| 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
|
|
|
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
|
|
|
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
|
|
|
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. |