Health Condition 1: O- Medical and Surgical Health Condition 2: PCS- Health Condition 3: K409- Unilateral inguinal hernia, without obstruction or gangrene Health Condition 4: N433- Hydrocele, unspecified Health Condition 5: K603- Anal fistula Health Condition 6: K602- Anal fissure, unspecified Health Condition 7: M959- Acquired deformity of musculoskeletal system, unspecified Health Condition 8: N210- Calculus in bladder Health Condition 9: N211- Calculus in urethra Health Condition 10: K649- U
Conditions
Interventions
Intervention1: Melatonin Gummies.: Melatonin Gummies to be given orally 2 hours prior to patients who are posted for surgery under regional anaesthesia.
Intervention2: Soothing music.: Patient is mad
Sponsors
Raipur Institute of Medical Sciences
Eligibility
Inclusion criteria
Inclusion criteria: 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.
Exclusion criteria
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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. | — |
Countries
India
Contacts
Public ContactAbhishek Bharadwaj
Raipur Institute of Medical Sciences
Outcome results
None listed