Virtual Reality Video-based Learning

June 27, 2022 updated by: The University of Hong Kong

Efficacy of Virtual Reality (VR) Video-based Learning for Enhancing Nursing Students' Self-efficacy in Delivering Smoking Cessation Intervention: A Randomized Controlled Trial

This teaching development aims to enhance the clinical reasoning and empathy of nursing students in nursing students in smoking cessation training. The evaluation aims to assess the feasibility and efficacy of virtual reality (VR) video-based learning for enhancing self-efficacy in delivering smoking cessation intervention. The proposed study is 2-arm, waitlist-control, pragmatic randomized controlled trial (RCT) (allocation ratio 1:1), by comparing the self-efficacy and performance of clinical reasoning between nursing students who are provided VR videos of a smoker's real-life scenario and reading materials (intervention group) and those who are only provided the same reading materials (control). Individual randomization will be used. All participants will be given a group assignment and expected to complete the assignment by the end of the tutorial. The group assignment and self-administered pre- and post-learning survey will be used for the teaching outcome evaluation.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

The proposed study is 2-arm, waitlist-control, pragmatic randomized controlled trial (RCT) (allocation ratio 1:1), by comparing the self-efficacy and performance of clinical reasoning between nursing students who are provided VR videos of a smoker's real-life scenario and reading materials (intervention group) and those who are only provided the same reading materials (control). Individual randomization will be used. All participants will be given a group assignment and expected to complete the assignment by the end of the tutorial. The group assignment and self-administered pre- and post-learning survey will be used for the teaching outcome evaluation.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
26

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Hong Kong
      • Hong Kong, Hong Kong
        • Faculty of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

The study targets to recruit candidates of Master of Nursing who are taking the course "Tobacco Dependency Nursing Intervention and Management (NURS8205)" (n=65). All candidates are registered nurses.

Exclusion Criteria:

Students who cannot understand Cantonese will be excluded from the trial.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Intervention group
Provided with a tutorial guide, and VR-based teaching materials in the tutorial session
Behavioral: VR materials
In the lecture room for the intervention group, participants in the intervention group will be given QR codes for viewing these online videos and VR cardboards, a web including photo hunt sections that allow viewers to find cues for smoking cessation treatment. They are asked to view these videos and photos with their own mobile phones.
Behavioral: Tutorial guide
A tutorial guide including description of the smokers' cases
Experimental: Control group
Provided with the tutorial guide in the tutorial session.
Behavioral: Tutorial guide
A tutorial guide including description of the smokers' cases

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Self-efficacy in delivering smoking cessation intervention
Time Frame: Before and after the tutorial (at 1-day)
(1) Understand the quitting barriers of smokers barriers; (2) Design quit plan for smoking patients; (3) Prioritize interventions for smoking patients; (4) Educate smoking patients on essential tasks; (5) Overall confidence in the management of smoking patients; and (6) Overall competence in the management of smoking patients. Each item can be scored from 0 (not at all competent) to 10 (extremely competent).
Before and after the tutorial (at 1-day)
Empathy in delivering smoking cessation intervention
Time Frame: Before and after the tutorial (at 1-day)
(1) Show empathy to smoking patients; (2) Show care to smoking patients; (3) Being positive; (4) See things from smokers' perspective; (5) Can you show tender feeling for smokers? (0: Not at all, 5: half and half, 10: extremely); (6) Do you feel sorry for smokers who are unable to quit? (0: Not sorry at all, 5: half and half, 10: extremely sorry); (7) Do you feel sorry for smokers who do not want to quit? (0: Not sorry at all, 5: half and half, 10: extremely sorry); and (8) Do you feel annoyed if smokers ignore your cessation advice (0: Not annoyed at all, 5: half and half, 10: extremely annoyed). Each item can be scored from 0 (not at all competent) to 10 (extremely competent).
Before and after the tutorial (at 1-day)
Lasater Clinical Judgment Rubric
Time Frame: After the tutorial (at 1-day)
(1) Effective noticing: Focused observation; (2) Effective noticing: Recognizing deviations from expected patterns; (3) Effective noticing: Information seeking; (4) Effective interpreting: Prioritizing data; (5) Effective interpreting: Making sense of data; (6) Effective responding: Well-planned intervention/flexibility; (7) Effective responding: Being skilful; (8) Effective reflecting: Evaluation/self-analysis. Each item can be scored from exemplary, accomplished, developing and beginning.
After the tutorial (at 1-day)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
The University of Hong Kong

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Yee Tak Derek Y Cheung, PhD, The University of Hong Kong

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 6, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 19, 2021

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 25, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 1, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 27, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 1, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 1, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 27, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2022

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • VR_smoking

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

The study information can be provided upon requests made to the principle investigator.

IPD Sharing Time Frame

5 years

IPD Sharing Access Criteria

For non-commercial purpose.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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