The Impact of Medical Play in the Dental Clinic Setting on the Cooperation of Neurotypical Patients
NCT ID: NCT05571423
Last Updated: 2024-02-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
100 participants
INTERVENTIONAL
2022-10-01
2025-10-31
Brief Summary
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The specific aims of the study are as follows:
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. 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. 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. 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. To evaluate patient perceptions of the dental exam, visit when medical play is used in comparison to dental exam visits without medical play.
The hypotheses are as follows:
1. Subjects will have increased positive behaviors and improved cooperation during dental exam visits when medical play is utilized beforehand.
2. Providers will report improved behavior and cooperation from patients when medical play is utilized beforehand.
3. Parents will report improved behavior and cooperation from their children and report greater satisfaction with the dental visit when medical play is utilized beforehand.
4. 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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Medical Play Intervention
This group of participants will be engaged in medical play before the dental exam visit.
Medical Play
Study subject will be engage in the medical play.
Routine Play Intervention
This group of participants be engaged in routine play (coloring exercise) before the dental exam visit.
Routine Play
Study subject will be engage in the routine play (coloring exercise).
Interventions
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Medical Play
Study subject will be engage in the medical play.
Routine Play
Study subject will be engage in the routine play (coloring exercise).
Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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
5 Years
10 Years
ALL
Yes
Sponsors
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University of Colorado, Denver
OTHER
Responsible Party
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Principal Investigators
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Chaitanya P Puranik, BDS,MS,PhD
Role: PRINCIPAL_INVESTIGATOR
University of Colorado, Denver
Locations
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Children's Hospital of Colorado Health Pavilion-Dental Clinic
Aurora, Colorado, United States
Countries
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Central Contacts
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Facility Contacts
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References
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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.
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.
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.
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.
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.
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.
Other Identifiers
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22-1302
Identifier Type: -
Identifier Source: org_study_id
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