Transcutaneous Photobiomodulation on the Control of Chilhood Anxiety in Dental Care.

Sponsor

University of Nove de Julho (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05549128

Collaborator

(none)

Enrollment

Arms

16.3

Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Anxiety	Device: Photobiomodulation Device: Photobiomodulation sham	N/A

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

90 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

2 groups: experimental group (G1), control group or placebo (G2) where ILIB and placebo will be applied respectively.2 groups: experimental group (G1), control group or placebo (G2) where ILIB and placebo will be applied respectively.

Masking:

Double (Participant, Outcomes Assessor)

Masking Description:

Blinding will be performed for the application of the ILIB during the clinical session. An operator will be trained who will be the one who will perform the application. Another operator, in this case the researcher (blind), will be in charge of collecting the parameters to be evaluated.

Primary Purpose:

Treatment

Official Title:

Effect of Transcutaneous Photobiomodulation on the Control of Chilhood Anxiety in Dental Care: Double- Blind Randomized Clinical Trial.

Anticipated Study Start Date :

Nov 10, 2022

Anticipated Primary Completion Date :

Nov 10, 2023

Anticipated Study Completion Date :

Mar 20, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: photobiomodulation laser therapy application for 10 minutes	Device: Photobiomodulation The red laser (DMC) will be applied with the aim of reducing the anxiety of children during the dental consultation. It will be continuously and directly with 60J of energy, wavelength of 660nm and 100mW/cm2 of power. The application will be located in the unilateral radial artery for 10 minutes. The laser will be transmitted through an appropriate bracelet where the laser tip fits perfectly. It is a painless, non-invasive method that does not cause any discomfort during application.
Sham Comparator: Sham photobiomodulation sham laser therapy application for 10 minutes	Device: Photobiomodulation sham The red laser (DMC) will be applied off. I

Arm

Intervention/Treatment

Experimental: photobiomodulation

laser therapy application for 10 minutes

Device: Photobiomodulation

The red laser (DMC) will be applied with the aim of reducing the anxiety of children during the dental consultation. It will be continuously and directly with 60J of energy, wavelength of 660nm and 100mW/cm2 of power. The application will be located in the unilateral radial artery for 10 minutes. The laser will be transmitted through an appropriate bracelet where the laser tip fits perfectly. It is a painless, non-invasive method that does not cause any discomfort during application.

Sham Comparator: Sham photobiomodulation

sham laser therapy application for 10 minutes

Device: Photobiomodulation sham

The red laser (DMC) will be applied off. I

Outcome Measures

Primary Outcome Measures

Anxiety [30 minutes]
Facial Image Scale (FIS) in the conditioned room prior to dental care.

Secondary Outcome Measures

heart rate [30 minutes]
The oximeter will be used in this work to measure the heart rate of children before and after dental treatment. The device will be placed on a finger of the child's hand, it is note worthy that it is a device or that it does not cause any type of discomfort.

Eligibility Criteria

Criteria

Ages Eligible for Study:

6 Years to 12 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

University of Nove de Julho

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Lara Jansiski Motta, Investigator, University of Nove de Julho

ClinicalTrials.gov Identifier:

NCT05549128

Other Study ID Numbers:

TPMBAnx

First Posted:

Sep 22, 2022

Last Update Posted:

Sep 22, 2022

Last Verified:

Sep 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Lara Jansiski Motta, Investigator, University of Nove de Julho

anxiety

photobiomodulation

Additional relevant MeSH terms:

Anxiety Disorders

Study Results

No Results Posted as of Sep 22, 2022