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CTRI Number  CTRI/2024/06/068364 [Registered on: 05/06/2024] Trial Registered Prospectively
Last Modified On: 04/06/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Process of Care Changes 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   A randomized controlled trial to check the effectiveness of VAK-based home care bundle on the patients undergoing pituitary region tumor surgery 
Scientific Title of Study   A Randomized Controlled Trial on effectiveness of VAK based visual auditory kinesthetic home care bundle on selected outcome variables among patients undergoing pituitary region tumor surgery admitted in Neurosurgical units Nehru hospital PGIMER Chandigarh 2023 25 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Priyanka 
Designation  M.Sc. Nursing 
Affiliation  National Institute of Nursing Education, Post-Graduate Institute of Medical Education and Research 
Address  National Institute of Nursing Education, Post-Graduate Institute of Medical Education and Research, Chandigarh

Chandigarh
CHANDIGARH
160012
India 
Phone  9465684364  
Fax    
Email  priyanka4info@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr. Manju Dhandapani 
Designation  Associate Professor 
Affiliation  National Institute of Nursing Education, Post-Graduate Institute of Medical Education and Research 
Address  Room no. 305, Department of Medical-Surgical Nursing, National Institute of Nursing Education, Post-Graduate Institute of Medical Education and Research

Chandigarh
CHANDIGARH
160012
India 
Phone  9855151528  
Fax    
Email  manjuseban@gmail.com  
 
Details of Contact Person
Public Query  
Name  Priyanka 
Designation  M.Sc. Nursing 
Affiliation  National Institute of Nursing Education, Post-Graduate Institute of Medical Education and Research 
Address  Room no. 208, Department of Medical-Surgical Nursing, National Institute of Nursing Education, Post-Graduate Institute of Medical Education and Research

Chandigarh
CHANDIGARH
160012
India 
Phone  9465684364  
Fax    
Email  priyanka4info@gmail.com  
 
Source of Monetary or Material Support  
Department of Neurosurgery, Nehru Hospital, Post-Graduate Institute of Medical Education and Research, Chandigarh 
Self funded 
 
Primary Sponsor  
Name  Priyanka 
Address  National institute of nursing education, PGIMER 
Type of Sponsor  Other [Self] 
 
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 Manju Dhandapni  Post- graduate institute of medical education and research  Department of Neurosurgery/ Neurosurgical units
Chandigarh
CHANDIGARH 		 9855151528

manjuseban@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Post - graduate institute of medical education and research, Institutional Ethics Committee ( Intramural)  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: E898||Other postprocedural endocrine andmetabolic complications and disorders,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Routine care  Traditional method of discharge teaching i.e. written format only Duration- 2 months 
Intervention  VAK ( visual, auditory, kinesthetic) based home care bundle  VAK ( visual, auditory, kinesthetic) based home care bundle involves providing discharge teaching in a different learning style other than the traditional method Duration- 2 months 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1. Willing to participate in the study
2. Conscious at the time of discharge
 
 
ExclusionCriteria 
Details  1. Known case of psychiatric disorder
2. Visual impairment due to any other disorder
3. Any sinonasal surgery
4. Any communication impairment
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   On-site computer system 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
1. Physical symptoms
2. Neuropsychological symptoms :
a) Fear
b) Social behaviour
c) Anxiety
3. Activity of daily living
4. Quality of life
5. Sinonasal quality of life
6. Visual quality of life
7. Therapeutic compliance
 		 3rd day and 4th week 
 
Secondary Outcome  
Outcome  TimePoints 
none   none 
 
Target Sample Size   Total Sample Size="70"
Sample Size from India="70" 
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   Phase 2 
Date of First Enrollment (India)   01/07/2024 
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="0"
Months="2"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
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 - 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 -  Statistical Analysis Plan
    Response - Clinical Study Report
    Response -  Analytic Code

  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 - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response (Others) -  priyanka4info@gmail.com

  6. For how long will this data be available start date provided 01-07-2024 and end date provided 31-08-2024?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary  

The primary goal of the support from the nurse care manager is to facilitate the patient’s own resources in managing illness as well as giving specific health education. Patient-held documentation and health books, frames the content of self-management support. They are also able to reflect and self-assess issues related to work, social support, economy, and other health factors such as physical activity, sleep and diet.10

Introduction of VAK based home care bundle will help them in getting active learning for various aspects of home care. Education delivery systems are increasingly being offered in different formats. Considering how a person learns best could improve their processing and retention of the information.

Discharge summary on a single paper handout is not enough. By focusing on educating patients and their caregivers, based on learning preferences, it was anticipated that they would have a better understanding of their health situation and increase their ability to prevent or deal with complications.

 
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