| CTRI Number |
CTRI/2019/01/017100 [Registered on: 16/01/2019] Trial Registered Prospectively |
| Last Modified On: |
29/09/2021 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry
Behavioral |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Role of music in stress reduction during surgical extraction of teeth |
|
Scientific Title of Study
|
Role of instrumental music in stress
reduction during surgical removal of
impacted teeth: A Randomized Control Study |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Ankita chugh |
| Designation |
Associate professor |
| Affiliation |
AIIMS , JODHPUR. |
| Address |
214 A block second floor
Aiims complex
Jodhpur
RAJASTHAN
342005
India
Jodhpur
RAJASTHAN
342005
India |
| Phone |
08003996891 |
| Fax |
|
| Email |
ankitamody@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
SHRUTI KHATANA |
| Designation |
SENIOR RESIDENT |
| Affiliation |
AIIMS , JODHPUR. |
| Address |
214, second floor A block
Department of dentistry
Jodhpur
RAJASTHAN
342005
India
Jodhpur
RAJASTHAN
342005
India |
| Phone |
|
| Fax |
|
| Email |
SHRU.K85@GMAIL.COM |
|
Details of Contact Person
Public Query
|
| Name |
SHRUTI KHATANA |
| Designation |
SENIOR RESIDENT |
| Affiliation |
AIIMS , JODHPUR. |
| Address |
214, A block, second floor
Department of dentistry
Aiims jodhpur
Jodhpur
RAJASTHAN
342005
India
Jodhpur
RAJASTHAN
342005
India |
| Phone |
|
| Fax |
|
| Email |
SHRU.K85@GMAIL.COM |
|
|
Source of Monetary or Material Support
|
| ALL INDIA INSTITUTE OF MEDICAL SCIENCES, JODHPUR, Rajasthan India
342005 |
|
|
Primary Sponsor
|
| Name |
All India Institute of Medical Sciences |
| Address |
Basni Industrial Area Jodhpur
Rajasthan India 342005
|
| Type of Sponsor |
Government medical college |
|
|
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 |
| ankita chugh |
AIIMS JODHPUR |
Department of dentistry room 214,2nd floor A block Basni Industrial area
Jodhpur
RAJASTHAN
Jodhpur
RAJASTHAN |
8003996891
ankitamody@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K011||Impacted teeth, |
|
Intervention / Comparator Agent
Modification(s)
|
| Type |
Name |
Details |
| Intervention |
Instrumental music |
Group B: They will undergo the surgical procedure with instrumental music in the background.
The music will be according to patient choice with the options ranging between old Bollywood
music, modern Bollywood music or religious music instrumental tunes. The music will start after explaining procedure and consent and will let the entire duration of surgery. |
| Comparator Agent |
No music |
Comparator agent will be no music and a regular way of the procedure. There will be no attempt to play any music |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. ASA I and II STATUS
2. Indication of surgical removal of impacted maxillary or mandibular third molar |
|
| ExclusionCriteria |
| Details |
1. ASA III, IV patients
2. Hearing impairment or difficulties
3. Refusal for informed consent
4. Patients requiring general anaesthesia
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Reduction in stress and anxiety
measured by noting following
Preop anxiety noted by S- STAI -6 scale ( Marteau and Bekker 6)
1. Heart Rate (HR)
2. Systolic Blood Pressure (SBP)
3. Diastolic Blood Pressure (DBP)
4. Respiratory Rate (RR)
Postop S- STAI -6 scale ( Marteau and Bekker 6)
Post op VAS
|
Preop
Intraop after bone cutting
Postoperative
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Any medical complication like syncope, hyperventilation etc. will be noted.
2. Operator assessment for comfort with ambience during procedure |
Postoperative |
|
|
Target Sample Size
|
Total Sample Size="90"
Sample Size from India="90"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="50" |
|
Phase of Trial
|
Phase 2 |
|
Date of First Enrollment (India)
|
17/01/2019 |
| Date of Study Completion (India) |
03/02/2020 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
Sato Ashida MM, MT-BC. The effect of reminiscence music therapy sessions on changes in depressive symptom in elderly persons with dementia. Journal of Music Therapy. 2000;37(3):170–182. |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This prospective randomized
control trial would be conducted in the Department of Dentistry, AIIMS Jodhpur.
All participants requiring a surgical removal of impacted tooth would be
included in the trial. All the participants will be randomly divided into two
groups as follows:
Group A: They will undergo the surgical procedure without any music
Group B: They will undergo the surgical procedure with instrumental
music in the background.
The music will be according to
patient choice with the options ranging between old Bollywood music, modern
Bollywood music or religious music instrumental tunes.
Patients of both the groups will
sign an informed written consent to undergo the surgical removal of impacted
maxillary or mandibular teeth. After seating the patient, preoperative readings
of vitals and the S- STAI -6 scale ( Marteau and Bekker 6) for
anxiety will be documented. Once the readings are noted, Music will be started
and the treatment started. All the treatment will be completed by one
clinician. During the treatment, one intraoperative reading of all vitals and
anxiety scale will be done after bone cutting is completed. Afterwards, a
reading of vitals will be completed postoperatively. At the end the patient and
the clinician will grade the comfort of the procedure and ambience respectively
on a 5 point Likert scale. Patients will also grade the pain perceived during
the procedure on a 11 point Visual analogue scale (VAS).
Any medical complication like
syncope, hyperventilation etc. will be noted.
Following parameters will be
noted:
1.
Heart Rate (HR)
2.
Systolic Blood Pressure (SBP)
3.
Diastolic Blood Pressure (DBP)
4.
Respiratory Rate (RR)
The data will be documented on a
case record form and relevant statistics applied.
|