Dental AnxietyNCT03993080
Virtual Reality Relaxation to Decrease Dental Anxiety
A study testing Virtual reality relaxation in people with Dental Anxiety, run by University of Turku at 1 site in Finland.
Trial summary
The aim is to apply short-term virtual reality relaxation to examine if it is effective in reducing pre-operative dental anxiety in primary health care using an RCT. Read more about this study
- Who is it for?
- Ages 18 to 120 yearsHealthy volunteers can take part
- Conditions the study is for
- Dental Anxiety
- What is being tested?
- Virtual reality relaxation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 277 participants
- Where
- 1 siteFinland
- Study dates
- 15 Oct 2018to 27 Feb 2019
- 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 to 120 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- attending for dental treatment
- consenting
- able to complete Finnish questionnaire without assistance
- age 18 years or older
Who cannot join
- those not meeting inclusion criteria
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Virtual Reality Relaxation to Decrease Dental Anxiety in Primary Dental Care
The aim is to apply short-term virtual reality relaxation to examine if it is effective in reducing pre-operative dental anxiety in primary health care using an RCT.
Read the detailed description
Randomized controlled single-center trial with two parallel arms: Virtual Reality Relaxation (VRR) and Treatment As Usual (TAU) in a public oral health care unit. VRR group receiving a 1-3.5 minute 360° video immersing them in peaceful virtual landscape with audio features and sound supporting the relaxing experience. TAU groups remaining seated for 3 minutes in similar setting.
- Conditions
- Dental Anxiety
- Being tested
- Virtual reality relaxation
- Keywords
- dental anxiety, virtual reality
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual reality relaxationDevice
1-3.5 minute 360° videos
| Study group | Role | What they receive |
|---|---|---|
| Virtual reality relaxation | Experimental | Virtual reality relaxation using virtual landscape and audio features and sound Receives: Device: Virtual reality relaxation |
| Treatment as usual | No intervention | Seated in similar environment as experimental group for same time |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dental anxiety
post-test measured with Modified Dental Anxiety Scale, The measure has five questions, each with five reply alternatives from not anxious to extremely anxious (on a scale 1-5), MDAS sums up to the total scale (range 5-25) which is used as primary outcome. Higher scores indicate higher dental anxiety.
Measured: immediately after intervention
Secondary outcomes (1)
Anticipatory dental anxiety and treatment related dental anxiety
The secondary outcome variables are post-test scores for the two sub-scales of the MDAS referred to as 'anticipatory' (MDAS items 1 and 2) and 'treatment' dental anxiety (MDAS items 3, 4 and 5). Scales for sum up as anticipatory anxiety (Items 1 and 2: range 2-10) and treatment anxiety (Items 3-5, range 3-15). Higher scores indicate higher dental anxiety
Measured: immediately after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jun 2019
- Study start15 Oct 2018
- Primary completion27 Feb 2019
- Study completion27 Feb 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Dental AnxietyStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized controlled single-center trial with two parallel arms
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 277 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Turku
- Sponsor type
- University, hospital or other
- Collaborators
- University of St Andrews, University of Dundee, City of Helsinki
- Responsible party
- Principal investigator, Satu Lahti, University of Turku
- Investigators
- Satu Lahti, Principal investigator, Department of Community Dentistry, University of Turku, Finland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03993080
- Sponsor's protocol ID
- HEL 2018-008940
- Status last verified
- Jun 2019
- First submitted
- 19 Jun 2019
- Last updated
- 25 Jun 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Lahti S, Suominen A, Freeman R, Lahteenoja T, Humphris G. Virtual Reality Relaxation to Decrease Dental Anxiety: Immediate Effect Randomized Clinical Trial. JDR Clin Trans Res. 2020 Oct;5(4):312-318. doi: 10.1177/2380084420901679. Epub 2020 Jan 21.
PubMed 31962052
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Virtual Reality Relaxation to Decrease Dental Anxiety in Primary Dental Care
- ClinicalTrials.gov ID
- NCT03993080
- Acronym / sponsor ID
- HEL 2018-008940
- Conditions
- Dental Anxiety
- Keywords
- dental anxiety, virtual reality
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 277 participants (actual)
- Lead sponsor
- University of TurkuUniversity, hospital or other
- Collaborators
- University of St Andrews, University of Dundee, City of Helsinki
- Study start
- 15 Oct 2018 (actual)
- Primary completion
- 27 Feb 2019 (actual)
- Study completion
- 27 Feb 2019 (actual)
- First posted
- 20 Jun 2019 (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 aim is to apply short-term virtual reality relaxation to examine if it is effective in reducing pre-operative dental anxiety in primary health care using an RCT.
Detailed description
Randomized controlled single-center trial with two parallel arms: Virtual Reality Relaxation (VRR) and Treatment As Usual (TAU) in a public oral health care unit. VRR group receiving a 1-3.5 minute 360° video immersing them in peaceful virtual landscape with audio features and sound supporting the relaxing experience. TAU groups remaining seated for 3 minutes in similar setting.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized controlled single-center trial with two parallel arms
| Arm | Type | Receives |
|---|---|---|
| Virtual reality relaxation | Experimental | Device: Virtual reality relaxationVirtual reality relaxation using virtual landscape and audio features and sound |
| Treatment as usual | No intervention | –Seated in similar environment as experimental group for same time |
Who may qualify
- Ages
- 18 to 120 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- attending for dental treatment
- consenting
- able to complete Finnish questionnaire without assistance
- age 18 years or older
Key exclusion criteria (1 listed)
- those not meeting inclusion criteria
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 |
|---|---|---|
| Virtual reality relaxation1-3.5 minute 360° videos | Device | Virtual reality relaxation |
Primary outcome
Dental anxiety
Time frame: immediately after intervention
post-test measured with Modified Dental Anxiety Scale, The measure has five questions, each with five reply alternatives from not anxious to extremely anxious (on a scale 1-5), MDAS sums up to the total scale (range 5-25) which is used as primary outcome. Higher scores indicate higher dental anxiety.
1 secondary outcome
Anticipatory dental anxiety and treatment related dental anxiety
Time frame: immediately after intervention
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 25 Jun 2019.
- Derived from this study: PubMed 31962052Lahti S, Suominen A, Freeman R, Lahteenoja T, Humphris G. Virtual Reality Relaxation to Decrease Dental Anxiety: Immediate Effect Randomized Clinical Trial. JDR Clin Trans Res. 2020 Oct;5(4):312-318. doi: 10.1177/2380084420901679. Epub 2020 Jan 21.
- 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.
Satu Lahti principal investigator
Department of Community Dentistry, University of Turku, Finland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Virtual reality relaxation in people with Dental Anxiety, run by University of Turku at 1 site in Finland.
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 4 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 25 Jun 2019. 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 Finland. 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?
Dental anxiety (time frame: immediately after intervention). 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 NCT03993080, which also lists 1 linked publication.
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 25 Jun 2019.