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CTRI Number  CTRI/2025/07/090209 [Registered on: 04/07/2025] Trial Registered Prospectively
Last Modified On: 03/07/2025
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   Development and standardization of Nursing Care Need Assessment Tool 
Scientific Title of Study   Development and standardization of Nursing Care Need Assessment Tool (NC-NAT) 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Baishali Deb 
Designation  PHD Scholar 
Affiliation  LGB Regional Institute of Mental Health Tezpur 
Address  3rd Floor Academic Building Department of Psychiatric Nursing LGB Regional Institute of Mental Health Tezpur, Assam

Sonitpur
ASSAM
784001
India 
Phone  8415008370  
Fax  -  
Email  vaishudeb@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr. Arunjyoti Baruah 
Designation  Professor and HOD 
Affiliation  LGB Regional Institute of Mental Health Tezpur 
Address  3rd Floor Academic Building Department of Psychiatric Nursing LGB Regional Institute of Mental Health Tezpur, Assam

Sonitpur
ASSAM
784001
India 
Phone  03712232942  
Fax  -  
Email  arunjyotibaruah@yahoo.co.in  
 
Details of Contact Person
Public Query
 
Name  Dr. Arunjyoti Baruah 
Designation  Professor and HOD 
Affiliation  LGB Regional Institute of Mental Health Tezpur 
Address  3rd Floor Academic Building Department of Psychiatric Nursing LGB Regional Institute of Mental Health Tezpur, Assam


ASSAM
784001
India 
Phone  03712232942  
Fax  -  
Email  arunjyotibaruah@yahoo.co.in  
 
Source of Monetary or Material Support  
NIL 
 
Primary Sponsor  
Name  BAISHALI DEB 
Address  3RD FLOOR ACADEMIC BUILDING DEPARTMENT OF PSYCHIATRIC NURSING LGB REGIONAL INSTITUTE OF MENTAL HEALTH TEZPUR 
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 
Baishali Deb  LGB REGIONAL INSTITUTE OF MENTAL HEALTH TEZPUR  IPD(Block E 1st, 2nd and 3rd Floor and Block F 1st, 2nd and 3rd floor) and OPD(Room no 22) of ADULT PSYCHIATRY, LGB REGIONAL INSTITUTE OF MENTAL HEALTH
Sonitpur
ASSAM 
8415008370

vaishudeb@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: F01-F99||Mental, Behavioral and Neurodevelopmental disorders,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Nil  Nil 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  All individuals above 18 years of age admitted with any one of the major mental illness which is Psychosis OCD BPAD and OCD will be included in the study
Caregivers of persons with major mental illness currently admitted will also be taken for data collection
Nurses with at least two years of experience in psychiatric hospital will be included for data collection 
 
ExclusionCriteria 
Details  Severe medical comorbidities and substance use disorders will be excluded from the study 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To develop a reliable and valid tool to assess the nursing care needs of persons with major mental illness  Single point data collection will be done 
 
Secondary Outcome  
Outcome  TimePoints 
NIL  NIL 
 
Target Sample Size   Total Sample Size="300"
Sample Size from India="300" 
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)   01/08/2025 
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="2"
Months="1"
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 - NO
Brief Summary  

The needs of persons with major mental illness extend beyond clinical treatment. Needs of persons are individualized and differ from one another. Persons with major mental illnesses often struggle with persistent symptoms that interfere with daily functioning. In order to have an understanding about the differing needs and care required by such persons with major mental illness, assessment is very much important. Few tools are available to assess the needs of patients in general but to the best of the knowledge of the researcher, there is dearth of comprehensive tool to capture context-specific nursing care needs of persons with major mental illness. Therefore, a tool is needed to be developed, which can assess different domains of nursing care needs in persons with major mental illness in clinical settings so that adequate care programs can be planned. The present study thus aims to develop a tool which is the ‘Nursing Care Need Assessment Tool (NC-NAT)’ to assess various needs of persons with major mental illness and to test the developed tool among persons with major mental illness. The aim of the study is to develop and validate a reliable tool to assess the nursing care needs of persons with major mental illness.

The study will be conducted at the in-patient and out-patient department of a tertiary mental health care institute of north-east India in two phases and five steps. It will employ a mixed method research design with the Institute Ethics Clearance. Phase I will include two steps i.e., i) Item generation and ii) Content adequacy assessment, where In-depth interview using case study method will be carried out by the researcher to explore the needs of persons with major mental illness to generate item pool, following which cognitive interviewing as well as content validation will be done. At least 5 units of case studies will be done (1 unit will comprise of data from the patient, caregiver, nurse and the patient’s file) for each diagnosis of Psychosis, OCD, BPAD and Dementia until no new themes are generated. Phase II will include three steps i.e., i) Questionnaire administration, ii) Item Evaluation and iii) Optimization of scale length.  Cross sectional descriptive research design will be used to establish reliability, evaluate items and optimise the scale length with the help of computing the correlation, variances, dimensionality and reliability. Purposive sampling will be done for establishing the psychometric property of the tool with 300 participants.

The analysis of Phase I will be done with the help of thematic analysis while analysis of Phase II will be done with the help of SPSS updated version. The statistical plan for analysis of the data will be on the basis of objectives in terms of descriptive and inferential statistics. 

 
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