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CTRI Number  CTRI/2025/09/095272 [Registered on: 22/09/2025] Trial Registered Prospectively
Last Modified On: 17/09/2025
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   Hindi translation and validation of the Amsterdam Preoperative Anxiety and Information Scale (APAIS) questionnaire used in assessment of preoperative anxiety in patients undergoing surgery under general anaesthesia. 
Scientific Title of Study   Translation, Cross-Cultural Adaptation, and Validation of the Hindi Version of the Amsterdam Preoperative Anxiety and Information Scale (APAIS) for the Assessment of Preoperative Anxiety in Adult Patients Undergoing Surgery Under General Anesthesia 
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 Ram Singh 
Designation  Assistant Professor 
Affiliation  All India Institute of Medical sciences 
Address  Dept of Anesthesiology Pain Medicine and Critical care AIIMS New Delhi
Ansari Nagar New Delhi 110029
South
DELHI
110029
India 
Phone  9958311829  
Fax    
Email  dr.ram2001@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Ram Singh 
Designation  Assistant Professor 
Affiliation  All India Institute of Medical sciences 
Address  Dept of Anesthesiology Pain Medicine and Critical care AIIMS New Delhi
Ansari Nagar New Delhi 110029
South
DELHI
110029
India 
Phone  9958311829  
Fax    
Email  dr.ram2001@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Ram Singh 
Designation  Assistant Professor 
Affiliation  All India Institute of Medical sciences 
Address  Dept of Anesthesiology Pain Medicine and Critical care AIIMS New Delhi
Ansari Nagar New Delhi 110029
South
DELHI
110029
India 
Phone  9958311829  
Fax    
Email  dr.ram2001@gmail.com  
 
Source of Monetary or Material Support  
AIIMS Ansari Nagar New Delhi India 110029 
 
Primary Sponsor  
Name  Dr Ram Singh 
Address  Dept of Anesthesiology Pain Medicine and Critical Care, AIIMS New Delhi 
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 Ram Singh  AIIMS New Delhi  Ansari Nagar-110029
South
DELHI 		 9958311829

dr.ram2001@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institute Ethics Committee AIIMS New Delhi  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Undergoing Surgery under general anaesthesia 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Nil  Nil 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  1. Adults more than 18 years, scheduled for elective surgery under general or regional anaesthesia.
2. Able to read and understand Hindi.
3. Provide informed consent.
 
 
ExclusionCriteria 
Details  1. Current psychiatric illness, use of anxiolytics/antipsychotics.
2. Emergency surgeries.
3. Communication barriers, sensory deficits, cognitive impairment.
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
A Validated Hindi translated and culturally adapted version of APAIS Questionnaire for the assessment of preoperative anxiety in patients undergoing surgery under general anaesthesia   1. Data collection at two points Baseline and 24 hours after first data collection in each patient.
2. Data analysis within 4 to 8 weeks of completion of data acquisition.
3. Publication of results within 3-6 months of data analysis.


 
 
Secondary Outcome  
Outcome  TimePoints 
1.Concurrent validity of the Hindi APAIS by correlating its anxiety scores with VAS-A.

2. Evaluation of internal consistency, test–retest reliability, & construct validity.
 		 Data collection at 2 points Baseline & 24 hours after first data collection for each patient.
 
 
Target Sample Size   Total Sample Size="240"
Sample Size from India="240" 
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)   01/11/2025 
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 - YES
  1. What data in particular will be shared?
    Response - All of the individual participant data collected during the trial, after de-identification.

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form
    Response - Clinical Study Report
    Response -  Analytic Code

  3. Who will be able to view these files?
    Response - Researchers who provide a methodologically sound proposal.

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [dr.ram2001@gmail.com].

  6. For how long will this data be available start date provided 10-08-2027 and end date provided 09-08-2030?
    Response - Beginning 9 months and ending 36 months following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary  

APAIS in non-English speaking populations depends on accurate translation, cultural adaptation, and validation in the target language. The APAIS was originally created in Dutch and validated among surgical patients. Since then, it has been translated and validated in multiple languages, including English, Japanese, German, French, Italian, Spanish, Chinese, Portuguese, and Kannada. Although Hindi is the most spoken language in India, there is no validated Hindi version of the APAIS. The Visual Analogue Scale for Anxiety (VAS-A) is commonly used as a gold-standard unidimensional reference in such validations. Establishing a reliable and culturally relevant Hindi version of APAIS will support better assessment and management of perioperative anxiety in diverse patient populations.

 
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