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

Phase 4

Not yet recruiting

• Conditions: Measurement and Monitoring,

• Registration Number: CTRI/2025/06/089614
• Lead Sponsor: Rajendra Institute of Medical Sciences

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.

Detailed Description

Not available

Study Timeline

• Last Update Posted: 2025-06-26
• Study Start: 2025-07-07

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 90

Inclusion Criteria

Greater than 18 years of age, either sex, ASA Grade 1-3, Upper limb orthopedic surgeries under supraclavicular brachial plexus block.

Exclusion Criteria

• 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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Measures

Name	Time	Method
To determine the effect of music/ noise cancellation on patient satisfaction	Visual Analogue Score for patient Satisfaction (VAS-S)
To determine the effect of music/ noise cancellation on patient sedation	Ramsay Sedation Score
To determine the effect of music/ noise cancellation on patient communication difficulty	Likert communication difficulty score
To determine the effect of music/ noise cancellation on patient haemodynamic parameters	Heart rate, Systolic blood pressure, diastolic blood pressure, mean blood pressure

Trial Locations

Locations (1)

Orthopaedic operation theatre and Department of Anaesthesiology, RIMS, Ranchi; 🇮🇳 Ranchi, JHARKHAND, India

Orthopaedic operation theatre and Department of Anaesthesiology, RIMS, Ranchi

🇮🇳Ranchi, JHARKHAND, India

Dr Adnan Naim

Principal investigator

9576962353

adnan.aa7135@gmail.com