| CTRI Number |
CTRI/2024/02/062958 [Registered on: 21/02/2024] Trial Registered Prospectively |
| Last Modified On: |
13/02/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Behavioral |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
Effectiveness of various kinds of music on vital signs and dental anxiety: a randomized double-blind controlled trial
|
|
Scientific Title of Study
|
Effectiveness of various kinds of music on vital signs and dental anxiety: a randomized double-blind controlled trial
|
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Bandi Blessi Sravya |
| Designation |
Post Graduate |
| Affiliation |
Sibar institute of dental sciences |
| Address |
Sibar institute of dental sciences, department of public health
dentistry, room no.10, takkellapadu, guntur, andhra pradesh.
Guntur
Guntur
ANDHRA PRADESH
522509
India |
| Phone |
9912024099 |
| Fax |
|
| Email |
blessibandi1997@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr P Srinivas |
| Designation |
Professor & HOD |
| Affiliation |
Sibar institute of dental sciences |
| Address |
Sibar institute of dental sciences, department of public health
dentistry, room no.10, takkellapadu, guntur, andhra pradesh.
Guntur
Guntur
ANDHRA PRADESH
522509
India |
| Phone |
9849368466 |
| Fax |
|
| Email |
srinivaspachava@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Bhimana Srilekha |
| Designation |
Assistant professor |
| Affiliation |
Sibar institute of dental sciences |
| Address |
Sibar institute of dental sciences, department of public health
dentistry, room no.10, takkellapadu, guntur, andhra pradesh.
Guntur
Guntur
ANDHRA PRADESH
522509
India |
| Phone |
9703420999 |
| Fax |
|
| Email |
srilekhabhimana1417@gmail.com |
|
|
Source of Monetary or Material Support
|
| SIBAR Institute of Dental Sciences, Takkellapdu, Guntur, Andhra Pradesh |
|
|
Primary Sponsor
|
| Name |
Dr L Krishna Prasad |
| Address |
Sibar institute of dental sciences, takkellapdu, guntur, andhra
pradesh |
| Type of Sponsor |
Other [Private Dental College (Dean)] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Bandi Blessi Sravya |
Sibar institute of dental sciences |
Outpatient department, Sibar institute of dental
sciences, Takkellapdu, Guntur 522509
Guntur
ANDHRA PRADESH |
9912024099
blessibandi1997@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, SIBAR Institute of Dental Sciences |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
people with dental problems |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Music |
The study will be performed in a closed room, free from other noises. Subjects lay in a supine position on the dental chair and asked to close their eyes and the subjects will be exposed to the respective music through headsets for 5 minutes. the whole time taken for recording vitals, filling questionnaire and music intervention together includes around 15 minutes per subject
Group A : Classical music (Carnatic music)
Group B : Acoustic music (Flute acoustic)
Group C : Pop music (Starboy)
|
| Comparator Agent |
Relaxation |
The study will be performed in a closed room, free from other noises. Subjects lay in a supine position on the dental chair and asked to close their eyes and get relaxed for 5 minutes. the whole time taken for recording vitals, filling questionnaire and relaxation together includes around 15 minutes per subject
Group D : Control group ( No music) |
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
First dental visit subjects attending the out patient department in a Dental institute for dental treatment
Aged 25-60 years
Those who are willing to participate and gives consent for the study.
|
|
| ExclusionCriteria |
| Details |
People who are on daily medication for any systemic diseases
People with psychological conditions
People with hearing impairment
peoples with alcohol and smoking habit
Pregnant and lactating mothers.
|
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Dental anxiety levels through MDAS questionnaire |
at 2 time intervals (at baseline and at 5 mins after intervention) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| vital signs (heart rate, blood pressure, SPO2) |
at 2 time intervals (at baseline & at 5 mins after intervention) |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="80" |
|
Phase of Trial
|
Phase 2 |
|
Date of First Enrollment (India)
|
26/02/2024 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="3"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
A total sample of 80 subjects will be selected randomly from the people attending the out patient department in a Dental institute. Subjects will be explained the entire procedure and written consent is obtained from each of them. subjects will be selected based on inclusion and exclusion criteria. The subjects will be randomized into 4 groups with systematic allocation ratio of 1:1:1:1 by a single investigator and the groups are named as Group A, B, C, D containing 20 subjects in each group. Care will be taken in order to match all the groups in all the aspects other than the intervention provided. Vital signs (Blood pressure, Heart rate, SpO2) and dental anxiety levels using modified dental anxiety scale (MDAS) will be recorded before and after the intervention for all the subjects. then analysis will be performed to know the effectiveness of various kinds of music on vital signs and dental anxiety levels by using statistical tests. Intervention provided: The study will be performed in a closed room, free from other noises. Subjects lay in a supine position on the dental chair and asked to close their eyes and the subjects will be exposed to the respective music through headsets for 5 minutes. 1)Group A : Classical music (Carnatic music) 2)Group B : Acoustic music (Flute acoustic) 3)Group C : Pop music (Starboy) 4)Group D : Control group ( No music) |