Efficacy of Iatrosedation and Music Therapy to Attenuate Dental Anxiety

Sponsor

Altamash Institute of Dental Medicine (Other)

Overall Status

Completed

CT.gov ID

NCT05755126

Collaborator

(none)

Enrollment

Location

Arms

Actual Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Dental Anxiety	Behavioral: Iatrosedation Behavioral: Musical Therapy	N/A

Detailed Description

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

60 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Participant)

Primary Purpose:

Treatment

Official Title:

The Comparative Efficacy of Iatrosedation and Music Therapy as Techniques to Attenuate Dental Anxiety in Patients Undergoing Dental Crown Preparation

Actual Study Start Date :

Aug 1, 2021

Actual Primary Completion Date :

Jan 31, 2022

Actual Study Completion Date :

Jan 31, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Iatrosedation	Behavioral: Iatrosedation Alleviating the anxiety of patients by iatrosedative interview and clinical encounter
Experimental: Musical Therapy	Behavioral: Musical Therapy Patients were provided with headphones and a playlist to listen to the music of their choice for 10 minutes
No Intervention: Control

Arm

Intervention/Treatment

Experimental: Iatrosedation

Behavioral: Iatrosedation

Alleviating the anxiety of patients by iatrosedative interview and clinical encounter

Experimental: Musical Therapy

Behavioral: Musical Therapy

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

No Intervention: Control

Outcome Measures

Primary Outcome Measures

Dental Anxiety [6 months]
Heart rate was measured using a pulse oximeter
Dental Anxiety [6 months]
Using verbal rating scale scores

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Altamash Institute of Dental Medicine	Karachi	Sindh	Pakistan	75500

Sponsors and Collaborators

Altamash Institute of Dental Medicine

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Abhishek Lal, Principal Investigator, Altamash Institute of Dental Medicine

ClinicalTrials.gov Identifier:

NCT05755126

Other Study ID Numbers:

Iatrosedation vs Music

First Posted:

Mar 6, 2023

Last Update Posted:

Mar 6, 2023

Last Verified:

Feb 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

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

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

Additional relevant MeSH terms:

Anxiety Disorders

Study Results

No Results Posted as of Mar 6, 2023