| 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
|
|
|
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
|
|
|
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. |