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

Not Applicable

Withdrawn

• Conditions: Pain
• Interventions: Behavioral: Stress ball; Behavioral: Hidden object

• Registration Number: NCT04595721
• Lead Sponsor: 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.

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 Timeline

• Study First Submitted: 2020-10-14
• Study First Submitted QC: 2020-10-14
• Study First Posted: 2020-10-20
• Study Start: 2022-03
• Status Verified: 2022-04
• Last Update Submitted: 2022-04-12
• Last Update Posted: 2022-04-20
• Primary Completion: 2022-07
• Study Completion: 2022-07

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Physical distraction	Stress ball	Participants engage in physical distraction during the injection procedures
Visual distraction	Hidden object	Participants engage in visual distraction during the injection procedures

Primary Outcome Measures

Name	Time	Method
Change in pain	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)