| CTRI Number |
CTRI/2021/12/038980 [Registered on: 28/12/2021] Trial Registered Prospectively |
| Last Modified On: |
26/12/2021 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Music therapy] |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A study to know music therapy effect on awakening after giving general anesthesia to jaw surgery patients |
|
Scientific Title of Study
|
A pilot study to evaluate the effect of music therapy on post anesthesia recovery in the patients who underwent maxillofacial surgery |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Mohit Aluria |
| Designation |
BSc Dental Student |
| Affiliation |
All India Institute of Medical Sciences New Delhi |
| Address |
First floor
Centre for dental education and research
All India Institute of medical sciences
South West
DELHI
110029
India |
| Phone |
8076522844 |
| Fax |
|
| Email |
mohitaluria@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Ajoy Roychoudhury |
| Designation |
Professor and Head of Oral and Maxillofacial Surgery |
| Affiliation |
All India Institute of Medical Sciences New Delhi |
| Address |
Center For Dental Education and Research
All India Institute of Medical Sciences New Delhi India
New Delhi
DELHI
110029
India |
| Phone |
9891007749 |
| Fax |
|
| Email |
ajoyroy@hotmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Ajoy Roychoudhury |
| Designation |
Professor and Head of Oral and Maxillofacial Surgery |
| Affiliation |
All India Institute of Medical Sciences New Delhi |
| Address |
Center For Dental Education and Research
All India Institute of Medical Sciences New Delhi India
New Delhi
DELHI
110029
India |
| Phone |
9891007749 |
| Fax |
|
| Email |
ajoyroy@hotmail.com |
|
|
Source of Monetary or Material Support
|
| Undergraduate Research Mentorship Scheme. Research Section AIIMS New Delhi |
|
|
Primary Sponsor
|
| Name |
Undergraduate Research Mentorship Scheme |
| Address |
Research Section AIIMS New Delhi |
| Type of Sponsor |
Research institution and hospital |
|
|
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 |
| Mohit Aluria |
Department of Oral and Maxillofacial surgery (CDER) AIIMS New Delhi |
BSc. Dental Operating Room Assistant, 7th floor CDER (OT) Department of Oral and Maxillofacial surgery CDER AIIMS New Delhi
New Delhi
DELHI |
8076522844
mohitaluria@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute ethical committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K090||Developmental odontogenic cysts, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Music will be played through bluetooth linked earbud throughout the surgery at 65 decible volume |
The nature of music will be dissimilar and it is specific for a particular patient as per willing. During basic data collection patient interest in music and his/her choice of music will be enquired and will be played at the time of surgery. The music that is appealing to the patient will be played during surgery. Frequency of intervention - only once during surgery (Not repeated) and the Duration of therapy is throughout the surgery (less than 3hrs) in the operative table |
| Comparator Agent |
Music will not be played at the time of surgery |
Standard anaesthesia and surgical protocol will be followed same as intervention group |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
ASA 1 and 2 patients. Patients undergoing scheduled maxillofacial surgery less than 3 hours under general anesthesia. |
|
| ExclusionCriteria |
| Details |
Patients undergoing urgent surgery.
Patients having hearing impairment diseases.
Patients having psychiatric or cognitive disorders.
Pregnant ladies.
Patients refusing for consent
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Post anaesthesia recovery was evaluated using Modified Aldrete post anesthesia recovery score.It has five indices 0 to 2 according to degree of functional disturbances. |
It will be recorded immediately after extubation and repeated after 20 mins |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Heart rate blood pressure |
it is measured intraoperatively till the end of surgery every twenty minutes |
| Quality of awakening evaluated by Riker scale |
At the time of extubation |
| Pain during recovery using VAS scale |
At the time of extubation |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
01/01/2022 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="9"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Surgery and anesthesia are generally unpleasant experiences for patients and are the source of stress and anxiety that can hinder the desired therapeutic goal. Several experimental studies have evaluated the effects of music therapy in improving the quality of perioperative care. Music therapy helps patients overcome emotional and physical alienation and offers a pleasant distraction from pain and anxiety. However, the influence of music therapy on patient’s recovery from general anesthesia was really unknown. Hence this pilot study aimed to evaluate the effect of music therapy on post anesthesia recovery in the patients who underwent maxillofacial surgery. |