Dental Anxiety Clinical Trial
Official title:
Effect of a Vibration System on Pain Reduction During Injection of Local Dental Anaesthesia in Children: a Randomized Controlled Clinical Trial
NCT number | NCT03953001 |
Other study ID # | JH123456 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | January 1, 2018 |
Est. completion date | June 1, 2018 |
Verified date | May 2019 |
Source | Imam Abdulrahman Bin Faisal University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The study assesses the effect of a new vibration system on pain reduction during the injection of local anesthesia. Children undergoing dental treatment are allocated to two groups; one receiving the Buzz, a vibration system and another group receiving nothing. Pain during injection of local anesthetic is assessed using a validated tool in addition to assessment of child cooperation during treatment.
Status | Completed |
Enrollment | 51 |
Est. completion date | June 1, 2018 |
Est. primary completion date | April 1, 2018 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 5 Years to 12 Years |
Eligibility |
Inclusion Criteria: 1. Children 5-12 years of age. 2. Positive or definitely positive behavior on Frankl scale.6 3. Children receiving treatment on the dental chair. 4. Free from allergies to topical anesthetic used in the study. 5. Parental consent for child participation in the study. Exclusion Criteria: 1. Those in need of treatment under general anesthesia will be excluded from the study. 2. Children with allergies from topical anesthesia |
Country | Name | City | State |
---|---|---|---|
Saudi Arabia | imam adbulrahman Bin Faisal University- College of Dentistry | Dammam |
Lead Sponsor | Collaborator |
---|---|
Imam Abdulrahman Bin Faisal University |
Saudi Arabia,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Self Reported pain intensity: Visual analogue scale (VAS) of pain intensity | Self reported pain intensity before the injection and directly after the injection. Each child scored pain intensity twice, one before the injection and one directly after the injection (0=no pain; 10=Very painful). | Procedure (immediately after the administration of Dental anesthesia) | |
Secondary | Parents Perception for the child tolerance of pain; Observational Pain rating scale | The parents were asked about the reaction and attitude of the child during the dental anesthesia administration. Parents rated the child ability to tolerate pain with (0=Didn't Tolerate and 10= Tolerated with a smile) | Procedure (immediately after the administration of Dental anesthesia.) | |
Secondary | External observation for Facial and Physical expression. Using Sounds, Eyes, and Motor (SEM) scale (RANGE 0-9). | Video was recorded for each child before, during and after the administration of local anesthesia. Each video was assessed by an external calibrated evaluator to score each child response. SEM (0=Comfortable, with no sound, no eye signs of discomfort and Hands are relaxed, no apparent body tenseness, 9= Painful, with verbal complain, crying tears and moving the hands to make aggressive physical contact and pulling the head away. The lowest record mean the child was comfortable and the higher the score mean the child experienced discomfort. | Procedure (immediately during and after the administration of Dental anesthesia.) | |
Secondary | Faces Legs Activity Cry Consolability (FLACC) Scale (RANGE 0-10) | Video was recorded for each child before, during and after the administration of local anesthesia. Each video was assessed by an external calibrated evaluator to score each child response. FLACC (0=The child did not express any facial discomfort with normal legs position no abnormal activity, not crying and relaxed. The highest score 10= Child experienced discomfort, moving his legs jerking crying and difficult to console. The lowest record mean the child was comfortable and the higher the score mean the child experienced discomfort. | Procedure (immediately during and after the administration of Dental anesthesia.) |
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