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CTRI Number  CTRI/2025/07/090579 [Registered on: 09/07/2025] Trial Registered Prospectively
Last Modified On: 07/07/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Medical Device
Homeopathy
Surgical/Anesthesia
Nutraceutical 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Assessing anxiety in Burn patient posted for Surgery  
Scientific Title of Study   Assessment of preoperative anxiety in Burn patient posted for Surgery – A Single Centre Prospective 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  Obenthung Obdyuo 
Designation  Junior Resident 
Affiliation  King Georges Medical University Lucknow 
Address  Department of Anaesthesiology Gandhi Memorial and Associated Hospital King Georges Medical University
Shahmina Road Chowk Lucknow
Lucknow
UTTAR PRADESH
226003
India 
Phone    
Fax    
Email  oben20dyuo@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Tanmay Tiwari 
Designation  Professor 
Affiliation  King Georges Medical University Lucknow 
Address  Department of Anaesthesiology Gandhi Memorial and Associated Hospital King Georges Medical University
Shahmina Road Chowk Lucknow
Lucknow
UTTAR PRADESH
226003
India 
Phone  9452526270  
Fax    
Email  tanmayanesthesia@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Tanmay Tiwari 
Designation  Professor 
Affiliation  King Georges Medical University Lucknow 
Address  Department of Anaesthesiology Gandhi Memorial and Associated Hospital King Georges Medical University
Shahmina Road Chowk Lucknow
Lucknow
UTTAR PRADESH
226003
India 
Phone  9452526270  
Fax    
Email  tanmayanesthesia@gmail.com  
 
Source of Monetary or Material Support    
Primary Sponsor  
Name  Anaesthesiology department  
Address  Department of Anaesthesiology Gandhi Memorial and Associated Hospital King Georges Medical University Shahmina Road Chowk Lucknow  
Type of Sponsor  Government medical college 
 
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 
Prof Tanmay Tiwari  Department of Anaesthesiology Plastic Surgery Burn unit  Department of Anaesthesiology Gandhi Memorial and Associated Hospital King Georges Medical University Shahmina Road Chowk Lucknow
Lucknow
UTTAR PRADESH 
9452526270

tanmayanesthesia@gmail.com  
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
King George medical University U.P, Institutional Ethics Committee   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: T205||Corrosion of first degree of head,face, and neck,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  • Age between 18 years to 60 years • Patient of ASA physical status class1 and class 2 of either sex • Patient admitted at least 1 day before the scheduled surgical procedure. • Patient giving informed and written consent   • Age between 18 years to 60 years • Patient of ASA physical status class1 and class 2 of either sex • Patient admitted at least 1 day before the scheduled surgical procedure. • Patient giving informed and written consent  
Comparator Agent  • Patient with any psychiatry diseases or mental retardation. • Patient taking anti-anxiety anti-depressant or medication • Patient suffering from any malignant condition • Patient not giving consent   • Patient with any psychiatry diseases or mental retardation. • Patient taking anti-anxiety anti-depressant or medication • Patient suffering from any malignant condition • Patient not giving consent  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  • Age between 18 years to 60 years
• Patient of ASA physical status class1 and class 2 of either sex
• Patient admitted at least 1 day before the scheduled surgical procedure.
• Patient giving informed and written consent

 
 
ExclusionCriteria 
Details  • Patient with any psychiatry diseases or mental retardation.
• Patient taking anti-anxiety anti-depressant or medication
• Patient suffering from any malignant condition
• Patient not giving consent
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Outcome parameters:
1. Total anxiety score= sum of responses of items 1,2,4 and 5
2. Anesthesia – related anxiety score = sum of responses of items 1 and 2
3. Surgery related anxiety score = sum of responses of items 4 and 5
4. Need for information score = sum of responses of items 3 and 6
 
Outcome parameters:
1. Total anxiety score= sum of responses of items 1,2,4 and 5
2. Anesthesia – related anxiety score = sum of responses of items 1 and 2
3. Surgery related anxiety score = sum of responses of items 4 and 5
4. Need for information score = sum of responses of items 3 and 6
 
 
Secondary Outcome  
Outcome  TimePoints 
Nil  nIl 
BilBil  Bil 
 
Target Sample Size   Total Sample Size="207"
Sample Size from India="207" 
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)   23/07/2025 
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="1"
Days="1" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
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  

INTRODUCTION

Preoperative anxiety is a significant concern in burn patients, who are not only physically debilitating but also emotionally distressing. Burn injuries, caused by heat, chemicals, electrical current, or radiation, have a significant impact on the sufferer’s mental, psychological, and physical health. Factors contributing to preoperative anxiety include the nature and extent of the burn, potential disfigurement, fear of pain, and concerns about the surgical outcome.
Assessment tools like the Hospital Anxiety and Depression Scale (HADS) and the State-Trait Anxiety Inventory (STAI) are essential for effective evaluation. Burn-specific tools like the Burn Specific Health Scale-Brief (BSHS-B) can provide insights into the emotional impact of burn injuries and aid in assessing preoperative anxiety. Clinical interviews are also crucial in assessing anxiety, allowing healthcare providers to explore individual concerns and tailor interventions accordingly.
Preoperative anxiety in surgical patients imposes stress and dissatisfaction, leading to altered neuroendocrine response and various perioperative complications. Anxiety is an unpleasant emotional experience involving tension, apprehension, nervousness, and high autonomic activity. Extreme anxiety prior to surgery has been shown to lead to cardiovascular disturbances such as tachycardia, hypertension, arrhythmias, and increased postoperative pain.
A tailored and comprehensive approach is needed to assess preoperative anxiety in burn patients scheduled for surgery. Utilizing standardized tools and incorporating burn-specific considerations in both assessment and intervention contributes to better understanding and addressing the emotional challenges faced by these patients, ultimately enhancing their overall surgical experience and recovery.


 

AIMS AND OBJECTIVES

Aims:

This study will be conducted to determine the changes in anxiety level and need for information about the anesthetic and the surgical procedures at3different time points before surgery in burn patients and to evaluate the correlating factors. Level of anxiety and need for information will be assessed with the Amsterdam Preoperative Anxiety and Information Scale

Amsterdam Preoperative Anxiety and Information Scale

The Amsterdam Preoperative Anxiety and Information Scale (APAIS) was developed, particularly for the preoperative patients, measures anxiety level, and need for information about surgery and anesthesia.

This study is designed to evaluate and quantify anxiety in burn patients scheduled for surgery based on the APAIS scoring

 

MATERIAL AND METHODS

 

Study setting ; The study will be conducted in the Department of Anaesthesiology, in collaboration with Department of Plastic Surgery, King George’s Medical University, Lucknow

Ethical Clearance : Approved, Research Cell, KGMU, Lucknow

Study duration-   One and half year

Study design-       Prospective observational study

Sample size   -      250

INCLUSION CRITERIA:

·        Age between 18 years to 60 years

·        Patient of ASA physical status class1 and class 2 of either sex

·        Patient admitted at least 1 day before the scheduled surgical procedure.

·        Patient giving informed and written consent

 

EXCLUSION CRITERIA:

·        Patient with any psychiatry diseases or mental retardation.

·        Patient taking anti-anxiety anti-depressant or medication

·        Patient suffering from any malignant condition

·        Patient not giving consent

Methods:

The study to evaluate and quantify anxiety levels in adult burn patients scheduled for surgery at King George’s Medical University, Lucknow over a period of one and a half years. The Amsterdam Preoperative Anxiety and Information Scale (APAIS) was developed to measure anxiety level and need for information about surgery and anesthesia. The primary outcome is to determine changes in anxiety level and need for information about anesthesia and surgery among the patients at three different time points preoperatively: evening before surgery, in the ward (T1), on the day of surgery, in the preoperative holding area (T2), and in the operating room after being positioned on the operating table (T3). The secondary outcome includes analyzing variables that can affect anxiety, such as age, sex, American Society of Anesthesiologists (ASA) Physical Status, level of education, profession, residential background, history of previous surgery, and serial number on the operation list. The study will also assess anxiety levels related to various types of burns, surgeries performed, and type of anesthesia administered. Patients underwent routine preoperative counseling in the outpatient department by the surgeon and another anesthesiologist, and each patient was asked to read the APAIS questionnaire consisting of six questions translated into local language Hindi. The measure of agreement with these statements was graded on a 5-point Likert scale, from 1 = not at all to 5 = extremely. No further counseling was done during this process. Outcome parameters will be assessed from the tables, including total anxiety score, anesthesia-related anxiety score, surgery-related anxiety score, and need for information score. The study aims to provide valuable insights into the factors affecting anxiety levels and the need for information about burn patients.

PRIMARY OUTCOME

To determine Changes in anxiety level at 3different time point using Amsterdam Preoperative Anxiety and Information Scale

1.Evening before surgery

2.Morning of surgery (preoperative area)

3.On OT table, in the operating table prior to anesthesia and surgery

SECONDARY OUTCOME

A. To determine the correlation between anxiety level before surgery and demographic

1.Age                               

2. Sex                                

3. ASA                               

4. Education

5. Profession

6 Residence

1.      History of previous surgery

2.      Serial number on operating list

B. To determine the correlation between anxiety level before surgery and related to burn

1. Mode of burns(thermal/electrical/chemical)

2. Percentage of burn

3. Facial and neck burns

4. Acute burns less than 2 months in ICU posted for surgery

5 Chronic burns more than 2 months posted for surgery

C. To determine the correlation between anxiety level before surgery and type of surgery performed

1. Debridement

2. Fasciotomy

3. Split skin grafting

4. Amputation

D. To determine the correlation between anxiety level before surgery and type of anaesthesia performed

1. Monitored anaesthesia care

2. Spinal anaesthesia

3. General anaesthesia

Amsterdam Preoperative Anxiety and Information Scale

The Amsterdam Preoperative Anxiety and Information Scale (APAIS) will be developed, particularly for the preoperative patients, measures anxiety level, and need for information about surgery and anesthesia.  This study will be designed to evaluate andquantify anxiety in burn patients scheduled for surgery based on the APAIS  scoring

QUESTIONS                                                The Amsterdam preoperative

                                                                     Anxiety and information scale

 

1 I am worried about the anesthetic           1        2          3          4        5

2.The anesthetic is on my mind                    1        2          3          4        5

   continually

3.I would like to know as much as              1        2          3          4        5

   possible about the anesthetic

4.I am worried about the procedure            1        2          3          4       5

5.The procedure is on my mind                   1        2          3          4       5

 Continual

6.Iwould like to know as much as                1        2          3          4      5

possible about the procedure

1: Not at all

2: Somewhat

3: Moderate

4: Moderately high

5: Extremely

The measure of agreement with these statements was graded on a 5  point Likert scale, from 1  not at all to 5  extremely. The patients were asked to put tick  mark where appropriate and sign the consent form. No further counseling was done with the patients during this process.

Outcome parameters:

1.      Total anxiety score= sum of responses of items 1,2,4 and 5

2.      Anesthesia – related anxiety score = sum of responses of items 1 and 2

3.      Surgery related anxiety score = sum of responses of items 4 and 5

4.      Need for information score = sum of responses of items 3 and 6

Statistical analysis

Statistical analysis will be performed by the SPSS version 24th version. Statistical analysis for the assessment of preoperative anxiety in burn patients will involve descriptive statistics to summarize demographics and anxiety levels. Preoperative anxiety scores will be compared using paired t tests or Wilcoxon signed-rank tests for related samples, depending on data distribution. Correlation analysis may be performed to assess relationships between anxiety scores and demographic variables. A significance level of p less than 0.05 will be set for all tests.

 

 

 

 
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