Comparison of Music and Melatonin for intraoperative anxiety reduction in patients undergoing surgery.
- Registration Number
- CTRI/2024/04/065216
- Lead Sponsor
- Raipur Institute of Medical Sciences
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
1.Adult patients aged 18 to 65 years.
2.Scheduled for elective surgical procedures with time duration of 1 to 3 hours.
3.Undergoing regional anesthesia.
4.Presence of mild to moderate intraoperative anxiety, as assessed through a validated anxiety scale.
5.American Society of Anesthesiologists (ASA) physical status classification I or II.
6.Ability to understand and provide informed consent.
1.Age below 18 or above 65 years.
2.Emergency or urgent surgical procedures.
3.Patients undergoing general anesthesia.
4.Severe or uncontrolled anxiety or psychiatric disorders.
5.Patients with a history of allergies or severe adverse reactions to melatonin.
6.History of substance abuse or addiction.
7.Pregnant or breastfeeding women.
8.Inability to understand or comply with study procedures.
9.Participation in another clinical trial concurrently.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To determine the level of patient satisfaction and comfort with the interventions(soothing music and melatonin)by assessing the perioperative anxiety levels with VAS-Anxiety scale and State Trait Anxiety Inventory scale. .Timepoint: 2 hours before surgery, 15 minutes before induction of anaesthesia, 30 mins after induction of anaesthesia and 15 minutes after completion of surgery.
- Secondary Outcome Measures
Name Time Method To assess and compare changes in hemodynamic parameters, including heart rate,respiratory rate, mean arterial pressure, and oxygen saturation(Spo2), between the music group and the melatonin group.Timepoint: 15 minutes before induction of anaesthesia, 30 mins after induction of anaesthesia and 15 minutes after completion of surgery.