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Trial record 9 of 61 for:    pain | First posted from 10/14/2020 to 10/20/2020

Comparison of Physical Versus Visual Distraction in the Reduction of Pain During Local Anesthesia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT04595721
Recruitment Status : Not yet recruiting
First Posted : October 20, 2020
Last Update Posted : July 28, 2021
Information provided by (Responsible Party):
Virginia Commonwealth University

Brief Summary:
The purpose of this study is to compare physical versus visual distractions to determine which technique reduces perceived pain better during local anesthesia injections.

Condition or disease Intervention/treatment Phase
Pain Behavioral: Hidden object Behavioral: Stress ball Not Applicable

Detailed Description:
Before the local anesthesia injection, patients will be asked to give a preliminary VAS score based on what level of pain 0-10 they anticipate they will feel during the local anesthesia injection. Following the injection the participant will be asked to quantify the pain felt during the injection on a 0-10 Visual analog scale (VAS). The VAS scores will only be taken from the first injection of the appointment. Participants will be asked their gender, race, age, geographic location they spent most of their lives as well. Participants will be de-identified and randomly assigned a number that will be recorded along with their collected data on a two-factor, password protected web server. Information collected during this study may be used for further analysis and publication.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 149 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Comparison of Physical Versus Visual Distraction in the Reduction of Pain During Local Anesthesia
Estimated Study Start Date : September 2021
Estimated Primary Completion Date : May 2022
Estimated Study Completion Date : May 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Health Checkup

Arm Intervention/treatment
No Intervention: Standard of care
Participants will receive standard injection procedures
Active Comparator: Visual distraction
Participants engage in visual distraction during the injection procedures
Behavioral: Hidden object
Participant will be instructed to look at the hidden object image on the overhead light to look for a number of objects and observe the image.

Active Comparator: Physical distraction
Participants engage in physical distraction during the injection procedures
Behavioral: Stress ball
Participants will be handed a single-use, squeezable stress ball and instructed to squeeze the stress ball.

Primary Outcome Measures :
  1. Change in pain [ Time Frame: Up to 30 minutes ]
    Participants will be asked to rate their pain on a visual analog pain scale. The scale is rated from 0 (no pain) to 10 (pain as bad as it can be)

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Patients needing a dental procedure that requires a buccal infiltration with Septocaine 1:100,000 epinephrine (EPI) (Articaine hydrochloride 4% and EPI 1:100,000) or an inferior alveolar nerve block injection with 2% lidocaine with 1:100,000 epinephrine.
  • Adults greater than 18 years old.
  • Patients with limited English proficiency will be included only if their primary language is Spanish.

Exclusion Criteria:

  • Patients with a known or suspected allergy to anesthetic agent, sulfites, amide-type local anesthetic, or to any ingredient in anesthetic solutions will not be included.
  • Any patients taking medications affecting pain response on the day of the dental appointment.
  • Children younger than 18 years old.
  • Patients with limited English proficiency with a primary language other than Spanish

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT04595721

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Contact: Caclinh Le 804 396 2965
Contact: Joshua Cardinal 385-777-6706

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United States, Virginia
Virginia Commonwealth University
Richmond, Virginia, United States, 23298
Sponsors and Collaborators
Virginia Commonwealth University
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Principal Investigator: Louis Formica, DDS Virginia Commonwealth University
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Responsible Party: Virginia Commonwealth University Identifier: NCT04595721    
Other Study ID Numbers: HM20020881
First Posted: October 20, 2020    Key Record Dates
Last Update Posted: July 28, 2021
Last Verified: July 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Virginia Commonwealth University:
Dental pain