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CompletedNCT06586944Updated Sep 19, 2024

Effect of Nursing Interventions Using Roy Adaptation Model with Virtual Reality on Social Anxiety in Youth

An interventional study of Nursing Practices Based On Roy Adaptation Model Integrated With Virtual Reality and Roy Adaptation Model in Social Anxiety Disorder, sponsored by Aytuğ Türk. Completed at 1 site in Turkey. Open to participants aged 18 Years to 24 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-09-19.

Sponsored by Aytuğ Türk · Not applicable, Interventional, and Supportive care

From the registry’s dates

  • Registered 1 year 10 months after the study started (first participant enrolled Oct 2022, registered Sep 2024).
Phase
Not applicable
Study type
Interventional
Enrollment
242
Allocation
Randomized
Ages
18 Years to 24 Years
Sex
All
01

Study 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 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.

02

Conditions studied

  • Social Anxiety Disorder

Keywords

  • social anxiety; young people; Roy Adaptation Model; virtual reality; psychiatric nursing
03

In context

Anxiety Disorders

4,864 studies on the registry are indexed under Anxiety Disorders; 1,388 are open to participants now.

This study's enrollment of 242 is above the median of 80 across 4,170 interventional studies indexed under Anxiety Disorders.

Browse Anxiety Disorders studies →

Lead sponsor

Aytuğ Türk is the lead sponsor of 2 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 24 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • 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.

Exclusion criteria

Exclusion Criteria:

  • Active suicide risk,
  • Psychotic symptoms,
  • Individuals who do not participate in two or more of the six interviews will be excluded from the study.
05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Single (Investigator)
Enrollment
242 participants (actual)

Study arms

  • Experimental
    Experimental group

    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.

    Behavioral: Nursing Practices Based On Roy Adaptation Model Integrated With Virtual Reality

  • No intervention
    Control Group-2

    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.

  • Active comparator
    Control Group

    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.

    Behavioral: Roy Adaptation Model

Interventions

  • BehavioralNursing Practices Based On Roy Adaptation Model Integrated With Virtual Reality

    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.

  • BehavioralRoy Adaptation Model

    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

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 3 Months

07

Study locations

1 site
  • Ege University
    İzmir, Bornova 35000, Turkey
08

References and documents

Individual participant data

Plan to share: Yes — The Complete Study

Supporting information: Study protocol, Sap, Icf, Csr

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 19, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06586944
Lead sponsor
Aytuğ Türk
Collaborators
Aliye Üster Foundation
Responsible party
Aytuğ Türk (Research Asistant, Muğla Sıtkı Koçman University) — Sponsor-investigator
First posted
Sep 19, 2024
Start date
Oct 15, 2022
Primary completion
Jul 10, 2023
Completion
Aug 15, 2024
Last update
Sep 19, 2024

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Sep 2023. You cannot join it, but the record below documents what was studied.

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