Effectiveness of Relaxation Technique for Behavioral Management of ADHD Children During Dental Treatment.
1 other identifier
interventional
40
0 countries
N/A
Brief Summary
Evaluation of effect of relaxation technique (Muscle Relaxation) on behavioral management and anxiety control of ADHD children during dental treatment.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jul 2019
Shorter than P25 for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 11, 2019
CompletedFirst Posted
Study publicly available on registry
May 15, 2019
CompletedStudy Start
First participant enrolled
July 1, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 30, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2019
CompletedMay 16, 2019
May 1, 2019
4 months
May 11, 2019
May 15, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Modified Frankl Scale for child cooperation
Rating 1: DEFINITLY NEGATIVE (--): Refusal of treatment, crying forcefully, fearful, or any other overt evidence of extreme negativism. * Rating 2: NEGATIVE (-): Reluctant to accept treatment, uncooperative, some evidence of negative attitude but not pronounced, i.e. sullen, withdrawn. * Rating 3: NEGATIVE POSITIVE (-+): Fluctuation between uncooperativeness and some evidence of unpronounced negative attitude, and cautious acceptance to treatment with reservation shifting throughout the visit. * Rating 4: POSITIVE (+): Acceptance of treatment; at times cautious, willingness to comply with the dentist, at times with reservation but patient follows the dentist's directions cooperatively. * Rating 5: DEFINITLY POSITIVE (++): Good rapport with the dentist, interested in the dental procedures, laughing and enjoying the situation.
one day
Secondary Outcomes (1)
Completion of treatment
one day
Study Arms (2)
ADHD Group
EXPERIMENTALMuscle Relaxation technique for behavioral management
Tell Show Do Group
NO INTERVENTIONTell Show Do Technique for behavioral management
Interventions
* Ask the child to lie down in a comfortable position. Ask him/her to notice how their muscles feel in each part of the body. Taking one area of the body at a time (face, shoulders, arms, hands, fingers, abdomen, legs, feet, and toes). * Instruct the child to contract the muscles for 5 seconds, take a deep breath, and release. * Next, instruct the child to contract all muscles simultaneously, hold for 5 seconds, then release. * Finally, ask him/her to notice how his/her muscles feel after the exercise.
Eligibility Criteria
You may qualify if:
- Children: 6 to 9 years old ADHD children
- Teeth: Teeth requiring dental treatment or preventive measure.
You may not qualify if:
- Non ADHD children.
- ADHD children having allergy to local anaesthesia or systemic problem that contraindicate dental treatment.
- Refusal of participation
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Cairo Universitylead
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Masking Details
- Outcome assessor responsible for evaluating child behavior \& cooperation will be masked
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principle investigator
Study Record Dates
First Submitted
May 11, 2019
First Posted
May 15, 2019
Study Start
July 1, 2019
Primary Completion
October 30, 2019
Study Completion
December 1, 2019
Last Updated
May 16, 2019
Record last verified: 2019-05
Data Sharing
- IPD Sharing
- Will not share
All data, information, participant's personal information, family history, social and medical history will be stored in the files assigned to each patient with limited access to minimum number of individuals necessary for quality control, audit, and analysis.