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Comparison of Binaural Beat Music and Noise Cancelling Headphones to Reduce Anxiety During Surgery Under Spinal Anaesthesia

Comparing Binaural Beat Music and Noise Cancelling Headphones for reducing intraoperative anxiety in patients undergoing surgery under spinal anaesthesia - A Randomized Controlled Study - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/07/090982
Enrollment
140
Registered
2025-07-16
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: O- Medical and Surgical Health Condition 2: K37- Unspecified appendicitis

Interventions

Intervention1: Noice cancellation: Duration 1 to 2 hrs Headphones without music Control Intervention1: Nil: Nil Control Intervention2: Binaural beat music: Duration 1 to 2 hrs Headphones with music

Sponsors

Ballari Medical College and research centre Ballari
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: All patients undergoing lower abdominal surgery under spinal anaesthesia ASA 1 and 2 Age 18-60 yrs Male and Female gender Patients able to provide written and informed consent

Exclusion criteria

Exclusion criteria: Patients with hearing impairment Pre-existing psychiatric or neurological disorders. Contraindications to spinal anaesthesia Pregnant and lactating mother Patients with chronic use of anxiolytics and sedatives

Design outcomes

Primary

MeasureTime frame
Comparison of change in intraoperative anxiety levelsTimepoint: 30min after spinal anaesthesia

Secondary

MeasureTime frame
Intraoperatively Sedation Ramsay score will used to monitor sedation, also any need for rescue sedation during surgery (e.g., midazolam, propofol) will be noted with dosage & frequency. Hemodynamic Parameters Heart rate, systolic/diastolic blood pressure Measured at baseline & intraoperatively at regular intervals (e.g., every 10 minutes) Used as physiological indicators of anxiety Communication Patients communication intraoperatively is monitored using Likert score Postoperatively Satisfaction Postoperative satisfaction survey regarding intraoperative experience is assessed using VAS-S score Incidence of Adverse Effects Dizziness, discomfort due to headphones/music Nausea, vomiting, or auditory disturbancesTimepoint: Preoperatively baseline Intraoperative 10min 20min 30min 40min 60min 80min 100min 120min Postoperatively

Countries

India

Contacts

Public ContactDr Jyothsna M

Ballari medical College and research centre Ballari

jyothsnabk@yahoo.com9900055996

Outcome results

None listed

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