NCT05052034

Brief Summary

Approximately 100 patients undergoing oral surgery will be divided in 3 groups of musical audition to control anxiety: baroque (N=35), classicism (N=35) and control group (N=30). Systolic Blood Pressure, Diastolic Blood Pressure, Heart Rate and Oxygen Saturation will be recorded.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jun 2020

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2020

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 23, 2020

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

September 16, 2021

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 22, 2021

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 27, 2022

Completed
Last Updated

December 13, 2022

Status Verified

December 1, 2022

Enrollment Period

6 months

First QC Date

September 16, 2021

Last Update Submit

December 11, 2022

Conditions

Dental AnxietyCovid19

Keywords

Oral ImplantsOral SurgeryDental AnxietyCovid19

Outcome Measures

Primary Outcomes (4)

  • Systolic Blood Pressure (SPB)

    SPB was recorded in mmHg

    SPB was recorded four times during intervention: "before starting the surgery once sitting in the chair", "immediately after anesthetizing", "immediately after introducing the first surgery drill", "immediately before getting up".

  • Diastolic Blood Pressure (DBP)

    DBP was recorded in mmHg

    SPB was recorded four times during intervention: "before starting the surgery once sitting in the chair", "immediately after anesthetizing", "immediately after introducing the first surgery drill", "immediately before getting up".

  • Heart Rate (HR)

    HR was recorded in bpm (beats per minute)

    HR was recorded four times during intervention: "before starting the surgery once sitting in the chair", "immediately after anesthetizing", "immediately after introducing the first surgery drill", "immediately before getting up".

  • Oxygen Saturation (Sp02)

    Sp02 was recorded in % (0-100)

    Sp02 was recorded four times during intervention: "before starting the surgery once sitting in the chair", "immediately after anesthetizing", "immediately after introducing the first surgery drill", "immediately before getting up".

Secondary Outcomes (2)

  • Change from Baseline in Anxiety on the 11-point Visual Analog Scale (VAS)

    Baseline before starting surgery to the end of surgery approximately 40 minutes later.

  • Change from Baseline in Pain on the 11-point Visual Analog Scale (VAS)

    Baseline before starting surgery to the end of surgery approximately 40 minutes later.

Study Arms (3)

BAROQUE MUSIC

This group would listen to baroque music to control their anxiety level during their oral surgeries.

Other: Music

CLASSICISM MUSIC

this group would listen to classical music to control their anxiety level during their oral surgeries.

Other: Music

CONTROL GROUP

This group would not listen to music during their oral intervention, acting as a control group.

Interventions

MusicOTHER

Through headphones, the patients would listen to different types of music during the intervention.

BAROQUE MUSICCLASSICISM MUSIC

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients without diseases that limit the performance of surgery, and that require the extraction of a tooth or the placement of a dental implant.

You may qualify if:

  • \. Spanish-speaking patients over 18 years of age who require the placement of a single implant or the extraction of a single tooth.

You may not qualify if:

  • Patients with mental illness (dementia)
  • Patients with psychiatric disorders
  • Patients under anxiolytic treatment
  • Patients with visual or motor loss or with any disability that makes it impossible to fill in the forms provided and the visual analog scale (VAS).
  • Patients under medical treatment that could interfere with the anesthesia used in oral surgery.
  • All implant surgeries were ruled out in patients requiring any type of bone regeneration, due to their greater morbidity.
  • All oral surgeries requiring a flap, due to their greater morbidity.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

European University of Madrid

Madrid, Spain

Location

MeSH Terms

Conditions

COVID-19

Interventions

Music Therapy

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Sensory Art TherapiesComplementary TherapiesTherapeuticsRehabilitationAftercareContinuity of Patient CarePatient CarePsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Esteban Lorenzo

    European University of Madrid

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Esteban LA

Study Record Dates

First Submitted

September 16, 2021

First Posted

September 22, 2021

Study Start

June 1, 2020

Primary Completion

November 23, 2020

Study Completion

May 27, 2022

Last Updated

December 13, 2022

Record last verified: 2022-12

Locations

ES(1)