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
About this trial
This is an interventional treatment trial for Dental Anxiety
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
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
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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