Can music and a drug (melatonin)help in decreasing nervousness before operation?

Not yet recruiting

• Conditions: Patients undergoing day-care surgery under general anaesthesia

• Registration Number: CTRI/2018/02/011895
• Lead Sponsor: Department of Anaesthesia and Intensive Care

Brief Summary

A randomized control study to Assess the effect of Preoperative melatonin and music on Anxiety and Recovery profile in patients undergoing day care surgery.

The anxiolytic properties of melatonin and music distinguish them as a better choices for premedication to reduce preoperative anxiety in day care patients.



99 adults patients will be enrolled in this study. They will be allocated in three groups Melatonin , Music and Placebo.



Study period: one year

Detailed Description

Not available

Study Timeline

• Last Update Posted: 2018-02-13
• Study Start: 2018-02-20

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 99

Inclusion Criteria

ASA I and ASA II patients undergoing day-care surgery under general anesthesia.

Exclusion Criteria

• 1.Patients refusal to participate in the study 2.Patients taking analgescis, sedatives, anti-depressant agents.
• 3.History of allergy to study drugs 4.Patients requiring hearing aid 5.Patients having history of any surgery or previous exposure to anesthesia.
• 6.Diabetic patients.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To compare preoperative anxiety in melatonin music and placebo groups	1. baseline (as soon as patient is received in preoperative area) | 2. Postintervention (5 min prior to shifting the patient to operation theatre)

Secondary Outcome Measures

Name	Time	Method
To compare incidence of emergence agitation using Richmond Agitation-sedation scale .	First 4 hrs in postoperative period
postoperative pain scores and rescue analgesics requirement	First 4hrs in postoperative period.
Incidence of postoperative nausea and vomiting and requirement of rescue agents	First 4hrs in postoperative period.
Time to attain Modified Aldrette Score 9	6 hr
Patient satisfaction score	At the time of discharge
Postoperative anxiety score	When Aldrette score will be more than 9

Trial Locations

Locations (1)

PGIMER; 🇮🇳 Chandigarh, CHANDIGARH, India

PGIMER

🇮🇳Chandigarh, CHANDIGARH, India

Anuja Pokhrel

Principal investigator

8288983451

pokhrelanuja584@gmail.com