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CTRI Number  CTRI/2021/06/034458 [Registered on: 29/06/2021] Trial Registered Prospectively
Last Modified On: 16/02/2022
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Process of Care Changes 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   "To evaluate the impact of nurse led psychoeducation on knowledge and psychological stress of the cancer patients undergoing radiological imaging studies" 
Scientific Title of Study   "An experimental study to evaluate the impact of nurse led psychoeducation on knowledge and psychological stress of the cancer patients undergoing radiological imaging studies" 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Anjali 
Designation  M.Sc. Nursing (Oncological) student 
Affiliation  All India Institute of Medical Sciences, New Delhi 
Address  Room number N-310, Hostel number 15, Medha hostel Masjid Moth, AIIMS Campus, AIIMS New Delhi, PIN Code- 110049
Room number N-310, Hostel number 15, Medha hostel Masjid Moth, AIIMS Campus, AIIMS New Delhi, PIN Code- 110049
South
DELHI
110049
India 
Phone  7988532743  
Fax    
Email  abhaanjali24@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Kamlesh Kumari Sharma 
Designation  Associate Professor 
Affiliation  ALL INDIA INSTITUTE OF MEDICAL SCIENCES, New Delhi 
Address  College of Nursing AIIMS Ansari Nagar New Delhi
College of Nursing AIIMS Ansari Nagar New Delhi
South
DELHI
110029
India 
Phone    
Fax    
Email  kamleshcon@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Rakesh Garg 
Designation  Additional Professor Department of Onco-Anaesthesia and Palliative Medicine 
Affiliation  All India Institute of Medical Sciences, New Delhi 
Address  Room No 139, FIRST FLOOR DR BRAIRCH ANSARI NAGAR
Room No 139, FIRST FLOOR DR BRAIRCH ANSARI NAGAR
South
DELHI
110049
India 
Phone  9810394950  
Fax    
Email  drrgarg@hotmail.com  
 
Source of Monetary or Material Support  
All India Institute of Medical Sciences, New Delhi 
 
Primary Sponsor  
Name  Anjali 
Address  Room number N-310, Hostel number 15, Medha hostel Masjid Moth, AIIMS Campus, AIIMS New Delhi 
Type of Sponsor  Other [Self - funded] 
 
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 
ANJALI  All India Institute of Medical Sciences, New Delhi  DR. BRAIRCH OPD GROUND FLOOR AIIMS, NEW DELHI 110029
South
DELHI 		 7988532743

abhaanjali24@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institute Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: C00-D49||Neoplasms,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Nurse led psychoeducation  Nurse led psychoeducation will be provided through face to face or web based to the intervention group. components of nurse led psychoeducation are- 1) Radiological imaging studies: What are the radiological imaging studies? Why radiological imaging study(ies) indicated for you? What preparation is needed prior to radiological imaging tests? What expected from them, during radiological imaging scan? How much time it will take? In which conditions, radiological imaging studies are to be avoided? Post-care, if needed. 2) Psychological Stress: What is psychological stress? What are the factors responsible for increasing psychological stress before the scan? What are the factors responsible for increasing psychological stress after the scan? What is the impact of psychological stress on imaging pictures? How to alleviate psychological stress? How to stay calm during the entire period of imaging scanning? What post procedure care may be required?  
Comparator Agent  Routine information  control group will received the Routine information that is given by the hospital staff regarding radiological imaging studies before the scan procedure 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  Patient with :
Age>18 years
Has clinical indication for undergoing the radiological imaging at Dr. BRAIRCH, AIIMS, New Delhi
Are able to read and write Hindi or English
Willing to give consent for participation in study
 
 
ExclusionCriteria 
Details  Patient with known history of active psychiatric illness. 
 
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 
Psychological stress when the the cancer patients undergoing radiological imaging studies   Baseline, at one week of imaging 
 
Secondary Outcome  
Outcome  TimePoints 
Knowledge regarding radiological imaging studies among the cancer patients undergoing radiological imaging.  Baseline, one week after imaging 
 
Target Sample Size   Total Sample Size="120"
Sample Size from India="120" 
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)   01/07/2021 
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="0"
Months="7"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Closed to Recruitment of Participants 
Publication Details    
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary   "An experimental study to evaluate the impact of nurse led psychoeducation on knowledge and psychological stress of the cancer patients undergoing radiological imaging studies" 
 This study focuses on the psychological stress that has been faced by the cancer patients while undergoing the radiological imaging studies. It will be an experimental study, in which two groups will be taken which then further randomized into the experimental group and control group. In both the groups, pre-test will be done and after that Nurse led psychoeducation will be provided to the experimental group in addition to the routine standard care provided by the hospital, while the control group will receive only the routine standard care before undergoing radiological imaging studies. After that, a post test will be done when the patient visit the hospital on the next scheduled consultation. 
After providing the nurse led psychoeducation, the cancer patients will able to cope up with the psychological stress (depression and anxiety) and their knowledge will be enhanced after giving the psychoeducation.

 
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