| CTRI Number |
CTRI/2024/06/068304 [Registered on: 04/06/2024] Trial Registered Prospectively |
| Last Modified On: |
04/06/2024 |
| 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
|
A study in patients undergoing operation under spinal anaesthesia to assess if providing detailed counselling before surgery is beneficial in reducing anxiety and pain during and after surgery. |
|
Scientific Title of Study
|
Evaluating the impact of Pre-operative patient education and counselling on anxiety and post-operative pain in patients undergoing surgery under spinal anaesthesia.
|
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Arun Kumar |
| Designation |
PG Trainee |
| Affiliation |
Sikkim Manipal Institute of Medical Sciences |
| Address |
Department of Anaesthesia, Level 6, Central Referral Hospital, 5th Mile, Tadong, Gangtok, SIKKIM 737102
East
SIKKIM
737102
India |
| Phone |
9958300795 |
| Fax |
|
| Email |
aktomar123@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sofia Batool |
| Designation |
Associate Professor |
| Affiliation |
Sikkim Manipal Institute of Medical Sciences, |
| Address |
Department of Anaesthesia, Level 6, Central Referral Hospital, 5th Mile, Tadong, Gangtok, SIKKIM 737102
East
SIKKIM
737102
India |
| Phone |
9733005809 |
| Fax |
|
| Email |
sofia.b@smims.smu.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Arun Kumar |
| Designation |
PG Trainee |
| Affiliation |
Sikkim Manipal Institute of Medical Sciences |
| Address |
Department of Anaesthesia, Level 6, Central referral hospital, 5th Mile, Tadong, Gangtok, SIKKIM 737102
East
SIKKIM
737102
India |
| Phone |
9958300795 |
| Fax |
|
| Email |
aktomar123@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sikkim Manipal Institute Of Medical Sciences,5th mile, Tadong,Gangtok,Sikkim,India,Pin Code-737102 |
|
|
Primary Sponsor
|
| Name |
Dr Arun Kumar |
| Address |
Department Of Anaesthesiology, level 6, Central referral Hospital, 5th Mile,Tadong, Gantok, Sikkim. 737102 |
| Type of Sponsor |
Other [Self] |
|
|
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 Arun Kumar |
Sikkim Manipal Institute of Medical Sciences |
All wards and Operation Theatre of Central Referral Hospital ,Sikkim Manipal Institute of medical Sciences, 5th mile, Tadong ,Gangtok
East
SIKKIM |
9958300795
aktomar123@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SMIMS INSTITUTION ETHICS COMMITTEE |
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 |
| Intervention |
Detailed Preoperative patient education and counselling. |
Detailed pre-operative counselling-
Patients will receive elaborate information about the anaesthetic and surgical procedure involved, including its benefits and potential risks. Patients will be given information regarding the probable financial expenditure (depending on the patient categories), postoperative pain management.
The duration of intervention will be 15 minutes on previous evening of surgery.
|
| Comparator Agent |
General preoperative patient information. |
General preoperative information- patients will receive a routine overview of the anaesthesia and surgical procedure. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1.American society of anaesthesiologist (ASA)
physical status I & II patients
2.Age from 18-65 years
3.Patient with educational qualification of matriculation or higher
4.Patient who can understand Hindi, English ,Nepali language |
|
| ExclusionCriteria |
| Details |
1.Refusal to participate.
2.Pregnant patients
3.American society of anaesthesiologist (ASA)
physical status III or IV patients.
4.Emergency case.
5.Patient with diagnosed psychiatric illness and on medication.
6.Patients with hearing impairment and difficulty in verbal communication. |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| This study is expected to provide valuable insights into the effectiveness of pre-operative education and counselling in reducing anxiety. |
This study is expected to provide valuable insights into the effectiveness of pre-operative education and counselling in reducing anxiety intraoperatively which will be assessed every 5 minutes and post operatively at 0 hr,6 hrs,12 hrs,18 hrs and 24 hrs. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| This study is expected to provide valuable insights into the effectiveness of pre-operative education & counselling in improving patient experience regarding pain after surgery. |
This study is expected to provide valuable insights into the effectiveness of pre-operative education & counselling in improving patient experience regarding pain after surgery at 0 hr,6 hrs,12 hrs,18 hrs & 24 hrs. |
|
|
Target Sample Size
|
Total Sample Size="120"
Sample Size from India="120"
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
|
Phase 4 |
|
Date of First Enrollment (India)
|
16/06/2024 |
| 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 Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
In this study, we will be evaluating the impact of pre operative patient education and counselling on anxiety by giving general pre operative information to one group and detailed pre operative information to another group and will be evaluating of post operative pain by using VAS score in patients undergoing surgery under spinal anaesthesia. |