NCT06938997

Brief Summary

This study aims to develop and evaluate a Virtual Reality (VR) Auditory Hallucination Program to enhance psychiatric nurses' comprehensive care competence in managing auditory hallucinations among patients with schizophrenia. Given that 60-80% of patients on the schizophrenia spectrum experience auditory hallucinations, and many continue to do so despite medication, improving nurses' professional skills in this area is critical. The research is conducted in two phases across four psychiatric institutions. Phase one involves the development and validation of the VR program and an OSCE (Objective Structured Clinical Examination), piloted with five participants and evaluated by psychiatric nursing experts. Phase two is a formal interventional study with 200 psychiatric nurses, using block randomization and three data collection time points. Assessment tools include five instruments measuring nurses' confidence, knowledge, attitude, empathy, immersion, and care performance related to auditory hallucinations. The study expects to strengthen nurses' ability to assess and manage auditory hallucinations effectively, and proposes the VR program as a potential tool for nursing in-service education.

Trial Health

63
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Trial Health Score

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

Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
12mo left

Started May 2025

Typical duration for not_applicable

Geographic Reach
1 country

4 active sites

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress51%
May 2025May 2027

First Submitted

Initial submission to the registry

April 14, 2025

Completed
8 days until next milestone

First Posted

Study publicly available on registry

April 22, 2025

Completed
9 days until next milestone

Study Start

First participant enrolled

May 1, 2025

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2027

Last Updated

May 8, 2025

Status Verified

March 1, 2025

Enrollment Period

2 years

First QC Date

April 14, 2025

Last Update Submit

May 5, 2025

Conditions

Keywords

Auditory hallucination care competencevirtual realityschizophreniaObjective Structured Clinical Examination

Outcome Measures

Primary Outcomes (2)

  • Auditory Hallucination Immersion and Empathy Scale

    To assess the impact of the intervention on empathy, this study uses the Situational Scale of Empathetic Responses (Schutte \& Stilinović, 2017), consisting of 15 items-7 on empathic perspective taking and 8 on empathic concern. Participants imagine interacting with a person hearing voices and rate items on a 5-point Likert scale (1 = strongly disagree to 5 = strongly agree); higher scores indicate greater empathy in auditory hallucination scenarios. The scale was translated and validated for content. Additionally, we will adopt the Jefferson Scale of Empathy (JSE-HP version), translated and adapted by Cheng et al. (2011), with a KMO of 0.93 and Cronbach's α = .73-.89.

    At baseline (pre-intervention), 6 weeks after the first intervention, and 6 weeks after the second intervention.

  • Auditory Hallucination Knowledge, Attitude, and Empathic Self-Awareness Scale; Auditory Hallucination Literacy Scale.

    This tool, developed by Mawson (2014), includes 11 items assessing knowledge, attitudes, and empathy toward auditory hallucinations. Participants respond using a 5-point Likert scale ranging from "strongly agree" (5) to "strongly disagree" (1). As it has not been used in Taiwan, we have completed forward and backward translation and content validity testing. Reliability and validity testing of the Chinese version will be completed before the intervention study.

    At baseline (pre-intervention), 6 weeks after the first intervention, and 6 weeks after the second intervention.

Secondary Outcomes (1)

  • Demographic variables

    Before intervention

Study Arms (2)

50-minute Auditory Hallucination Care instructional video

PLACEBO COMPARATOR

Control Group * Pre-test: No intervention * Intervention 1: Auditory Hallucination Care Video only * Post-test: Conduct measurement (no new intervention) * Intervention 2: 50-minute Auditory Hallucination Care instructional video only * Follow-up: Conduct measurements (no new intervention)

Other: Auditory Hallucination Care Video

Virtual clinical auditory hallucination solution and Auditory Hallucination Care instructional vide

EXPERIMENTAL

Experimental Group * Pre-test: No intervention * Intervention 1: Accept intervention A+B * A: Virtual clinical auditory hallucination solution combining AR/VR technology and virtual human interactive platform * B: 50-minute Auditory Hallucination Care instructional video * Post-test: Conduct measurement (no new intervention) * Intervention 2: Re-intervention of A+B * Follow-up: Conduct measurements (no new intervention)

Other: Virtual clinical auditory hallucination solution combining AR/VR technologyOther: Auditory Hallucination Care Video

Interventions

This study, titled "Effectiveness of AR/VR-integrated OSCE on Psychiatric Nurses' Comprehensive Auditory Hallucination Care Ability: A Randomized Controlled Trial," involves both experimental and control groups watching videos. The control group views standard educational videos, while the experimental group uses AR/VR technology, virtual patient interaction platforms, and educational videos in a simulated clinical environment. Four scripts were developed: two for training and two for pre/post-testing. All scripts and OSCE checklists are researcher-developed, reviewed by experts, and pilot tested.

Virtual clinical auditory hallucination solution and Auditory Hallucination Care instructional vide

The videos include professional knowledge and skills related to auditory hallucinations.

50-minute Auditory Hallucination Care instructional videoVirtual clinical auditory hallucination solution and Auditory Hallucination Care instructional vide

Eligibility Criteria

Age20 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • A psychiatric nurse who has been engaged in nursing work in a psychiatric unit for at least three months;
  • Those who were willing to participate in the study and filled out the consent form;
  • Willing to use smartphones to watch VR360 videos;
  • Willing to cooperate with the study and use 3D glasses.

You may not qualify if:

  • Nurses who are about to leave or be transferred out of the psychiatric ward within six months
  • Part-time nurses
  • Part-time supervisors
  • Specialist nurses.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Yuli Hospital, Ministry of Health and Welfare

Hualien City, 981, Taiwan

Location

Tsaotun Psychiatric Center, Ministry of Health and Welfare

Nantou County, 542, Taiwan

Location

Bali Psychiatric Center, Ministry of Health and Welfare

New Taipei City, 249, Taiwan

Location

Tri-Service General Hospital Beitou Branch

Taipei, 112, Taiwan

Location

Related Publications (8)

  • Dutta TK, Veeresh A, Mathur C, Phani V, Mandal A, Sagar D, Nebapure SM. The induced knockdown of GmCAD receptor protein encoding gene in Galleria mellonella decreased the insect susceptibility to a Photorhabdus akhurstii oral toxin. Virulence. 2021 Dec;12(1):2957-2971. doi: 10.1080/21505594.2021.2006996.

  • Lee JH, An CH, Yoo NJ, Lee SH. Mutational intratumoral heterogeneity of a putative tumor suppressor gene RARRES3 in colorectal cancers. Pathol Res Pract. 2018 Apr;214(4):601-602. doi: 10.1016/j.prp.2017.12.011. Epub 2017 Dec 21. No abstract available.

  • Della Libera C, Goosse M, Laroi F, Willems S. Examining the impact of experiencing auditory verbal hallucinations from a first-person perspective on the degree of empathy and stigmatization in a group of psychology students: A study using 360 degrees immersive videos. Compr Psychiatry. 2023 May;123:152379. doi: 10.1016/j.comppsych.2023.152379. Epub 2023 Feb 26.

  • de Leede-Smith S, Barkus E. A comprehensive review of auditory verbal hallucinations: lifetime prevalence, correlates and mechanisms in healthy and clinical individuals. Front Hum Neurosci. 2013 Jul 16;7:367. doi: 10.3389/fnhum.2013.00367. eCollection 2013.

  • Craig TK, Rus-Calafell M, Ward T, Leff JP, Huckvale M, Howarth E, Emsley R, Garety PA. AVATAR therapy for auditory verbal hallucinations in people with psychosis: a single-blind, randomised controlled trial. Lancet Psychiatry. 2018 Jan;5(1):31-40. doi: 10.1016/S2215-0366(17)30427-3. Epub 2017 Nov 23.

  • Carlson CG. Virtual and Augmented Simulations in Mental Health. Curr Psychiatry Rep. 2023 Sep;25(9):365-371. doi: 10.1007/s11920-023-01438-4. Epub 2023 Aug 25.

  • Browne C, Wall P, Walters J. Exploring Nursing Students' Experiences With Different Teaching Pedagogies: A Mixed-Methods Study. J Nurs Educ. 2022 Mar;61(3):147-152. doi: 10.3928/01484834-20220109-04. Epub 2022 Mar 1.

  • Abdolrahimi M, Ghiyasvandian S, Zakerimoghadam M, Ebadi A. Therapeutic communication in nursing students: A Walker & Avant concept analysis. Electron Physician. 2017 Aug 25;9(8):4968-4977. doi: 10.19082/4968. eCollection 2017 Aug.

MeSH Terms

Conditions

HallucinationsSchizophrenia

Condition Hierarchy (Ancestors)

Perceptual DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsSchizophrenia Spectrum and Other Psychotic DisordersMental Disorders

Central Study Contacts

Chiu-Yueh Yang, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 14, 2025

First Posted

April 22, 2025

Study Start

May 1, 2025

Primary Completion (Estimated)

May 1, 2027

Study Completion (Estimated)

May 1, 2027

Last Updated

May 8, 2025

Record last verified: 2025-03

Data Sharing

IPD Sharing
Will not share

Locations