| CTRI Number |
CTRI/2024/03/063829 [Registered on: 08/03/2024] Trial Registered Prospectively |
| Last Modified On: |
29/07/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [EDUCATIONAL PROGRAMME ON TREATMENT COMPLIANCE , RELAXATION TECHNIQUES] |
| Study Design |
Non-randomized, Active Controlled Trial |
|
Public Title of Study
|
Impact of nursing intervention on treatment and psychological state among patients undergoing hemodialysis |
|
Scientific Title of Study
|
Effectiveness of nurse led intervention on treatment compliance and psychological distress among patients undergoing hemodialysis |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Jesna S |
| Designation |
MSc Nursing Student |
| Affiliation |
GOVT. COLLEGE OF NURSING, ALAPPUZHA |
| Address |
Second Year MSc Nursing Student
Medical Surgical Nursing - Critical Care Nursing
Govt. College of Nursing
Alappuzha
pin : 688005
Second Year MSc Nursing Student
Medical Surgical Nursing - Critical Care Nursing
Govt. College of Nursing
Alappuzha
pin : 688005
Alappuzha
KERALA
688005
India |
| Phone |
8606405795 |
| Fax |
|
| Email |
jesnas97@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Preemy Mathew A |
| Designation |
Associate Professor |
| Affiliation |
Govt. College of Nursing, Alappuzha |
| Address |
Department of medical surgical nursing
Division : Critical Care Nursing
Room no : 1
Govt. College of Nursing
Alappuzha
Nil
Alappuzha
KERALA
688005
India |
| Phone |
9072118972 |
| Fax |
|
| Email |
preemygeorge@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Jesna S |
| Designation |
MSc Nursing Student |
| Affiliation |
GOVT. COLLEGE OF NURSING, ALAPPUZHA |
| Address |
Second Year MSc Nursing
Medical Surgical Nursing- Critical Care Nursing
Govt. College of Nursing
Alappuzha
pin : 688005
Second Year MSc Nursing
Medical Surgical Nursing- Critical Care Nursing
Govt. College of Nursing
Alappuzha
pin : 688005
Alappuzha
KERALA
688005
India |
| Phone |
8606405795 |
| Fax |
|
| Email |
jesnas97@gmail.com |
|
|
Source of Monetary or Material Support
|
| General Hospital
Alappuzha
pin : 688011 |
| Govt. T D Medical College Hospital
Alappuzha
Kerala
pin : 688005 |
|
|
Primary Sponsor
|
| Name |
Jesna S |
| Address |
Second Year MSc Nursing
Department of medical surgical nursing
Division : Critical Care Nursing
Govt. College of Nursing
Alappuzha
pin : 688005 |
| 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 |
| Preemy Mathew A |
Govt. T D Medical College Hospital, Alappuzha |
Department of Nephrology
Division : Dialysis Unit
Room no : 2
Alappuzha
Kerala
PIN : 688005
Alappuzha
KERALA |
9072118972
preemygeorge@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional human ethics committee, Govt. College of Nursing, Alappuzha |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N186||End stage renal disease, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Conventional treatment |
Treatment as per hospital protocol |
| Intervention |
Nurse led intervention |
Educational programme on treatment compliance (Lecture cum discussion) - 10 minutes - day 1,
Relaxation techniques (Demonstration and return demonstration) - 20 minutes - day 1 :instructed the participants to practice 2 times daily for 2 weeks |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
Patients with chronic kidney disease on hemodialysis who are,
-on treatment for 6 months or more
-on maintenance hemodialysis
-above 18 yrs
-willing to participate
-able to perform the relaxation techniques
- |
|
| ExclusionCriteria |
| Details |
Patients with chronic kidney disease on hemodialysis who are,
-not able to read and comprehend malayalam
-having altered sensorium |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Treatment compliance
Psychological distress
|
Day 1 and Day 15 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "60"
Final Enrollment numbers achieved (India)="60" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
14/03/2024 |
| Date of Study Completion (India) |
13/04/2024 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
13/04/2024 |
|
Estimated Duration of Trial
|
Years="0"
Months="2"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - YES
- 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).
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Informed Consent Form
Response - Clinical Study Report
- Who will be able to view these files?
Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response - Data are available indefinitely at (Link to be included effectiveness of nurse led intervention on treatment compliance and psychological distress among patients undergoing hemodialysis).
- For how long will this data be available start date provided 26-08-2024 and end date provided 30-12-2024?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - Nil
|
Brief Summary
Modification(s)
|
PURPOSE OF THE STUDY Non adherence to treatment regimen and psychological distress lead to poor patient outcome. Systematically organized nurse led interventions focused on fluid and dietary management, compliance to medication and dialysis session as well as adoption of relaxation technique decreases symptom severity and hospital re-admission. incorporation of nurse led interventions are highly beneficial for the better patient outcome. STATEMENT OF THE PROBLEM Effectiveness of nurse led intervention on treatment compliance and psychological distress among patients undergoing hemodialysis attending selected hospitals in Alappuzha district. OBJECTIVES 1. Evaluate the effectiveness of nurse led intervention on treatment compliance among patients undergoing hemodialysis. 2. Evaluate the effectiveness of nurse led intervention on psychological distress among patients undergoing hemodialysis. HYPOTHESES All hypotheses will be tested at 0.05 level of significance. H1 : There is a significant difference in the treatment compliance among patients undergoing hemodialysis between control and experimental group. H2 : There is a significant difference in the psychological distress among patients undergoing hemodialysis between control and experimental group. |