NCT05755126

Brief Summary

Dental anxiety is a common problem encountered in the dental clinics that affect both patients and dentists. Adequate management of the dental anxiety is critical for optimal treatment outcomes of the patient. In this clinical trial, a total of sixty patients were randomly assigned to three groups as follows: Group 1, Iatrosedation, Group 2, Music Therapy, and Group 3, Control. Patients in all of the three groups underwent dental crown preparation. . To measure the anxiety levels of the patients, heart rate was measured using a pulse oximeter, and verbal rating scale scores were assessed

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2021

Shorter than P25 for not_applicable

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

August 1, 2021

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2022

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

February 14, 2023

Completed
20 days until next milestone

First Posted

Study publicly available on registry

March 6, 2023

Completed
Last Updated

March 6, 2023

Status Verified

February 1, 2023

Enrollment Period

6 months

First QC Date

February 14, 2023

Last Update Submit

February 22, 2023

Conditions

Dental Anxiety

Outcome Measures

Primary Outcomes (2)

  • Dental Anxiety

    Heart rate was measured using a pulse oximeter

    6 months

  • Dental Anxiety

    Using verbal rating scale scores

    6 months

Study Arms (3)

Iatrosedation

EXPERIMENTAL
Behavioral: Iatrosedation

Musical Therapy

EXPERIMENTAL
Behavioral: Musical Therapy

Control

NO INTERVENTION

Interventions

IatrosedationBEHAVIORAL

Alleviating the anxiety of patients by iatrosedative interview and clinical encounter

Iatrosedation
Musical TherapyBEHAVIORAL

Patients were provided with headphones and a playlist to listen to the music of their choice for 10 minutes

Musical Therapy

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • patients who were above 18 years of age
  • no systemic diseases
  • no previous dental treatment experience
  • showed willingness to participate

You may not qualify if:

  • patients below the age of 18 years
  • medically compromised
  • previous history of dental treatment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Altamash Institute of Dental Medicine

Karachi, Sindh, 75500, Pakistan

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

February 14, 2023

First Posted

March 6, 2023

Study Start

August 1, 2021

Primary Completion

January 31, 2022

Study Completion

January 31, 2022

Last Updated

March 6, 2023

Record last verified: 2023-02

Locations

PA(1)