The Impact of Medical Play in the Dental Clinic Setting on the Cooperation of Neurotypical Patients

NCT05571423 | Unknown

• 1 other identifier: 22-1302
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this pilot study is to investigate the efficacy of medical play in the dental setting to improve the behaviors and cooperation of neurotypical patients during dental visits. The specific aims of the study are as follows:

1. 1.To evaluate differences in behaviors and cooperation levels of subjects utilizing medical play before a routine dental exam visit in comparison to those undergoing a routine dental exam visit without use of medical play.
2. 2.To evaluate whether subjects who have a dental exam visit, with or without use of medical play, show improved behaviors and improved completion of components of the dental exam compared to their previous routine dental visit.
3. 3.To evaluate provider perceptions of the behavior and cooperation of children using medical play before dental exam visits compared to dental exam visits without medical play.
4. 4.To evaluate caregiver perceptions of the behavior and cooperation of children using medical play before dental exam visits compared to dental exam visits without medical play.
5. 5.To evaluate patient perceptions of the dental exam, visit when medical play is used in comparison to dental exam visits without medical play.
6. 6.Subjects will have increased positive behaviors and improved cooperation during dental exam visits when medical play is utilized beforehand.
7. 7.Providers will report improved behavior and cooperation from patients when medical play is utilized beforehand.
8. 8.Parents will report improved behavior and cooperation from their children and report greater satisfaction with the dental visit when medical play is utilized beforehand.
9. 9.Patients will report experiencing less anxiety, via the Modified Child Dental Anxiety Scale - Faces Version (MCDAS-f) after appointments in which medical play is utilized.

Conditions

Dental Phobia; Dental Anxiety; Oral Aversion

Outcome Measures

Primary Outcomes (2)

• Behavior as measured by Frankl score

  This outcome will evaluate differences in behaviors and cooperation levels of subjects engaged in medical play during routine dental exam visits in comparison to those engaged in routine play before their dental exam visit. The subject's behaviors categorized according to the Frankl score which is a standardized ordinal scale to categorize patient behaviors in the dental clinic setting. This score will be determined at the end of the dental visit by the dental provider and compared to the previous routine dental visit for the same subject. Frankl Behavior Rating Scale is between 1-4 and the scoring is as follows: 1 = definitely negative, 2 = negative, 3 = positive, and 4 = definitely positive.

  baseline (post-intervention)

• Completion of Components of dental examination

  This outcome will evaluate whether subjects who have a dental exam visit, with medical or routine play, show completion of components of the dental exam compared to their previous routine dental visit. The subject's level of cooperation which will be determined by the number of procedures completed during the routine dental check-up visit which will consist of (1) a dental cleaning (rubber cup or toothbrush prophylaxis), (2) a dental examination (completed with mouth mirror and explorer), and (3) a fluoride varnish application. The number of procedures completed with or without difficulty will be compared to those completed at a previous routine dental visit.

  baseline (post-intervention)

Secondary Outcomes (3)

• Pre-intervention parental perceptions about their child's behavior

  baseline (pre-intervention), post-intervention (immediately after dental visit)

• Patient perception before and after dental visit

  baseline (pre-intervention), post-intervention (immediately after dental visit)

• Post-intervention parental perceptions about their child's behavior

  baseline (pre-intervention), post-intervention (immediately after dental visit)

Study Arms (2)

Medical Play Intervention

ACTIVE COMPARATOR

This group of participants will be engaged in medical play before the dental exam visit.

Behavioral: Medical Play

Routine Play Intervention

PLACEBO COMPARATOR

This group of participants be engaged in routine play (coloring exercise) before the dental exam visit.

Behavioral: Routine Play

Interventions

Medical Play BEHAVIORAL

Study subject will be engage in the medical play.

Medical Play Intervention

Routine Play BEHAVIORAL

Study subject will be engage in the routine play (coloring exercise).

Routine Play Intervention

Eligibility Criteria

• Age: 5 Years - 10 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Previously identified as Frankl 1 or Frankl 2 per the electronic dental record during dental exam visits (Epic)
• Child subject is neurotypical
• Patient of record at Children's Hospital Colorado Dental Center
• Child subject is 5-10 years of age
• Caregiver must be the child's legal guardian

You may not qualify if:

• Previously identified as Frankl 3 or Frankl 4 per the electronic dental record during dental exam visits (Epic)
• Children who have not previously received care at the Children's Hospital Colorado Dental Center
• Children that have a diagnosis of Autism or other neurologically atypical diagnosis
• Children not in the age range of 5-10 years
• Adult in attendance to dental visit with child is not the legal guardian

Sponsors & Collaborators

• University of Colorado, Denver: lead

Study Sites (1)

Children's Hospital of Colorado Health Pavilion-Dental Clinic

Aurora, Colorado, 80011, United States

RECRUITING

Related Publications (6)

• Dp Kiran S, Vithalani A, J Sharma D, C Patel M, Bhatt R, Srivastava M. Evaluation of the Efficacy of Play Therapy among Children Undergoing Dental Procedure through Drawings Assessed by Graphological Method: A Clinical Study. Int J Clin Pediatr Dent. 2018 Sep-Oct;11(5):412-416. doi: 10.5005/jp-journals-10005-1549. Epub 2018 Oct 1.

  PMID: 30787555 BACKGROUND

• Hinze T, McDonald C, Kerins CA, McWhorter AG. Child Life Interventions for Pediatric Dental Patients: A Pilot Study. Pediatr Dent. 2020 Jul 15;42(4):252-255.

  PMID: 32847664 BACKGROUND

• Romito B, Jewell J, Jackson M; AAP COMMITTEE ON HOSPITAL CARE; ASSOCIATION OF CHILD LIFE PROFESSIONALS. Child Life Services. Pediatrics. 2021 Jan;147(1):e2020040261. doi: 10.1542/peds.2020-040261.

  PMID: 33372119 BACKGROUND

• Sridhar S, Suprabha BS, Shenoy R, Shwetha KT, Rao A. Effect of a relaxation training exercise on behaviour, anxiety, and pain during buccal infiltration anaesthesia in children: Randomized clinical trial. Int J Paediatr Dent. 2019 Sep;29(5):596-602. doi: 10.1111/ipd.12497. Epub 2019 Apr 8.

  PMID: 30887592 BACKGROUND

• He HG, Zhu L, Chan SW, Liam JL, Li HC, Ko SS, Klainin-Yobas P, Wang W. Therapeutic play intervention on children's perioperative anxiety, negative emotional manifestation and postoperative pain: a randomized controlled trial. J Adv Nurs. 2015 May;71(5):1032-43. doi: 10.1111/jan.12608. Epub 2015 Jan 6.

  PMID: 25561079 BACKGROUND

• Li WHC, Chung JOK, Ho KY, Kwok BMC. Play interventions to reduce anxiety and negative emotions in hospitalized children. BMC Pediatr. 2016 Mar 11;16:36. doi: 10.1186/s12887-016-0570-5.

  PMID: 26969158 BACKGROUND

Study Officials

• Chaitanya P Puranik, BDS,MS,PhD

  University of Colorado, Denver

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Chaitanya P Puranik, BDS,MS,PhD

CONTACT

7207772719; chaitanya.puranik@childrenscolorado.org

Dominique E Bertucci, D.M.D.

CONTACT

3126071029; dominique.bertucci@childrenscolorado.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Masking Details: The dental providers and study subjects will be blinded to the intervention: medical or routine play
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Prospective, randomized clinical controlled trial

Study Record Dates

• First Submitted: October 5, 2022
• First Posted: October 7, 2022
• Study Start: October 1, 2022
• Primary Completion: October 1, 2025
• Study Completion: October 1, 2025
• Last Updated: February 1, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)