Clinical trial NCT05549128: Transcutaneous Photobiomodulation on the Control of Chilhood Anxiety in Dental Care.
Official title: Effect of Transcutaneous Photobiomodulation on the Control of Chilhood Anxiety in Dental Care: Double- Blind Randomized Clinical Trial.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Anxiety
Keywords: anxiety
photobiomodulation
Lead sponsor: University of Nove de Julho
Sponsor class: OTHER
First posted: 2022-09-22
Enrollment: 90
Sex: ALL
Minimum age (years): 6
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 2 groups: experimental group (G1), control group or placebo (G2) where ILIB and placebo will be applied respectively.
Primary purpose: TREATMENT

Brief summary: The objective of this study is to investigate whether photobiomodulation helps, collaborates, in the management of the child's anxiety in the dental office.

Detailed description: Generalized anxiety disorder (GAD) is a chronic psychiatric condition characterized by a widespread and disproportionate concern for adverse life circumstances and the anticipated occurrence of catastrophic and dramatic events. Often, the challenges of everyday life, whether potential or real, are feared, as they are expected to increase and lead to irreparable consequences. Currently photobiomodulation is a practice used in many areas of health successfully. In the area of anxiety disorders has shown very promising results improving patient behavior. If we understand that photobiomodulation is a non-invasive therapy and with enough evidence of its safety, we must investigate to complement traditional behavioral management techniques. The objective of this study is to investigate whether photobiomodulation (ILIB) helps, collaborates, in the management of the child's anxiety in the dental office.

The sample will be selected from the assistance centers that have an agreement with UCU, Federico Ozanam School, San José College, UCU University Health Clinic. Participants will be randomly distributed into 2 groups: experimental group (G1), control group or placebo (G2) where ILIB and placebo will be applied respectively. It will be evaluated in level of anxiety by: Facial Image Scale (FIS) and the Venham Imaging Test (VPT) in the conditioned room prior to dental care (16)(17). Physiological parameters will also be measured: blood pressure, oximetry, heart rate, pulse, weight, height. ILIB applications will be carried out in 2 clinical sessions with an interval between them of at least 48hrs.

Eligibility criteria: Inclusion Criteria:

Children 6 and 12 years old. Children who do not consume oral anxiolytics. Children who need dental treatment. Children whose responsible adults have accepted informed consent. Children who have signed a nod of care.

Exclusion Criteria:

Children who are taking medications that alter the central nervous system ( Children with psychiatric or psychological disorders. Children with motor disorders such as cerebral palsy. Patients who do not fall into the age range of inclusion. Patients whose responsible adults do not agree to sign the informed consent. Children who do not give their assent to attention.

Primary outcomes:
measure: Anxiety
timeFrame: 30 minutes
Secondary outcomes:
measure: heart rate
timeFrame: 30 minutes
Other outcomes:
Locations:
Study officials:
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