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Efficacy of Iatrosedation and Music Therapy to Attenuate Dental Anxiety

Primary Purpose

Dental Anxiety

Status
Completed
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
Iatrosedation
Musical Therapy
Sponsored by
Altamash Institute of Dental Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dental Anxiety

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Altamash Institute of Dental Medicine

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

No Intervention

Arm Label

Iatrosedation

Musical Therapy

Control

Arm Description

Outcomes

Primary Outcome Measures

Dental Anxiety
Heart rate was measured using a pulse oximeter
Dental Anxiety
Using verbal rating scale scores

Secondary Outcome Measures

Full Information

First Posted
February 14, 2023
Last Updated
February 22, 2023
Sponsor
Altamash Institute of Dental Medicine
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1. Study Identification

Unique Protocol Identification Number
NCT05755126
Brief Title
Efficacy of Iatrosedation and Music Therapy to Attenuate Dental Anxiety
Official Title
The Comparative Efficacy of Iatrosedation and Music Therapy as Techniques to Attenuate Dental Anxiety in Patients Undergoing Dental Crown Preparation
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Completed
Study Start Date
August 1, 2021 (Actual)
Primary Completion Date
January 31, 2022 (Actual)
Study Completion Date
January 31, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Altamash Institute of Dental Medicine

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
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
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dental Anxiety

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Iatrosedation
Arm Type
Experimental
Arm Title
Musical Therapy
Arm Type
Experimental
Arm Title
Control
Arm Type
No Intervention
Intervention Type
Behavioral
Intervention Name(s)
Iatrosedation
Intervention Description
Alleviating the anxiety of patients by iatrosedative interview and clinical encounter
Intervention Type
Behavioral
Intervention Name(s)
Musical Therapy
Intervention Description
Patients were provided with headphones and a playlist to listen to the music of their choice for 10 minutes
Primary Outcome Measure Information:
Title
Dental Anxiety
Description
Heart rate was measured using a pulse oximeter
Time Frame
6 months
Title
Dental Anxiety
Description
Using verbal rating scale scores
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
Altamash Institute of Dental Medicine
City
Karachi
State/Province
Sindh
ZIP/Postal Code
75500
Country
Pakistan

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Efficacy of Iatrosedation and Music Therapy to Attenuate Dental Anxiety

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