Trial Outcomes & Findings for Comparing Brief Relaxation Period to Virtual Reality Period in Reducing Dental Anxiety Prior to Root Canal Treatment (NCT NCT05720897)
NCT ID: NCT05720897
Last Updated: 2024-09-19
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
60 participants
Primary outcome timeframe
End of the appointment, approximately 90+ minutes after baseline
Results posted on
2024-09-19
Participant Flow
Participant milestones
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
STARTED
|
30
|
30
|
|
Overall Study
COMPLETED
|
28
|
30
|
|
Overall Study
NOT COMPLETED
|
2
|
0
|
Reasons for withdrawal
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
Two patients did not complete Endodontic Treatment & there was technical VR difficulties for pts.
|
2
|
0
|
Baseline Characteristics
Comparing Brief Relaxation Period to Virtual Reality Period in Reducing Dental Anxiety Prior to Root Canal Treatment
Baseline characteristics by cohort
| Measure |
Auditory Alone Brief Relaxation
n=28 Participants
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.
|
Relaxation Virtual Reality
n=30 Participants
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.
|
Total
n=58 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
|
41.9 Years
n=5 Participants
|
45.9 Years
n=7 Participants
|
43.9 Years
n=5 Participants
|
|
Sex/Gender, Customized
Gender Identification · Male
|
10 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
26 Participants
n=5 Participants
|
|
Sex/Gender, Customized
Gender Identification · Female
|
18 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
31 Participants
n=5 Participants
|
|
Sex/Gender, Customized
Gender Identification · Additional Identification
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
5 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
23 Participants
n=5 Participants
|
26 Participants
n=7 Participants
|
49 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
8 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
16 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
33 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
STAI-S
|
33.75 units on a scale
STANDARD_DEVIATION 9.87 • n=5 Participants
|
35.13 units on a scale
STANDARD_DEVIATION 10.64 • n=7 Participants
|
34.46 units on a scale
STANDARD_DEVIATION 10.21 • n=5 Participants
|
|
STAI-T
|
31.86 units on a scale
STANDARD_DEVIATION 10.94 • n=5 Participants
|
33.77 units on a scale
STANDARD_DEVIATION 10.22 • n=7 Participants
|
32.85 units on a scale
STANDARD_DEVIATION 10.52 • n=5 Participants
|
|
Visual Analogue Scale (VAS) for Anxiety
|
2.68 units on a scale
STANDARD_DEVIATION 2.44 • n=5 Participants
|
2.43 units on a scale
STANDARD_DEVIATION 2.05 • n=7 Participants
|
2.55 units on a scale
STANDARD_DEVIATION 2.23 • n=5 Participants
|
|
Systolic Blood Pressure
|
134.68 mmHg
STANDARD_DEVIATION 15.63 • n=5 Participants
|
131.90 mmHg
STANDARD_DEVIATION 16.81 • n=7 Participants
|
133.24 mmHg
STANDARD_DEVIATION 16.17 • n=5 Participants
|
|
Diastolic Blood Pressure
|
82.36 mmHg
STANDARD_DEVIATION 10.29 • n=5 Participants
|
81.83 mmHg
STANDARD_DEVIATION 10.65 • n=7 Participants
|
82.09 mmHg
STANDARD_DEVIATION 10.39 • n=5 Participants
|
|
Heart Rate
|
77.82 bpm
STANDARD_DEVIATION 11.53 • n=5 Participants
|
76.97 bpm
STANDARD_DEVIATION 11.89 • n=7 Participants
|
77.38 bpm
STANDARD_DEVIATION 11.62 • n=5 Participants
|
PRIMARY outcome
Timeframe: End of the appointment, approximately 90+ minutes after baselineSTAI-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.
Outcome measures
| Measure |
Auditory Alone Brief Relaxation
n=28 Participants
Participants randomized to this arm received 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 received earphones to listen to an 8 minute guided brief relaxation recording, focusing on breathing and a body scan. Participants listened to the recording prior to their dental procedure.
|
Relaxation Virtual Reality
n=30 Participants
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 headset and choose a scene of their liking to experience. Participants choose from 11 different themed environments (such as savannah, beach, meadow, or space), and experienced the chosen virtual reality environment for 8 minutes. Participants completed the virtual reality intervention prior to their dental procedure.
|
|---|---|---|
|
State-Trait Anxiety Inventory State Sub-scale (STAI-S) Score at the End of the Appointment
|
27.39 units on a scale
Standard Deviation 7.84
|
29.37 units on a scale
Standard Deviation 9.0
|
PRIMARY outcome
Timeframe: End of the appointment, approximately 90+ minutes after baselineThe 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.
Outcome measures
| Measure |
Auditory Alone Brief Relaxation
n=28 Participants
Participants randomized to this arm received 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 received earphones to listen to an 8 minute guided brief relaxation recording, focusing on breathing and a body scan. Participants listened to the recording prior to their dental procedure.
|
Relaxation Virtual Reality
n=30 Participants
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 headset and choose a scene of their liking to experience. Participants choose from 11 different themed environments (such as savannah, beach, meadow, or space), and experienced the chosen virtual reality environment for 8 minutes. Participants completed the virtual reality intervention prior to their dental procedure.
|
|---|---|---|
|
Visual Analog Score (VAS) at the End of the Appointment
|
0.96 units on a scale
Standard Deviation 0.96
|
1.17 units on a scale
Standard Deviation 1.97
|
PRIMARY outcome
Timeframe: End of the appointment, approximately 90+ minutes after baselineBP 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.
Outcome measures
| Measure |
Auditory Alone Brief Relaxation
n=28 Participants
Participants randomized to this arm received 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 received earphones to listen to an 8 minute guided brief relaxation recording, focusing on breathing and a body scan. Participants listened to the recording prior to their dental procedure.
|
Relaxation Virtual Reality
n=30 Participants
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 headset and choose a scene of their liking to experience. Participants choose from 11 different themed environments (such as savannah, beach, meadow, or space), and experienced the chosen virtual reality environment for 8 minutes. Participants completed the virtual reality intervention prior to their dental procedure.
|
|---|---|---|
|
Systolic Blood Pressure (SBP) at the End of the Appointment
|
142.64 mmHg
Standard Deviation 20.03
|
137.47 mmHg
Standard Deviation 22.45
|
PRIMARY outcome
Timeframe: End of the appointment, approximately 90+ minutes after baselineBP 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.
Outcome measures
| Measure |
Auditory Alone Brief Relaxation
n=28 Participants
Participants randomized to this arm received 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 received earphones to listen to an 8 minute guided brief relaxation recording, focusing on breathing and a body scan. Participants listened to the recording prior to their dental procedure.
|
Relaxation Virtual Reality
n=30 Participants
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 headset and choose a scene of their liking to experience. Participants choose from 11 different themed environments (such as savannah, beach, meadow, or space), and experienced the chosen virtual reality environment for 8 minutes. Participants completed the virtual reality intervention prior to their dental procedure.
|
|---|---|---|
|
Diastolic Blood Pressure (DBP) at the End of the Appointment
|
90.00 mmHg
Standard Deviation 12.56
|
85.97 mmHg
Standard Deviation 15.48
|
PRIMARY outcome
Timeframe: End of the appointment, approximately 90+ minutes after baselineHR 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.
Outcome measures
| Measure |
Auditory Alone Brief Relaxation
n=28 Participants
Participants randomized to this arm received 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 received earphones to listen to an 8 minute guided brief relaxation recording, focusing on breathing and a body scan. Participants listened to the recording prior to their dental procedure.
|
Relaxation Virtual Reality
n=30 Participants
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 headset and choose a scene of their liking to experience. Participants choose from 11 different themed environments (such as savannah, beach, meadow, or space), and experienced the chosen virtual reality environment for 8 minutes. Participants completed the virtual reality intervention prior to their dental procedure.
|
|---|---|---|
|
Heart Rate (HR) at the End of the Appointment
|
72.89 bpm
Standard Deviation 9.09
|
72.17 bpm
Standard Deviation 10.90
|
PRIMARY outcome
Timeframe: End of the appointment, approximately 90+ minutes after baselineSTAI-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.
Outcome measures
| Measure |
Auditory Alone Brief Relaxation
n=28 Participants
Participants randomized to this arm received 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 received earphones to listen to an 8 minute guided brief relaxation recording, focusing on breathing and a body scan. Participants listened to the recording prior to their dental procedure.
|
Relaxation Virtual Reality
n=30 Participants
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 headset and choose a scene of their liking to experience. Participants choose from 11 different themed environments (such as savannah, beach, meadow, or space), and experienced the chosen virtual reality environment for 8 minutes. Participants completed the virtual reality intervention prior to their dental procedure.
|
|---|---|---|
|
State-Trait Anxiety Inventory Trait Sub-scale (STAI-T) Score at the End of the Appointment
|
30.18 units on a scale
Standard Deviation 11.55
|
29.90 units on a scale
Standard Deviation 8.53
|
Adverse Events
Auditory Alone Brief Relaxation
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Relaxation Virtual Reality
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place