NCT05828329

Brief Summary

The new technologies may facilitate the teaching-learning process through the ubiquitous and active approach. However, stress from academic exams remains being high among undergraduate students. Although new technologies could be useful to simulate and control academic stressful situations through immersive virtual reality, no studies to date have evaluated its effectiveness. This study is designed to evaluate the effects of a virtual reality program to visualize stressful academic situations like exams on the level of psychological and physiological stress and academic performance of Physiotherapy and Nursing undergraduate students. To this end, an experimental study with two experimental groups and one control group is designed: experimental group 1 (EG1) will complete a 4-weeks program of guided visualization of exams through immersive virtual reality; experimental group 2 (EG2) will complete a 4-weeks program of traditional guided visualization of exams (through audio); control group (CG) will not receive any visualization program, as the most habitual strategy to cope with exams among students. Before and after the intervention period, all students will fulfill an online questionnaire to inform about their level of academic stress (SISCO inventory) and perceived stress from the last month (Perceived Stress Scale). Also, just before starting the exam they will have been visualizing, level of stress (0 to 10 points), blood pressure (mmHg), maximal heart rate (ppm) and salivary cortisol level will be assessed in all students. Qualifications of the exam will be also collected. Intra-group differences and between-group differences at post-intervention time will be obtained.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2023

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 29, 2023

Completed
4 days until next milestone

Study Start

First participant enrolled

April 2, 2023

Completed
23 days until next milestone

First Posted

Study publicly available on registry

April 25, 2023

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 9, 2023

Completed
12 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2024

Completed
Last Updated

July 11, 2024

Status Verified

July 1, 2024

Enrollment Period

3 months

First QC Date

March 29, 2023

Last Update Submit

July 9, 2024

Conditions

Keywords

EducationVirtual RealityStudents

Outcome Measures

Primary Outcomes (2)

  • Academic stress

    Between-group and intra-group differences in academic stress, which will be registered with the SISCO Inventory version-21. This is the 21-items "Inventario SIStémico COgnoscitivista" for the study of the academic stress, composed by 21 items: the first item is dichotomous (yes-no) and the remaining 20 items are 5-point Likert scale, scored from 1 (never) to 5 (always). The maximal punctuation is 100 (maximal stress).

    4 weeks

  • Perceived stress in the last month

    Between-group and intra-group differences in perceived stress of the last month, which will be registered with the Perceived Stress Scale. This survey has 10 questions (using Likert scales from 0-5, being 0 never and 5 very often). To interpret this questionnaire, individual scores can range from 0 to 40 with higher scores indicating higher perceived stress.

    4 weeks

Secondary Outcomes (5)

  • Level of current perceived stress

    Immediately before the exam

  • Blood pressure

    Immediately before the exam

  • Maximal heart rate

    Immediately before the exam

  • Salivary cortisol level

    Immediately before the exam

  • Exam qualification (0 to 10 punctuation) pondered by the average qualification of the degree

    One week after the exam (an only measurement)

Study Arms (3)

Experimental group 1

EXPERIMENTAL

The program with virtual reality will consist of a 30-minutes guided visualization session through virtual reality glasses. Students will visualize a 360º video that simulates the entire experience of an exam, from first person perspective.

Behavioral: Guided visualization of exams through immersive virtual reality

Experimental group 2

ACTIVE COMPARATOR

The 4-weeks program will consist of a 30-minutes traditional guided visualization session, by listening only the part of the audio used for EG1.

Behavioral: Guided visualization of exams through traditional method

Control group

NO INTERVENTION

This group will not receive any intervention, as the most used strategy to cope with exams among students.

Interventions

During 4 weeks (twice per week), students will visualize a 30-minutes 360º video that simulates the experience of an exam, from first person perspective.

Experimental group 1

During 4 weeks (twice per week), students will listen a 30-minutes audio that explains the experience of an exam from first person.

Experimental group 2

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • To be enrolled in at least 80% of subjects of an usual academic course during the year in which the study is carrying out.
  • Not to have previous experience in guided visualization to cope with stressful situations.

You may not qualify if:

  • Not to understand the Spanish language

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of the Balearic Islands

Palma de Mallorca, Balearic Islands, 07122, Spain

Location

Related Publications (3)

  • Seabrook E, Kelly R, Foley F, Theiler S, Thomas N, Wadley G, Nedeljkovic M. Understanding How Virtual Reality Can Support Mindfulness Practice: Mixed Methods Study. J Med Internet Res. 2020 Mar 18;22(3):e16106. doi: 10.2196/16106.

  • Riva G, Banos RM, Botella C, Mantovani F, Gaggioli A. Transforming Experience: The Potential of Augmented Reality and Virtual Reality for Enhancing Personal and Clinical Change. Front Psychiatry. 2016 Sep 30;7:164. doi: 10.3389/fpsyt.2016.00164. eCollection 2016.

  • Lacey C, Frampton C, Beaglehole B. oVRcome - Self-guided virtual reality for specific phobias: A randomised controlled trial. Aust N Z J Psychiatry. 2023 May;57(5):736-744. doi: 10.1177/00048674221110779. Epub 2022 Jul 11.

MeSH Terms

Conditions

Stress, Psychological

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehavior

Study Officials

  • Natalia Romero-Franco, PhD

    University of the Balearic Islands

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
Participants will be randomly assigned with a code with which investigators and outcomes assessors will not be able to know from whom data are or the group to which participants belong.
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: Randomized controlled trial
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 29, 2023

First Posted

April 25, 2023

Study Start

April 2, 2023

Primary Completion

July 9, 2023

Study Completion

June 30, 2024

Last Updated

July 11, 2024

Record last verified: 2024-07

Data Sharing

IPD Sharing
Will not share

Locations