To study how music helps in reducing anxiety in patients undergoing lower limb surgeries under spinal anaesthesia

The impact of Binaural beat music and noise cancelling headphones on intraoperative anxiety and pain Catastrophizing in patients undergoing lower limb surgeries under spinal Anaesthesia - A Randomised Controlled study - Nil

Status

Active, not recruiting

Phases

Phase 2Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2024/07/071113

Enrollment

Registered

2024-07-23

Start date

Unknown

Completion date

Unknown

Last updated

2024-08-19

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

Conditions

Health Condition 1: M00-M99- Diseases of the musculoskeletal system and connective tissue

Interventions

Intervention1: Binaural beat music usage: Patient is subjected to wear a headphone and binaural beat music is played 30 minutes after giving spinal anaesthesia till the end of surgery and the effect o

Eligibility

Inclusion criteria

Inclusion criteria: American Society Of Anaesthesiology Class I / II Patients planned for elective lower limb surgeries

Exclusion criteria

Exclusion criteria: Patient refusal Hearing impairment Patients having psychiatric disorders and those who are having difficulty in comprehension Contraindications to spinal anaesthesia Pregnant and Lactating mothers

Design outcomes

Primary

Measure	Time frame
To determine the effect of binaural beat music and active noise cancellation on intraoperative anxiety using State-Trait Anxiety Inventory -6(STAI-6) Score in patients pre and post surgery.Timepoint: The STAI-6 score will be assessed preoperatively 30 minutes before shifting the patient to OT and postoperatively 2 hours after the surgery.	—

Secondary

Measure	Time frame
To evaluate the effect of music/noise cancellation on patient satisfaction, sedation, hemodynamic parameters, pain catastrophizing and analgesic requirementsTimepoint: Preoperatively before shifting to OT, After 30 minutes of spinal anesthesia ( 1min , 15min , 30min , 45min , 60 min, 90min , 120min , 150min , 180min , 210min , 241min) and postoperatively	—

Countries

India

Contacts

Public ContactDr Radhakrishnan A

Sri Venkateshwaraa Medical College Hospital and Research Centre

rkpuduvai@gmail.com8825778958

Outcome results

None listed

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