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Comparison Between Jacobson's Progressive Muscle Relaxation Technique and Audio-visual Distraction Technique in Reducing Dental Anxiety in Children During Dental Visit

Primary Purpose

Dental Anxiety

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
jacobson's progressive muscle relaxation technique
audio-visual distraction technique
Sponsored by
Dina Hussien Abdelhafez
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dental Anxiety

Eligibility Criteria

6 Years - 9 Years (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Children: 6 to 9 years old children. Teeth: tooth requiring dental treatment

Exclusion Criteria:

  • Children having allergy to local anaesthesia or systemic problem. Refusal of participation Mentally ill or mentally retarded children

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Experimental

    Experimental

    No Intervention

    Arm Label

    jacobson's progressive muscle relaxation technique

    audiovisual distraction technique

    conventional

    Arm Description

    Outcomes

    Primary Outcome Measures

    cooperation measured by modified venham rating scale
    Modified Venham rating scale provides details of positive and negative child's behavior. The scale ranges from total cooperation (0) to no cooperation (5)

    Secondary Outcome Measures

    Full Information

    First Posted
    April 16, 2019
    Last Updated
    April 18, 2019
    Sponsor
    Dina Hussien Abdelhafez
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03923088
    Brief Title
    Comparison Between Jacobson's Progressive Muscle Relaxation Technique and Audio-visual Distraction Technique in Reducing Dental Anxiety in Children During Dental Visit
    Official Title
    Comparison Between Jacobson's Progressive Muscle Relaxation Technique and Audio-visual Distraction Technique in Reducing Dental Anxiety in Children During Dental Visit ; Randomized Clinical Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2019
    Overall Recruitment Status
    Unknown status
    Study Start Date
    June 2019 (Anticipated)
    Primary Completion Date
    January 2020 (Anticipated)
    Study Completion Date
    January 2020 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor-Investigator
    Name of the Sponsor
    Dina Hussien Abdelhafez

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    Brief Summary
    Dental anxiety is fear associated with the thought of visiting the dentist for preventive care and dental procedures. Children with dental anxiety characterized by crying before dental checkup, tachycardia and aggressively clinging to the accompanying parent. It has been cited as the fifthmost common cause of anxiety by Agras et al. Dental anxiety may have major and long-lasting implications for the child and their family. Cohen et al reported that dental anxiety affects an individual's life in multiple ways. The physiological impacts included signs and symptoms of the fright response and feelings of exhaustion after a dental appointment, while the cognitive impacts included an array of negative thoughts, beliefs, and fears. Dental anxiety in children could remain a problem in adulthood if not handled properly thus it will affect oral health and psycho-social condition. This research is conducted to deliver different concepts in psychological and behavioral techniques in management of anxious pediatric dental patients.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Dental Anxiety

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    30 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    jacobson's progressive muscle relaxation technique
    Arm Type
    Experimental
    Arm Title
    audiovisual distraction technique
    Arm Type
    Experimental
    Arm Title
    conventional
    Arm Type
    No Intervention
    Intervention Type
    Behavioral
    Intervention Name(s)
    jacobson's progressive muscle relaxation technique
    Intervention Description
    This involves tensing specific muscle groups for 5-7 seconds, followed by 20 seconds of relaxation. The method can be demonstrated chairside, and should be practiced and rehearsed by the patient at home. Four major muscle groups are commonly tensed and relaxed. These are: 1) feet, calves, thighs, and buttocks; 2) hands, forearms, and biceps; 3) chest, stomach, and lower back; and 4) head, face, throat, and shoulders
    Intervention Type
    Behavioral
    Intervention Name(s)
    audio-visual distraction technique
    Intervention Description
    audiovisual distraction not only leads to full involvement of scenes (visual and auditory), but it also induces a positive emotional reaction resulting in a relaxed experience.
    Primary Outcome Measure Information:
    Title
    cooperation measured by modified venham rating scale
    Description
    Modified Venham rating scale provides details of positive and negative child's behavior. The scale ranges from total cooperation (0) to no cooperation (5)
    Time Frame
    1 hour

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    6 Years
    Maximum Age & Unit of Time
    9 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Children: 6 to 9 years old children. Teeth: tooth requiring dental treatment Exclusion Criteria: Children having allergy to local anaesthesia or systemic problem. Refusal of participation Mentally ill or mentally retarded children

    12. IPD Sharing Statement

    Learn more about this trial

    Comparison Between Jacobson's Progressive Muscle Relaxation Technique and Audio-visual Distraction Technique in Reducing Dental Anxiety in Children During Dental Visit

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