Social Anxiety DisorderNCT06586944
Effect of Nursing Interventions Using Roy Adaptation Model with Virtual Reality on Social Anxiety in Youth
A study testing Nursing Practices Based On Roy Adaptation Model Integrated With Virtual Reality and Roy Adaptation Model in people with Social Anxiety Disorder, run by Aytuğ Türk at 1 site in Turkey (Türkiye).
Trial summary
The study was conducted to determine the effect of nursing practices based on the RAM integrated with VR on the social anxiety level of young people.The main questions it aims to answer are: H1: "Nursing practices based on the Roy Adaptation Model integrated with virtual reality are effective in reducing the level of… Read more about this study
- Who is it for?
- Ages 18 to 24 yearsHealthy volunteers can take part
- Conditions the study is for
- Social Anxiety Disorder
- What is being tested?
- Nursing Practices Based On Roy Adaptation Model Integrated With Virtual Reality and Roy Adaptation Model
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 242 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Oct 2022to 15 Aug 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 18 to 24 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Liebowitz Social Anxiety Scale (LSAS) anxiety subscale score of 30 and above,
- Having not used a psychiatric drug in the last three months,
- Not having received psychotherapy for social anxiety before,
- Willingness and volunteering to participate in the research.
Who cannot join
- Active suicide risk,
- Psychotic symptoms,
- Individuals who do not participate in two or more of the six interviews will be excluded from the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: After the Research Groups Were Formed, a Six-session Interview Program Was Created for the Participants Included in the Experimental Group. During These Sessions, Nursing and Psychiatric Nursing Interventions (psychoeducation, Relaxation, Awareness, Effective Coping, Cognitive Restructuring) Based on RAM Were Conducted to Address the Negative Situations Caused by Anxiety and Anxiety Experienced by Individuals. Subjective Goals Were Determined for the Adaptive or Maladaptive Behavior, Attitude, and Thought Patterns Caused by the Anxiety-causing Stimuli.
The study was conducted to determine the effect of nursing practices based on the RAM integrated with VR on the social anxiety level of young people.The main questions it aims to answer are:
H1: "Nursing practices based on the Roy Adaptation Model integrated with virtual reality are effective in reducing the level of social anxiety in young people." H2: "Nursing practices based on the Roy Adaptation Model integrated with virtual reality are effective on the level of life satisfaction, independent of anxiety level and as a predictor of social anxiety"
This single-blinded randomized controlled study utilized a pretest-posttest control group and single-blinded randomized control group, preintervention pretest, postintervention posttest, and follow-up test design. The study population consisted of students from a foreign language preparatory class at a university. In this context, the Anxiety Subdimension of the LSCQ was calculated for 785 preparatory class students aged 18-26. A total of 242 students scoring 30 and above on the Anxiety Subdimension of the LSCQ were reached. The research was completed with a sample of 72 students who met the inclusion criteria within this target group. Individuals who do not participate in two or more of the six interviews will be excluded from the study. The study\'s experimental design was organized according to the CONSORT guidelines
Read the detailed description
The study used virtual environments and characters based on "The Amelia VR Platform" for mental health researchers developed by Psious software company as a supportive tool in nursing interventions for social anxiety. The virtual environments included scenarios such as presentating in a large conference hall, conducting a business/office meeting with an authority figure and colleagues, presenting to a small group in a seminar hall, and socializing with friends. These environments comprehensively evaluate individuals' issues in public speaking and can also be used within the scope of a separate program to test and improve skills such as verbal communication and academic presentation. The whole process is controlled by a counselor via a computer connected to the platform. The counselor can manipulate the content, duration, and intensity of the process in a controlled manner for the purpose of the application.
- Conditions
- Social Anxiety Disorder
- Being tested
- Nursing Practices Based On Roy Adaptation Model Integrated With Virtual Reality, Roy Adaptation Model
- Keywords
- social anxiety; young people; Roy Adaptation Model; virtual reality; psychiatric nursing
- Medical subject headings
- Phobia, Social
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nursing Practices Based On Roy Adaptation Model Integrated With Virtual RealityBehavioural
After the research groups were formed, a six-session interview programme was created for the participants included in the experimental group (Table...). In the sessions, nursing and psychiatric nursing interventions (psychoeducation, relaxation, awareness, effective coping, cognitive restructuring) based on the Roy Adaptation Model were carried out for the negative situations caused by anxiety and anxiety experienced by individuals. Subjective goals were determined for adaptive or maladaptive behaviour, attitude and thought patterns caused by anxiety-causing stimulus(s) and appropriate nursing interventions from the Nursing Interventions Classification System (NIC) were applied for these goals.Virtual reality-based intervention was effectively used as an important intervention tool in the implementation of the interventions and in the evaluation of the implemented interventions in four sessions of a total of six sessions.
Roy Adaptation ModelBehavioural
After the research groups were formed, a six-session interview programme was created for the participants included in the experimental group. In the sessions, nursing and psychiatric nursing interventions (psychoeducation, relaxation, awareness, effective coping, cognitive restructuring) based on the Roy Adaptation Model were carried out for the negative situations caused by anxiety and anxiety experienced by individuals. Subjective goals were determined for adaptive or maladaptive behaviour, attitude and thought patterns caused by anxiety-causing stimulus(s) and appropriate nursing interventions from the Nursing Interventions Classification System (NIC) were applied for these goals
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | After the research groups were formed, a six-session interview programme was created for the participants included in the experimental group . In the sessions, nursing and psychiatric nursing interventions (psychoeducation, relaxation, awareness, effective coping, cognitive restructuring) based on the Roy Adaptation Model were carried out for the negative situations caused by anxiety and anxiety experienced by individuals. Virtual reality-based intervention was effectively used as an important intervention tool in the implementation of the interventions and in the evaluation of the implemented interventions in four sessions of a total of six sessions. During the application, the participants were asked to evaluate their anxiety in the range of 0-10 as subjective feedback via the 'Amelia VR Platform', and ratings were requested every three minutes during the 15-minute experience of the virtual reality platform, especially at moments when their anxiety increased subjectively. Receives: Behavioral: Nursing Practices Based On Roy Adaptation Model Integrated With Virtual Reality |
| Control Group-2 | No intervention | No intervention was made to the participants in the II. Control group except for the completion of the pre-test, post-test and follow-up test. |
| Control Group | Active comparator | For the participants in the control group, a six-session interview programme was created in a way that virtual reality application was not used. In the sessions, nursing and psychiatric nursing interventions (psychoeducation, relaxation, awareness, effective coping, cognitive restructuring) based on the Roy Adaptation Model were carried out for the negative situations caused by anxiety and anxiety experienced by individuals. Subjective goals were determined for the adaptive or maladaptive behaviour, attitude and thought patterns caused by anxiety-inducing stimulus(s) and appropriate interventions from the Nursing Interventions Classification System (NIC) were carried out for these goals. Receives: Behavioral: Roy Adaptation Model |
What is being measured
The primary outcome is the main question the study is designed to answer.
Social Anxiety Scale Scores
Measurement of the change in Social Anxiety Scale Scores Liebowitz Social Anxiety Scale (LSAS) and Satisfaction with Life Scale (SWLS) were reapplied to the experimental and control groups as post-test measurement tools after the intervention and six-week follow-up period.
Measured: 3 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start15 Oct 2022
- Primary completion10 Jul 2023
- Study completion15 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Social Anxiety DisorderStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- After the research groups were formed, a six-session interview program was created for the participants included in the experimental group. During these sessions, nursing and psychiatric nursing interventions (psychoeducation, relaxation, awareness, effective coping, cognitive restructuring) based on RAM were conducted to address the negative situations caused by anxiety and anxiety experienced by individuals.
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 242 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aytuğ Türk
- Sponsor type
- University, hospital or other
- Collaborators
- Aliye Üster Foundation
- Responsible party
- Sponsor-investigator, Aytuğ Türk, Muğla Sıtkı Koçman University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06586944
- Sponsor's protocol ID
- ATurk
- Status last verified
- Sep 2023
- First submitted
- 4 Sep 2024
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The Complete Study
Publications
Turk A, Donmez A, Avci A. Effect of a Roy Adaptation Model-Based Nursing Intervention on Psychosocial Adjustment and Psychological Resilience in Women Newly Diagnosed with Breast Cancer: A Randomized Controlled Trial. Semin Oncol Nurs. 2026 Jul 6:152294. doi: 10.1016/j.soncn.2026.152294. Online ahead of print.
PubMed 42409704
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- After the Research Groups Were Formed, a Six-session Interview Program Was Created for the Participants Included in the Experimental Group. During These Sessions, Nursing and Psychiatric Nursing Interventions (psychoeducation, Relaxation, Awareness, Effective Coping, Cognitive Restructuring) Based on RAM Were Conducted to Address the Negative Situations Caused by Anxiety and Anxiety Experienced by Individuals. Subjective Goals Were Determined for the Adaptive or Maladaptive Behavior, Attitude, and Thought Patterns Caused by the Anxiety-causing Stimuli.
- ClinicalTrials.gov ID
- NCT06586944
- Acronym / sponsor ID
- ATurk
- Conditions
- Social Anxiety Disorder
- Keywords
- social anxiety; young people; Roy Adaptation Model; virtual reality; psychiatric nursing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 242 participants (actual)
- Lead sponsor
- Aytuğ TürkUniversity, hospital or other
- Collaborators
- Aliye Üster Foundation
- Study start
- 15 Oct 2022 (actual)
- Primary completion
- 10 Jul 2023 (actual)
- Study completion
- 15 Aug 2024 (actual)
- First posted
- 19 Sep 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 study was conducted to determine the effect of nursing practices based on the RAM integrated with VR on the social anxiety level of young people.The main questions it aims to answer are:
H1: "Nursing practices based on the Roy Adaptation Model integrated with virtual reality are effective in reducing the level of social anxiety in young people." H2: "Nursing practices based on the Roy Adaptation Model integrated with virtual reality are effective on the level of life satisfaction, independent of anxiety level and as a predictor of social anxiety"
This single-blinded randomized controlled study utilized a pretest-posttest control group and single-blinded randomized control group, preintervention pretest, postintervention posttest, and follow-up test design. The study population consisted of students from a foreign language preparatory class at a university. In this context, the Anxiety Subdimension of the LSCQ was calculated for 785 preparatory class students aged 18-26. A total of 242 students scoring 30 and above on the Anxiety Subdimension of the LSCQ were reached. The research was completed with a sample of 72 students who met the inclusion criteria within this target group. Individuals who do not participate in two or more of the six interviews will be excluded from the study. The study\'s experimental design was organized according to the CONSORT guidelines
Detailed description
The study used virtual environments and characters based on "The Amelia VR Platform" for mental health researchers developed by Psious software company as a supportive tool in nursing interventions for social anxiety. The virtual environments included scenarios such as presentating in a large conference hall, conducting a business/office meeting with an authority figure and colleagues, presenting to a small group in a seminar hall, and socializing with friends. These environments comprehensively evaluate individuals' issues in public speaking and can also be used within the scope of a separate program to test and improve skills such as verbal communication and academic presentation. The whole process is controlled by a counselor via a computer connected to the platform. The counselor can manipulate the content, duration, and intensity of the process in a controlled manner for the purpose of the application.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (investigator)
- Number of arms
- 3
- Model description
- After the research groups were formed, a six-session interview program was created for the participants included in the experimental group. During these sessions, nursing and psychiatric nursing interventions (psychoeducation, relaxation, awareness, effective coping, cognitive restructuring) based on RAM were conducted to address the negative situations caused by anxiety and anxiety experienced by individuals.
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Behavioral: Nursing Practices Based On Roy Adaptation Model Integrated With Virtual RealityAfter the research groups were formed, a six-session interview programme was created for the participants included in the experimental group . In the sessions, nursing and psychiatric nursing interventions (psychoeducation, relaxation, awareness, effective coping, cognitive restructuring) based on the Roy Adaptation Model were carried out for the negative situations caused by anxiety and anxiety experienced by individuals. Virtual reality-based intervention was effectively used as an important intervention tool in the implementation of the interventions and in the evaluation of the implemented interventions in four sessions of a total of six sessions. During the application, the participants were asked to evaluate their anxiety in the range of 0-10 as subjective feedback via the 'Amelia VR Platform', and ratings were requested every three minutes during the 15-minute experience of the virtual reality platform, especially at moments when their anxiety increased subjectively. |
| Control Group-2 | No intervention | –No intervention was made to the participants in the II. Control group except for the completion of the pre-test, post-test and follow-up test. |
| Control Group | Active comparator | Behavioral: Roy Adaptation ModelFor the participants in the control group, a six-session interview programme was created in a way that virtual reality application was not used. In the sessions, nursing and psychiatric nursing interventions (psychoeducation, relaxation, awareness, effective coping, cognitive restructuring) based on the Roy Adaptation Model were carried out for the negative situations caused by anxiety and anxiety experienced by individuals. Subjective goals were determined for the adaptive or maladaptive behaviour, attitude and thought patterns caused by anxiety-inducing stimulus(s) and appropriate interventions from the Nursing Interventions Classification System (NIC) were carried out for these goals. |
Who may qualify
- Ages
- 18 to 24 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Liebowitz Social Anxiety Scale (LSAS) anxiety subscale score of 30 and above,
- Having not used a psychiatric drug in the last three months,
- Not having received psychotherapy for social anxiety before,
- Willingness and volunteering to participate in the research.
Key exclusion criteria (3 listed)
- Active suicide risk,
- Psychotic symptoms,
- Individuals who do not participate in two or more of the six interviews will be excluded from the study.
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 |
|---|---|---|
| Nursing Practices Based On Roy Adaptation Model Integrated With Virtual RealityAfter the research groups were formed, a six-session interview programme was created for the participants included in the experimental group (Table...). In the sessions, nursing and psychiatric nursing interventions (psychoeducation, relaxation, awareness, effective coping, cognitive restructuring) based on the Roy Adaptation Model were carried out for the negative situations caused by anxiety and anxiety experienced by individuals. Subjective goals were determined for adaptive or maladaptive behaviour, attitude and thought patterns caused by anxiety-causing stimulus(s) and appropriate nursing interventions from the Nursing Interventions Classification System (NIC) were applied for these goals.Virtual reality-based intervention was effectively used as an important intervention tool in the implementation of the interventions and in the evaluation of the implemented interventions in four sessions of a total of six sessions. | Behavioural | Experimental group |
| Roy Adaptation ModelAfter the research groups were formed, a six-session interview programme was created for the participants included in the experimental group. In the sessions, nursing and psychiatric nursing interventions (psychoeducation, relaxation, awareness, effective coping, cognitive restructuring) based on the Roy Adaptation Model were carried out for the negative situations caused by anxiety and anxiety experienced by individuals. Subjective goals were determined for adaptive or maladaptive behaviour, attitude and thought patterns caused by anxiety-causing stimulus(s) and appropriate nursing interventions from the Nursing Interventions Classification System (NIC) were applied for these goals | Behavioural | Control Group |
Primary outcome
Social Anxiety Scale Scores
Time frame: 3 Months
Measurement of the change in Social Anxiety Scale Scores Liebowitz Social Anxiety Scale (LSAS) and Satisfaction with Life Scale (SWLS) were reapplied to the experimental and control groups as post-test measurement tools after the intervention and six-week follow-up period.
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 19 Sep 2024.
- Derived from this study: PubMed 42409704Turk A, Donmez A, Avci A. Effect of a Roy Adaptation Model-Based Nursing Intervention on Psychosocial Adjustment and Psychological Resilience in Women Newly Diagnosed with Breast Cancer: A Randomized Controlled Trial. Semin Oncol Nurs. 2026 Jul 6:152294. doi: 10.1016/j.soncn.2026.152294. Online ahead of print.
- Individual participant dataSharing planned: Yes. The Complete Study
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nursing Practices Based On Roy Adaptation Model Integrated With Virtual Reality and Roy Adaptation Model in people with Social Anxiety Disorder, run by Aytuğ Türk 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 4 inclusion and 3 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 19 Sep 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?
Social Anxiety Scale Scores (time frame: 3 Months). 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 NCT06586944, which also lists 1 linked publication.
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 19 Sep 2024.