| CTRI Number |
CTRI/2025/06/088982 [Registered on: 17/06/2025] Trial Registered Prospectively |
| Last Modified On: |
16/06/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Teaching learning Module-Nursing] |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Cultural competent care module for nUrses and Enhance Patient Satisfaction |
|
Scientific Title of Study
|
Development and Validation of Culturally Competent Care Module, and to comparatively assess the efficacy of culturally competent care module (CCCM) on Cultural Competence of Nurses and Patient Care Satisfaction compared to Standard Nursing care among Nurses and Patients in Medical Surgical wards of Tertiary care Hospital |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
LigyC Ittup |
| Designation |
PhD scholar |
| Affiliation |
SRMMCON |
| Address |
Srimati Radhikabai Meghe Memorial College Of Nursing
DMIMSU Campus, Meghe, Sawangi, Wardha, Maharashtra 442004
rimati Radhikabai Meghe Memorial College Of Nursing
DMIMSU Campus, Meghe, Sawangi, Wardha, Maharashtra 442004
Wardha
MAHARASHTRA
442004
India |
| Phone |
9869979326 |
| Fax |
|
| Email |
ligissps@gamil.com |
|
Details of Contact Person
Scientific Query
|
| Name |
LigyC Ittup |
| Designation |
PhD scholar |
| Affiliation |
SRMMCON |
| Address |
Srimati Radhikabai Meghe Memorial College Of Nursing
DMIMSU Campus, Meghe, Sawangi, Wardha, Maharashtra 442004
rimati Radhikabai Meghe Memorial College Of Nursing
DMIMSU Campus, Meghe, Sawangi, Wardha, Maharashtra 442004
Wardha
MAHARASHTRA
442004
India |
| Phone |
9869979326 |
| Fax |
|
| Email |
ligissps@gamil.com |
|
Details of Contact Person
Public Query
|
| Name |
DrRanjana Sahrma |
| Designation |
Professor Cum Principal |
| Affiliation |
SRMMCON |
| Address |
Srimati Radhikabai Meghe Memorial College Of Nursing
DMIMSU Campus, Meghe, Sawangi, Wardha, Maharashtra 442004
Srimati Radhikabai Meghe Memorial College Of Nursing
DMIMSU Campus, Meghe, Sawangi, Wardha, Maharashtra 442004
Wardha
MAHARASHTRA
442004
India |
| Phone |
9960027855 |
| Fax |
|
| Email |
ranjanasharma1234@rediffmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
DMIHER |
| Address |
DMIHER Campus, Meghe, Sawangi, Wardha, Maharashtra 442004 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 |
| DrRanjana Sharma |
Acharya Vinoba Bhave Rural Hospital Medical Surgical wards |
DMIHER Campus, Meghe, Sawangi, Wardha, Maharashtra 442004
Wardha
MAHARASHTRA |
9960027855
ranjanasharma1234@rediffmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Commitee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
cultural competnce of Nurses and Patient Satisfaction |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
CULTURALLY COMPETENT CARE MODULE |
DEVELOPMENT, VALIDATION, AND IMPLEMENTATION OF THE MODULE FOR NURSES. 4 weeks |
| Comparator Agent |
Standard Nursing care |
comparing standard nursing care, |
|
|
Inclusion Criteria
|
| Age From |
21.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Nurses working in medical or surgical ward at least 1 year
2. Nurses and patients Willing to participate
3. Patients from Medical Surgical Ward
Patients possess the ability to read and write.
|
|
| ExclusionCriteria |
| Details |
1. Nurses who have been trained in culturally sensitive care.
2. The patients suffer from cognitive or neurological impairments.
|
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Improving level of cultural competence of Nurses and patients satisfaction |
The duration ranges from 4 weeks to 8 weeks. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Improving quality patient care and patient satisfaction. Improving level of cultural competence of Nursess |
baseline and 16 weeks |
|
|
Target Sample Size
|
Total Sample Size="3000"
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)
|
30/06/2025 |
| 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="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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 study calledDevelopment and Validation of Culturally Competent Care Module (CCCM) and a Comparative Assessment of its Efficacy on Cultural Competence of Nurses and Patient Care Satisfaction in Medical Surgical Wards of Tertiary Care Hospital" has two parts. In Phase 1, the primary objectives are to develop and validate a new CCCM and identify the barriers and facilitators affecting its implementation in a clinical setting. Phase 11 aims to compare the level of cultural competence among nurses who receive CCCM training versus those who follow standard nursing care and to see patient satisfaction in both the control and interventional groups. the study test two null hypotheses. First, there is no significant difference in the level of cultural competence among nurses with and without CCCM training, and second, there is no significant difference in patient care satisfaction between patients receiving standard nursing care and those cared for under the CCCM model. The corresponding research hypothesis proposes that this CCCM training will significantly improve both the cultural competence of nurses and the satisfaction of patients. . |