| 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
|
|
|
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
|
|
|
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. |