Skip to content

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

Exploring the impact of binaural beat auditory stimulation and noise reducing headphones on intraoperative anxiety during upper limb orthopedic surgeries under regional block - NIL

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/06/089614
Enrollment
90
Registered
2025-06-26
Start date
Unknown
Completion date
Unknown
Last updated
2025-07-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: 4- Measurement and Monitoring

Interventions

Intervention1: Noise cancellation headphone: Patients undergoing upper limb surgeries will be given ultrasound guided supraclavicular block and then noise cancellation will be provided through headpho

Sponsors

Rajendra Institute of Medical Sciences
Lead Sponsor

Eligibility

Inclusion criteria

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

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.

Design outcomes

Primary

MeasureTime frame
To determine the effect of music and noise cancellation on intraoperative anxietyTimepoint: State Trait Anxiety Inventory-6 (SATI-6) score Preoperative before giving supraclavicular block Postoperative before shifting the patient from operation theatre

Secondary

MeasureTime frame
To determine the effect of music/ noise cancellation on patient satisfactionTimepoint: 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 sedationTimepoint: 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 difficultyTimepoint: 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 parametersTimepoint: 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

Countries

India

Contacts

Public ContactDr Ladhu Lakra

Rajendra Institute of Medical Sciences

dr.ladhulakra007@gmail.com9835160608

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026