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CTRI Number  CTRI/2023/03/050373 [Registered on: 06/03/2023] Trial Registered Prospectively
Last Modified On: 27/02/2023
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Effect Of Preoperative Audio-visual Tools On Quality of Recovery After Elective Caesarean Delivery  
Scientific Title of Study   Effect Of Preoperative Audio-visual Tools On Quality of Recovery After Elective Caesarean Delivery In A Developing Country Setting - A Randomised Controlled Trial 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Vighnesh Ashok 
Designation  Assistant Professor 
Affiliation  Department of Anaesthesia and Intensive Care 
Address  Assistant Professor, Dept of Anaesthesia and Intensive Care, Level 4, Nehru Block, Post Graduate Institute of Medical Education and Research, Sector 12, Chandigarh

Chandigarh
CHANDIGARH
160012
India 
Phone    
Fax    
Email  vighneshmmc@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Vighnesh Ashok 
Designation  Assistant Professor 
Affiliation  Department of Anaesthesia and Intensive Care 
Address  Assistant Professor, Dept of Anaesthesia and Intensive Care, Level 4, Nehru Block, Post Graduate Institute of Medical Education and Research, Sector 12, Chandigarh

Chandigarh
CHANDIGARH
160012
India 
Phone    
Fax    
Email  vighneshmmc@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Vighnesh Ashok 
Designation  Assistant Professor 
Affiliation  Department of Anaesthesia and Intensive Care 
Address  Assistant Professor, Dept of Anaesthesia and Intensive Care, Level 4, Nehru Block, Post Graduate Institute of Medical Education and Research, Sector 12, Chandigarh

Chandigarh
CHANDIGARH
160012
India 
Phone    
Fax    
Email  vighneshmmc@gmail.com  
 
Source of Monetary or Material Support  
Dept of Anaesthesia and Intensive Care, Post Graduate Institute of Medical Education and Research  
 
Primary Sponsor  
Name  Post Graduate Institute of Medical Education and Research 
Address  Dept of Anaesthesia and Intensive Care, Level 4, Nehru Block, PGIMER, Sector 12, Chandigarh  
Type of Sponsor  Research institution and hospital 
 
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 Vighnesh Ashok  Post Graduate Institute of Medical Education and Research  Department of Anaesthsia and Intensive Care, Level 4, Nehru Block, PGIMER, Sector 12, Chandigarh, 160012
Chandigarh
CHANDIGARH 		 9003242109

vighneshmmc@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: O993||Mental disorders and diseases of the nervous system complicating pregnancy, childbirth and the puerperium,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Audio-visual tools  A brief video (with audio) explaining in Hindi the perioperative care to be expected 
Comparator Agent  Not applicable  Not applicable 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  45.00 Year(s)
Gender  Female 
Details  Parturients planned for elective caesarean section under either neuraxial or general anaesthesia 
 
ExclusionCriteria 
Details  1. Patient refusal
2. Parturients who have vision, hearing or speech diabilities
3. Parturients with psychiatric illnesses
4. Inability to read and understand the Hindi version of the ObsQoR-10 questionnaire 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
Quality of postoperative recovery, as measured using the ObsQoR-10 scoring tool  24 hours postoperative 
 
Secondary Outcome  
Outcome  TimePoints 
Preoperative anxiety, measured using the visual Analogue Scale (VAS)  30 minutes prior to transfer to the operating theatre 
Overall patient satisfaction score, measure using a Likert scale  24 hours postoperative 
 
Target Sample Size   Total Sample Size="110"
Sample Size from India="110" 
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)   20/03/2023 
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="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details    
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-identiļ¬cation.

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

  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 - For individual participant data meta-analysis.

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

  6. For how long will this data be available start date provided 20-06-2024 and end date provided 20-11-2024?
    Response - Beginning 3 months and ending 5 years following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary   Anxiety before elective caesarean delivery is common, and the factors are multifactorial. High preoperative anxiety can have several unfavourable perioperative effects, and is associated with poor patient satisfaction. Preoperative patient preparation using specifically designed audio-visual tools in the local language can help reduce preoperative anxiety. The effect of such interventions on the quality of recovery (QoR) after elective caesarean section has not been studied.
This prospective randomised trial will explore the effect of preoperative audio-visual tools on the postoperative QoR (primary outcome), preoperative anxiety (secondary outcome) and overall patient satisfaction (secondary outcome) in women scheduled to undergo elective caesarean section. 
 
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