Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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:
The hypotheses are as follows:
The purpose of this study is to investigate the efficacy of medical play to improve the behaviors and cooperation of patients during routine dental exam visits at Children's Hospital Colorado Dental Center through a prospective, randomized controlled trial. The specific aims of this study are to: (1) evaluate differences in behaviors and cooperation levels of subjects utilizing medical play during routine dental exam visits in comparison to those undergoing a routine dental exam visit without use of medical play; (2) 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) evaluate provider perceptions of the behavior and cooperation of children using medical play during dental exam visits compared to dental exam visits without medical play; (4) evaluate caregiver perceptions of the behavior and cooperation of children using medical play during dental exam visits compared to dental exam visits without medical play; and (5) evaluate patient perceptions of the dental exam visit when medical play is used in comparison to dental exam visits without medical play. To investigate these specific aims, this study will involve recruiting up to 100 neurotypical patients, ages 5-10 years old, who will be seen for their dental exam visits who were previously identified by providers using the Frankl Behavior Rating Scale as Frankl 1 and Frankl 2. Subjects meeting including criteria were screened and offered participating in the study using a telephonic script. Patients agreeing for participation were screened for inclusion and exclusion criteria when they report for routine dental exam and cleaning using pre-screening consent script. Study information, patient rights including voluntary participation and withdrawal of consent without consequences will be provided and informed consent or assent will be collected. The recruited subjects will be randomly divided into two groups so that one group of participants will engage in medical play before the dental exam visit and the other group will be engaged to routine play (coloring exercise) before their dental exam visit. The provider will be blinded to whether the intervention (medical or routine play) before the dental exam visit. The caregivers will complete Dental Behavior Assessment survey before while post-visit survey after the visit to help assess their perceptions of their child's behaviors before and after the visit, respectively. The subjects will also rate their perceived well-being before and after the dental visit using the Modified Child Dental Anxiety Scale - Faces Version. The provider will record patient behavior using a Frankl behavior rating scale and levels of cooperation (which components of the dental exam were completed without coaxing beyond two minutes).
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Medical Play Intervention | Active Comparator | This group of participants will be engaged in medical play before the dental exam visit. |
|
| Routine Play Intervention | Placebo Comparator | This group of participants be engaged in routine play (coloring exercise) before the dental exam visit. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Medical Play | Behavioral | Study subject will be engage in the medical play. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| Pre-intervention parental perceptions about their child's behavior |
|
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Chaitanya P Puranik, BDS,MS,PhD | Contact | 7207772719 | chaitanya.puranik@childrenscolorado.org | |
| Dominique E Bertucci, D.M.D. | Contact | 3126071029 | dominique.bertucci@childrenscolorado.org |
| Name | Affiliation | Role |
|---|---|---|
| Chaitanya P Puranik, BDS,MS,PhD | University of Colorado, Denver | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Children's Hospital of Colorado Health Pavilion-Dental Clinic | Recruiting | Aurora | Colorado | 80011 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30787555 | Background | 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. | |
| 32847664 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Prospective, randomized clinical controlled trial
Not provided
Not provided
The dental providers and study subjects will be blinded to the intervention: medical or routine play
| Routine Play |
| Behavioral |
Study subject will be engage in the routine play (coloring exercise). |
|
| baseline (pre-intervention), post-intervention (immediately after dental visit) |
| Patient perception before and after dental visit | Provided by Modified Child Dental Anxiety Scale - Faces Version (MCDAS-f). 5 different depictions of faces ranging from very worried to worried are included in the options. Children will point or circle how they feel about the following three questions:
5 options include:
| baseline (pre-intervention), post-intervention (immediately after dental visit) |
| Post-intervention parental perceptions about their child's behavior | A Post visit parent survey will include 3 questions:
| baseline (pre-intervention), post-intervention (immediately after dental visit) |
| 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. |
| 33372119 | 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. |
| 30887592 | 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. |
| 25561079 | 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. |
| 26969158 | 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. |