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Evaluation of non-pharmacological and pharmacological methods to reduce intra-operative anxiety and improve patient outcome in lower limb surgeries under spinal anaesthesia

A study assessing the effects using three different modalities- music combined with active noise cancellation, active noise cancellation alone and intravenous dexmedetomidine infusion on intra-operative anxiety and sedation in patients undergoing lower limb surgeries under spinal anaesthesia - nil

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2026/06/113142
Enrollment
90
Registered
2026-06-29
Start date
Unknown
Completion date
Unknown
Last updated
2026-08-03

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 Health Condition 2: M95- Other acquired deformities of musculoskeletal system and connective tissue

Interventions

Intervention1: Nil: Nil Intervention2: Nil: Nil Control Intervention1: Music Therapy with noise cancellation group: Patients will receive binaural beat music through noise-cancelling headphones intra-

Sponsors

Swami Rama Himalayan University
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: -Patients giving writen informed consent -Either Sex -American Society of Anaesthesiologists physical status ASA I and II Duration of surgery less than or equal to 180 minutes

Exclusion criteria

Exclusion criteria: -Patients unwilling to take part in the research. -American Society of Anaesthesiologists physical status ASA III or IV -Patient with hearing impairment or any aural pathologies - History of psychiatric illness or cognitive dysfunction - Patients on chronic sedative or anxiolytic medications - Known allergy or contraindication to dexmedetomidine - Patients with cardiovascular, pulmonary, hepatic co-morbidities - Pregnant and lactating women - Patients with spinal deformity or contraindications to spinal anaesthesia

Design outcomes

Primary

MeasureTime frame
To evaluate and compare the effects of three modalities on intraoperative anxiety and sedationTimepoint: 1. State Trait Anxiety inventory -6 score preoperative and post-operative 30 minutes after surgery. 2. Modified Ramsay Score at 15 minutes, 30 minutes, 45 minutes, 1 hour, 1.5 hour, 2 hour, 2.5 hour, 3 hours

Secondary

MeasureTime frame
To observe and compare hemodynamic parameters (heart rate, blood pressure, mean arterial pressure, oxygen saturation, bispectral index) amomgst three groups.Timepoint: baseline,5 minutes after spinal anaesthesia,10 minutes,15 minutes,20minutes, 25minutes,30minutes, 40minutes,50minutes,1 hour,1 hour 15minutes,1 hour 30 minutes,1 hour 45 minutes,2 hours,2 hour 30minutes,3 hours

Countries

India

Contacts

Public ContactDr Divya Gupta

Department of Anaesthesia, Himalyan Institute of Medical Sciences, Dehradun

divyagupta@srhu.edu.in9456570288

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Aug 10, 2026