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

Sponsor
Virginia Commonwealth University (Other)
Overall Status
Withdrawn
CT.gov ID
NCT04595721
Collaborator
(none)
0
3
4

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Hidden object
  • Behavioral: Stress ball
N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
0 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Supportive Care
Official Title:
Comparison of Physical Versus Visual Distraction in the Reduction of Pain During Local Anesthesia
Anticipated Study Start Date :
Mar 1, 2022
Anticipated Primary Completion Date :
Jul 1, 2022
Anticipated Study Completion Date :
Jul 1, 2022

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. 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)

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Virginia Commonwealth University

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Virginia Commonwealth University
ClinicalTrials.gov Identifier:
NCT04595721
Other Study ID Numbers:
  • HM20020881
First Posted:
Oct 20, 2020
Last Update Posted:
Apr 20, 2022
Last Verified:
Apr 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Virginia Commonwealth University

Study Results

No Results Posted as of Apr 20, 2022