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CTRI Number  CTRI/2024/02/063043 [Registered on: 22/02/2024] Trial Registered Prospectively
Last Modified On: 10/03/2025
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Process of Care Changes 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   Study to test comforting manoevures for reducing post partum depressive symptoms in patients who underwent cesarean patients 
Scientific Title of Study   A study to assess efficacy of comforting manoeuvres (Hand holding and Calming conversation) in reducing symptoms of depression in post partum period in patients undergoing cesarean section under regional anaesthesia. 
Trial Acronym  PPD study 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Pritam Yadav 
Designation  Associate Professor 
Affiliation  Pt BDS PGIMS, Rohtak, Haryana 
Address  Room no 22, Department of anaesthesiology, Pt BDS PGIMS, Rohtak

Rohtak
HARYANA
124001
India 
Phone    
Fax    
Email  pksatoriya@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Pritam Yadav 
Designation  Associate Professor 
Affiliation  Pt BDS PGIMS, Rohtak, Haryana 
Address  Room no 22, Department of anaesthesiology, Pt BDS PGIMS, Rohtak

Rohtak
HARYANA
124001
India 
Phone    
Fax    
Email  pksatoriya@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Pritam Yadav 
Designation  Associate Professor 
Affiliation  Pt BDS PGIMS, Rohtak, Haryana 
Address  Room no 22, Department of anaesthesiology, Pt BDS PGIMS, Rohtak

Rohtak
HARYANA
124001
India 
Phone    
Fax    
Email  pksatoriya@gmail.com  
 
Source of Monetary or Material Support  
Pt BDS PGIMS, Rohtak, Haryana 
 
Primary Sponsor  
Name  Pt BDS PGIMS Rohtak 
Address  Pt BDS PGIMS, Rohtak, Haryana 
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 PRITAM YADAV  Pt BDS PGIMS,ROHTAK  Operation theatre complex, Department of anaesthesiology,
Rohtak
HARYANA 		 9034907826

pksatoriya@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
biomedical research ethics committee, Pt BDS PGIMS,ROHTAK  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: F53||Puerperal psychosis,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  comforting manoevure  - Intervention of comforting manoevures will be carried out by one of three female resident doctor adequately trained by psychiatric consultant. Calming conversation will be started in the preoperative waiting room by answering questions of the patient, explaining the procedure, position during anaesthesia and surgery, expected duration and recovery. Conversation will be done in a soft but easily audible voice in language best understood by patient. Calming conversation will be continued to prompt positive thinking. Simple questions will be asked like: where are you from, how many siblings do you have, who has escorted you to the hospital, have you decided on any name for the baby yet, what does your name mean? - In the operative room hand of the patient will be held by female resident gently with medium pressure and warm hands ensuring the comfort of the patient after giving regional anaesthesia.Resident will be standing on the side of patient and and will continue to hold hand along with calming conversation until the end of surgery. Along with this calming conversation will be continued through till the end of surgery  
Comparator Agent  Routine intraoperative care  Patient will be Counselled in the preoperative waiting room by answering questions of the patient, explaining the procedure, position during anaesthesia and surgery, expected duration and recovery.During intraoperative period questions of patient will be answered but no proactive calming conversation and hand holding will be done.  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  40.00 Year(s)
Gender  Female 
Details  Pregnant patients in the age group 18-40 years, ASA II admitted for cesarean
section under regional anaesthesia. 
 
ExclusionCriteria 
Details  - refusal by patient
- History of psychiatric/neurological disorder
- History of head injury
- History of drug abuse
- History of alcohol abuse
- Any psychological trauma in past 6 months
- Any life threatening medical complications
- Multipara ( >2 previous birth )
- pregnant with a serious obstetric complication or serious foundational
diseases
- new born with serious genetic or congenital diseases
- Fetal distress
- Preference for general anaesthesia 
 
Method of Generating Random Sequence   Permuted block randomization, fixed 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant, Investigator and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
EPDS( Edinburgh Postnatal Depression Scale) SCORE
 		 At one week, two weeks and four weeks postoperative
 
 
Secondary Outcome  
Outcome  TimePoints 
Patient Satisfaction Score (1-5)
(1-not at all, 5- extremely) 		 at 48 hours post partum 
 
Target Sample Size   Total Sample Size="80"
Sample Size from India="80" 
Final Enrollment numbers achieved (Total)= "90"
Final Enrollment numbers achieved (India)="90" 
Phase of Trial   Phase 2 
Date of First Enrollment (India)   05/03/2024 
Date of Study Completion (India) 12/10/2024 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) 12/10/2024 
Estimated Duration of Trial   Years="0"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
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 - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  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 whose proposed use of the data has been approved by an independent review committee identified for this purpose.

  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 [pksatoriya@gmail.com].

  6. For how long will this data be available start date provided 14-03-2025 and end date provided 14-03-2028?
    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   Post partum depression is a serious yet under attended healthcare issue affecting both mother and new born. Some studies has linked higher post partum depression in patients undergoing cesarean section than normal vaginal delivery. At the same time , simple techniques of comforting manoevures are found to decrease perioperative anxiety and increase patient satisfaction in patients undergoing cesarean section. Reduced perioperative anxiety and increased satisfaction could lead to reduction in post partum depressive symptoms. Hence  this study is planned to assess efficacy of comforting manoevures for prevention of post partum depressive symptoms in patients undergoing cesarean section in regional anaesthesia 
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