Dental PhobiaNCT05571423
The Impact of Medical Play in the Dental Clinic Setting on the Cooperation of Neurotypical Patients
A study testing Medical Play and Routine Play in people with Dental Phobia and Dental Anxiety, run by University of Colorado, Denver at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 5 to 10 yearsHealthy volunteers can take part
- Conditions the study is for
- Dental Phobia, Dental Anxiety, Oral Aversion
- What is being tested?
- Medical Play and Routine Play
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2022to Oct 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 10 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Children's Hospital of Colorado Health Pavilion-Dental Clinic
Aurora, Colorado, 80011
Chaitanya P Puranik, BDS,MS,PhD, 720-777-2719, chaitanya.puranik@childrenscolorado.org
Dominique E Bertucci, D.M.D., 3126071029, dominique.bertucci@childrenscolorado.org
About this study
Official title: The Impact of Medical Play in the Dental Clinic Setting on the Cooperation of Neurotypical Patients at Children's Hospital Colorado Dental Center
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:
Read more
- 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.
- 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.
- 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.
- 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.
- 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:
- Subjects will have increased positive behaviors and improved cooperation during dental exam visits when medical play is utilized beforehand.
- Providers will report improved behavior and cooperation from patients when medical play is utilized beforehand.
- Parents will report improved behavior and cooperation from their children and report greater satisfaction with the dental visit when medical play is utilized beforehand.
- 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.
Read the detailed description
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).
- Conditions
- Dental Phobia, Dental Anxiety, Oral Aversion
- Being tested
- Medical Play, Routine Play
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Medical PlayBehavioural
Study subject will be engage in the medical play.
Routine PlayBehavioural
Study subject will be engage in the routine play (coloring exercise).
| Study group | Role | What they receive |
|---|---|---|
| Medical Play Intervention | Active comparator | This group of participants will be engaged in medical play before the dental exam visit. Receives: Behavioral: Medical Play |
| Routine Play Intervention | Placebo comparator | This group of participants be engaged in routine play (coloring exercise) before the dental exam visit. Receives: Behavioral: Routine Play |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: baseline (post-intervention)
Secondary outcomes (3)
Pre-intervention parental perceptions about their child's behavior
- My child appears worried during dental visits.
- My child initially refuses to enter the room.
- My child initially refuses to sit on the dental chair.
- My child sits in a chair other than the dental chair or on the ground, or stands, during visits.
- My child appears anxious about the dental provider brushing his/her teeth.
- My child will not easily cooperate for a regular dental cleaning.
- The dental provider is only able to use the regular toothbrush and cannot use the electrical cleaning brush for my child's teeth during the dental visit.
- My child appears worried about the dentist using the dental mirror to check his/her teeth.
- The dental provider cannot use the dental mirror and has to look at the teeth directly.
- The dental provider is not able to use a dental explorer to check my child's teeth.
- My child needs frequent breaks during dental visits.
- My child will not allow the dental provider to apply fluoride varnish on his/her teeth.
Measured: 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:
- How do you feel about going to visit the dentist?
- How do you feel about having your teeth looked at?
- How do you feel about having your teeth cleaned and polished?
5 options include:
- relaxed/not worried
- very slightly worried
- fairly worried
- worried a lot
- very worried
Measured: 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:
- Do you feel your child's behavior improved today compared to past dental visits? Will be evaluated as: 0. no change. 1. little improvement. 2. Improved. 3. significant improvement. or 4. not sure
- Do you feel that the intervention/session before dental exam was helpful for your child's behavior and cooperation at today's visit? Will be evaluated as: 0. not helpful. 1. little helpful. 2. helpful. 3. significantly helpful. or 4. not sure
- Would you want to use the same intervention/session for your child before future dental visits? Will be evaluated as 0.never. 1. maybe. 2. yes. 3. not sure.
Measured: baseline (pre-intervention), post-intervention (immediately after dental visit)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2022
- Study start1 Oct 2022
- Primary completionOct 2025 (estimated)
- Study completionOct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Dental PhobiaStudies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Prospective, randomized clinical controlled trial
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Chaitanya P Puranik, BDS,MS,PhD, Principal investigator, University of Colorado, Denver
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05571423
- Sponsor's protocol ID
- 22-1302
- Status last verified
- Jan 2024
- First submitted
- 5 Oct 2022
- Last updated
- 1 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 30787555Hinze 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.
PubMed 32847664Romito 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.
PubMed 33372119Sridhar 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.
PubMed 30887592He 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.
PubMed 25561079Li 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.
PubMed 26969158
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Medical Play in the Dental Clinic Setting on the Cooperation of Neurotypical Patients at Children's Hospital Colorado Dental Center
- ClinicalTrials.gov ID
- NCT05571423
- Acronym / sponsor ID
- 22-1302
- Conditions
- Dental Phobia, Dental Anxiety, Oral Aversion
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Study start
- 1 Oct 2022 (actual)
- Primary completion
- Oct 2025 (estimated)
- Study completion
- Oct 2025 (estimated)
- First posted
- 7 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
- 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.
- 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.
- 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.
- 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:
- Subjects will have increased positive behaviors and improved cooperation during dental exam visits when medical play is utilized beforehand.
- Providers will report improved behavior and cooperation from patients when medical play is utilized beforehand.
- Parents will report improved behavior and cooperation from their children and report greater satisfaction with the dental visit when medical play is utilized beforehand.
- 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.
Detailed description
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
- Model description
- Prospective, randomized clinical controlled trial
| Arm | Type | Receives |
|---|---|---|
| Medical Play Intervention | Active comparator | Behavioral: Medical PlayThis group of participants will be engaged in medical play before the dental exam visit. |
| Routine Play Intervention | Placebo comparator | Behavioral: Routine PlayThis group of participants be engaged in routine play (coloring exercise) before the dental exam visit. |
Who may qualify
- Ages
- 5 to 10 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Medical PlayStudy subject will be engage in the medical play. | Behavioural | Medical Play Intervention |
| Routine PlayStudy subject will be engage in the routine play (coloring exercise). | Behavioural | Routine Play Intervention |
Primary outcome
Behavior as measured by Frankl score
Time frame: baseline (post-intervention)
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.
Completion of Components of dental examination
Time frame: baseline (post-intervention)
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.
3 secondary outcomes
Pre-intervention parental perceptions about their child's behavior
Time frame: baseline (pre-intervention), post-intervention (immediately after dental visit)
Patient perception before and after dental visit
Time frame: baseline (pre-intervention), post-intervention (immediately after dental visit)
Post-intervention parental perceptions about their child's behavior
Time frame: baseline (pre-intervention), post-intervention (immediately after dental visit)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Feb 2024.
- Background: PubMed 30787555Dp 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.
- Background: PubMed 32847664Hinze 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.
- Background: PubMed 33372119Romito 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.
- Background: PubMed 30887592Sridhar 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.
- Background: PubMed 25561079He 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.
- Background: PubMed 26969158Li 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chaitanya P Puranik, BDS,MS,PhD principal investigator
University of Colorado, Denver
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Medical Play and Routine Play in people with Dental Phobia and Dental Anxiety, run by University of Colorado, Denver at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Chaitanya P Puranik, BDS,MS,PhD (7207772719, chaitanya.puranik@childrenscolorado.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Behavior as measured by Frankl score (time frame: baseline (post-intervention)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05571423, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Feb 2024.