Clinical trial NCT06586944: Effect of Nursing Interventions Using Roy Adaptation Model with Virtual Reality on Social Anxiety in Youth
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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Social Anxiety Disorder
Keywords: social anxiety; young people; Roy Adaptation Model; virtual reality; psychiatric nursing
Lead sponsor: Muğla Sıtkı Koçman University
Sponsor class: OTHER
Collaborators: name: Aliye Üster Foundation
First posted: 2024-09-19
Enrollment: 242
Sex: ALL
Minimum age (years): 18
Maximum age (years): 24
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention 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.
Primary purpose: SUPPORTIVE_CARE

Brief 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\&amp;#39;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.

Eligibility criteria: 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:

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

Primary outcomes:
measure: Social Anxiety Scale Scores
timeFrame: 3 Months
Secondary outcomes:
Other outcomes:
Locations:
city: İzmir
country: Turkey
facility: Ege University
state: Bornova
Study officials:
References: