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CTRI Number  CTRI/2024/02/062301 [Registered on: 06/02/2024] Trial Registered Prospectively
Last Modified On: 01/02/2024
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Single Arm Study 
Public Title of Study   Evaluation of Anxiety and Pain in External Dacryocystorhinostomy Surgery 
Scientific Title of Study   Evaluation of Preoperative Anxiety and Intraoperative and Postoperative Pain in Patients undergoing External Dacryocystorhinostomy- An Observational Study 
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 Ojus K Bhanot 
Designation  Primary Resident Doctor 
Affiliation  Aravind Eye Hospital, Pondicherry 
Address  Orbit and Oculoplasty Clinic, Aravind Eye Hospital, Cuddalore Main Road, Thavalakuppam, Pondicherry

Pondicherry
PONDICHERRY
605007
India 
Phone  6382260132  
Fax    
Email  ojuskbhanot@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Dayakar Yadalla 
Designation  Medical Consultant, Orbit and Oculoplasty Clinic 
Affiliation  Aravind Eye Hospital, Pondicherry 
Address  Orbit and Oculoplasty Clinic, Aravind Eye Hospital, Cuddalore Main Road, Thavalakuppam, Pondicherry

Pondicherry
PONDICHERRY
605007
India 
Phone  9786396129  
Fax    
Email  dayakar.dr@aravind.org  
 
Details of Contact Person
Public Query  
Name  Dr Ojus K Bhanot 
Designation  Primary Resident Doctor 
Affiliation  Aravind Eye Hospital, Pondicherry 
Address  Orbit and Oculoplasty Clinic, Aravind Eye Hospital, Cuddalore Main Road, Thavalakuppam, Pondicherry

Pondicherry
PONDICHERRY
605007
India 
Phone  6382260132  
Fax    
Email  ojuskbhanot@gmail.com  
 
Source of Monetary or Material Support  
Aravind Eye Hospital, Cuddalore Main Road, Thavalakuppam, Pondicherry 
 
Primary Sponsor  
Name  Dr Ojus K Bhanot 
Address  Aravind Eye Hospital, Cuddalore Main Road, Thavalakuppam, Pondicherry - 605007, India 
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 Ojus K Bhanot  Aravind Eye Hospital  Orbit and Oculplasty Clinic, Aravind Eye Hospital, Cuddalore Main Road, Thavalakuppam, Pondicherry - 605007
Pondicherry
PONDICHERRY 		 6382260132

ojuskbhanot@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee, Aravind Eye Hospital, Pondicherry  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: H045||Stenosis and insufficiency of lacrimal passages,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  NIL  NIL 
Comparator Agent  NIL  NIL 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  1.Patients aged 18-70 years.
2.Patients diagnosed with nasolacrimal duct blockage requiring an external dacryocystorhinostomy.
 
 
ExclusionCriteria 
Details   
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Patients with nasolacrimal duct blockage, already having anxiety and fear about their condition, are exposed to dacryocystorhinostomy surgery to treat their condition. Intra operative experiences further increases their fear and anxiety. To what level does the patient undergoing dacryocystorhinostomy experience anxiety would be the primary outcome of the study.  1 year 4 months 
 
Secondary Outcome  
Outcome  TimePoints 
In which stage of the surgery does the patient experience maximum pain.
To study how marital status and occupation affects pain and anxiety perception.  		 1 year 4 months 
 
Target Sample Size   Total Sample Size="96"
Sample Size from India="96" 
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)   11/02/2024 
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="3"
Days="30" 
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  

Objectives:

1.      To assess the level of preoperative anxiety subjectively with the help of a questionnaire and objectively by measuring the vitals of the patients.

2.      The degree of discomfort during the different stages of surgery by using the Visual Analogue Scale (VAS) for pain.


Aims:

To estimate the subjective and objective patient experiences during preoperative, intraoperative and post-operative periods in terms of degree of anxiety and pain among patients with nasolacrimal duct blockage undergoing external dacryocystorhinostomy.


Exclusion Criteria:

  1. Patients on anxiolytic drugs prior to the surgery.
  2. Patients undergoing the intraocular surgery under sedation/general anesthesia.
  3. Patients with known history of psychiatric illness or on treatment for the same, cardiac diseases, uncontrolled diabetes mellitus and uncontrolled systemic hypertension.
  4. Patients on drugs that can influence cardiac rhythm and heart rate (eg: beta blockers).
  5. Patients with history of recurrence of NLDO.
  6. Patients with history of failed DCR surgery.
  7. Patients with hearing impairment and speech disorders.
  8. Pregnant women. 

 
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