- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03923088
Comparison Between Jacobson's Progressive Muscle Relaxation Technique and Audio-visual Distraction Technique in Reducing Dental Anxiety in Children During Dental Visit
April 18, 2019 updated by: Dina Hussien Abdelhafez
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
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.
Study Overview
Status
Unknown
Conditions
Study Type
Interventional
Enrollment (Anticipated)
30
Phase
- Not Applicable
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
6 years to 9 years (CHILD)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: DOUBLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: jacobson's progressive muscle relaxation technique
|
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
|
EXPERIMENTAL: audiovisual distraction technique
|
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.
|
NO_INTERVENTION: conventional
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
cooperation measured by modified venham rating scale
Time Frame: 1 hour
|
Modified Venham rating scale provides details of positive and negative child's behavior.
The scale ranges from total cooperation (0) to no cooperation (5)
|
1 hour
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ANTICIPATED)
June 1, 2019
Primary Completion (ANTICIPATED)
January 1, 2020
Study Completion (ANTICIPATED)
January 1, 2020
Study Registration Dates
First Submitted
April 16, 2019
First Submitted That Met QC Criteria
April 18, 2019
First Posted (ACTUAL)
April 22, 2019
Study Record Updates
Last Update Posted (ACTUAL)
April 22, 2019
Last Update Submitted That Met QC Criteria
April 18, 2019
Last Verified
April 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 01234
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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