Role of music in stress reduction during surgical extraction of teeth

Phase 2

Completed

Conditions: Impacted teeth,

Registration Number: CTRI/2019/01/017100

Lead Sponsor: All India Institute of Medical Sciences

Brief Summary: This prospective randomizedcontrol trial would be conducted in the Department of Dentistry, AIIMS Jodhpur.All participants requiring a surgical removal of impacted tooth would beincluded in the trial. All the participants will be randomly divided into twogroups as follows:

**Group A:** They will undergo the surgical procedure without any music

**Group B:** They will undergo the surgical procedure with instrumentalmusic in the background.

The music will be according topatient choice with the options ranging between old Bollywood music, modernBollywood music or religious music instrumental tunes.

Patients of both the groups willsign an informed written consent to undergo the surgical removal of impactedmaxillary or mandibular teeth. After seating the patient, preoperative readingsof vitals and the S- STAI -6 scale ( Marteau and Bekker 6) foranxiety will be documented. Once the readings are noted, Music will be startedand the treatment started. All the treatment will be completed by oneclinician. During the treatment, one intraoperative reading of all vitals andanxiety scale will be done after bone cutting is completed. Afterwards, areading of vitals will be completed postoperatively. At the end the patient andthe clinician will grade the comfort of the procedure and ambience respectivelyon a 5 point Likert scale. Patients will also grade the pain perceived duringthe procedure on a 11 point Visual analogue scale (VAS).

Any medical complication likesyncope, hyperventilation etc. will be noted.

Following parameters will benoted:

1.      Heart Rate (HR)

2.      Systolic Blood Pressure (SBP)

3.      Diastolic Blood Pressure (DBP)

4.      Respiratory Rate (RR)

The data will be documented on acase record form and relevant statistics applied.

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: All

Target Recruitment: 90

Inclusion Criteria

ASA I and II STATUS 2.
Indication of surgical removal of impacted maxillary or mandibular third molar.

Exclusion Criteria

1.ASA III, IV patients 2.Hearing impairment or difficulties 3.Refusal for informed consent 4.Patients requiring general anaesthesia.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Reduction in stress and anxiety	Preop \| Intraop after bone cutting \| Postoperative
1.Heart Rate (HR)	Preop \| Intraop after bone cutting \| Postoperative
measured by noting following	Preop \| Intraop after bone cutting \| Postoperative
2.Systolic Blood Pressure (SBP)	Preop \| Intraop after bone cutting \| Postoperative
Preop anxiety noted by S- STAI -6 scale ( Marteau and Bekker 6)	Preop \| Intraop after bone cutting \| Postoperative
4.Respiratory Rate (RR)	Preop \| Intraop after bone cutting \| Postoperative
Postop S- STAI -6 scale ( Marteau and Bekker 6)	Preop \| Intraop after bone cutting \| Postoperative
3.Diastolic Blood Pressure (DBP)	Preop \| Intraop after bone cutting \| Postoperative
Post op VAS	Preop \| Intraop after bone cutting \| Postoperative

Secondary Outcome Measures

Name	Time	Method
1. Any medical complication like syncope, hyperventilation etc. will be noted.	2. Operator assessment for comfort with ambience during procedure

Trial Locations

Locations (1): AIIMS JODHPUR
🇮🇳
Jodhpur, RAJASTHAN, India
AIIMS JODHPUR
🇮🇳Jodhpur, RAJASTHAN, India
ankita chugh
Principal investigator
8003996891
ankitamody@gmail.com