A study on the effect of music therapy on anxiety, stress and sedative requirements in patients undergoing lower limb orthopedic surgery under spinal anaesthesia.

Effect of music therapy on anxiety, stress and sedative requirements in patients undergoing lower limb orthopedic surgery under spinal anaesthesia: A randomized controlled study. - NIL

Status

Active, not recruiting

Phases

Phase 2Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2024/05/067076

Enrollment

Registered

2024-05-09

Start date

Unknown

Completion date

Unknown

Last updated

2024-11-11

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

Conditions

Health Condition 1: M171- Unilateral primary osteoarthritisof knee Health Condition 2: S878- Crushing injury of lower leg Health Condition 3: S880- Traumatic amputation at knee level Health Condition 4: S723- Fracture of shaft of femur Health Condition 5: S823- Fracture of lower end of tibia Health Condition 6: S824- Fracture of shaft of fibula Health Condition 7: S818- Open wound of lower leg Health Condition 8: S730- Subluxation and dislocation of hip Health Condition 9: S820- Fracture of pate

Interventions

Intervention1: music therapy: Duration of music therapy from onset of surgery to the end of surgery Control Intervention1: serum cortisol and serum IgA: Taking the blood sample 10minutes before spinal

Eligibility

Inclusion criteria

Inclusion criteria: 1. ASA Physical status classification I and II 2. Patients aged between 18-65years. 3. Patients body mass index between 18-25 kg/m2. 4. Patients posted for lower limb orthopedic surgeries under spinal anaesthesia.

Exclusion criteria

Exclusion criteria: 1. Patients who refused to listen music. 2. Having hearing abnormality. 3. History of head and neck surgery 4. Having mental or psychiatric disorders

Design outcomes

Primary

Measure	Time frame
To compare the effect of music therapy on anxiety, stress, and sedative requirements in patients undergoing lower limb orthopedic surgery under spinal anaesthesia.Timepoint: 10 mints before surgery to 12 hours after surgery	—

Secondary

Measure	Time frame
1.To evaluate total sedative requirements Bispectral index(BIS) as end point inpatients between two groups. 2.To compare the anxiety levels by using the state-trait anxiety inventory and changes in the hemodynamics parameters in patients between two groups. 3.To compare the stress levels by measuring the serum cortisol and immunoglobulin A level in patients between two groups Timepoint: 1.will be taken from after administered of propofol to till end of surgery. 2.10 mints before surgery and 12 hours after surgery. 3.taking the blood sample 10minutes before spinal anaesthesia,30 minutes and 12 hours after spinal anaesthesia to measure the serum cortisol and serum lgA level.	—

Measure

Time frame

1.To evaluate total sedative requirements Bispectral index(BIS) as end point inpatients between two groups. 2.To compare the anxiety levels by using the state-trait anxiety inventory and changes in the hemodynamics parameters in patients between two groups. 3.To compare the stress levels by measuring the serum cortisol and immunoglobulin A level in patients between two groups Timepoint: 1.will be taken from after administered of propofol to till end of surgery. 2.10 mints before surgery and 12 hours after surgery. 3.taking the blood sample 10minutes before spinal anaesthesia,30 minutes and 12 hours after spinal anaesthesia to measure the serum cortisol and serum lgA level.

—

Countries

India

Contacts

Public ContactDr Usha shukla

ttar Pradesh University of Medical Sciences, Saifai

ushashukla1970@gmail.com9412201915

Outcome results

None listed

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