An interventional study of Audiovisual Distraction in Symptomatic Irreversible Pulpitis, Symptomatic Irreversible Pulpitis (SIP) and Symptomatic Irreversible Pulpitis and Post Operative Pain, sponsored by Ramón Miguéns-Vila. Completed at 1 site in Spain. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-02.
Sponsored by Ramón Miguéns-Vila · Not applicable, Interventional, and Supportive care
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.
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.
5,640 studies on the registry are indexed under Pain, Postoperative; 1,230 are open to participants now.
This study's enrollment of 100 is above the median of 75 across 4,821 interventional studies indexed under Pain, Postoperative.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
ASA physical status
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Behavioral: Audiovisual Distraction
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.
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.
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.
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.
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.
Time frame: Same day, single treatment session: immediately before treatment (baseline); during local anesthetic injection; during active endodontic treatment; immediately after treatment completion.
Plan to share: No — Individual participant data will not be made publicly available. The study findings will be reported in aggregate form to protect participant confidentiality.
No publications or documents are linked to this record.
Ran from Mar 2026 to primary completion in Jun 2026, 3 months.
Of 2,089 non-industry interventional studies with no phase under Pain, Postoperative, half reached primary completion within 11 months of starting (the median), counting those still running; a quarter within 6 and three quarters within 23. This study's 3 months is below that.
Counting every sponsor, half of 2,102 studies reached it within 11 months; a quarter within 6 and three quarters within 23.
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From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is completed, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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