Dental AnxietyNCT06524154
Effect of Verbal Positive Reinforcement, Contingent Escape and Rewarding on Behaviour of Children Undergoing Primary Molar Pulpotomy: a Randomized Clinical Study
A study testing positive reinforcement, rewarding and contingent escape in people with Dental Anxiety, run by Mansoura University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 4 to 6 yearsHealthy volunteers can take part
- Conditions the study is for
- Dental Anxiety
- What is being tested?
- positive reinforcement, rewarding and contingent escape
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteEgypt
- Study dates
- 24 Jan 2024to 3 Mar 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 4 to 6 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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.
Who cannot join
- Children with special health care needs.
- Children suffering from systemic diseases.
- Unrestorable tooth.
- Extremely uncooperative children.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed description
this study evaluated Effect of Verbal Positive Reinforcement, Contingent Escape and Rewarding on Behaviour of Children Undergoing Primary Molar Pulpotomy
- Conditions
- Dental Anxiety
- Being tested
- positive reinforcement, rewarding, contingent escape
- Keywords
- dental anxiety, Contingent Escape, Positive Reinforcement,, Pulpotomy, Behavior management
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
positive reinforcementBehavioural
normal treatment with with praising the child with encouraging words and pleasing smiles.
rewardingBehavioural
normal treatment with giving simple gifts like stickers at the end of the procedure.
contingent escapeBehavioural
normal treatment with giving some rest of the procedure while the child on the chair.
| Study group | Role | What they receive |
|---|---|---|
| positive reinforcement | Experimental | apply normal treatment with praising the child with encouraging words and pleasing smiles. Receives: Behavioral: positive reinforcement |
| contingent escape | Experimental | apply normal treatment with giving some rest of the procedure while the child on the chair. Receives: Behavioral: contingent escape |
| rewarding the child | Experimental | apply normal treatment with giving simple gifts like stickers at the end of the procedure.
8 Receives: Behavioral: rewarding |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 12 weeks
Secondary outcomes (1)
Frankl Behavior Rating Scale
classified child's behavior into four groups according to the child's attitude and cooperation or lack of cooperation during dental treatment
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2024
- Study start24 Jan 2024
- Primary completion4 Jul 2024
- Study completion3 Mar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dental AnxietyStudies of the same condition, open and under way.
- More trials run by Mansoura UniversityThe 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 42 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Khalid Aldhafeeri, Mansoura University
- Investigators
- khalid m aldhafeeri, master, Principal investigator, Researcher of Pediatric Dentistry Faculty of Dentistry Mansoura Universityabeer Mostafa A, Prof, Study director, Professor and Head of Pediatric Dentistry Department- Department of Pediatric Dentistry- Faculty of Dentistry- Mansoura UniversityRizk A Elagamy, PhD, Study director, lecturer Pediatric Dentistry Department- Department of Pediatric Dentistry- Faculty of Dentistry- Mansoura University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06524154
- Sponsor's protocol ID
- A01012023PP
- Status last verified
- Jul 2024
- First submitted
- 23 Jul 2024
- Last updated
- 29 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Verbal Positive Reinforcement, Contingent Escape and Rewarding on Behaviour of Children Undergoing Primary Molar Pulpotomy: a Randomized Clinical Study
- ClinicalTrials.gov ID
- NCT06524154
- Acronym / sponsor ID
- A01012023PP
- Conditions
- Dental Anxiety
- Keywords
- dental anxiety, Contingent Escape, Positive Reinforcement,, Pulpotomy, Behavior management
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 42 participants (estimated)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- 24 Jan 2024 (actual)
- Primary completion
- 4 Jul 2024 (actual)
- Study completion
- 3 Mar 2025 (estimated)
- First posted
- 29 Jul 2024 (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 study to evaluate the effect of verbal positive reinforcement, contingent escape and rewarding on behaviour of children undergoing primary molar pulpotomy.
Detailed description
this study evaluated Effect of Verbal Positive Reinforcement, Contingent Escape and Rewarding on Behaviour of Children Undergoing Primary Molar Pulpotomy
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| positive reinforcement | Experimental | Behavioral: positive reinforcementapply normal treatment with praising the child with encouraging words and pleasing smiles. |
| contingent escape | Experimental | Behavioral: contingent escapeapply normal treatment with giving some rest of the procedure while the child on the chair. |
| rewarding the child | Experimental | Behavioral: rewardingapply normal treatment with giving simple gifts like stickers at the end of the procedure. 8 |
Who may qualify
- Ages
- 4 to 6 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- Children with special health care needs.
- Children suffering from systemic diseases.
- Unrestorable tooth.
- Extremely uncooperative children.
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 |
|---|---|---|
| positive reinforcementnormal treatment with with praising the child with encouraging words and pleasing smiles. | Behavioural | positive reinforcement |
| rewardingnormal treatment with giving simple gifts like stickers at the end of the procedure. | Behavioural | rewarding the child |
| contingent escapenormal treatment with giving some rest of the procedure while the child on the chair. | Behavioural | contingent escape |
Primary outcome
RMS Pictorial Scale (RMS-PS)
Time frame: 12 weeks
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
1 secondary outcome
Frankl Behavior Rating Scale
Time frame: 12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2024.
- Individual participant dataSharing planned: No
Related trials for Dental Anxiety
Active, not recruiting
HRVB for Stress and Anxiety During Dentistry Students' Clinical Transition
Stress (Psychology), Anxiety
Recruiting
Pain Perception With Cordless Electronic Local Anesthetic Delivery System
Decayed Primary Molars
RecruitingObservational study
Bruxism, Anxiety, and Periodontal Status Among Dental Students
Bruxism, Anxiety
Recruiting
Comparative Evaluation of Intranasal Atomized Midazalom Combined With Nitrous Oxide Versus Nitrous Oxide Monotherapy
Dental Anxiety in Children, Child Behaviour
Active, not recruiting
Musical Intervention for Dental Anxiety
Dental Anxiety
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.
khalid m aldhafeeri, master principal investigator
Researcher of Pediatric Dentistry Faculty of Dentistry Mansoura University
abeer Mostafa A, Prof study director
Professor and Head of Pediatric Dentistry Department- Department of Pediatric Dentistry- Faculty of Dentistry- Mansoura University
Rizk A Elagamy, PhD study director
lecturer Pediatric Dentistry Department- Department of Pediatric Dentistry- Faculty of Dentistry- Mansoura University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing positive reinforcement, rewarding and contingent escape in people with Dental Anxiety, run by Mansoura University at 1 site in Egypt.
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 4 inclusion and 4 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 29 Jul 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 Egypt. 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. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
RMS Pictorial Scale (RMS-PS) (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 29 Jul 2024.