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CTRI Number  CTRI/2021/12/038576 [Registered on: 10/12/2021] Trial Registered Prospectively
Last Modified On: 06/11/2023
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Process of Care Changes 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   A prospective single center study to assess the effect of pre operative spiritual intervention on stress in patients post surgery 
Scientific Title of Study   Prospective single center study to assess the utility of pre operative spiritual care intervention on post operative stress. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Vaishali Chaudhary 
Designation  Consultant Gynaecologist 
Affiliation  Bhaktivedanta Hospital and Research Center 
Address  Gynecology and Obstetrics Department OPD3 Ground Floor Bhaktivedanta Hospital and Research Institute Mira Road East Thane Maharashtra 401107

Thane
MAHARASHTRA
401107
India 
Phone  9321996831  
Fax    
Email  drvaishali231980@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Vaishali Chaudhary 
Designation  Consultant Gynaecologist 
Affiliation  Bhaktivedanta Hospital and Research Center 
Address  Gynecology and Obstetrics Department OPD3 Ground Floor Bhaktivedanta Hospital and Research Institute Mira Road East Thane Maharashtra 401107

Thane
MAHARASHTRA
401107
India 
Phone  9321996831  
Fax    
Email  drvaishali231980@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Vijaykumar Gawali  
Designation  Head of Department Clinical Research and Education  
Affiliation  Bhaktivedanta Hospital and Research Institute 
Address  5th Floor B Wing Medical Research Department Bhaktivedanta Hospital and Research Institute Mira Road East Thane Maharashtra 401107

Thane
MAHARASHTRA
401107
India 
Phone  9320199122   
Fax    
Email  drvijaykumar.g@bhaktivedantahospital.com  
 
Source of Monetary or Material Support  
Bhaktivedanta Hospital and Research Institute Mira Road East Thane Maharashtra 401107  
 
Primary Sponsor  
Name  Nil 
Address  Nil 
Type of Sponsor  Other [Nil] 
 
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 Vaishali Chaudhary  Bhaktivedanta Hospital and Research Institute  Gynaecology and Obstetrics IPD 4th Floor Bhaktivedanta Hospital and Research Institute Mira Road Thane Maharashtra 401107
Thane
MAHARASHTRA 		 9321996831

drvaishali231980@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Bhaktivedanta Hospital Ethics Committee for Biomedical and Health Research  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: F09||Unspecified mental disorder due toknown physiological condition,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Spiritual Intervention  In addition to the routine standard care Spiritual care would be given to patients in the intervention group pre-operation i.e. before operative procedures. Study team member will offer the intervention to the patient before the operative procedures for 30 minutes based on the MATCH guidelines (MERCY AUSTERITY TRUTHFULNESS CLEANLINESS and HOLY NAME). These guidelines were validated previously in the same set up. The intervention consists of Spiritual Prayer and Counseling Spiritual Reading and Spiritual Chanting or Mantra Meditation 1) Spiritual Prayer and Counseling Study team member will explain the process and the importance of spiritual care to the patient. Prayer will depend on the religion that patient follows. Patient will be asked to do prayer under the supervision of the study team member. If the patient is unable to do prayer then the patient relative or the caregiver or the study team member will do the prayer in front of the patient. Prayer also includes Mantra Meditation and Chanting. 2) Spiritual Reading Spiritual Reading includes reading of the Spiritual Literatures depending on the religion that the patient follows and the patient acceptability. Patient will be asked to read Spiritual Literatures for a minimum of 10 minutes at a time under the supervision of the study team member. If the patient is unable to read then the patient relative or caregiver or the study team member will read the Spiritual Literatures according to the patient interest in front of the patient and the patient will be requested to listen it. 3) Spiritual Chanting or Mantra Meditation Study team member will do Spiritual Chanting. During the surgical procedures, Mantra Meditation CD will be played. 
Comparator Agent  Standard regular counselling   Standard regular counselling will be offered as per the standard care program of the Institute. The post operative Counseling sessions begin after the surgery and continue until patient is discharged from the hospital. The aim of these sessions is to build rapport with the patients, address postoperative fears, emotional issues and provide supportive care for patients and their relatives. The counselors from Spiritual Care Department of the Hospital counsel, provide assistance and address concerns of patients and their relatives by using relevant excerpts from The Bhagwat Gita or any other religious scriptures. The hospitals spiritual ambience that is maintained by 24×7 chant of Mahamantra, bhajans and kirtans also help in strengthening the coping abilities and creating realistic hope on recovery in patients and their relatives. Prior to discharge, the patients are counseled to mentally and emotionally prepare them and their relatives to ensure adherence to the treatment regimen and to clarify individual questions or concerns regarding follow-up care. Patients are also requested to seek blessings from idol of Lord Jaganath before discharge for their speedy recovery. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Female 
Details  Patients of the gynecological department undergoing major surgery at Bhaktivedanta
Hospital.
Patients of under the age group of 18-65 
 
ExclusionCriteria 
Details  Patients in the ICU
Patients without signed ICF 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Not Applicable 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
To assess the effect of spiritual intervention on stress levels, acute and chronic pain levels and negative emotional symptoms   Assessment of the patient would be performed pre operation (before the surgery) and post operation (after 24 hours of the surgery).
Mode of assessment is verbal (questionnaire). 
 
Secondary Outcome  
Outcome  TimePoints 
Vital signs such as blood pressure, pulse rate, and oxygen saturation.
Overall wellbeing of the patients 		 Every 4 hours  
 
Target Sample Size   Total Sample Size="90"
Sample Size from India="90" 
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)   20/12/2021 
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)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Closed to Recruitment of Participants 
Publication Details   NIL 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  
Anxiety occurs both before and after surgery in up to 80% of patients. Anxiety of patients before and after surgery can lead to unwanted events and effects. Studies have shown that stress has various effects on surgery such as delayed wound healing, elevated blood sugars in diabetics could result in diabetic complications and also difficulty managing post-operative pain. Hence giving the patient proper mental and physical care is utmost essential.  In this study we aim to support the patient by supplying appropriate mental care to the patient through spiritual intervention pre-operation and assessing its utility post operation. The effectiveness of the intervention provided would be measured by the visual analog scale (VAS) and Depression Anxiety Stress Scale (DASS-21).
 
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