Attention Deficit Disorder With HyperactivityNCT03951155
Effectiveness of Relaxation Technique for Behavioral Management of ADHD Children During Dental Treatment.
A study testing Muscle Relaxation in people with Attention Deficit Disorder With Hyperactivity, run by Cairo University.
Trial summary
Evaluation of effect of relaxation technique (Muscle Relaxation) on behavioral management and anxiety control of ADHD children during dental treatment. Read more about this study
- Who is it for?
- Ages 6 to 9 years
- Conditions the study is for
- Attention Deficit Disorder With Hyperactivity
- What is being tested?
- Muscle Relaxation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- 1 Jul 2019to Dec 2019
- 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 6 to 9 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children: 6 to 9 years old ADHD children
- Teeth: Teeth requiring dental treatment or preventive measure.
Who cannot join
- Non ADHD children.
- ADHD children having allergy to local anaesthesia or systemic problem that contraindicate dental treatment.
- Refusal of participation
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Effectiveness of Relaxation Technique (Muscle Relaxation) for Behavioral Management of ADHD Children During Dental Treatment. (Randomized Clinical Trial)
Evaluation of effect of relaxation technique (Muscle Relaxation) on behavioral management and anxiety control of ADHD children during dental treatment.
Read the detailed description
Evaluation of effect of relaxation technique (Muscle Relaxation) on behavioral management and anxiety control of ADHD children during dental treatment compared to Tell Show Do technique (control group) using modified Frankl scale.
- Being tested
- Muscle Relaxation
- Keywords
- ADHD, behavioral management, dental management
- Medical subject headings
- Attention Deficit Disorder with Hyperactivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Muscle RelaxationBehavioural
Also called Relaxation technique
- 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.
| Study group | Role | What they receive |
|---|---|---|
| ADHD Group | Experimental | Muscle Relaxation technique for behavioral management Receives: Behavioral: Muscle Relaxation |
| Tell Show Do Group | No intervention | Tell Show Do Technique for behavioral management |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: one day
Secondary outcomes (1)
Completion of treatment
weather the dental treatment completed or not
Measured: one day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2019
- Study start1 Jul 2019 (estimated)
- Primary completion30 Oct 2019 (estimated)
- Study completionDec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Attention Deficit Disorder With HyperactivityStudies of the same condition, open and under way.
- More trials run by Cairo 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nouran Khalifa Hamed, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03951155
- Sponsor's protocol ID
- 14422016457337
- Status last verified
- May 2019
- First submitted
- 11 May 2019
- Last updated
- 16 May 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Relaxation Technique (Muscle Relaxation) for Behavioral Management of ADHD Children During Dental Treatment. (Randomized Clinical Trial)
- ClinicalTrials.gov ID
- NCT03951155
- Acronym / sponsor ID
- 14422016457337
- Keywords
- ADHD, behavioral management, dental management
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Jul 2019 (estimated)
- Primary completion
- 30 Oct 2019 (estimated)
- Study completion
- Dec 2019 (estimated)
- First posted
- 15 May 2019 (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.
Evaluation of effect of relaxation technique (Muscle Relaxation) on behavioral management and anxiety control of ADHD children during dental treatment.
Detailed description
Evaluation of effect of relaxation technique (Muscle Relaxation) on behavioral management and anxiety control of ADHD children during dental treatment compared to Tell Show Do technique (control group) using modified Frankl scale.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ADHD Group | Experimental | Behavioral: Muscle RelaxationMuscle Relaxation technique for behavioral management |
| Tell Show Do Group | No intervention | –Tell Show Do Technique for behavioral management |
Who may qualify
- Ages
- 6 to 9 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Children: 6 to 9 years old ADHD children
- Teeth: Teeth requiring dental treatment or preventive measure.
Key exclusion criteria (3 listed)
- Non ADHD children.
- ADHD children having allergy to local anaesthesia or systemic problem that contraindicate dental treatment.
- Refusal of participation
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 |
|---|---|---|
| Muscle RelaxationAlso: Relaxation technique* 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. | Behavioural | ADHD Group |
Primary outcome
Modified Frankl Scale for child cooperation
Time frame: one day
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.
1 secondary outcome
Completion of treatment
Time frame: one day
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2019.
- Individual participant dataSharing planned: No. 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.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Muscle Relaxation in people with Attention Deficit Disorder With Hyperactivity, run by Cairo University.
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 3 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 16 May 2019. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Nouran Khalifa (+201091694444, nouran.khalifa@dentistry.cu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Modified Frankl Scale for child cooperation (time frame: one day). 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 16 May 2019.