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CTRI Number  CTRI/2025/06/089614 [Registered on: 26/06/2025] Trial Registered Prospectively
Last Modified On: 26/06/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Other (Specify) [Noise reducing headphones]  
Study Design  Randomized, Parallel Group, Multiple Arm Trial 
Public Title of Study   We are trying to assess the effect of binaural beat and noise cancelation to reduce stress during upper limb bone surgery under effect of nerve block  
Scientific Title of Study   Exploring the impact of binaural beat auditory stimulation and noise reducing headphones on intraoperative anxiety during upper limb orthopedic surgeries under regional block 
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 Adnan Naim 
Designation  Junior Resident  
Affiliation  Rajendra Institute of Medical Sciences 
Address  Department of Anesthesiology and Department of Orthopedic, Rajendra Institute of Medical Sciences, Bariatu, Ranchi, Jharkhand, 834009
Department of Anesthesiology and Department of Orthopedic, Rajendra Institute of Medical Sciences, Bariatu, Ranchi, Jharkhand, 834009
Ranchi
JHARKHAND
834009
India 
Phone  9576962353  
Fax    
Email  adnan.aa7135@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Ladhu Lakra 
Designation  Professor 
Affiliation  Rajendra Institute of Medical Sciences 
Address  Department of Anesthesiology and Department of Orthopedic, Rajendra Institute of Medical Sciences, Bariatu, Ranchi, Jharkhand, 834009
Department of Anesthesiology and Department of Orthopedic, Rajendra Institute of Medical Sciences, Bariatu, Ranchi, Jharkhand, 834009
Ranchi
JHARKHAND
834009
India 
Phone  9835160608  
Fax    
Email  dr.ladhulakra007@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Ladhu Lakra 
Designation  Professor 
Affiliation  Rajendra Institute of Medical Sciences 
Address  Department of Anesthesiology and Department of Orthopedic, Rajendra Institute of Medical Sciences, Bariatu, Ranchi, Jharkhand, 834009
Department of Anesthesiology and Department of Orthopedic, Rajendra Institute of Medical Sciences, Bariatu, Ranchi, Jharkhand, 834009
Ranchi
JHARKHAND
834009
India 
Phone  9835160608  
Fax    
Email  dr.ladhulakra007@gmail.com  
 
Source of Monetary or Material Support  
NIL 
 
Primary Sponsor  
Name  Rajendra Institute of Medical Sciences 
Address  Department of Anaesthesiology, Rajendra Institute of Medical Sciences, Bariatu, Ranchi, Jharkhand, 834009 
Type of Sponsor  Government 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 Adnan Naim  Orthopaedic operation theatre and Department of Anaesthesiology, RIMS, Ranchi  Department of Anaesthesiology, Rajendra Institute of Medical Sciences, Bariatu, Ranchi, Jharkhand, 834009
Ranchi
JHARKHAND 		 9576962353

adnan.aa7135@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee, RIMS, Ranchi  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: 4||Measurement and Monitoring,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Binaural beats  Patients undergoing upper limb surgeries will be given ultrasound guided supraclavicular block and then binaural beat music will be provided through headphone throughout the duration of surgery 
Comparator Agent  No headphone  Patients undergoing upper limb surgeries will be given ultrasound guided supraclavicular block and will be monitored throughout the duration of surgery 
Intervention  Noise cancellation headphone  Patients undergoing upper limb surgeries will be given ultrasound guided supraclavicular block and then noise cancellation will be provided through headphone throughout the duration of surgery 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  Greater than 18 years of age, either sex, ASA Grade 1-3, Upper limb orthopedic surgeries under supraclavicular brachial plexus block. 
 
ExclusionCriteria 
Details  ASA grade 4-5, patient’s refusal, anaphylaxis to regional anaesthetic agents, pre-existing neuropathy, coagulopathy, neurological or neuromuscular disease, hepatic or kidney failure, hearing impairment and patients on hearing aids, neurological deficits like paresis of the upper limb.
Who do not want to wear headphones during the intraoperative period.
 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
To determine the effect of music and noise cancellation on intraoperative anxiety  State Trait Anxiety Inventory-6 (SATI-6) score
Preoperative before giving supraclavicular block
Postoperative before shifting the patient from operation theatre 
 
Secondary Outcome  
Outcome  TimePoints 
To determine the effect of music/ noise cancellation on patient satisfaction  Visual Analogue Score for patient Satisfaction (VAS-S)
Preoperative before giving supraclavicular block
Postoperative before shifting the patient from operation theatre
 
To determine the effect of music/ noise cancellation on patient sedation  Ramsay Sedation Score
Preoperative before giving supraclavicular block
Intraoperative after 30 min of giving supraclavicular block
Postoperative before shifting the patient from operation theatre 
To determine the effect of music/ noise cancellation on patient communication difficulty  Likert communication difficulty score
Preoperative before giving supraclavicular block
Intraoperative after 30 min of giving supraclavicular block
Postoperative before shifting the patient from operation theatre 
To determine the effect of music/ noise cancellation on patient haemodynamic parameters  Heart rate, Systolic blood pressure, diastolic blood pressure, mean blood pressure
Baseline
1 minute
10 minutes
20 minutes
30 minutes
40 minutes
60 minutes
End of surgery 
 
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   Phase 4 
Date of First Enrollment (India)   07/07/2025 
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)   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 study aims to evaluate the effect of binaural beat auditory stimulation and noise-cancelling headphones on intraoperative anxiety levels, patient satisfaction, sedation, communication difficulty and haemodynamic parameters in patients undergoing upper limb orthopedic surgeries under a supraclavicular brachial plexus block. 
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