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

NCT04595721 | Withdrawn

• 1 other identifier: HM20020881
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Pain

Keywords

Dental pain

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (3)

Standard of care

NO INTERVENTION

Participants will receive standard injection procedures

Visual distraction

ACTIVE COMPARATOR

Participants engage in visual distraction during the injection procedures

Behavioral: Hidden object

Physical distraction

ACTIVE COMPARATOR

Participants engage in physical distraction during the injection procedures

Behavioral: Stress ball

Interventions

Hidden object BEHAVIORAL

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.

Visual distraction

Stress ball BEHAVIORAL

Participants will be handed a single-use, squeezable stress ball and instructed to squeeze the stress ball.

Physical distraction

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Virginia Commonwealth University: lead

MeSH Terms

Conditions

Pain; Toothache

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Tooth Diseases; Stomatognathic Diseases; Facial Pain

Study Officials

• Louis Formica, DDS

  Virginia Commonwealth University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 14, 2020
• First Posted: October 20, 2020
• Study Start: March 1, 2022
• Primary Completion: July 1, 2022
• Study Completion: July 1, 2022
• Last Updated: April 20, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share