NCT06586944

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\'s experimental design was organized according to the CONSORT guidelines

Trial Health

87
On Track

Trial Health Score

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

Enrollment
242

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2022

Typical duration 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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 15, 2022

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 10, 2023

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 15, 2024

Completed
20 days until next milestone

First Submitted

Initial submission to the registry

September 4, 2024

Completed
15 days until next milestone

First Posted

Study publicly available on registry

September 19, 2024

Completed
Last Updated

September 19, 2024

Status Verified

September 1, 2023

Enrollment Period

9 months

First QC Date

September 4, 2024

Last Update Submit

September 4, 2024

Conditions

Keywords

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

Outcome Measures

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.

    3 Months

Study Arms (3)

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.

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.

Behavioral: Roy Adaptation Model

Interventions

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.

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. 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

Control Group

Eligibility Criteria

Age18 Years - 24 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ege University

Izmir, Bornova, 35000, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Phobia, Social

Condition Hierarchy (Ancestors)

Phobic DisordersAnxiety DisordersMental Disorders

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
SUPPORTIVE CARE
Intervention Model
CROSSOVER
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Research Asistant

Study Record Dates

First Submitted

September 4, 2024

First Posted

September 19, 2024

Study Start

October 15, 2022

Primary Completion

July 10, 2023

Study Completion

August 15, 2024

Last Updated

September 19, 2024

Record last verified: 2023-09

Data Sharing

IPD Sharing
Will share

The Complete Study

Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR
Time Frame
Indefinite Duration
Access Criteria
Since the study is a doctoral thesis, people who want to access the full study can access the study in the database of the Council of Higher Education of Turkey (YÖK).
More information

Locations