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CTRI Number  CTRI/2024/11/077487 [Registered on: 29/11/2024] Trial Registered Prospectively
Last Modified On: 27/11/2024
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Single Arm Study 
Public Title of Study   Pre-op anxiety in military personnel 
Scientific Title of Study   Prevalence of pre-operative anxiety among serving military personnel undergoing elective abdominal surgery - an observational study pre-op anxiety in military personnel 
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 Deepjyoti Chaudhuri 
Designation  Junior Resident, Dept of Surgery 
Affiliation  Armed Forces Medical College, Pune, India 
Address  Department of Surgery Armed Forces Medical College Pune, Solapur - Pune Highway, near Race Course, Wanowrie, Pune
Lecture Hall 12
Pune
MAHARASHTRA
411040
India 
Phone  9804704087  
Fax    
Email  drdeepjyoti2012@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Ameet Kumar 
Designation  Professor  
Affiliation  Armed Forces Medical College, Pune, India 
Address  Dept of Surgery Armed Forces Medical College Pune, Solapur - Pune Highway, near Race Course, Wanowrie, Pune

Pune
MAHARASHTRA
411040
India 
Phone  6002092231  
Fax    
Email  ameetsurg@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Deepjyoti Chaudhuri 
Designation  Junior Resident 
Affiliation  Armed Forces Medical College, Pune, India 
Address  Dept of Surgery Armed Forces Medical College Pune, Solapur - Pune Highway, near Race Course, Wanowrie, Pune
Lecture Hall 12
Pune
MAHARASHTRA
411040
India 
Phone  9804704087  
Fax    
Email  drdeepjyoti2012@gmail.com  
 
Source of Monetary or Material Support  
Nil 
 
Primary Sponsor  
Name  Armed Forces Medical College 
Address  Department of Surgery Armed Forces Medical College Pune, Solapur - Pune Highway, near Race Course, Wanowrie, Pune 411040 
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 
Dr Deepjyoti Chaudhuri  Armed Forces Medical College, Pune  Department of Surgery Armed Forces Medical College Pune, Solapur - Pune Highway, near Race Course, Wanowrie, Pune
Pune
MAHARASHTRA 
09804704087

drdeepjyoti2012@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee, AFMC Pune  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K00-K95||Diseases of the digestive system,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  NIL  NIL 
Comparator Agent  NIL  NIL 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  54.00 Year(s)
Gender  Male 
Details  All patients undergoing abdominal surgery at AFMC, Pune between October 2024 - December 2024 
 
ExclusionCriteria 
Details  1.Patients undergoing emergency abdominal surgery (acute abdomen)
2.Patients undergoing abdominal surgery for trauma
3.Patients who had undergone any previous laparotomy/ laparoscopy or surgical intervention under general or spinal anesthesia
4.Patients who are not serving military personnel (dependents of military personnel, military veterans, civilians, non-entitled patients)
5.Patients who would not consent to participation/ withdraw consent
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Prevalence of pre-operative anxiety   October 24 to December 24 
 
Secondary Outcome  
Outcome  TimePoints 
Variations of anxiety with age, military service profile, domicile state   October 24 to December 24 
 
Target Sample Size   Total Sample Size="94"
Sample Size from India="94" 
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)   11/12/2024 
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="0"
Months="3"
Days="0" 
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  

Prevalence of pre-operative anxiety among serving military personnel undergoing elective abdominal surgery: an observational study

 

Surg Lt Cdr Deep J Chaudhuri(PI)1, Gp Capt Ameet Kumar (Corresponding author)2, Dr Subhashis Sharma3, Maj Sidharth Gautam4, Maj Naveen Tiwari5, Col Animesh Vats6, Brig Alok Bhalla7, Sharayu Dattatreya Gaikwad8

1,3,4,5,8: Residents of Surgery, AFMC Pune

2: Professor of Surgery, AFMC Pune and Head, Dept of GI Surgery, CHSC Pune

6: Professor of Surgery, AFMC Pune and Prosthetic Surgeon

7: Head, Dept of Surgery, AFMC Pune

 

INTRODUCTION:

Preoperative anxiety is a prevalent issue affecting 60-85% of patients undergoing elective surgery, with potentially adverse effects on patient outcomes (Sarah & Lynn, 2019). Multiple studies have investigated this phenomenon, its impacts, and potential interventions. Research indicates that high levels of preoperative anxiety can lead to increased postoperative pain, lower quality of life, poorer cognitive performance, longer hospitalization, and increased physical disability (Cutrona et al., 2016; Oteri et al., 2021; Vaughn et al., 2007). Pre-operative anxiety dysregulates the neurogenic component of surgical stress response and has been recommended to be addressed in the ERAS 2018 protocol.

 

Interestingly, the prevalence of preoperative anxiety varies widely across studies, ranging from 17% to 89%, with higher rates observed in female patients (Oteri et al., 2021). Factors contributing to preoperative anxiety include concerns about surgical procedures, complications, symptoms, recovery process, and the organization and delivery of care (King et al., 2017). Additionally, temperament has been found to play a role in preoperative anxiety, particularly in pediatric patients (Chow et al., 2019).

 

Several interventions have shown promise in reducing preoperative anxiety. These include the use of multi-media technology (Cutrona et al., 2016), acupuncture, music therapy, virtual reality, and pharmacological support (Oteri et al., 2021). Notably, a randomized controlled trial found that patient-preferred music significantly reduced state anxiety levels in day surgery patients (Cooke et al., 2005). Another study suggested that the essential oil lavandin could be a simple, low-risk, and cost-effective intervention for reducing preoperative anxiety (Braden et al., 2009). However, the most important intervention remains priming the patient about the plan of surgery including timelines for expected post operative recovery (RA: Roshan Lall 18th ed). Given the prevalence and impact of preoperative anxiety, early detection, prevention, and optimal management are crucial for achieving better patient care and outcomes in surgical settings (Bryan, 2021; Oteri et al., 2021; Wizano & Kurnia, 2022).

 

Military population is a special demography that has frequent exposure to stressors and anxiety situations. Often, armed forces personnel need to serve at war zones or areas of conflict. Besides, gruelling during training and maintenance of physical fitness on priority basis shape the behaviour of a military person. However, it is yet unknown how prevalent pre-operative anxiety is among the military population and its’ interplay with socio-demographic and military service profiles as some occupational profiles in the military, like the Commando training, are believed to wean away fear and anxiety permanently in the very few who have the mental robustness to complete the training.

 

 

AIMS & OBJECTIVES:

Study Setting: Department of Surgery and GI Surgery, Command Hospital, Pune.

 

Study Population: All serving personnel undergoing abdominal surgery.

 

Study Duration: September 2024 - November 2024.

 

Aim: To estimate the  prevalence of pre-operative anxiety among serving military personnel undergoing elective abdominal surgery and asses their relationship with other factors.

 

Objective 1: To evaluate the grades and asses the prevalence of pre-operative anxiety by evaluating the responses to a validated questionnaire based instrument.

 

Objective 2: To evaluate the roles of socio-demographic and military service profiles in determining pre-operative anxiety

 

 

 

 

 

METHODOLOGY:

 

 

 

INCLUSION CRITERIA: 

 

All patients undergoing abdominal surgery at CHSC, Pune between September 2024 - November 2024

 

EXCLUSION CRITERIA:

 

1. Patients undergoing emergency abdominal surgery (acute abdomen)

2. Patients undergoing abdominal surgery for trauma

3. Patients who had undergone any previous laparotomy/ laparoscopy or surgical intervention under general or spinal anesthesia

4. Patients who are not serving military personnel (dependents of military personnel, military veterans, civilians, non-entitled patients)

5. Patients who would not consent to participation/ withdraw consent

 

SAMPLE SIZE:

 

Monthly Surgical Audits have revealed that nearly 80 exclusively abdominal operations are performed each month by the Departments of Surgery and GI Surgery. Over a three month duration, the population expected to undergo abdominal surgery are: 240. After applying the Incl and Excl criteria, ~ 150 serving soldiers are expected to undergo elective abdominal surgeries. With the literature showing maximum 80% prevalence of pre-operative anxiety, the sample size is calculated by the formula:

 

Sample size n = [DEFF*Np(1-p)]/ [(d2/Z21-α/2*(N-1)+p*(1-p)]  

 

where

Population size(for finite population correction factor or fpc)(N):

150

 

Hypothesized % frequency of outcome factor in the population (p):

 

80%+/-5

 

Confidence limits as % of 100(absolute +/- %)(d):

5%

Design effect (for cluster surveys-DEFF):

1

 

 

By this formula, for 95% confidence level, a sample size of 94 is calculated.

SAMPLING: A convenient sampling of all patients getting admitted for elective abdominal surgery will be taken

 

STUDY DESIGN: This will be a descriptive observational study.

STUDY PROCEDURE: After obtaining consent, the study population will be handed out printed proforma containing the Amsterdam Preoperative Anxiety and Information Scale (APAIS), a validated questionnaire for this purpose, and their responses will be collected. Data on their socio-demographic and military service profiles will also be collected, along with data of their blood pressures and pulse rates on the pre-operative evening in a relaxed state.

ETHICAL ISSUES: All data will be collected in the form of a single printed proforma for individual patients. Safety of the data, including confidential information, will be ensured by personal custody by the PI. For all analysis and publication purpose, the data will be de-identified.

 

 

 

 

References 

 

Cutrona D, Bednar ME, Geoghegan L, et al. The Effects Of A Surgical Virtual Tour On Adult Preoperative Anxiety And Understanding Of The Surgical Process. Journal of PeriAnesthesia Nursing. 2016;31(4):e60-e61. doi:10.1016/j.jopan.2016.04.137

 

 

Vaughn F, Wichowski H, Bosworth G. Does Preoperative Anxiety Level Predict Postoperative Pain? AORN Journal. 2007;85(3):589-604. doi:10.1016/s0001-2092(07)60130-6

 

Oteri V, Martinelli A, Gigli F, Crivellaro E. The impact of preoperative anxiety on patients undergoing brain surgery: a systematic review. Neurosurgical Review. 2021;44(6):3047-3057. doi:10.1007/s10143-021-01498-1

 

 

Chow CHT, Buckley N, Rizwan A, et al. Association of Temperament With Preoperative Anxiety in Pediatric Patients Undergoing Surgery. JAMA Network Open. 2019;2(6):e195614. doi:10.1001/jamanetworkopen.2019.5614

 

 

King A, Johanson DL, Bartley J, Broadbent E. Components of preoperative anxiety: A qualitative study. Journal of Health Psychology. 2017;24(13):1897-1908. doi:10.1177/1359105317709512

 

 

Braden R, Halm MA, Reichow S. The Use of the Essential Oil Lavandin to Reduce Preoperative Anxiety in Surgical Patients. Journal of PeriAnesthesia Nursing. 2009;24(6):348-355. doi:10.1016/j.jopan.2009.10.002

 

 

Cooke M, Hiratos M, Chaboyer W, Schluter P. The effect of music on preoperative anxiety in day surgery. Journal of Advanced Nursing. 2005;52(1):47-55. doi:10.1111/j.1365-2648.2005.03563.x

 

 

Wizano Y, Kurnia D. Assessment of Anxiety Before Surgery In Cardiac Surgery Patients Who Have No History of Anxiety: Supporting Factors and Postoperative Morbidity. Devotion : Journal of Research and Community Service. 2022;3(13):2270-2277. doi:10.36418/dev.v3i13.277

 

 

Bryan JP. Concerns Related to Preoperative Anxiety in the Total Joint Arthroplasty Patient. JBJS Journal of Orthopaedics for Physician Assistants. 2021;9(4). doi:10.2106/jbjs.jopa.21.00020

 

 

Sarah S, Lynn S. Is the Amsterdam Preoperative Anxiety and Information Scale (APAIS) a Valid Tool in Guiding the Management of Preoperative Anxiety in Adult Patients? A Literature Review. Journal of Nursing and Practice. 2019;3(1). doi:10.36959/545/368

 
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