Effect of Verbal Positive Reinforcement, Contingent Escape and Rewarding on Behaviour of Children Undergoing Primary Molar Pulpotomy: a Randomized Clinical Study

NCT06524154 | Active Not Recruiting

• 1 other identifier: A01012023PP
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study to evaluate the effect of verbal positive reinforcement, contingent escape and rewarding on behaviour of children undergoing primary molar pulpotomy.

Conditions

Dental Anxiety

Keywords

dental anxiety; Contingent Escape; Positive Reinforcement,; Pulpotomy; Behavior management

Outcome Measures

Primary Outcomes (1)

• RMS Pictorial Scale (RMS-PS)

  The pictorial Scale (RMS) compromise's a row of five faces ranging from very happy very unhappy. The children will be asked to choose the face they feel like about themselves at that moment. The scale will be scored by giving a value of one to the very happy face and five to the very unhappy face

  12 weeks

Secondary Outcomes (1)

• Frankl Behavior Rating Scale

  12 weeks

Other Outcomes (1)

• Pulse oximeter

  12 weeks

Study Arms (3)

positive reinforcement

EXPERIMENTAL

apply normal treatment with praising the child with encouraging words and pleasing smiles.

Behavioral: positive reinforcement

contingent escape

EXPERIMENTAL

apply normal treatment with giving some rest of the procedure while the child on the chair.

Behavioral: contingent escape

rewarding the child

EXPERIMENTAL

apply normal treatment with giving simple gifts like stickers at the end of the procedure. 8

Behavioral: rewarding

Interventions

positive reinforcement BEHAVIORAL

normal treatment with with praising the child with encouraging words and pleasing smiles.

positive reinforcement

rewarding BEHAVIORAL

normal treatment with giving simple gifts like stickers at the end of the procedure.

rewarding the child

contingent escape BEHAVIORAL

normal treatment with giving some rest of the procedure while the child on the chair.

contingent escape

Eligibility Criteria

• Age: 4 Years - 6 Years
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Children aged between 4 to 6 years of both sexes.
• Children with behavior rating score 2,3 or 4 of Frankl 's behavior rating scale.
• Children with carious lesions indicated for pulpotomy.
• Restorable primary molars.

You may not qualify if:

• Children with special health care needs.
• Children suffering from systemic diseases.
• Unrestorable tooth.
• Extremely uncooperative children.

Sponsors & Collaborators

• Mansoura University: lead

Study Sites (1)

Mansoura University

Al Mansurah, Dakahlia Governorate, 35511, Egypt

Location

Study Officials

• khalid m aldhafeeri, master

  Researcher of Pediatric Dentistry Faculty of Dentistry Mansoura University

  PRINCIPAL INVESTIGATOR

• abeer Mostafa A, Prof

  Professor and Head of Pediatric Dentistry Department- Department of Pediatric Dentistry- Faculty of Dentistry- Mansoura University

  STUDY DIRECTOR

• Rizk A Elagamy, PhD

  lecturer Pediatric Dentistry Department- Department of Pediatric Dentistry- Faculty of Dentistry- Mansoura University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Model Details: The study sample will comprise three groups, 14 children each randomly chosen. Group I: positive reinforcement, with praising the child with encouraging words and pleasing smiles. Group II: contingent escape, by giving some rest of the procedure while the child on the chair. Group III: rewarding the child with simple gifts like stickers at the end of the procedure.

Study Record Dates

• First Submitted: July 23, 2024
• First Posted: July 29, 2024
• Study Start: January 24, 2024
• Primary Completion: July 4, 2024
• Study Completion: March 3, 2025
• Last Updated: July 29, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)