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Effect of virtual reality and music on anxiety and perioperative pain in impacted third molar extraction under local anesthesia.

Effect of virtual reality and music on anxiety and perioperative pain in impacted third molar extraction under local anesthesia in adults.

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12622000384752
Enrollment
280
Registered
2022-03-04
Start date
2020-05-01
Completion date
2021-04-28
Last updated
2022-03-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

Procedures with local anesthesia are very prevalent in the medical field, representing the most frequent surgical procedure in Oral and Maxillofacial Surgery Services, and it is widely known that, especially the interventions in our field and dentistry, are situations experienced as a moment of stress, fear and anxiety for the patient, which is why there is interest in finding and applying non-invasive therapies, with the aim of attenuating and improving these undesirable states. Music therapy and virtual reality are disciplines that are increasingly studied and growing in the field of medicine, especially in areas aimed at controlling pain and anxiety, to ensure better comfort for the patient who undergoes invasive procedures. The objective of the work is to evaluate the role of virtual reality and music in reducing anxiety and perioperative pain in the surgical extraction of impacted third molars under local anesthesia. For this, a controlled parallel group clinical trial (RCT) has been proposed, with three groups: experimental 1 (91 patients) who will undergo surgical extraction of the third molar receiving musical stimulation during the surgical procedure. Experimental group 2 (91 patients) to whom virtual reality will be applied during the surgical procedure. And control group (91 patients) who will be the patients who will have the third molar extracted without receiving musical stimulation or virtual reality during the surgical procedure. The variables to be studied will be: the evaluation of anxiety and pain in all the subjects that make up the three arms of the trial, being evaluated using the Trait and State anxiety questionnaire (STAI) and the numerical visual analogue scale (VAS). And epidemiological variables such as age, sex, dental laterality, degree of inclusion, variation in basic vital signs (HR, Sat O2, TA). Music therapy and virtual reality can provide new knowledge in medical practice and become a resource for the control of anxiety and pain in patients undergoing oral surgery; offering the healthcare professional non-pharmacological or invasive tools that will enable them to provide holistic and comprehensive care to the user, improving their comfort and quality of care.

Interventions

INTERVNETION GROUP 1 (MUSIC GROUP) Once the bibliographic search has been carried out and based on the most effective, comfortable studies and with the best results for the patient, it has been proved that there is no clear evidence of which type of music is more beneficial decreasing anxiety, but music determined by patient is preferred. For their use, patients will be given an iPOD®-type electronic acoustic reproduction device with free and unlimited access to Spotify Premium® music applicatio

INTERVNETION GROUP 1 (MUSIC GROUP) Once the bibliographic search has been carried out and based on the most effective, comfortable studies and with the best results for the patient, it has been proved that there is no clear evidence of which type of music is more beneficial decreasing anxiety, but music determined by patient is preferred. For their use, patients will be given an iPOD®-type electronic acoustic reproduction device with free and unlimited access to Spotify Premium® music application, with wireless headphones headband type (Trust Urban®) (property of the Service of Oral and Maxillofacial Surgery), with pads that improve acoustics and an adjustable headband, which allow individual and isolated listening to the music during the process. In the pre-operating room, when the patient is alone, the headband-type headset will be delivered 15 minutes before the molar extraction with the music selected by the patient. For the effectiveness of the musical effect, and to avoid the risk or possibility of acoustic damage to the patient, the recommended volume is about 60-70 decibels (db). After 15 minutes alone listening to music, the patient goes to the operating room where the standard surgical extraction of the lower third molar is performed while the patient uses the music player throughout the surgery. During the surgery, the basic vital signs will be taken again: TAD / TAS, Sat O2 and HR through the same tower with which they were taken in the consultation and in the ante-operating room. These constants will be taken at different times during the surgical procedure: during the infiltration of local anesthetic (articaine with epinephrine 40 / 0.005mg / ml (brand name Ultracain ®)); during mandibulotomy and dental section carried out with a handpiece at 40,000 revolutions with a 23 milling cutter; and after the closure of the flap and placement of local compressive gauze. This procedure may take around 15 minutes 15 minutes after the surgery, the STAI-Y1 questionnaire will be passed again and the basic vital signs will be taken again. And finally, a visual analog scale (VAS) will be used to indicate the perioperative pain experienced by the patient. INTERVENTION GROUP 2 (VIRTUAL REALITY GROUP) In this study, virtual reality glasses from Bnext ® (property of Oral and Maxillofacial Surgery service) will be used, these have adjustable straps to the contour of the head to give greater comfort to the patient and allow a prolonged use of them. It also has the ability to adjust the focus and distance that optimize the quality and focus of the image. It has a protection system for the patient's sight, to guarantee their visual safety. For its use, it is only necessary to insert a compatible smartphone in the front part of the glasses, thus allow to see images in a 360º world where the limit is the imagination. A 3D video with relaxing images of nature will then be played, along with the relaxing sounds that accompany the 3D images, that allow the patient to disconnect as there is a continuous fusion between listening and visualizing a relaxing situation. In the same way as in the music intervention group, in the pre-operating room and being unaccompanied, the patient will be provided virtual reality glasses 15 minutes before the intervention. After 15 minutes alone and viewing the 3D video, the patient goes to the operating room where the standard surgical extraction of the lower third molar is carried out while the patient uses the virtual reality device that will be used throughout the surgery. During the surgery, the basic vital signs will be taken again: TAD / TAS, Sat O2 and HR through the same tower with which they were taken in the consultation and in the ante-operating room. These constants will be taken at different times during the surgical procedure: during the infiltration of local anesthetic (articaine with epinephrine 40 / 0.005mg / ml (brand name Ultracain ®)); during mandibulotomy and odontosection carried out with a handpiece at 40,000 revolutions with a 23 bur; and after the closure of the flap and placement of local compressive gauze. 15 minutes after the surgery, the STAI-Y1 questionnaire will be passed again and the basic vital signs will be taken again. And finally, a visual analog scale (VAS) will be used to indicate and record the periopertory pain experienced by the patient.

Sponsors

Ana Rocío García Carricondo
Lead SponsorIndividual

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
All
Age
18 Years to 51 Years
Healthy volunteers
No

Inclusion criteria

1. Adult patients between 18-50 years of age, the age range in which tooth eruption generally occurs 2. Both men and women will be selected. 3. Single procedure per surgical act, that is, only one extraction per patient and episode. 4. Procedure performed under exclusive local anesthesia. 5. Patients who have authorized their participation in the clinical trial as well as undergo the surgical removal by signing the Informed Consent.

Exclusion criteria

1. Patients under 18 years of age or over 51 years of age. 2. Multiple procedure, that is, dental polyextraction in the same surgical act. 3. Patients with deafness or with hearing pathology. 4. Patients who are blind or with significant loss of visual acuity. 5. Patients who suffer from epilepsy or have had an epileptic seizure in the last 6 months. 6. Anticoagulated patients or with bleeding disorders. 7. Patients undergoing cancer treatment or immunosuppressed. 8. Patients being treated with bisphosphonates. 9. Patients with systemic pathology that may interfere with the result. 10. Patients who have received locoregional radiotherapy. 11. Previous surgery in the lower retromolar trigone area. 12. Disabled patients, non-collaborators. 13. Patients unable to understand and fill in the visual analog scale and the anxiety questionnaire. 14. Patients operated under general anesthesia and / or sedation. 15. Presence of active suppurative infection at the time of surgery. 16. Pregnant patients or possibility of pregnancy (verified by pregnancy test). 17. Any medical or surgical condition that, at the discretion of the investigator, puts the patient at risk or that prevents the patient from meeting the requirements of the study or terminating the same. 18. Patient who does not want or authorize to participate in the study or does not have a correct command or understanding of the Spanish language. 19. Patients with severe cardiac impulse conduction dysfunctions. 20. Patients with decompensated heart failure.

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 12, 2026