NCT05440877

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
26

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2021

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

First Submitted

Initial submission to the registry

March 1, 2020

Completed
1 year until next milestone

Study Start

First participant enrolled

March 6, 2021

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 19, 2021

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 25, 2022

Completed
6 days until next milestone

First Posted

Study publicly available on registry

July 1, 2022

Completed
Last Updated

July 1, 2022

Status Verified

June 1, 2022

Enrollment Period

1 month

First QC Date

March 1, 2020

Last Update Submit

June 27, 2022

Conditions

Keywords

Virtual realityNursingSmoking

Outcome Measures

Primary Outcomes (3)

  • Self-efficacy in delivering smoking cessation intervention

    (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

    (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

    (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)

Study Arms (2)

Intervention group

EXPERIMENTAL

Provided with a tutorial guide, and VR-based teaching materials in the tutorial session

Behavioral: VR materialsBehavioral: Tutorial guide

Control group

EXPERIMENTAL

Provided with the tutorial guide in the tutorial session.

Behavioral: Tutorial guide

Interventions

VR materialsBEHAVIORAL

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.

Intervention group
Tutorial guideBEHAVIORAL

A tutorial guide including description of the smokers' cases

Control groupIntervention group

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Medicine

Hong Kong, Hong Kong

Location

Related Publications (1)

  • Cheung YTD, Zhang G, Luk TT, Zhang M, Lam VSF, Chan MMK, Wang MP, Chan SSC. Effect of narrative videos and mini-VR games in nursing smoking cessation training on empathy and self-efficacy of smoking cessation counseling: A randomized controlled trial. Nurse Educ Today. 2024 Sep;140:106272. doi: 10.1016/j.nedt.2024.106272. Epub 2024 Jun 4.

MeSH Terms

Conditions

Smoking CessationSmoking

Condition Hierarchy (Ancestors)

Health BehaviorBehavior

Study Officials

  • Yee Tak Derek Y Cheung, PhD

    The University of Hong Kong

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
Individual randomization by serially numbered opaque sealed envelope (SNOSE) will be used to ensure the allocation sequence was concealed from both course teacher and participants before the group allocation. he participants will know the trial group and discussion group allocation by opening an envelop after they submit the consent form. All pre-post questionnaires are anonymous. All participants will be concealed of group allocation before consent, but they will not be blinded of the intervention. Two specialists in smoking cessation who will mark the group assignment will be blinded to group allocation of all participants.
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 1, 2020

First Posted

July 1, 2022

Study Start

March 6, 2021

Primary Completion

April 19, 2021

Study Completion

June 25, 2022

Last Updated

July 1, 2022

Record last verified: 2022-06

Data Sharing

IPD Sharing
Will share

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

Shared Documents
STUDY PROTOCOL, SAP, ICF
Time Frame
5 years
Access Criteria
For non-commercial purpose.

Locations