FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2024/05/067483 [Registered on: 16/05/2024] Trial Registered Prospectively
Last Modified On: 16/05/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group, Multiple Arm Trial 
Public Title of Study   Comparing the effect of eyemask with headphones and headset video to decrease anxiety, stress and pain scores in pregnant patients undergoing caesarean section. 
Scientific Title of Study   A Randomized Control Study comparing the effect of intraoperative external audiovisual blockade, immersive distraction and standard care on anxiety, stress and pain catastrophizing score in parturients undergoing caesarean delivery under spinal anaesthesia 
Trial Acronym  ASPADE 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Shaivya Srivastava  
Designation  Post graduate resident 
Affiliation  Maulana Azad Medical College  
Address  Department of Anaesthesiology and Intensive Care, Maulana Azad Medical College and Associated Lok Nayak Hospital, New Delhi

Central
DELHI
110002
India 
Phone  8802073823  
Fax    
Email  srivastavashaivya97@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Kapil Chaudhary 
Designation  Professor  
Affiliation  Maulana Azad Medical College  
Address  Department of Anaesthesiology and Intensive Care, Maulana Azad Medical College and Associated Lok Nayak Hospital, New Delhi

Central
DELHI
110002
India 
Phone  9871262699  
Fax    
Email  kapsdr@yahoo.com  
 
Details of Contact Person
Public Query  
Name  Dr Shaivya Srivastava  
Designation  Post graduate resident 
Affiliation  Maulana Azad Medical College  
Address  Department of Anaesthesiology and Intensive Care, Maulana Azad Medical College and Associated Lok Nayak Hospital, New Delhi

Central
DELHI
110002
India 
Phone  110002  
Fax    
Email  srivastavashaivya97@gmail.com  
 
Source of Monetary or Material Support  
Maulana Azad Medical College and Lok Nayak Hospital, 2 Bahadur Shah Zafar Marg, New Delhi- 110002, India  
 
Primary Sponsor  
Name  Maulana Azad Medical College and Lok Nayak Hospital  
Address  Department of Anaesthesiology and Intensive Care, Maulana Azad Medical College, New Delhi- 110002 
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 Shaivya Srivastava  Lok Nayak Hospital, New Delhi  OT Blocks, Department of Anaesthesiology, Maulana Azad Medical College and associted hospitals, Bahadur Shah Zafar Marg, New Delhi
Central
DELHI 		 8802073823

srivastavashaivya97@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee, Maulana Azad Medical College  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: O00-O9A||Pregnancy, childbirth and the puerperium,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Control  Standard care will be given to the patient. 
Intervention  External audiovisual blockade  Cooling gel eye mask and noise cancellation headphones will be applied to the patient intraoperatively, after administration of subarachnoid block and turning the patient supine wedged till the completion of skin suture. 
Intervention  Immersive Distraction  Distraction using virtual reality video after applying VR headset to the patient intraoperatively, after administration of subarachnoid block and turning the patient supine wedged till the completion of skin suture. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  45.00 Year(s)
Gender  Female 
Details  1. Patients of American Society of Anaesthesiologists (ASA) Physical Status II, III.
2. Singleton pregnancy.

 
 
ExclusionCriteria 
Details  1. Severe preclampsia, eclampsia.
2. Significant hepatic, renal and cardiovascular disease.
3. Significant vision and hearing impairment.
4. History of generalized anxiety disorder or mental illness
5. Contraindication to spinal anaesthesia.
6. Any psychiatric/ cognitive disorder affecting anxiety and pain assessment.
7. Patients in active labour.
8. Known history of seizures, migraine, motion sickness, claustrophobia.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Change in anxiety scores using Novel Visual Facial Anxiety (NVFAS) from baseline to 2 hours post operatively among the three groups.   1. After shifting to OT.
2. Two hours post operatively. 
 
Secondary Outcome  
Outcome  TimePoints 
Change in anxiety scores using Novel Visual Facial Anxiety (NVFAS) from baseline to the end of surgery and 6 hours post-operatively among the three groups.  1. After shifting to OT.
2. End of surgery.
3. Six hours post operatively. 
Change in stress scores using Brief Measure Of Emotional Perioperative Stress (BMEPS) at different time points.   1. After shifting to OT.
2. End of surgery.
3. Two hours post operatively.
4. Six hours post operatively. 
Change in total and subgroup pain catastrophizing score using Pain Catastrophizing Scale (PCS) at different time points.   1. After shifting to OT.
2. End of surgery.
3. Two hours post operatively.
4. Six hours post operatively. 
Change in serum cortisol, serum IL-6, neutrophil lymphocyte ratio and salivary cortisol levels at different time points.   Serum cortisol, Serum IL-6 and neutrophil lymphocyte ratio at pre-operatively and 6 hours post operatively.
Salivary cortisol at pre-operatively and end of surgery. 
Change in acute pain scores using Numerical Rating Scale (0-10) at different time points.  1. After shifting to OT.
2. At L.A. injection.
3. End of surgery.
4. Two hours post operatively.
5. Six hours post operatively. 
Patient satisfaction questionnaire score and feedback regarding intervention.   2 hours postoperatively. 
 
Target Sample Size   Total Sample Size="45"
Sample Size from India="45" 
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)   27/05/2024 
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="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 - NO
Brief Summary   High levels of stress and anxiety before or during caesarean delivery may increase the prospects of anaesthesia related complications during surgery, increase postoperative analgesic requirement, prolong recovery time, delay lactation and have a relatively higher risk of developing behaviour problems in their children during preschool period. It is thus imperative to decrease caesarean delivery related stress and anxiety.

 Various interventions have been used for reduction of anxiety and stress. The aim of our study is to evaluate and compare the effect of intraoperative external audiovisual blockade, immersive distraction and standard care on anxiety, stress and pain catastrophizing score in parturients undergoing caesarean delivery under spinal anaesthesia. 
 
Close