| CTRI Number |
CTRI/2018/02/011895 [Registered on: 13/02/2018] Trial Registered Prospectively |
| Last Modified On: |
13/02/2018 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Can music and a drug (melatonin)help in decreasing nervousness before operation? |
|
Scientific Title of Study
|
To assess the effect of preoperative melatonin and music on anxiety and recovery profile in patients undergoing day care surgery: A randomized control trial. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Anuja Pokhrel |
| Designation |
Junior Resident |
| Affiliation |
Post graduate Institute of Medical Education and Research |
| Address |
Department of Anaesthesia and Intensive Care, PGIMER, sector-12,Chandigargh
Chandigarh
CHANDIGARH
160012
India |
| Phone |
|
| Fax |
|
| Email |
pokhrelanuja584@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ishwar Bhukal |
| Designation |
Professor |
| Affiliation |
PGIMER sector-12 Chandigargh |
| Address |
Department of Anesthesia
PGIMER sector-12
Chandigargh
Chandigarh
CHANDIGARH
160012
India |
| Phone |
9417936566 |
| Fax |
|
| Email |
ishwar_bhukal@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ishwar Bhukal |
| Designation |
Professor |
| Affiliation |
Post Graduate Institute of Medical Education and Research |
| Address |
Department of Anesthesia and Intensive Care, PGIMER, sector-12, Chandigargh
Chandigarh
CHANDIGARH
160012
India |
| Phone |
9417936566 |
| Fax |
|
| Email |
ishwar_bhukal@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Department of Anaesthesia and Intensive Care, PGIMER,Chandigarh |
|
|
Primary Sponsor
|
| Name |
Department of Anaesthesia and Intensive Care |
| Address |
Nehru Hospital, PGIMER, Chandigarh. |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Anuja Pokhrel |
PGIMER |
Operation Theatres, PGIMER, Chandigarh
Chandigarh
CHANDIGARH |
8288983451
pokhrelanuja584@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute Ethics Committee (Intramural) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Patients undergoing day-care surgery under general anaesthesia, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Group Melatonin |
Group melatonin: Patients will receive 3 mg melatonin dissolved in 50 ml of water 2 hrs prior to surgery and earphone without music 1 hr prior to surgery. |
| Intervention |
Group Music |
Group Music: Patients will receive multivitamin tablet (placebo) dissolved in 50 ml water 2 hrs prior to surgery and earphones with music 1 hr prior to surgery. |
| Comparator Agent |
Group Placebo |
Group placebo: Patients will receive multivitamin tablets (placebo)dissolved in 50 ml of water 2 hrs prior and earphones without music 1 hr prior to surgery |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
ASA I and ASA II patients undergoing day-care surgery under general anesthesia.
|
|
| ExclusionCriteria |
| Details |
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. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| 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
|
| Outcome |
TimePoints |
| 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 |
|
|
Target Sample Size
|
Total Sample Size="99"
Sample Size from India="99"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
20/02/2018 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
not yet publiished |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
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
|