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CTRI Number  CTRI/2024/04/065216 [Registered on: 04/04/2024] Trial Registered Prospectively
Last Modified On: 14/12/2024
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug
Surgical/Anesthesia
Other (Specify) [soothing music via headphones]  
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Comparison of Music and Melatonin for intraoperative anxiety reduction in patients undergoing surgery. 
Scientific Title of Study   Intraoperative anxiety reduction: A comparison of Music and Melatonin interventions. 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Abhishek Bharadwaj 
Designation  Assistant Professor 
Affiliation  Raipur Institute of Medical Sciences 
Address  Faculty room,Department of Anaesthesiology, 3rd floor OT, Hospital Building, RIMS knowledge park, Bhansoj road.

Raipur
CHHATTISGARH
492101
India 
Phone  8860272013  
Fax    
Email  Bharadwaj.abhishek@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Abhishek Bharadwaj 
Designation  Assistant Professor 
Affiliation  Raipur Institute of Medical Sciences 
Address  Faculty room,3rd Floor OT,Department of Anaesthesiology,Main hospital Building,RIMS knowledge park,Bhansoj road.

Raipur
CHHATTISGARH
492101
India 
Phone  8860272013  
Fax    
Email  Bharadwaj.abhishek@gmail.com  
 
Details of Contact Person
Public Query  
Name  Abhishek Bharadwaj 
Designation  Assistant Professor 
Affiliation  Raipur Institute of Medical Sciences 
Address  Faculty room,3rd floor OT, Department of Anaesthesiology,Main hospital Building,RIMS knowledge park,Bhansoj Road.
SF-2, old faculty building, RIMS campus, infront of MM funcity
Raipur
CHHATTISGARH
492101
India 
Phone  8860272013  
Fax    
Email  Bharadwaj.abhishek@gmail.com  
 
Source of Monetary or Material Support  
Raipur Institute of Medical Sciences,Raipur,Chhattisgarh-492101. 
 
Primary Sponsor  
Name  Raipur Institute of Medical Sciences 
Address  RIMS Knowledge Park Bhansoj Road, Off NH-6 Raipur – 492101 Chhattisgarh, India 
Type of Sponsor  Private medical college 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Abhishek Bharadwaj  Raipur Institute of Medical Sciences,Raipur,Chhattisgarh-492101.  3rd floor operation theatre complex,Department of Anaesthesiology,Main hospital Building.
Raipur
CHHATTISGARH 		 08860272013

Bharadwaj.abhishek@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee, Raipur Institute of Medical Sciences  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: O||Medical and Surgical, (2) ICD-10 Condition: PCS||, (3) ICD-10 Condition: K409||Unilateral inguinal hernia, without obstruction or gangrene, (4) ICD-10 Condition: N433||Hydrocele, unspecified, (5) ICD-10 Condition: K603||Anal fistula, (6) ICD-10 Condition: K602||Anal fissure, unspecified, (7) ICD-10 Condition: M959||Acquired deformity of musculoskeletal system, unspecified, (8) ICD-10 Condition: N210||Calculus in bladder, (9) ICD-10 Condition: N211||Calculus in urethra, (10) ICD-10 Condition: K649||Unspecified hemorrhoids,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Melatonin Gummies.  Melatonin Gummies to be given orally 2 hours prior to patients who are posted for surgery under regional anaesthesia. 
Comparator Agent  Soothing Music  Patients will listen to Soothing music through headphones throughout the duration of surgery. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  1. Adult patients aged 18 to 65 years.
2. Scheduled for elective surgical procedures with time duration of 1 to 3 hours.
3. Undergoing regional anesthesia.
4. Presence of mild to moderate intraoperative anxiety, as assessed through a validated anxiety scale.
5. American Society of Anesthesiologists (ASA) physical status classification I or II.
6. Ability to understand and provide informed consent.
 
 
ExclusionCriteria 
Details  1. Age below 18 or above 65 years.
2. Emergency or urgent surgical procedures.
3. Patients undergoing general anesthesia.
4. Severe or uncontrolled anxiety or psychiatric disorders.
5. Patients with a history of allergies or severe adverse reactions to melatonin.
6. History of substance abuse or addiction.
7. Pregnant or breastfeeding women.
8. Inability to understand or comply with study procedures.
9. Participation in another clinical trial concurrently.
 
 
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 
To determine the level of patient satisfaction and comfort with the interventions(soothing music and melatonin)by assessing the perioperative anxiety levels with VAS-Anxiety scale and State Trait Anxiety Inventory scale. .  2 hours before surgery, 15 minutes before induction of anaesthesia, 30 mins after induction of anaesthesia and 15 minutes after completion of surgery. 
 
Secondary Outcome  
Outcome  TimePoints 
To assess and compare changes in hemodynamic parameters, including heart rate,respiratory rate, mean arterial pressure, and oxygen saturation(Spo2), between the music group and the melatonin group.  15 minutes before induction of anaesthesia, 30 mins after induction of anaesthesia and 15 minutes after completion of surgery. 
 
Target Sample Size   Total Sample Size="59"
Sample Size from India="59" 
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   Phase 4 
Date of First Enrollment (India)   15/04/2024 
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="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
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 study aims to compare the effect of soothing music versus melatonin in management of intraoperative anxiety in patients undergoing surgery under regional anesthesia.
A total sample size of 59 will be employed for recruiting patients in the two groups. After a computer generated randomisation and application of inclusion and exclusion criteria , patients will be allotted to each group. Music group will be made to hear soothing music through headphones intraoperatively, whereas the melatonin group will be given Melatonin orally 2 hours before induction of anaesthesia. Both the groups will be compared on the basis of primary and secondary objectives. 
The various time points of the study are 15 minutes before induction of anaesthesia, 30 minutes after induction of anaesthesia, 15 minutes after completion of surgery. 

 
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