| CTRI Number |
CTRI/2024/09/074055 [Registered on: 19/09/2024] Trial Registered Prospectively |
| Last Modified On: |
13/09/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Melody before operation or medicine before operation. |
|
Scientific Title of Study
|
Comparison of effect of music therapy alone or with intravenous midazolam on pre-operative anxiety in adult patients undergoing laparoscopic cholecystectomy |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Gijo Paul |
| Designation |
DNB TRAINEE |
| Affiliation |
The Mission Hospital |
| Address |
PAC room
Third floor
Department of Anaesthesiology
The Mission Hospital
Immon Kalyan Sarani
Sector II C
Bidhan Nagar
Durgapur 713212
Paschim Bardhaman
West Bengal
PAC room
Third floor
Department of Anaesthesiology
The Mission Hospital
Immon Kalyan Sarani
Sector II C
Bidhan Nagar
Durgapur 713212
Paschim Bardhaman
West Bengal
Barddhaman
WEST BENGAL
713212
India |
| Phone |
9048807799 |
| Fax |
|
| Email |
gijopaul007@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Tamalika Das |
| Designation |
Consultant Anaesthesiologist |
| Affiliation |
The Mission Hospital |
| Address |
PAC room
Third floor
Department of Anaesthesiology
The Mission Hospital
Immon Kalyan Sarani
Sector II C
Bidhan Nagar
Durgapur 713212
Paschim Bardhaman
West Bengal
PAC room
Third floor
Department of Anaesthesiology
The Mission Hospital
Immon Kalyan Sarani
Sector II C
Bidhan Nagar
Durgapur 713212
Paschim Bardhaman
West Bengal
Barddhaman
WEST BENGAL
713212
India |
| Phone |
9048807799 |
| Fax |
|
| Email |
tamalika19@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Gijo Paul |
| Designation |
DNB TRAINEE |
| Affiliation |
The Mission Hospital |
| Address |
PAC room
Third floor
Department of Anaesthesiology
The Mission Hospital
Immon Kalyan Sarani
Sector II C
Bidhan Nagar
Durgapur 713212
Paschim Bardhaman
West Bengal
PAC room
Third floor
Department of Anaesthesiology
The Mission Hospital
Immon Kalyan Sarani
Sector II C
Bidhan Nagar
Durgapur 713212
Paschim Bardhaman
West Bengal
Barddhaman
WEST BENGAL
713212
India |
| Phone |
9048807799 |
| Fax |
|
| Email |
gijopaul007@gmail.com |
|
|
Source of Monetary or Material Support
|
| The Mission Hospital
Immon Kalyan Sarani
Sector II C
Bidhan Nagar
Durgapur 713212
Paschim Bardhaman
West Bengal |
|
|
Primary Sponsor
|
| Name |
Dr Gijo Paul |
| Address |
PAC room
Third floor
Department of Anaesthesiology
The Mission Hospital
Immon Kalyan Sarani
Sector II C
Bidhan Nagar
Durgapur 713212
Paschim Bardhaman
West Bengal |
| Type of Sponsor |
Other [self] |
|
|
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 Gijo Paul |
The Mission Hospital |
Pre operative room
Third floor
Department of Anaesthesiology
Immon Kalyan Sarani
Sector II C
Bidhan Nagar
Durgapur 713212
Paschim Bardhaman
West Bengal
Barddhaman
WEST BENGAL |
9048807799
gijopaul007@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| The Mission Hospital Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Intravenous Midazolam |
Administration of preoperative intravenous midazolam |
| Intervention |
Music Therapy |
Administration of music of patients choice in the pre-operative room |
| Intervention |
Music Therapy and Intravenous Midazolam |
Administration of music of patients choice in preoperative period along with intravenous Midazolam |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
American society of anesthesiologists Grade I and II
Elective laparoscopic cholecystectomy surgical procedure requiring general anesthesia
Patients with informed consent
|
|
| ExclusionCriteria |
| Details |
Patient refusal
History of allergy to midazolam
Patients with cardiovascular diseases
Patients with known respiratory disease
Patients with significant hepatic and/ or renal dysfunction
Patients suffering from any psychiatric disorder
Deaf or hearing-impaired patients
Pregnant and lactating patients
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| APAIS SCORE |
baseline
20 minutes |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To establish efficacy of music therapy and midazolam on:
Hemodynamics- Heart Rate and Blood Pressure
Sedation
Side effects ( nausea, vomiting )
|
20 minutes after intervention |
|
|
Target Sample Size
|
Total Sample Size="90"
Sample Size from India="90"
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)
|
29/09/2024 |
| 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="2"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
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
|
This is a randomized control study comparing three techniques to decrease pre operative anxiety using: (i) Music therapy (ii) Intravenous midazolam (iii) combination of music therapy and intravenous midazolam. |