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临床试验/NCT06938997
NCT06938997尚未招募不适用

The Effectiveness of Combining AR/VR Technology in Virtual Clinical Auditory Hallucinations on the Comprehensive Auditory Hallucination Nursing Competency of Psychiatric Nurses

National Yang Ming Chiao Tung University4 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2025年5月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
尚未招募
入组人数
200
试验地点
4
主要终点
Auditory Hallucination Immersion and Empathy Scale

研究概览

简要总结

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.

详细描述

Background: The lifetime prevalence of auditory hallucinations among patients on the schizophrenia spectrum is 60-80%. More than half of these patients continue to experience auditory hallucinations even with regular medication adherence. The professional competence of nurses in managing auditory hallucinations affects the stability of patients' symptoms and their recovery process, highlighting the importance of nurses' capabilities in caring for patients with auditory hallucinations.

Purpose: To develop and test the effectiveness of a virtual reality auditory hallucination program on the comprehensive care competence of psychiatric nurses in managing auditory hallucinations.

Methods: This is a two-phase study conducted in four psychiatric medical institutions. The study includes a development phase, a testing phase, and a formal research phase. In the pilot phase, five participants are expected to be recruited. The first phase involves the development and testing of the virtual reality auditory hallucination program and the Objective Structured Clinical Examination (OSCE), which includes components such as auditory hallucination assessment, communication with individuals experiencing auditory hallucinations, and management of auditory hallucinations. Upon completion, content validation will be conducted by psychiatric experts. Five psychiatric nursing master's students will be invited as simulated candidates to examine the applicability of the "VR-based Auditory Hallucination Nursing OSCE" for psychiatric nurses. The second phase is the formal interventional study, which will recruit 200 psychiatric nurses through convenience sampling. Participants will be grouped by institution using block randomization software. Data will be collected at three time points using the HTC virtual human system in conjunction with Google online questionnaires. The research instruments include:

  • Self-rated Confidence Questionnaire on Auditory Hallucination Assessment and Management,② Auditory Hallucination Knowledge, Attitude, and Empathy Self-awareness Scale,③ Auditory Hallucination Immersion and Empathy Scale, ④ Comprehensive Auditory Hallucination Nursing OSCE Evaluation Form, and ⑤ Nurse Auditory Hallucination Literacy Scale. Expected Results: This study is expected to enhance psychiatric nurses' capabilities in assessing and managing auditory hallucinations. The program may be routinely used in in-service education for nursing staff and may serve as a reference to assist nurses in helping patients improve their insight into auditory hallucinations.

Keywords: Auditory hallucination care competence, interventional study, virtual reality, schizophrenia, Objective Structured Clinical Examination (OSCE)

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Health Services Research
盲法
Single (Participant)

入排标准

年龄范围
20 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者
是

入选标准

  • •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.

排除标准

  • •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.

研究组 & 干预措施

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)

干预措施: Auditory Hallucination Care Video (Other)

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)

干预措施: Virtual clinical auditory hallucination solution combining AR/VR technology (Other)

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)

干预措施: Auditory Hallucination Care Video (Other)

结局指标

主要结局

Auditory Hallucination Immersion and Empathy Scale

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

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.

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

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

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.

次要结局

  • Demographic variables(Before intervention)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (4)

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