search
Back to results

Effectiveness of Relaxation Technique for Behavioral Management of ADHD Children During Dental Treatment.

Primary Purpose

Attention Deficit Disorder With Hyperactivity

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Muscle Relaxation
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Attention Deficit Disorder With Hyperactivity focused on measuring ADHD, behavioral management, dental management

Eligibility Criteria

6 Years - 9 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Children: 6 to 9 years old ADHD children
  • Teeth: Teeth requiring dental treatment or preventive measure.

Exclusion Criteria:

  • Non ADHD children.
  • ADHD children having allergy to local anaesthesia or systemic problem that contraindicate dental treatment.
  • Refusal of participation

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    ADHD Group

    Tell Show Do Group

    Arm Description

    Muscle Relaxation technique for behavioral management

    Tell Show Do Technique for behavioral management

    Outcomes

    Primary Outcome Measures

    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(-): Reluctant to accept treatment, uncooperative, some evidence of negative attitude but not pronounced, i.e. sullen, withdrawn.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.

    Secondary Outcome Measures

    Completion of treatment
    weather the dental treatment completed or not

    Full Information

    First Posted
    May 11, 2019
    Last Updated
    May 15, 2019
    Sponsor
    Cairo University
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT03951155
    Brief Title
    Effectiveness of Relaxation Technique for Behavioral Management of ADHD Children During Dental Treatment.
    Official Title
    Effectiveness of Relaxation Technique (Muscle Relaxation) for Behavioral Management of ADHD Children During Dental Treatment. (Randomized Clinical Trial)
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2019
    Overall Recruitment Status
    Unknown status
    Study Start Date
    July 1, 2019 (Anticipated)
    Primary Completion Date
    October 30, 2019 (Anticipated)
    Study Completion Date
    December 2019 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Cairo University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Attention Deficit Disorder With Hyperactivity
    Keywords
    ADHD, behavioral management, dental management

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Outcomes Assessor
    Masking Description
    Outcome assessor responsible for evaluating child behavior & cooperation will be masked
    Allocation
    Randomized
    Enrollment
    40 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    ADHD Group
    Arm Type
    Experimental
    Arm Description
    Muscle Relaxation technique for behavioral management
    Arm Title
    Tell Show Do Group
    Arm Type
    No Intervention
    Arm Description
    Tell Show Do Technique for behavioral management
    Intervention Type
    Behavioral
    Intervention Name(s)
    Muscle Relaxation
    Other Intervention Name(s)
    Relaxation technique
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    Modified Frankl Scale for child cooperation
    Description
    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.
    Time Frame
    one day
    Secondary Outcome Measure Information:
    Title
    Completion of treatment
    Description
    weather the dental treatment completed or not
    Time Frame
    one day

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    6 Years
    Maximum Age & Unit of Time
    9 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Children: 6 to 9 years old ADHD children Teeth: Teeth requiring dental treatment or preventive measure. Exclusion Criteria: Non ADHD children. ADHD children having allergy to local anaesthesia or systemic problem that contraindicate dental treatment. Refusal of participation
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Nouran Khalifa
    Phone
    +201091694444
    Email
    nouran.khalifa@dentistry.cu.edu.eg
    First Name & Middle Initial & Last Name or Official Title & Degree
    Rasha Adel
    Phone
    +201007505888
    Email
    rashaadelragab@gmail.com

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    IPD Sharing Plan Description
    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.

    Learn more about this trial

    Effectiveness of Relaxation Technique for Behavioral Management of ADHD Children During Dental Treatment.

    We'll reach out to this number within 24 hrs