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CTRI Number  CTRI/2024/04/066408 [Registered on: 26/04/2024] Trial Registered Prospectively
Last Modified On: 24/04/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Screening 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   PEACE Study of Preprocedural Video Demonstration for Patients Undergoing Epidural Analgesia. 
Scientific Title of Study   Analyzing the Impact of Preprocedural Video Demonstration for Patients Undergoing Epidural Analgesia - An Interventional Study on Patient Experience, Anxiety, and Perceived Efficacy. 
Trial Acronym  Patient Experience, Anxiety, & Comfort Evaluation 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Pradeepa C 
Designation  Junior Resident 
Affiliation  Christian Medical College, Vellore 
Address  Room No 211, TPK Residency 2, TPK Nagar, Vellore
Christian Medical College, IDA Scudder Rd, Vellore,632004
Vellore
TAMIL NADU
632004
India 
Phone  9944348124  
Fax    
Email  dr.pradeepachellaiah@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Ekta Rai 
Designation  Professor & Head of the Department of Anaesthesiology 
Affiliation  Christian Medical College 
Address  IDA Scudder Rd,

Vellore
TAMIL NADU
632004
India 
Phone  9789250113  
Fax    
Email  drektarai@yahoo.com  
 
Details of Contact Person
Public Query
 
Name  Ekta Rai 
Designation  Professor & Head of the Department of Anaesthesiology 
Affiliation  Christian Medical College 
Address  IDA Scudder Rd,

Vellore
TAMIL NADU
632004
India 
Phone  9789250113  
Fax    
Email  drektarai@yahoo.com  
 
Source of Monetary or Material Support  
Preprocedural Demonstration Video & Sham Video 
Tablet to Show Intervention Video & sham video to appropriate Patient 
 
Primary Sponsor  
Name  Christian Medical College Fluid Research Fund 
Address  Ethics Committee Silver, Office of Research, 1st Floor, Carman Block, Christian Medical College, Vellore 
Type of Sponsor  Private medical college 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 2  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Pradeepa C  Christian Medical College, Ranipet Campus  Department of Urology, Christian Medical College, Ranipet Campus, Ratnagiri Kilminnal, Tamil Nadu - 632517
Vellore
TAMIL NADU 
9944348124

dr.pradeepachellaiah@gmail.com 
Dr Pradeepa C  Christian Medical College, Vellore  Department of Gynaecology, & Department of General Surgery, Christian Medical College, Ida Scudder Road, Vellore – 632004
Vellore
TAMIL NADU 
9944348124

dr.pradeepachellaiah@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Review Board (IRB) Office of Research Christian Medical College  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: O||Medical and Surgical,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Preprocedural Video Demonstration  The intervention in this study is the preprocedural video demonstration. The intervention group will watch a video that provides a step-by-step explanation of the epidural analgesia procedure, its benefits, potential risks, and instructions for patient preparation. 
Comparator Agent  Sham Video ( Placebo Video )  The comparator agent in this study is the use of sham video. The control group will receive the placebo video, which we regularly use in the (PAC) pre-anesthetic clinic to educate patients regarding anaesthesia. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  Patients:
Age: Participants must be within the age range of 18 to 65 years.

Diagnosis/Indication: Participants scheduled for epidural analgesia undergoing various surgical procedures.

Position: Must be able to sit upright.

BMI: BMI should be less than 35

Procedure: Thoracic and lumbar Epidural Procedures.

Ability to understand and Provide Informed Consent: Participants should possess stable mental health.

Healthcare Providers:
Healthcare providers involved in administering epidural analgesia (Anaesthesiologists and senior anaesthesiology residents). 
 
ExclusionCriteria 
Details  Patients:
Age Limitations: Participants must be within the age range of 18 to 65 years.

BMI: BMI greater than 35

Contraindications to Epidural Analgesia: Individuals with active infections, bleeding disorders, severe allergies, or other conditions that pose risks to the procedure will be excluded from participation.

Other Health conditions: Pregnancy, Previous surgery, and abnormal anatomy in the back.

Pre-existing Severe Anxiety or Psychiatric Conditions.

Inability to Provide Informed Consent: Those who are comatose, low GCS, or mentally unstable patients will be excluded.

Prior Experience: Participants with prior experience with epidural analgesia will be excluded.

Healthcare Providers:
Healthcare providers who do not have sufficient experience in performing epidural analgesia procedures. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
1. Anxiety Levels  Time Frame: 12 months from time of
randomization 
 
Secondary Outcome  
Outcome  TimePoints 
1. Patient Satisfaction
2. Doctors Perceived Efficacy 
Time Frame: 12 months from time of
randomization 
 
Target Sample Size   Total Sample Size="150"
Sample Size from India="150" 
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 2 
Date of First Enrollment (India)   06/05/2024 
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="0"
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  
This prospective interventional study seeks to investigate the impact of preprocedural video demonstrations on patient satisfaction, anxiety levels, and doctors’ perceived efficacy within the context of epidural analgesia procedures. Patients scheduled for epidural analgesia will be randomly assigned to either the intervention group, which will receive a comprehensive preprocedural video explaining the procedure, its benefits, and potential risks, or the control group, which will receive a sham video instead of the comprehensive interventional video. The sham video is what we use regularly to educate patients regarding anesthesia in the pre-anesthetic Clinic.
Data collection will comprise the use of standardized questionnaires. Anxiety levels will be assessed using the Amsterdam Preoperative Anxiety and Information Scale (APAIS), a validated tool measuring patients’ emotional state and information needs. Patient satisfaction will be evaluated using a Likert scale, focusing on overall satisfaction and the quality of information that the healthcare team provides. Additionally, doctors’ perceived efficacy will be examined through structured questionnaires, which reflect their procedural effectiveness.
The data will be analyzed using appropriate statistical methods like t-tests, chi-square tests, or analysis of variance (ANOVA) to compare outcomes between the intervention and control groups. This analysis aims to uncover the impact of the preprocedural video intervention on patient anxiety levels, satisfaction, and doctors’ perceived efficacy during epidural analgesia procedures.
The significance of this study lies in its potential to provide valuable insights into the patient experience during epidural analgesia procedures. Ultimately, the study’s findings may contribute to improved patient outcomes, increased procedural efficiency, and the advancement of patient-centered care in the field of epidural analgesia.
 
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