FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2026/03/105952 [Registered on: 11/03/2026] Trial Registered Prospectively
Last Modified On: 10/03/2026
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Behavioral 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Effectiveness of Eye Closing on Anxiety During Non-Sedated Upper Gastrointestinal Endoscopy 
Scientific Title of Study   Effectiveness of Eye Closing on Clinical Anxiety During Non-Sedated Upper Gastrointestinal Endoscopy: A Randomized Controlled Single Centre Study In Eastern India 
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 Sanjib Kumar Kar 
Designation  Senior Consultant 
Affiliation  Indian Institute of Gastroenterology and Hepatology 
Address  Room No - 209,Department of gastroenterology,Service Road,NH 16,Unit 27,Gandarpur,Sikharpur,Cuttack,Odisha,753003.

Cuttack
ORISSA
753003
India 
Phone  7978900184  
Fax    
Email  drsanjibkar@yahoo.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Sanjib Kumar Kar 
Designation  Senior Consultant 
Affiliation  Indian Institute of Gastroenterology and Hepatology 
Address  Service Road,NH 16,Unit 27,Gandarpur,Sikharpur,Cuttack,Odisha,753003.

Cuttack
ORISSA
753003
India 
Phone  7978900184  
Fax    
Email  drsanjibkar@yahoo.com  
 
Details of Contact Person
Public Query
 
Name  Dr Sanjib Kumar Kar 
Designation  Senior Consultant 
Affiliation  Indian Institute of Gastroenterology and Hepatology 
Address  Room No - 209,Department of gastroenterology,Service Road,NH 16,Unit 27,Gandarpur,Sikharpur,Cuttack,Odisha,753003.

Cuttack
ORISSA
753003
India 
Phone  7978900184  
Fax    
Email  drsanjibkar@yahoo.com  
 
Source of Monetary or Material Support  
Service Road,NH 16,Unit 27,Gandarpur,Sikharpur,Cuttack,Odisha,753003.,Cuttack,Odisha 
 
Primary Sponsor  
Name  Dr Sanjib Kumar Kar 
Address  Service Road,NH 16,Unit 27,Gandarpur,Sikharpur,Cuttack,Odisha,753003. 
Type of Sponsor  Other [SELF] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Sanjib Kumar Kar  Indian Institute Of Gastroenterology And Hepatology  Room No 209,Endoscopy division, Department Of Gastroenterology,Service Road,NH 16,Unit 27,Gandarpur,Sikharpur,Cuttack,Odisha,753003.
Cuttack
ORISSA 
7978900184

drsanjibkar@yahoo.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
IEC IIGH  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K30||Functional dyspepsia,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Eye Closing  Eye Elosing During Non Sedated Upper GI Endoscopy, Approximately 5 Minutes. 
Comparator Agent  Eye Opening  Eye Opening During Non sedated Upper GI Endoscopy, Approximately 5 Minutes. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  90.00 Year(s)
Gender  Both 
Details  Consecutive adult (Morethan 18 years age) patients undergoing Non sedated upper GI endoscopy in our hospital will be included in the study 
 
ExclusionCriteria 
Details  Inability to communicate, very sick patient, Patient undergoing Sedation during UGIE Study. 
 
Method of Generating Random Sequence   Random Number Table 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Comparison of mean Beck Anxiety Inventory (BAI) Score between the eye-closing group and eye -opening group During non-sedated Upper Gastrointestinal Endoscopy.  BAI anxiety score will be assessed at baseline (before the procedure) and Immediately after completion of the non-sedated upper gastrointestinal endoscopy. 
 
Secondary Outcome  
Outcome  TimePoints 
1. Comparing of Mean BAI anxiety score between 1st time endoscopy group and repeated endoscopy group before and after non sedated UGIE.  3 Months 
 
Target Sample Size   Total Sample Size="142"
Sample Size from India="142" 
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)   01/04/2026 
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="0"
Months="3"
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  

Upper gastrointestinal endoscopy (UGIE) is an effective and reliable procedure that is widely used

for the diagnosis and treatment of gastrointestinal disorders. However, UGIE is a difficult, stressful, anxiety-associated, and unpleasant diagnostic and therapeutic method.

This situation destroys the communication between the patient and the endoscopy team, decreases the comfort of the patient, and prevents an optimal performance by the endoscopist.

Patients experience anxiety prior to surgical and gastrointestinal procedures due to the fear of pain and/or to the negative past experiences of those around them. Anxiety is defined as an emotional state of fear, tension, panic, or anticipation of an unpleasant experience.

Recent literature highlights the multifaceted nature of preoperative anxiety, identifying factors such as fear of diagnosis, procedural pain, and the general unknown as critical contributors to increased patient distress. The BAI is designed to assess the physical manifestations of anxiety. The Beck Anxiety Inventory (BAI), a reliable self-reporting tool, has been extensively used to quantify levels of anxiety, offering clinicians a practical means to assess and address this critical aspect of patient care .The BAI is less concerned with the cognitive dimensions of anxiety and is therefore more suitable for patients presenting with physical symptoms.

 

Pain-related anxiety is one of the main concerns for EGD patients. Although endoscopic procedures are generally not painful, patients may still experience anxiety about potential sensations during upper gastrointestinal endoscopy.

Visual stimuli are known to arouse physiologic indicators of anxiety.Coverage of patients’ eyes with surgical pads may eliminate these stimuli. So reduction of anxiety can be achieved by closing of eye during procedure. However The exact mechanism of this is yet to be understood.

 

Anxiety before and after the procedure adversely affects patients compliance with treatment and quality of life. In several studies, various methods, including informing patients and playing music before the procedure, have been attempted to reduce anxiety in patients.

Despite the recognised impact of anxiety on patient outcomes, there exists a gap in the literature regarding the comparative analysis of anxiety levels between patients undergoing UGIE with close eye vs open eye during procedure.

While sedation can be used to improve patient comfort, unsedated endoscopy remains a viable alternative due to its cost-effectiveness and lower risk of complications. However, performing endoscopy without sedation can significantly exacerbate anxiety in many patients, affecting their experience of the procedure and their co-operation.

 
Close