Improving Children's Cooperation During Dental Injection

NCT03978390 | Withdrawn

• 1 other identifier: Pro00091797
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

This clinical trial aims to investigate how to increase children cooperation in dental settings using ideas adopted from psychology to make an effective interdisciplinary approach. We want to test how showing images of mainstream superheroes such as Superman, Batman, etc. can prepare children, 6-12 years old, to behave desirably during the dental injection. Also, new modification will be applied to providing awards to children by telling them that they can keep the rewards they receive before starting the procedure only if they behave accordingly during the treatment. Moreover, it will be shown that if children's baseline psychological characteristic, age, gender, and family income affect their cooperation in the dental office. The results of this study help to manage children's behavior more efficiently in the clinical settings which is crucial to achieving effective treatment.

Conditions

Child Behavior; Acute Pain

Keywords

Dental Injection; Behavioral Intervention; Behavioral Priming; Endowment Effect; Personality Traits

Outcome Measures

Primary Outcomes (1)

• Behavior of the children during the dental injection

  Accessing behavior of children during dental injection (from the time of needle penetration until taking out the needle) using Frankl's scale which categorize behaviors into four levels i.e. 1. definitely negative 2. negative 3. positive 4. definitely positive

  Approximately 20 seconds

Study Arms (4)

Superhero images, Reward at the beginning,

EXPERIMENTAL

Also, Showing superhero images for 5 minutes before starting the dental procedure. Also, providing the children with reward before begging the dental procedure and telling them that they can only keep it if they cooperate during the treatment procedure.

Behavioral: behavioral priming; Behavioral: endowment effect

Superhero images, Reward at the end

EXPERIMENTAL

Universally-accepted positive reinforcement to increase children cooperation in dental settings

Behavioral: behavioral priming; Behavioral: Positive reinforcement

No Superhero Images, Reward at the beginning

EXPERIMENTAL

Showing superhero images for 5 minutes before starting the dental procedure

Behavioral: endowment effect

No Superhero Images, Reward at the end

ACTIVE COMPARATOR

Showing no picture before starting the dental procedure

Behavioral: Positive reinforcement

Interventions

behavioral priming BEHAVIORAL

Priming the children with images of superheroes in order to behave desirably during the dental injection

Superhero images, Reward at the beginning,; Superhero images, Reward at the end

endowment effect BEHAVIORAL

Giving the rewards to children before starting the dental treatment and telling children they can only keep it if they behave desirably during the dental procedure

No Superhero Images, Reward at the beginning; Superhero images, Reward at the beginning,

Positive reinforcement BEHAVIORAL

Giving rewards to the children at the end if they cooperate desirably during the treatment

No Superhero Images, Reward at the end; Superhero images, Reward at the end

Eligibility Criteria

• Age: 6 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• children who need dental treatment and injection
• children between 6 to 12 years old
• children without severe or chronic orofacial pain
• children without chronic systemic disease
• children who had not dental injection in the past six months
• children whose parents are present at the operation room

You may not qualify if:

• being a non-English speaker
• children whose parents are not willing their child to be videotaped or participate in the study
• history of post-traumatic stress disorders or specific phobia related to the dental settings
• children who supposed to have a dental extraction
• children who stay in the waiting room for more than one hour

Sponsors & Collaborators

• University of Alberta: lead

MeSH Terms

Conditions

Child Behavior; Acute Pain

Condition Hierarchy (Ancestors)

Behavior; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Mohammad Moharrami, DDS

  University of Alberta

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 5, 2019
• First Posted: June 7, 2019
• Study Start: June 12, 2019
• Primary Completion: June 12, 2019
• Study Completion: June 12, 2019
• Last Updated: July 27, 2020

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will not share