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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Auditory Alone Brief Relaxation | Experimental | 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. |
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| Relaxation Virtual Reality | Experimental | Participants will receive virtual reality goggles and choose a scene of their liking to experience, prior to their dental procedure. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Auditory Alone | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| State-Trait Anxiety Inventory State Sub-scale (STAI-S) Score at the End of the Appointment | 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. | End of the appointment, approximately 90+ minutes after baseline |
| Visual Analog Score (VAS) at the End of the Appointment | 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. | End of the appointment, approximately 90+ minutes after baseline |
| Systolic Blood Pressure (SBP) 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. | End of the appointment, approximately 90+ minutes after baseline |
| 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. | End of the appointment, approximately 90+ minutes after baseline |
| Heart Rate (HR) at the End of the Appointment | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Stuart Schrader, PhD | Indiana University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Indiana University, School of Dentistry | Indianapolis | Indiana | 46202 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | State-Trait Anxiety Inventory State Sub-scale (STAI-S) Score at the End of the Appointment | 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. | Posted | Mean | Standard Deviation | units on a scale | End of the appointment, approximately 90+ minutes after baseline |
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The 1 day in which data was collected.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Stuart Schrader | Indiana University | 3172781409 | sschrade@iu.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Nov 22, 2022 | May 15, 2024 | Prot_SAP_000.pdf |
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| Relaxation Virtual Reality | Device | 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. |
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| End of the appointment, approximately 90+ minutes after baseline |
| State-Trait Anxiety Inventory Trait Sub-scale (STAI-T) Score at the End of the Appointment | 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. | End of the appointment, approximately 90+ minutes after baseline |
| BG001 | 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. |
| BG002 | Total | Total of all reporting groups |
| Years |
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| Sex/Gender, Customized | Male, Female and Open Reporting for Additional Identification | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| STAI-S | The State Trait Anxiety Inventory State sub-scale (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 "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. | Mean | Standard Deviation | units on a scale |
|
| STAI-T | The State Trait Anxiety Inventory Trait sub-scale (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. | Mean | Standard Deviation | units on a scale |
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| Visual Analogue Scale (VAS) for Anxiety | Visual Analogue Scale for Anxiety: 0 Least Anxiety to 10 Most Anxiety | Mean | Standard Deviation | units on a scale |
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| Systolic Blood Pressure | CDC Normal Overall Mean Systolic Blood Pressure <120 Elevate risk for hypertension: >129 Stage 1 hypertension: 130-139 Stage 2 hypertension 140-180 Potential hypertensive Crisis: >180 | Mean | Standard Deviation | mmHg |
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| Diastolic Blood Pressure | Accord to CDC: Normal - <80 At Risk - 80-89 for Hypertension Higher Risk - >90 for Hypertension | Mean | Standard Deviation | mmHg |
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| Heart Rate | According to the CDC Avg resting heart rate for adults - 60-100 beats per minute (BPM) Above 100 - may need medical attention Above 140 - may be dangerous | Mean | Standard Deviation | bpm |
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| OG001 | 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 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. |
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| Primary | Visual Analog Score (VAS) at the End of the Appointment | 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. | Posted | Mean | Standard Deviation | units on a scale | End of the appointment, approximately 90+ minutes after baseline |
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| Primary | Systolic Blood Pressure (SBP) 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. | Posted | Mean | Standard Deviation | mmHg | End of the appointment, approximately 90+ minutes after baseline |
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| 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. | Posted | Mean | Standard Deviation | mmHg | End of the appointment, approximately 90+ minutes after baseline |
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| Primary | Heart Rate (HR) at the End of the Appointment | 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. | Posted | Mean | Standard Deviation | bpm | End of the appointment, approximately 90+ minutes after baseline |
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| Primary | State-Trait Anxiety Inventory Trait Sub-scale (STAI-T) Score at the End of the Appointment | 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. | Posted | Mean | Standard Deviation | units on a scale | End of the appointment, approximately 90+ minutes after baseline |
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| 0 |
| 30 |
| 0 |
| 30 |
| 0 |
| 30 |
| EG001 | Relaxation Virtual Reality | Participants will receive virtual reality headsets and choose a VR 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. | 0 | 28 | 0 | 28 | 0 | 28 |
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