| CTRI Number |
CTRI/2025/10/096123 [Registered on: 16/10/2025] Trial Registered Prospectively |
| Last Modified On: |
15/10/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Percieved communication barriers among nurses and patients in palliative care settings |
|
Scientific Title of Study
|
An exploratory study on perceived nurse- patient communication barriers among nurses and patients in palliative care settings of selected hospitals in Udupi district, Karnataka. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| nil |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Sherap Palmu Wangchuk Bhutia |
| Designation |
PG Student |
| Affiliation |
Manipal Academy of Higher Education |
| Address |
Room number 402,
Department of Medical Surgical Nursing,
Manipal College of Nursing, MAHE, Madhav Nagar, Manipal.
Udupi
KARNATAKA
576104
India |
| Phone |
7679123667 |
| Fax |
|
| Email |
sherrap10@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Anil Raj A |
| Designation |
Assistant Professor |
| Affiliation |
Manipal Academy of Higher Education |
| Address |
Department of Medical Surgical Nursing, Manipal College of Nursing,
MAHE, Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
7411892986 |
| Fax |
|
| Email |
anil.raj@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sushmitha Ramona Karkada |
| Designation |
Assistant Professor - Senior Scale |
| Affiliation |
Manipal Academy of Higher Education |
| Address |
Department of Obstetrical and Gynaecological Nursing, Manipal College of Nursing, MAHE, Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
9964144224 |
| Fax |
|
| Email |
sushmitha.karkada@manipal.edu |
|
|
Source of Monetary or Material Support
|
| Kasturba Hospital, MAHE, Manipal
Udupi district,
Karnataka,
576104,
India |
|
|
Primary Sponsor
|
| Name |
Manipal Academy of Higher Education |
| Address |
Manipal Academy of Higher Education, Madhav Nagar, Manipal, Karnataka, 576104. |
| Type of Sponsor |
Private medical college |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Shreya Suresh Nair |
Kasturba Medical College Hospital, Manipal |
Kasturba Medical College Hospital, department of palliative care.
Udupi
KARNATAKA |
8976001201
shreya.n@manipal.edu |
| Dr Vishal Shanbhag |
Kasturba Medical College Hospital, Manipal |
Kasturba Medical College Hospital, department of critical care.
Udupi
KARNATAKA |
9901960496
vishal.shanbhag@manipal.edu |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Kasturba Medical College and Kasturba Hospital Institutional Ethics Committee-2 (Student Research) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Participants working as staff nurses in palliative care settings in selected hospitals |
| Patients |
(1) ICD-10 Condition: C00-D49||Neoplasms, (2) ICD-10 Condition: E00-E89||Endocrine, nutritional and metabolic diseases, (3) ICD-10 Condition: G00-G99||Diseases of the nervous system, (4) ICD-10 Condition: D50-D89||Diseases of the blood and blood-forming organs and certain disorders involving the immune mechanism, (5) ICD-10 Condition: I00-I99||Diseases of the circulatory system, (6) ICD-10 Condition: N00-N99||Diseases of the genitourinary system, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
85.00 Year(s) |
| Gender |
Both |
| Details |
Nurses working in palliative care, who have experience working in palliative care settings for more than 3 months and give consent to participate in the study.
Patients above the age of 18 who are receiving palliative care, gives consent to participate in the study and can read and comprehend instructions and answer questions on thier own accord |
|
| ExclusionCriteria |
| Details |
Nurses who are not full-time employees of the selected palliative care settings
Patients with cognitive impairments, poor GCS/sedated, hearing and language impairment, intubated or with tracheostomy. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Perceived nurse-patient communication barriers among nurses and patients in palliative care settings |
At baseline and three months before the intervention, at three months, six months and one year after the intervention |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nurses perceived communication barriers with palliative care patients |
At baseline & three months before the intervention, at three months, six months & one year after the intervention |
| Patients perceived communication barriers with nurses. |
At baseline & three months before the intervention, at three months, six months & one year after the intervention |
|
|
Target Sample Size
|
Total Sample Size="482"
Sample Size from India="482"
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)
|
01/12/2025 |
| 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="1"
Months="1"
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
|
This study will help explore and identify barriers that can hinder effective nurse- patient communication in palliative care settings. By finding the issues nurses perceive to communicate with the patient and why patients might hesitate to communicate their needs to their nurses, we can provide strategies and recommendations to overcome these barriers. This study further aims to emphasise the need for communication training programs to nurses who are catered to manage the complexities involved in palliative care. The selected sample will be asked for verbal and written consent along with a participant information sheet to participate in the study, explaining the assurance that no harm will be done to the participants involved in the study, their personal identity will not be disclosed and the data collected will be kept confidential. The investigator will use self-prepared tools, Social Demographic Pro-forma and Perceived Communication Barrier Assessment Questionnaire to collect the data.
The hypothesis for this study is that, there will be an association between communication barriers and selected demographic variables in nurses providing palliative care and patients receiving palliatiative care in palliative care settings.
|