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

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

Study Overview

• Status: Withdrawn
• Conditions: Pain
• Intervention / Treatment: Behavioral: Hidden object; Behavioral: Stress ball

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.

• Study Type: Interventional
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in pain	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)	Up to 30 minutes

Collaborators and Investigators

• Sponsor: Virginia Commonwealth University
• Investigators: Principal Investigator: Louis Formica, DDS, Virginia Commonwealth University

Study record dates

Study Major Dates

• Study Start (Anticipated): March 1, 2022
• Primary Completion (Anticipated): July 1, 2022
• Study Completion (Anticipated): July 1, 2022

Study Registration Dates

• First Submitted: October 14, 2020
• First Submitted That Met QC Criteria: October 14, 2020
• First Posted (Actual): October 20, 2020

Study Record Updates

• Last Update Posted (Actual): April 20, 2022
• Last Update Submitted That Met QC Criteria: April 12, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Keywords: Dental pain
• Other Study ID Numbers: HM20020881

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No