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

NCT ID: NCT04595721

Last Updated: 2022-04-20

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-03-31
• Study Completion Date: 2022-07-31

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.

Conditions

Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Standard of care

Participants will receive standard injection procedures

Group Type: NO_INTERVENTION

No interventions assigned to this group

Visual distraction

Participants engage in visual distraction during the injection procedures

Group Type: ACTIVE_COMPARATOR

Hidden object

Intervention Type: 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.

Physical distraction

Participants engage in physical distraction during the injection procedures

Group Type: ACTIVE_COMPARATOR

Stress ball

Intervention Type: BEHAVIORAL

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

Interventions

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.

Intervention Type: BEHAVIORAL

Stress ball

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

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Virginia Commonwealth University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Louis Formica, DDS

Role: PRINCIPAL_INVESTIGATOR

Virginia Commonwealth University

Other Identifiers

HM20020881

Identifier Type: -

Identifier Source: org_study_id