Comparing Brief Relaxation Period to Virtual Reality Period in Reducing Dental Anxiety Prior to Root Canal Treatment

Comparing Brief Relaxation Period to Virtual Reality Period in Reducing Dental Anxiety Prior to Root Canal Treatment; a Randomized Control Trial

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05720897

Enrollment

Registered

2023-02-09

Start date

2023-01-11

Completion date

2023-04-03

Last updated

2024-09-19

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

Conditions

Dental Anxiety

Brief summary

The goal of this study is to evaluate non-drug approaches to reducing dental anxiety prior to non-surgical root canal treatment. This will be done by comparing two relaxation methods which will be performed immediately prior to scheduled, clinical non-surgical root canal treatment. Measures of anxiety will be evaluated prior to, and after, the relaxation intervention, as well as after the non-surgical root canal treatment is completed. Participation in the study is completed in a single study visit.

Detailed description

Fifty-eight participants who needed non-surgical root canal treatment were randomly assigned into 2 groups of ABR and VRR. One group received earphones to listen to a guided brief relaxation recording, focusing on a body scan of tense points with diaphragmatic breathing. The other group received Meta 2 virtual reality headsets to listen and watch a 360 inclusive and integrative experience of ambient music, high resolution graphic illustrations and immersive scenery. Participants self-reported levels of anxiety were assessed prior to and post treatment by conducting evaluations using the State Trait Anxiety Indicator (STAI-State & Trait) and the use of both a self-reported Visual Analog Scale (VAS) as well as by assessing objective secondary biometrics of anxiety of heart rate (HR) and Blood Pressure (BP) pre intervention, post intervention and following treatment completion.

Interventions

OTHERAuditory Alone

Participants randomized to this arm will receive earphones to listen to an 8 minute guided brief relaxation recording, focusing on breathing and a body scan. Participants will listen to the recording prior to their dental procedure.

DEVICERelaxation Virtual Reality

Participants randomized to this arm will receive will receive virtual reality goggles and choose a scene of their liking to experience. Participants will choose from 11 different themed environments (such as savannah, beach, meadow, or space), and will experience the chosen virtual reality environment for 8 minutes. Participants will complete the virtual reality intervention prior to their dental procedure.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 90 Years

Healthy volunteers

Inclusion criteria

* requires non-surgical root canal treatment * is able to independently provide informed consent for root canal treatment * proficient in English

Exclusion criteria

* history of vertigo or severe motion sickness * history of severe psychiatric disease * history of seizures, concussions, or severe neurological conditions * visual or hearing impairments * cardiac pacemaker or defibrillator * will require nitrous oxide sedation, nor pharmacologic anxiolytics or sedatives for dental treatment

Design outcomes

Primary

Measure	Time frame	Description
State-Trait Anxiety Inventory State Sub-scale (STAI-S) Score at the End of the Appointment	End of the appointment, approximately 90+ minutes after baseline	STAI-S is a 20 item sub-scale questionnaire which measures subjective self-reported feelings of state anxiety. Responses for each item include four possible responses that range from very much to not at all and which correlate to a numerical value. Scores range from 20 to 80. A score of 45-80 indicates high anxiety: 38-44 indicate moderate anxiety: 20-37 indicate low or no anxiety.
Visual Analog Score (VAS) at the End of the Appointment	End of the appointment, approximately 90+ minutes after baseline	The VAS will be a single question in which the participant is asked to assign and report a numerical value to the amount of anxiety one is feeling in the moment. It consists of a 10 point scale, with one symbolizing no anxiety and 10 symbolizing unbearable anxiety.
Systolic Blood Pressure (SBP) at the End of the Appointment	End of the appointment, approximately 90+ minutes after baseline	BP will be measured three times during the single study visit: at enrollment (prior to the assigned relaxation intervention), at the end of the assigned relaxation intervention, and at the end of the appointment.
Diastolic Blood Pressure (DBP) at the End of the Appointment	End of the appointment, approximately 90+ minutes after baseline	BP will be measured three times during the single study visit: at enrollment (prior to the assigned relaxation intervention), at the end of the assigned relaxation intervention, and at the end of the appointment.
State-Trait Anxiety Inventory Trait Sub-scale (STAI-T) Score at the End of the Appointment	End of the appointment, approximately 90+ minutes after baseline	STAI-T is a 20 item sub-scale questionnaire which measures subjective self-reported feelings of trait anxiety. Responses for each item include four possible responses that range from not at all to very much and which correlate to a numerical value. Scores range from 20 to 80. A score of 45-80 indicates high anxiety: 38-44 indicate moderate anxiety: 20-37 indicate low or no anxiety.
Heart Rate (HR) at the End of the Appointment	End of the appointment, approximately 90+ minutes after baseline	HR will be measured three times during the single study visit: at enrollment (prior to the assigned relaxation intervention), at the end of the assigned relaxation intervention, and at the end of the appointment.

Countries

United States

Participant flow

Participants by arm

Arm	Count
Auditory Alone Brief Relaxation Participants randomized to this arm will receive earphones to listen to a guided brief relaxation recording, focusing on breathing and a body scan, prior to their dental procedure. Auditory Alone: Participants randomized to this arm will receive earphones to listen to an 8 minute guided brief relaxation recording, focusing on breathing and a body scan. Participants will listen to the recording prior to their dental procedure.	28
Relaxation Virtual Reality Participants will receive virtual reality headset and choose a scene of their liking to experience, prior to their dental procedure. Relaxation Virtual Reality: Participants randomized to this arm will receive will receive virtual reality headsets and choose a scene of their liking to experience. Participants will choose from 11 different themed environments (such as savannah, beach, meadow, or space), and will experience the chosen virtual reality environment with accompanying music for 8 minutes. Participants will complete the virtual reality intervention prior to their dental procedure.	30
Total	58

Withdrawals & dropouts

Period	Reason	FG000	FG001
Overall Study	Two patients did not complete Endodontic Treatment & there was technical VR difficulties for pts.	2	0

Baseline characteristics

Characteristic	Auditory Alone Brief Relaxation	Relaxation Virtual Reality	Total
Age, Customized	41.9 Years	45.9 Years	43.9 Years
Diastolic Blood Pressure	82.36 mmHg STANDARD_DEVIATION 10.29	81.83 mmHg STANDARD_DEVIATION 10.65	82.09 mmHg STANDARD_DEVIATION 10.39
Ethnicity (NIH/OMB) Hispanic or Latino	5 Participants	4 Participants	9 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	23 Participants	26 Participants	49 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants	0 Participants	0 Participants
Heart Rate	77.82 bpm STANDARD_DEVIATION 11.53	76.97 bpm STANDARD_DEVIATION 11.89	77.38 bpm STANDARD_DEVIATION 11.62
Race (NIH/OMB) American Indian or Alaska Native	0 Participants	1 Participants	1 Participants
Race (NIH/OMB) Asian	1 Participants	3 Participants	4 Participants
Race (NIH/OMB) Black or African American	8 Participants	5 Participants	13 Participants
Race (NIH/OMB) More than one race	3 Participants	3 Participants	6 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants	1 Participants	1 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) White	16 Participants	17 Participants	33 Participants
Sex/Gender, Customized Gender Identification Additional Identification	0 Participants	1 Participants	1 Participants
Sex/Gender, Customized Gender Identification Female	18 Participants	13 Participants	31 Participants
Sex/Gender, Customized Gender Identification Male	10 Participants	16 Participants	26 Participants
STAI-S	33.75 units on a scale STANDARD_DEVIATION 9.87	35.13 units on a scale STANDARD_DEVIATION 10.64	34.46 units on a scale STANDARD_DEVIATION 10.21
STAI-T	31.86 units on a scale STANDARD_DEVIATION 10.94	33.77 units on a scale STANDARD_DEVIATION 10.22	32.85 units on a scale STANDARD_DEVIATION 10.52
Systolic Blood Pressure	134.68 mmHg STANDARD_DEVIATION 15.63	131.90 mmHg STANDARD_DEVIATION 16.81	133.24 mmHg STANDARD_DEVIATION 16.17
Visual Analogue Scale (VAS) for Anxiety	2.68 units on a scale STANDARD_DEVIATION 2.44	2.43 units on a scale STANDARD_DEVIATION 2.05	2.55 units on a scale STANDARD_DEVIATION 2.23

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk
deaths Total, all-cause mortality	0 / 30	0 / 28
other Total, other adverse events	0 / 30	0 / 28
serious Total, serious adverse events	0 / 30	0 / 28

Outcome results

Primary

Diastolic Blood Pressure (DBP) at the End of the Appointment

BP will be measured three times during the single study visit: at enrollment (prior to the assigned relaxation intervention), at the end of the assigned relaxation intervention, and at the end of the appointment.