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A study to find out if using noise-cancelling headphones during hip replacement surgery helps reduce pain after surgery

Effect of noise cancellation headphones during total hip arthroplasty under spinal anaesthesia on postoperative pain; a randomized trial controlled study - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/08/092868
Enrollment
70
Registered
2025-08-12
Start date
Unknown
Completion date
Unknown
Last updated
2025-08-18

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

Interventions

Intervention1: Noise cancellation headphones: Spinal anaesthesia + noise-cancelling headphones till end of surgery Control Intervention1: No headphones (standard care): No headphones applied. Patients
midazolam 1 mg aliquots only on patient request. Control Intervention2: No headphones (standard care): Spinal anaesthesia without headphones.

Sponsors

Maulana Azad Medical College
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Patients aged 18 to 65 years with American Society of Anaesthesiologists (ASA) physical status I to III.

Exclusion criteria

Exclusion criteria: Patients with hearing impairment or use of hearing aids; chronic pain syndromes or regular opioid analgesic use in the last three months; neurological disorders including dementia, Parkinson s disease, or stroke; psychiatric illness such as major depression, schizophrenia, or severe anxiety; contraindications to spinal anaesthesia such as coagulopathy, infection at injection site, or spinal deformities; BMI greater than 35 kg/m ; uncontrolled cardiovascular disease such as severe hypertension, recent myocardial infarction, or heart failure.

Design outcomes

Primary

MeasureTime frame
Difference between mean of highest pain scores in the first 24 hours after surgery, measured using a 11-point numeric rating scale (NRS)in both groups.Timepoint: First 24 hours after surgery.—

Secondary

MeasureTime frame
Mean post operative pain scores using NRS at 4, 8, 12, and 24 hours after surgery.Timepoint: 4, 8, 12, and 24 hours after surgery.;Mean time to requirement of first postoperative analgesic.Timepoint: Within first 24 hours after surgery.;Mean analgesic consumption over first 24 hrs postoperatively.Timepoint: First 24 hours after surgery.;Mean duration of sensory blockade and motor blockade of spinal anaesthesia.Timepoint: From administration of spinal anaesthesia until complete recovery of sensory and motor function.;Mean quality of Recovery -15 (QoR- 15) scores at 24 hours.Timepoint: 24 hours after surgery.;Mean intraoperative Bispectral Index Scores (BIS).Timepoint: During intraoperative period.—

Countries

India

Contacts

Public ContactArun Prasannan

Maulana Azad Medical College

drakgk@yahoo.co.in9968604219

Outcome results

None listed

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