search
Back to results

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

Primary Purpose

Anxiety

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Photobiomodulation
Photobiomodulation sham
Sponsored by
University of Nove de Julho
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Anxiety focused on measuring anxiety, photobiomodulation

Eligibility Criteria

6 Years - 12 Years (Child)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Sham Comparator

    Arm Label

    photobiomodulation

    Sham photobiomodulation

    Arm Description

    laser therapy application for 10 minutes

    sham laser therapy application for 10 minutes

    Outcomes

    Primary Outcome Measures

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

    Secondary Outcome Measures

    heart rate
    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.

    Full Information

    First Posted
    September 14, 2022
    Last Updated
    September 17, 2022
    Sponsor
    University of Nove de Julho
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT05549128
    Brief Title
    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

    2. Study Status

    Record Verification Date
    September 2022
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    November 10, 2022 (Anticipated)
    Primary Completion Date
    November 10, 2023 (Anticipated)
    Study Completion Date
    March 20, 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    University of Nove de Julho

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. 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.
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Anxiety
    Keywords
    anxiety, photobiomodulation

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    2 groups: experimental group (G1), control group or placebo (G2) where ILIB and placebo will be applied respectively.
    Masking
    ParticipantOutcomes 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.
    Allocation
    Randomized
    Enrollment
    90 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    photobiomodulation
    Arm Type
    Experimental
    Arm Description
    laser therapy application for 10 minutes
    Arm Title
    Sham photobiomodulation
    Arm Type
    Sham Comparator
    Arm Description
    sham laser therapy application for 10 minutes
    Intervention Type
    Device
    Intervention Name(s)
    Photobiomodulation
    Intervention Description
    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.
    Intervention Type
    Device
    Intervention Name(s)
    Photobiomodulation sham
    Intervention Description
    The red laser (DMC) will be applied off. I
    Primary Outcome Measure Information:
    Title
    Anxiety
    Description
    Facial Image Scale (FIS) in the conditioned room prior to dental care.
    Time Frame
    30 minutes
    Secondary Outcome Measure Information:
    Title
    heart rate
    Description
    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.
    Time Frame
    30 minutes

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    6 Years
    Maximum Age & Unit of Time
    12 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    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.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Lara RENE Motta, PhD
    Phone
    11998829511
    Email
    larajmotta@terra.com.br

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

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

    We'll reach out to this number within 24 hrs