Child BehaviorNCT03366467
Effect of Sensory Adapted Dental Environment on Children's Behavior During Dental Treatment
A study testing SADE and RDE in people with Child Behavior, run by Hadassah Medical Organization.
Trial summary
The objective of the present study is to determine the effect of sensory adapted dental environment (SADE) in healthy children during a routine dental restorative treatment. The hypothesis is that the SADE would have a favorable effect in calming the subjects during dental treatment. Read more about this study
- Who is it for?
- Ages 3 to 10 yearsHealthy volunteers can take part
- Conditions the study is for
- Child Behavior
- What is being tested?
- SADE and RDE
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 22 Mar 2022to 22 Mar 2022
- 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 3 to 10 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- ASA1
- Needs at least 2 similar dental treatment appointments
Who cannot join
- Needs only one dental treatment
About this study
The objective of the present study is to determine the effect of sensory adapted dental environment (SADE) in healthy children during a routine dental restorative treatment. The hypothesis is that the SADE would have a favorable effect in calming the subjects during dental treatment.
the study is a random cross-over design. The participants will be randomly assigned into two groups. Group 1 will initially be treated under SADE (Time 1) and receive regular dental environment (RDE) on the second encounter (Time 2). For the second group, the procedure is reversed (RDE at Time 1 and SADE at Time 2).
Read the detailed description
- Dental treatment- will include restorations, crowns, pulp treatment, with local anesthesia. The use of oral/inhaled sedation will be decided according to the patient's behavior and cooperation assessment.
- Dental settings- The SADE: the sensory stimuli addressed are visual and auditory, as follows: (i) Visual sensation. All ceiling fluorescent lighting are removed. The adapted lighting consisted of slow-moving, repetitive visual color effects created by a projector, in the child's visual field. (ii) Auditory stimuli include rhythmic music, which was heard via loudspeakers. The RDE utilized fluorescent lighting on the ceiling, without special visual effects and without music stimulation.
- Instruments- 1) the children will be observed during the treatments. The observer will code all behaviors according to the Houpt Scale used for rating patient behavior during treatment. In addition, the examiner will count the number and duration (in minutes) of the anxious behavior (crying and movements). Because of the nature of the study (one environment with sensory adaptation and the other without), the observer cannot be blind to the treatment environment. 2) Physiologic arousal states, evaluated by the assessment of EDA (Mindlife Co, Jerusalem, Israel). Changes in the electrical conductance of the skin are a sensitive way of monitoring autonomic responses to external stimuli.
- Conditions
- Child Behavior
- Being tested
- SADE, RDE
- Keywords
- dental treatment, sensory adapted environment
- Medical subject headings
- Child Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SADEOther
The SADE: the sensory stimuli addressed are visual and auditory, as follows: (i) Visual sensation. All ceiling fluorescent lighting are removed. The adapted lighting consisted of slow-moving, repetitive visual color effects created by a projector, in the child's visual field. (ii) Auditory stimuli include rhythmic music, which was heard via loudspeakers.
RDEOther
The RDE utilized fluorescent lighting on the ceiling, without special visual effects and without music stimulation.
| Study group | Role | What they receive |
|---|---|---|
| SADE first | Experimental | SADE first will initially be treated under SADE (Time 1) and receive RDE on the second encounter (Time 2) Receives: Other: SADE; Other: RDE |
| RDE first | Experimental | RDE first will initially be treated under RDE (Time 1) and receive SADE on the second encounter (Time 2) Receives: Other: SADE; Other: RDE |
What is being measured
The primary outcome is the main question the study is designed to answer.
Physiologic arousal states
Evaluated by palmar electrodermal activity (EDA) during dental treatment
Measured: Data will be reported through study completion, an average of 2 years
Secondary outcomes (3)
Houpt Scale
Rating patient behavior during treatment according to Houpt scale. The Houpt scale is a tool used to assess a child's behavior during dental sedation according to specific categories and scores including: sleep (1-awake, 2-drowsy, disoriented), movement (1-violent, 2-continuous, 3-controllable, 4-no movement), cry (1-hysterical, 2-continuous, 3-intermittent, 4-no cry), and overall behavior (1-treatment aborted, 2-poor, 3-regular, 4-good, 5-very good, 6-excellent).
Measured: Data will be reported through study completion, an average of 2 years
Anxious behavior-number
Examiner will count the number of the anxious behavior episodes (crying and movements) during dental treatment.
Measured: Data will be reported through study completion, an average of 2 years
Anxious behavior-duration
Examiner will count the duration, in minute, of the anxious behavior (crying and movements) during dental treatment..
Measured: Data will be reported through study completion, an average of 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2017
- Study start22 Mar 2022
- Primary completion22 Mar 2022
- Study completion22 Mar 2022
Why it stopped: The clinic no longer have sensory adapted environment equipment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Child BehaviorStudies of the same condition, open and under way.
- More trials run by Hadassah Medical OrganizationThe 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
- Crossover
- Model description
- The participants will be randomly assigned into two groups. Group 1 will initially be treated under SADE (Time 1) and receive RDE on the second encounter (Time 2). For the second group, the procedure is reversed (RDE at Time 1 and SADE at Time 2).
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hadassah Medical Organization
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Avia Fux, Hadassah Medical Organization
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03366467
- Sponsor's protocol ID
- 0469-17-HMO
- Status last verified
- Mar 2022
- First submitted
- 27 Nov 2017
- Last updated
- 4 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Sensory Adapted Dental Environment on Children's Behavior During Dental Treatment
- ClinicalTrials.gov ID
- NCT03366467
- Acronym / sponsor ID
- 0469-17-HMO
- Conditions
- Child Behavior
- Keywords
- dental treatment, sensory adapted environment
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: The clinic no longer have sensory adapted environment equipment
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Hadassah Medical OrganizationUniversity, hospital or other
- Study start
- 22 Mar 2022 (actual)
- Primary completion
- 22 Mar 2022 (actual)
- Study completion
- 22 Mar 2022 (actual)
- First posted
- 8 Dec 2017 (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 objective of the present study is to determine the effect of sensory adapted dental environment (SADE) in healthy children during a routine dental restorative treatment. The hypothesis is that the SADE would have a favorable effect in calming the subjects during dental treatment.
the study is a random cross-over design. The participants will be randomly assigned into two groups. Group 1 will initially be treated under SADE (Time 1) and receive regular dental environment (RDE) on the second encounter (Time 2). For the second group, the procedure is reversed (RDE at Time 1 and SADE at Time 2).
Detailed description
- Dental treatment- will include restorations, crowns, pulp treatment, with local anesthesia. The use of oral/inhaled sedation will be decided according to the patient's behavior and cooperation assessment.
- Dental settings- The SADE: the sensory stimuli addressed are visual and auditory, as follows: (i) Visual sensation. All ceiling fluorescent lighting are removed. The adapted lighting consisted of slow-moving, repetitive visual color effects created by a projector, in the child's visual field. (ii) Auditory stimuli include rhythmic music, which was heard via loudspeakers. The RDE utilized fluorescent lighting on the ceiling, without special visual effects and without music stimulation.
- Instruments- 1) the children will be observed during the treatments. The observer will code all behaviors according to the Houpt Scale used for rating patient behavior during treatment. In addition, the examiner will count the number and duration (in minutes) of the anxious behavior (crying and movements). Because of the nature of the study (one environment with sensory adaptation and the other without), the observer cannot be blind to the treatment environment. 2) Physiologic arousal states, evaluated by the assessment of EDA (Mindlife Co, Jerusalem, Israel). Changes in the electrical conductance of the skin are a sensitive way of monitoring autonomic responses to external stimuli.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The participants will be randomly assigned into two groups. Group 1 will initially be treated under SADE (Time 1) and receive RDE on the second encounter (Time 2). For the second group, the procedure is reversed (RDE at Time 1 and SADE at Time 2).
| Arm | Type | Receives |
|---|---|---|
| SADE first | Experimental | Other: SADE, Other: RDESADE first will initially be treated under SADE (Time 1) and receive RDE on the second encounter (Time 2) |
| RDE first | Experimental | Other: SADE, Other: RDERDE first will initially be treated under RDE (Time 1) and receive SADE on the second encounter (Time 2) |
Who may qualify
- Ages
- 3 to 10 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- ASA1
- Needs at least 2 similar dental treatment appointments
Key exclusion criteria (1 listed)
- Needs only one dental treatment
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 |
|---|---|---|
| SADEThe SADE: the sensory stimuli addressed are visual and auditory, as follows: (i) Visual sensation. All ceiling fluorescent lighting are removed. The adapted lighting consisted of slow-moving, repetitive visual color effects created by a projector, in the child's visual field. (ii) Auditory stimuli include rhythmic music, which was heard via loudspeakers. | Other | RDE first, SADE first |
| RDEThe RDE utilized fluorescent lighting on the ceiling, without special visual effects and without music stimulation. | Other | RDE first, SADE first |
Primary outcome
Physiologic arousal states
Time frame: Data will be reported through study completion, an average of 2 years
Evaluated by palmar electrodermal activity (EDA) during dental treatment
3 secondary outcomes
Houpt Scale
Time frame: Data will be reported through study completion, an average of 2 years
Anxious behavior-number
Time frame: Data will be reported through study completion, an average of 2 years
Anxious behavior-duration
Time frame: Data will be reported through study completion, an average of 2 years
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2022.
Related trials for Child Behavior
Active, not recruiting
Digital Therapeutics for Behavior Problems
Problem Behavior, Child Behavior
Recruiting
Digital Behavioral Parenting Programs With and Without Added Emotion Regulation Strategies to Manage Anger in Parenting
Parenting Intervention, Anger
Active, not recruiting
Tailoring CPP for the Foster Care Setting
Behavior Problem
Active, not recruiting
Chicago Parent Program for Foster and Kinship Caregivers
Behavior Problem, Parenting
Not yet recruiting
QAIAx - SGI/SI Smart Health Cities: Microcity Enclave Program (Quantum SI/AGI Agency a/k/a AI City Hall Project - UPSTO App Nos. 64/074,526, 64/063,557, 64/105,164, 63/903,181, 63/729,428, 64/125,360; USPTO EO 9424 Assignment ID: 2101042 / ARN: REEL/FRAME: 76481/0026 - OUSD-R&E, Department of War)
Asperger's Disorder, Asperger Disorder
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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing SADE and RDE in people with Child Behavior, run by Hadassah Medical Organization.
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 2 inclusion and 1 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: withdrawn, as of the sponsor's last update on 4 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
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?
The study was withdrawn before enrolling participants, so there are no results.
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?
Physiologic arousal states (time frame: Data will be reported through study completion, an average of 2 years). 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 4 Apr 2022.