| CTRI Number |
CTRI/2022/11/047468 [Registered on: 21/11/2022] Trial Registered Prospectively |
| Last Modified On: |
18/11/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
We will measure patient and their relative anxiety level after allowing patient to talk to their relative over phone. |
|
Scientific Title of Study
|
Effect Of Intraoperative Telephonic Conversation With The Relative On Anxiety level Of Patient Undergoing
Surgery Under Perinhral Nerve Block |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Shashi Kumar |
| Designation |
PG Resident |
| Affiliation |
Safdarjung Hospital |
| Address |
Dr. Shashi Kumar,PG Resident, Department of Anaesthesia,Vardhman Mahavir Medical College and Safdarjung Hospital
South
DELHI
110029
India |
| Phone |
8368386902 |
| Fax |
|
| Email |
drsubject17@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Amita Gupta |
| Designation |
Consultant and professor |
| Affiliation |
Safdarjung Hospital |
| Address |
Dr. Amita Gupta, Side Room, First Floor, Department of Anaesthesia, Vardhman Mahavir Medical College and Safdarjung Hospital
South
DELHI
110029
India |
| Phone |
9910382190 |
| Fax |
|
| Email |
amitaguptadr@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Shashi Kumar |
| Designation |
PG Resident |
| Affiliation |
Safdarjung Hospital |
| Address |
Dr. Shashi Kumar
PG Resident Hostel, Department of Anaesthesia,Vardhman Mahavir Medical College and Safdarjung Hospital
South
DELHI
110029
India |
| Phone |
8368386902 |
| Fax |
|
| Email |
drsubject17@gmail.com |
|
|
Source of Monetary or Material Support
|
| VMMC and Safdarjung hospital |
|
|
Primary Sponsor
|
| Name |
VMMC and Safdarjung Hospital |
| Address |
VMMC and Safdarjung Hospital, New Delhi 110029 |
| Type of Sponsor |
Government medical college |
|
|
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 |
| Dr Shashi Kumar |
Vardhman Mahavir Medical College and Safdarjung Hospital |
Department of Anaesthesia,OT Building, Ground Floor.
South
DELHI |
8368386902
drsubject17@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics Committee, VMMC and Safdarjung Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
No telephone call |
Surgery will proceed as usual after nerve block and patient will not be allowed to talk to relative over telephone. |
| Intervention |
Telephonic conversation |
Patient will be made to talk to their relative over telephone for 1-2 minutes after nerve block is given. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients of age 18-65 years of either sex with American Society of Anesthesiologists (ASA) grade I & II, undergoing surgery under peripheral nerve
block. |
|
| ExclusionCriteria |
| Details |
1. Patient and relatives who are unable to speak Hindi or English.
2. Patient on long term anti-anxiety medication/psychatric disorder. |
|
|
Method of Generating Random Sequence
|
Stratified block randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Measure Anxiety levels using Visual Analogue Scale - Anxiety
(VAS-A) scoring system, during surgery under peripheral nerve block. |
Baseline, After Start of Surgery, After telephonic conversation and in postoperative room. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Measure hemodynamic parameters of patient – heart rate, blood pressure, oxygen saturation after periphral nerve block.
2. Measurement of pre-operative anxiety in patient undergoing surgery using Amsterdam
Preoperative Anxiety and Information Scale (APAIS).
3. Comparision of anxiety levels among relative of patient undergoing surgery. |
Baseline, Intraoperative period and postoperative period. |
|
|
Target Sample Size
|
Total Sample Size="130"
Sample Size from India="130"
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)
|
11/09/2023 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - YES
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identification.
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Informed Consent Form
Response - Clinical Study Report
- Who will be able to view these files?
Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.
- For what types of analyses will this data be available?
Response - For individual participant data meta-analysis.
- By what mechanism will data be made available?
Response - Proposals should be directed to [drsubject17@gmail.com].
- For how long will this data be available start date provided 11-10-2024 and end date provided 11-10-2026?
Response - Beginning 9 months and ending 36 months following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - nil
|
|
Brief Summary
|
This study will evaluate the effect of intraoperative telephonic conversation (between patient and relatives) on patient’s anxiety. All patients who meet the study inclusion criteria will be explained about the study in the language that they understand. Written informed consent will be taken from willing participants (patient and relative). All patient will undergo a preoperative evaluation (in preoperative room) that will include history, examination, baseline vital monitoring (heart rate, systolic blood pressure, diastolic blood pressure and SpO2) and baseline anxiety score using Amsterdam Preoperative Anxiety and Information Scale (APAIS) and Visual Analogue Scale - Anxiety (VAS-A). There Anxiety level will be assesed at various points - baseline anxiety in preoperative room, once surgical incision is made, 10 minutes after surgical incision and in postoperative room. Results will be compared between control and test group. |