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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05755126
Other study ID # Iatrosedation vs Music
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date August 1, 2021
Est. completion date January 31, 2022

Study information

Verified date February 2023
Source Altamash Institute of Dental Medicine
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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


Description:

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. This study aims to assess the efficacy of different anxiety reduction techniques (Iatrosedation and music therapy) in adult patients for dental crown preparations. 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. One-way ANOVA, Post hoc, and Spearman's correlation was used to compare the mean values of the three groups.


Recruitment information / eligibility

Status Completed
Enrollment 60
Est. completion date January 31, 2022
Est. primary completion date January 31, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - patients who were above 18 years of age - no systemic diseases - no previous dental treatment experience - showed willingness to participate Exclusion Criteria: - patients below the age of 18 years - medically compromised - previous history of dental treatment

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Iatrosedation
Alleviating the anxiety of patients by iatrosedative interview and clinical encounter
Musical Therapy
Patients were provided with headphones and a playlist to listen to the music of their choice for 10 minutes

Locations

Country Name City State
Pakistan Altamash Institute of Dental Medicine Karachi Sindh

Sponsors (1)

Lead Sponsor Collaborator
Altamash Institute of Dental Medicine

Country where clinical trial is conducted

Pakistan, 

Outcome

Type Measure Description Time frame Safety issue
Primary Dental Anxiety Heart rate was measured using a pulse oximeter 6 months
Primary Dental Anxiety Using verbal rating scale scores 6 months
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