Symptomatic Irreversible PulpitisAV-ENDONCT07910513
Effect of Audiovisual Distraction on Dental Anxiety and Heart Rate During Root Canal Treatment
A study testing Audiovisual Distraction in people with Symptomatic Irreversible Pulpitis and Symptomatic Irreversible Pulpitis (SIP), run by Ramón Miguéns-Vila at 1 site in Spain.
Trial summary
Dental anxiety is common among patients undergoing root canal treatment and may negatively affect their experience during dental care. Audiovisual distraction, combining visual entertainment with sound delivered through headphones, may help reduce anxiety by redirecting patients' attention away from the dental… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Symptomatic Irreversible Pulpitis, Symptomatic Irreversible Pulpitis (SIP), Symptomatic Irreversible Pulpitis and Post Operative Pain
- What is being tested?
- Audiovisual Distraction
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteSpain
- Study dates
- 16 Mar 2026to 30 Jun 2026
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults aged 18 years or older.
- Diagnosis of symptomatic irreversible pulpitis in a single tooth requiring nonsurgical root canal treatment.
- Moderate-to-severe dental pain with a prolonged response to cold testing, consistent with symptomatic irreversible pulpitis.
- American Society of Anesthesiologists (ASA) physical status I or II.
Who cannot join
- Current use of anxiolytic or antidepressant medication.
- Uncontrolled hypertension.
- Cardiac arrhythmias.
- Diagnosed psychiatric disorders.
- Visual or hearing impairment severe enough to interfere with the use of the audiovisual distraction system.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of a Ceiling-Mounted Audiovisual Entertainment System on Dental Anxiety and Heart Rate During Endodontic Treatment for Symptomatic Irreversible Pulpitis: A Randomized Clinical Trial
Dental anxiety is common among patients undergoing root canal treatment and may negatively affect their experience during dental care. Audiovisual distraction, combining visual entertainment with sound delivered through headphones, may help reduce anxiety by redirecting patients' attention away from the dental procedure.
The purpose of this randomized clinical trial was to evaluate whether a ceiling-mounted audiovisual entertainment system could reduce dental anxiety and heart rate during root canal treatment in patients diagnosed with symptomatic irreversible pulpitis.
Read more
A total of 100 adult patients were allocated to two groups. Participants in the intervention group received root canal treatment while watching audiovisual entertainment on a ceiling-mounted screen and listening through headphones. Participants in the control group underwent conventional root canal treatment without audiovisual entertainment.
Dental anxiety and heart rate were assessed at four predefined time points during the treatment appointment. The study compared changes in these outcomes between the two groups to determine whether audiovisual distraction could improve the patient experience during endodontic treatment.
Read the detailed description
Background and rationale
Root canal treatment is frequently associated with anxiety, particularly among patients experiencing dental pain. Symptomatic irreversible pulpitis may increase psychological distress before and during treatment. Anxiety can influence patients' perception of dental procedures and may be accompanied by physiological responses, including changes in heart rate.
Non-pharmacological approaches to anxiety management are of interest because they can be incorporated into routine clinical practice without the need for additional medication. Audiovisual distraction is intended to redirect attention away from potentially stressful stimuli associated with dental treatment.
Study objective
The primary objective of this randomized clinical trial was to assess the effect of a ceiling-mounted audiovisual entertainment system on dental anxiety and heart rate during nonsurgical root canal treatment in adult patients with symptomatic irreversible pulpitis.
Study design
This was a two-arm, parallel-group randomized clinical trial involving 100 participants, with 50 allocated to each group.
Participants assigned to the intervention group underwent root canal treatment while viewing audiovisual content on a ceiling-mounted screen and listening through headphones. Participants assigned to the control group received conventional root canal treatment without the audiovisual distraction system.
Study procedures
All participants underwent endodontic treatment according to the clinical protocol established for the study. Dental anxiety was assessed using a patient-reported visual analog scale, and heart rate was recorded as a physiological indicator of anxiety-related responses.
Both variables were evaluated at four predefined assessment points during the treatment appointment, allowing the investigators to examine changes over time and compare the responses of the two study groups.
Clinical relevance
The study was designed to investigate whether audiovisual distraction could be a practical, non-pharmacological adjunct for anxiety management during endodontic treatment. Its findings may help clinicians evaluate the potential usefulness of this approach in routine dental practice.
- Conditions
- Symptomatic Irreversible Pulpitis, Symptomatic Irreversible Pulpitis (SIP), Symptomatic Irreversible Pulpitis and Post Operative Pain, Dental Anxiety
- Being tested
- Audiovisual Distraction
- Keywords
- Audiovisual Distraction, Endodontic Treatment, Root Canal Treatment, Dental Anxiety, Heart Rate, Non-pharmacological Intervention
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Audiovisual DistractionBehavioural
Audiovisual distraction was provided during nonsurgical root canal treatment using a ceiling-mounted screen and headphones. Participants assigned to the experimental group watched audiovisual entertainment while undergoing the dental procedure. The intervention was intended to redirect attention away from treatment-related stimuli and reduce dental anxiety.
| Study group | Role | What they receive |
|---|---|---|
| Audiovisual Distraction Group | Experimental | Participants received conventional nonsurgical root canal treatment while watching audiovisual entertainment on a ceiling-mounted screen and listening through headphones. The audiovisual distraction system was used during the treatment appointment to reduce dental anxiety. Receives: Behavioral: Audiovisual Distraction |
| Conventional Treatment Group | No intervention | Participants received conventional nonsurgical root canal treatment without audiovisual entertainment. All other aspects of endodontic treatment followed the same clinical protocol as in the experimental group. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Dental Anxiety Assessed Using a Visual Analog Scale (VAS)
Dental anxiety was assessed using a 10-cm visual analog scale (VAS), with higher scores indicating greater anxiety. Assessments were conducted immediately before treatment, immediately after the local anesthetic injection, during active endodontic treatment, and immediately after treatment completion. The assessment obtained immediately after the injection referred to the anxiety experienced during administration of local anesthesia. All assessments took place on the same day, during a single endodontic treatment appointment. Changes in VAS scores over time and the difference between baseline and the final assessment were compared between groups.
Measured: Same day, single treatment session: immediately before treatment (baseline); immediately after local anesthetic injection (anxiety experienced during injection); during active endodontic treatment; immediately after treatment completion.
Change in Heart Rate During Root Canal Treatment
Heart rate was measured in beats per minute (bpm) immediately before treatment, during administration of the local anesthetic injection, during active endodontic treatment, and immediately after treatment completion. All measurements took place on the same day, during a single endodontic treatment appointment. Changes in heart rate over time and the difference between baseline and the final assessment were compared between the audiovisual distraction and control groups.
Measured: Same day, single treatment session: immediately before treatment (baseline); during local anesthetic injection; during active endodontic treatment; immediately after treatment completion.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2026
- Study start16 Mar 2026
- Primary completion30 Jun 2026
- Study completion30 Jun 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Symptomatic Irreversible PulpitisStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Two-arm, parallel-group randomized clinical trial comparing conventional nonsurgical root canal treatment with the same treatment supplemented by ceiling-mounted audiovisual distraction. A total of 100 participants were allocated to two groups (50 participants per group). Dental anxiety and heart rate were assessed at four predefined time points during the treatment appointment.
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ramón Miguéns-Vila
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Ramón Miguéns-Vila, University of Santiago de Compostela
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07910513
- Sponsor's protocol ID
- AV-ENDO-2026-001
- Other IDs
- 2026/279
- Acronym
- AV-ENDO
- Status last verified
- Oct 2026
- First submitted
- 19 Oct 2026
- Last updated
- 2 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be made publicly available. The study findings will be reported in aggregate form to protect participant confidentiality.
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of a Ceiling-Mounted Audiovisual Entertainment System on Dental Anxiety and Heart Rate During Endodontic Treatment for Symptomatic Irreversible Pulpitis: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT07910513
- Acronym / sponsor ID
- AV-ENDO / AV-ENDO-2026-001
- Conditions
- Symptomatic Irreversible Pulpitis, Symptomatic Irreversible Pulpitis (SIP), Symptomatic Irreversible Pulpitis and Post Operative Pain, Dental Anxiety
- Keywords
- Audiovisual Distraction, Endodontic Treatment, Root Canal Treatment, Dental Anxiety, Heart Rate, Non-pharmacological Intervention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Ramón Miguéns-VilaUniversity, hospital or other
- Study start
- 16 Mar 2026 (actual)
- Primary completion
- 30 Jun 2026 (actual)
- Study completion
- 30 Jun 2026 (actual)
- First posted
- 2 Nov 2026 (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.
Dental anxiety is common among patients undergoing root canal treatment and may negatively affect their experience during dental care. Audiovisual distraction, combining visual entertainment with sound delivered through headphones, may help reduce anxiety by redirecting patients' attention away from the dental procedure.
The purpose of this randomized clinical trial was to evaluate whether a ceiling-mounted audiovisual entertainment system could reduce dental anxiety and heart rate during root canal treatment in patients diagnosed with symptomatic irreversible pulpitis.
A total of 100 adult patients were allocated to two groups. Participants in the intervention group received root canal treatment while watching audiovisual entertainment on a ceiling-mounted screen and listening through headphones. Participants in the control group underwent conventional root canal treatment without audiovisual entertainment.
Dental anxiety and heart rate were assessed at four predefined time points during the treatment appointment. The study compared changes in these outcomes between the two groups to determine whether audiovisual distraction could improve the patient experience during endodontic treatment.
Detailed description
Background and rationale
Root canal treatment is frequently associated with anxiety, particularly among patients experiencing dental pain. Symptomatic irreversible pulpitis may increase psychological distress before and during treatment. Anxiety can influence patients' perception of dental procedures and may be accompanied by physiological responses, including changes in heart rate.
Non-pharmacological approaches to anxiety management are of interest because they can be incorporated into routine clinical practice without the need for additional medication. Audiovisual distraction is intended to redirect attention away from potentially stressful stimuli associated with dental treatment.
Study objective
The primary objective of this randomized clinical trial was to assess the effect of a ceiling-mounted audiovisual entertainment system on dental anxiety and heart rate during nonsurgical root canal treatment in adult patients with symptomatic irreversible pulpitis.
Study design
This was a two-arm, parallel-group randomized clinical trial involving 100 participants, with 50 allocated to each group.
Participants assigned to the intervention group underwent root canal treatment while viewing audiovisual content on a ceiling-mounted screen and listening through headphones. Participants assigned to the control group received conventional root canal treatment without the audiovisual distraction system.
Study procedures
All participants underwent endodontic treatment according to the clinical protocol established for the study. Dental anxiety was assessed using a patient-reported visual analog scale, and heart rate was recorded as a physiological indicator of anxiety-related responses.
Both variables were evaluated at four predefined assessment points during the treatment appointment, allowing the investigators to examine changes over time and compare the responses of the two study groups.
Clinical relevance
The study was designed to investigate whether audiovisual distraction could be a practical, non-pharmacological adjunct for anxiety management during endodontic treatment. Its findings may help clinicians evaluate the potential usefulness of this approach in routine dental practice.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Two-arm, parallel-group randomized clinical trial comparing conventional nonsurgical root canal treatment with the same treatment supplemented by ceiling-mounted audiovisual distraction. A total of 100 participants were allocated to two groups (50 participants per group). Dental anxiety and heart rate were assessed at four predefined time points during the treatment appointment.
| Arm | Type | Receives |
|---|---|---|
| Audiovisual Distraction Group | Experimental | Behavioral: Audiovisual DistractionParticipants received conventional nonsurgical root canal treatment while watching audiovisual entertainment on a ceiling-mounted screen and listening through headphones. The audiovisual distraction system was used during the treatment appointment to reduce dental anxiety. |
| Conventional Treatment Group | No intervention | –Participants received conventional nonsurgical root canal treatment without audiovisual entertainment. All other aspects of endodontic treatment followed the same clinical protocol as in the experimental group. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adults aged 18 years or older.
- Diagnosis of symptomatic irreversible pulpitis in a single tooth requiring nonsurgical root canal treatment.
- Moderate-to-severe dental pain with a prolonged response to cold testing, consistent with symptomatic irreversible pulpitis.
- American Society of Anesthesiologists (ASA) physical status I or II.
Key exclusion criteria (5 listed)
- Current use of anxiolytic or antidepressant medication.
- Uncontrolled hypertension.
- Cardiac arrhythmias.
- Diagnosed psychiatric disorders.
- Visual or hearing impairment severe enough to interfere with the use of the audiovisual distraction system.
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 |
|---|---|---|
| Audiovisual DistractionAudiovisual distraction was provided during nonsurgical root canal treatment using a ceiling-mounted screen and headphones. Participants assigned to the experimental group watched audiovisual entertainment while undergoing the dental procedure. The intervention was intended to redirect attention away from treatment-related stimuli and reduce dental anxiety. | Behavioural | Audiovisual Distraction Group |
Primary outcome
Change in Dental Anxiety Assessed Using a Visual Analog Scale (VAS)
Time frame: Same day, single treatment session: immediately before treatment (baseline); immediately after local anesthetic injection (anxiety experienced during injection); during active endodontic treatment; immediately after treatment completion.
Dental anxiety was assessed using a 10-cm visual analog scale (VAS), with higher scores indicating greater anxiety. Assessments were conducted immediately before treatment, immediately after the local anesthetic injection, during active endodontic treatment, and immediately after treatment completion. The assessment obtained immediately after the injection referred to the anxiety experienced during administration of local anesthesia. All assessments took place on the same day, during a single endodontic treatment appointment. Changes in VAS scores over time and the difference between baseline and the final assessment were compared between groups.
Change in Heart Rate During Root Canal Treatment
Time frame: Same day, single treatment session: immediately before treatment (baseline); during local anesthetic injection; during active endodontic treatment; immediately after treatment completion.
Heart rate was measured in beats per minute (bpm) immediately before treatment, during administration of the local anesthetic injection, during active endodontic treatment, and immediately after treatment completion. All measurements took place on the same day, during a single endodontic treatment appointment. Changes in heart rate over time and the difference between baseline and the final assessment were compared between the audiovisual distraction and control groups.
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 2 Nov 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be made publicly available. The study findings will be reported in aggregate form to protect participant confidentiality.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Audiovisual Distraction in people with Symptomatic Irreversible Pulpitis and Symptomatic Irreversible Pulpitis (SIP), run by Ramón Miguéns-Vila 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 4 inclusion and 5 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 2 Nov 2026. 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?
Change in Dental Anxiety Assessed Using a Visual Analog Scale (VAS) (time frame: Same day, single treatment session: immediately before treatment (baseline); immediately after local anesthetic injection (anxiety experienced during injection); during active endodontic treatment; immediately after treatment completion.). 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?
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 2 Nov 2026.