Stress, PhysiologicalNCT05828329
Virtual Reality to Cope With Academic Stress
A study testing Guided visualization of exams through immersive virtual reality and Guided visualization of exams through traditional method in people with Stress, Physiological and Stress, Psychological, run by University of the Balearic Islands at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Stress, Physiological, Stress, Psychological
- What is being tested?
- Guided visualization of exams through immersive virtual reality and Guided visualization of exams through traditional method
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteSpain
- Study dates
- 2 Apr 2023to 30 Jun 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Not to understand the Spanish language
Trial locations and contacts
1 site in 1 country.
Spain1 site
University of the Balearic Islands
Palma de Mallorca, Balearic Islands, 07122
About this study
Official title: Virtual Reality to Cope With Academic Exams: Effects on Stress and Academic Performance in Physiotherapy and Nursing Students of University of the Balearic Islands
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.
Read the detailed description
As eligibility criteria, participants should be enrolled in at least 80% of subjects of an usual academic course during the year in which the study is carrying out; and not to have previous experience in similar guided visualization to cope with stressful situations.
Intervention of EG1: The 4-weeks program with virtual reality will consist of a 30-minutes guided visualization session through virtual reality glasses (two sessions per week). Students will visualize a 360º video that simulates the entire experience of an exam, from first person perspective.
Intervention of EG2: The 4-weeks program of traditional visualization will consist of a 30-minutes traditional guided visualization session, by listening only the part of the audio used for EG1.
CG will not receive any intervention, as the most used strategy to cope with exams among students. After finishing the study, this group will receive the same program that EG1 or EG2 received, if they are interested.
The main outcomes will be the intra-group and between-group changes in the level of academic stress and the perceived stress from the last month. Also, between-group differences in the level of stress (0 to 10 points), arterial tension (mmHg), maximal heart rate (ppm) and salivary cortisol level just before exams.
As secondary outcomes, between-group differences in qualifications of exams that they will have been visualizing will be also considered (it will be taken into account their average qualifications in the degree).
- Conditions
- Stress, Physiological, Stress, Psychological
- Being tested
- Guided visualization of exams through immersive virtual reality, Guided visualization of exams through traditional method
- Keywords
- Education, Virtual Reality, Students
- Medical subject headings
- Stress, Psychological
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Guided visualization of exams through immersive virtual realityBehavioural
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.
Guided visualization of exams through traditional methodBehavioural
During 4 weeks (twice per week), students will listen a 30-minutes audio that explains the experience of an exam from first person.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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.
Measured: 4 weeks
Secondary outcomes (5)
Level of current perceived stress
Between-group differences in the level of perceived stress just at the moment prior to start the exam (10 minutes earlier). To evaluate it, students will inform about what level of stress they are feeling at that moment (being 0, no stress, and 10 maximal stress).
Measured: Immediately before the exam
Blood pressure
Between-group differences in the blood pressure just before starting the exam. It will be recorded by a healthcare professional by using a stethoscope and registering the systolic and diastolic blood pressure.
Measured: Immediately before the exam
Maximal heart rate
Between-group differences in the maximal heart rate just before starting the exam
Measured: Immediately before the exam
Salivary cortisol level
Between-group differences in the salivary cortisol level just before starting the exam
Measured: Immediately before the exam
Exam qualification (0 to 10 punctuation) pondered by the average qualification of the degree
Between-group differences in the exam qualification (it refers to exam that students will have been visualizing) just before starting the exam. The qualification of the exam will range from 0 (the worst punctuation) to 10 (perfect punctuation). In this outcome, the average qualification of the degree for each student will be considered (from the worst, 0 points, to the best, 10 points). For example, if the student has 8 points as average qualification of the degree and obtains an exam qualification of 9 points, it will be pondered as follows: 9/8 = 1.125.
Measured: One week after the exam (an only measurement)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2023
- Study start2 Apr 2023
- Primary completion9 Jul 2023
- Study completion30 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Stress, PhysiologicalStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized controlled trial
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of the Balearic Islands
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Natalia Romero-Franco, PhD, Principal investigator, University of the Balearic Islands
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05828329
- Sponsor's protocol ID
- IB4958/22PI
- Status last verified
- Jul 2024
- First submitted
- 29 Mar 2023
- Last updated
- 11 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 32186519Riva 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.
PubMed 27746747Lacey 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.
PubMed 35818296
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Virtual Reality to Cope With Academic Exams: Effects on Stress and Academic Performance in Physiotherapy and Nursing Students of University of the Balearic Islands
- ClinicalTrials.gov ID
- NCT05828329
- Acronym / sponsor ID
- IB4958/22PI
- Conditions
- Stress, Physiological, Stress, Psychological
- Keywords
- Education, Virtual Reality, Students
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University of the Balearic IslandsUniversity, hospital or other
- Study start
- 2 Apr 2023 (actual)
- Primary completion
- 9 Jul 2023 (actual)
- Study completion
- 30 Jun 2024 (actual)
- First posted
- 25 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
As eligibility criteria, participants should be enrolled in at least 80% of subjects of an usual academic course during the year in which the study is carrying out; and not to have previous experience in similar guided visualization to cope with stressful situations.
Intervention of EG1: The 4-weeks program with virtual reality will consist of a 30-minutes guided visualization session through virtual reality glasses (two sessions per week). Students will visualize a 360º video that simulates the entire experience of an exam, from first person perspective.
Intervention of EG2: The 4-weeks program of traditional visualization will consist of a 30-minutes traditional guided visualization session, by listening only the part of the audio used for EG1.
CG will not receive any intervention, as the most used strategy to cope with exams among students. After finishing the study, this group will receive the same program that EG1 or EG2 received, if they are interested.
The main outcomes will be the intra-group and between-group changes in the level of academic stress and the perceived stress from the last month. Also, between-group differences in the level of stress (0 to 10 points), arterial tension (mmHg), maximal heart rate (ppm) and salivary cortisol level just before exams.
As secondary outcomes, between-group differences in qualifications of exams that they will have been visualizing will be also considered (it will be taken into account their average qualifications in the degree).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- Randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| Experimental group 1 | Experimental | Behavioral: Guided visualization of exams through immersive virtual realityThe 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. |
| Experimental group 2 | Active comparator | Behavioral: Guided visualization of exams through traditional methodThe 4-weeks program will consist of a 30-minutes traditional guided visualization session, by listening only the part of the audio used for EG1. |
| Control group | No intervention | –This group will not receive any intervention, as the most used strategy to cope with exams among students. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (1 listed)
- Not to understand the Spanish language
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Guided visualization of exams through immersive virtual realityDuring 4 weeks (twice per week), students will visualize a 30-minutes 360º video that simulates the experience of an exam, from first person perspective. | Behavioural | Experimental group 1 |
| Guided visualization of exams through traditional methodDuring 4 weeks (twice per week), students will listen a 30-minutes audio that explains the experience of an exam from first person. | Behavioural | Experimental group 2 |
Primary outcome
Academic stress
Time frame: 4 weeks
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).
Perceived stress in the last month
Time frame: 4 weeks
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.
5 secondary outcomes
Level of current perceived stress
Time frame: Immediately before the exam
Blood pressure
Time frame: Immediately before the exam
Maximal heart rate
Time frame: Immediately before the exam
Salivary cortisol level
Time frame: Immediately before the exam
Exam qualification (0 to 10 punctuation) pondered by the average qualification of the degree
Time frame: One week after the exam (an only measurement)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jul 2024.
- Results publication: PubMed 32186519Seabrook 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.
- Results publication: PubMed 27746747Riva 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.
- Results publication: PubMed 35818296Lacey 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Natalia Romero-Franco, PhD principal investigator
University of the Balearic Islands
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Guided visualization of exams through immersive virtual reality and Guided visualization of exams through traditional method in people with Stress, Physiological and Stress, Psychological, run by University of the Balearic Islands at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Academic stress (time frame: 4 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05828329, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jul 2024; AzTrials last refreshed its copy on 1 Nov 2026.