly, Roy adaptation model, adaptation difficulty in the elderly, psychological well-being, virtual reality glasses, virtual reality
- Medical subject headings
- Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Experimental RAM-based virtual reality glassesBehavioural
RAM-based virtual reality glasses were applied to the experimental group for 4 weeks.
Video contents:
- week; 1st sub-dimension (physiological domain)
- weeks; 2nd sub-dimension (self-space) Three weeks; 3rd sub-dimension (Role function/function area) week 4; 4th sub-dimension (Independence and interdependence/autonomy)
pre-post testOther
Adaptation Difficulty Assessment Scale in the Elderly, Life Satisfaction Scale in the Elderly , and Psychological Well-Being Scale in the Elderly
| Study group | Role | What they receive |
|---|---|---|
| experimental group | Experimental | RAM-based virtual reality glasses were applied to the experimental group for 4 weeks. Receives: Behavioral: Experimental RAM-based virtual reality glasses; Other: pre-post test |
| Control group | Other | Nursing students will receive their regular semester courses; no additional intervention will be implemented. Receives: Other: pre-post test |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: one months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2024
- Study start1 Apr 2024
- Primary completion31 May 2024
- Study completion30 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for NursingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- RAM-based virtual reality glasses were applied to the experimental group for 4 weeks.
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kafkas University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gönül GÖKÇAY, Kafkas University
- Investigators
- Eda ERSARI ŞEN, Student, Principal investigator, Kafkas University-Kafkas University Faculty of Health SciencesGönül GÖKÇAY, Asist. Prof., Study director, Bayan.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06508970
- Sponsor's protocol ID
- 818295502.903/6
- Acronym
- RAM
- Status last verified
- Jul 2024
- First submitted
- 6 Jul 2024
- Last updated
- 18 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 36003030Barsasella 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.
PubMed 33280934Skjaeret 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.
PubMed 26559887
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of RAM-Based Virtual Reality Glasses Application on Adaptation, Life Satisfaction, and Psychological Well-Being in the Elderly
- ClinicalTrials.gov ID
- NCT06508970
- Acronym / sponsor ID
- RAM / 818295502.903/6
- Conditions
- Nursing, Evidence-Based Nursing
- Keywords
- Elderly, Roy adaptation model, adaptation difficulty in the elderly, psychological well-being, virtual reality glasses, virtual reality
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Kafkas UniversityUniversity, hospital or other
- Study start
- 1 Apr 2024 (actual)
- Primary completion
- 31 May 2024 (actual)
- Study completion
- 30 Jun 2024 (actual)
- First posted
- 18 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
In the 21st century, advances in science and technology have led to demographic changes, resulting in an increase in the elderly population. In this process, developments in the field of health such as increased preventive health services and early diagnosis and treatment of diseases played an important role. Aging is a natural process and can be defined as a decrease in an individual's physical and spiritual functions and an increase in external dependency. Adapting the elderly to this period supports psychological well-being by increasing functionality and life satisfaction. The Roy Adaptation Model aims for nurses to meet the needs of individuals to adapt, and this model can also be applied to the elderly. With technological advances, innovations such as virtual reality are used in the field of health and help improve the quality of life of the elderly. In the literature, studies examining the effects of Roy Adaptation Model and virtual reality glasses application on adaptation difficulties, life satisfaction and psychological well-being in the elderly are limited. This study aims to determine the effects of Roy Adaptation Model and virtual reality glasses application on adaptation difficulties, life satisfaction and psychological well-being in the elderly and to lay the foundation for evidence-based research. The thesis is a pre-posttest randomized controlled study with experimental and control groups. In the thesis study, data were collected as pre-post test from the elderly living in nursing homes using the Personal Information Form, Adaptation Difficulty Assessment Scale in the Elderly, Life Satisfaction Scale in the Elderly, and Psychological Well-Being Scale in the Elderly.In the thesis study, the experimental group was shown educational videos and nature videos with VR SHINECON 360 degree virtual reality glasses, based on the Roy adaptation model adaptation areas titles (physiological needs, self-concept area, role function area, interdependence area) twice a week for four weeks.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- RAM-based virtual reality glasses were applied to the experimental group for 4 weeks.
| Arm | Type | Receives |
|---|---|---|
| experimental group | Experimental | Behavioral: Experimental RAM-based virtual reality glasses, Other: pre-post testRAM-based virtual reality glasses were applied to the experimental group for 4 weeks. |
| Control group | Other | Other: pre-post testNursing students will receive their regular semester courses; no additional intervention will be implemented. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Those aged 60 and over
- Residents of Kocaeli nursing home
- Those who score 25 and above in the Standardized Mini Mental Test
Key exclusion criteria (2 listed)
- Not wanting to participate in the research voluntarily
- Those who score 24 or below on the Standardized Mini Mental Test
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Experimental RAM-based virtual reality glassesRAM-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) | Behavioural | experimental group |
| pre-post testAdaptation Difficulty Assessment Scale in the Elderly, Life Satisfaction Scale in the Elderly , and Psychological Well-Being Scale in the Elderly | Other | Control group, experimental group |
Primary outcome
Adaptation Difficulty Assessment Scale in the Elderly
Time frame: one months
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.
Life Satisfaction Scale for the Elderly
Time frame: one months
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.
Psychological Well-Being Scale in the Elderly
Time frame: one months
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jul 2024.
- Results publication: PubMed 36003030Aydogdu 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.
- Results publication: PubMed 33280934Barsasella 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.
- Results publication: PubMed 26559887Skjaeret 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eda ERSARI ŞEN, Student principal investigator
Kafkas University-Kafkas University Faculty of Health Sciences
Gönül GÖKÇAY, Asist. Prof. study director
Bayan.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Experimental RAM-based virtual reality glasses and pre-post test in people with Nursing and Evidence-Based Nursing, run by Kafkas University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adaptation Difficulty Assessment Scale in the Elderly (time frame: one months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06508970, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jul 2024.