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

Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04595721
• Other study ID #: HM20020881
• Status: Withdrawn
• Phase: N/A
• Start date: March 2022
• Est. completion date: July 2022

Study information

• Verified date: April 2022
• Source: Virginia Commonwealth University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: July 2022
• Est. primary completion date: July 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Pain

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Virginia Commonwealth University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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