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

Study Overview
=================
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.

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

Conditions
-----------------
Pain

Intervention / Treatment
-----------------
* Behavioral: Hidden object
* Behavioral: Stress ball


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Standard of care<br>Participants will receive standard injection procedures | |
| Active Comparator: Visual distraction<br>Participants engage in visual distraction during the injection procedures | Behavioral: Hidden object<br>* 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.<br>|
| Active Comparator: Physical distraction<br>Participants engage in physical distraction during the injection procedures | Behavioral: Stress ball<br>* Participants will be handed a single-use, squeezable stress ball and instructed to squeeze the stress ball.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Dental pain