| CTRI Number |
CTRI/2025/03/082880 [Registered on: 20/03/2025] Trial Registered Prospectively |
| Last Modified On: |
25/01/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Supportive Educative System] |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Explore the effect of a supportive, educative nursing system booklet on self-care efficacy. |
|
Scientific Title of Study
|
A randomized controlled trial to determine the effect of supportive educative nursing system based on Orem‘s nursing theory on self-care efficacy among patients undergoing hemodialysis at selected hospital of Mohali, Punjab |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Bindya Dhiman |
| Designation |
PG Student |
| Affiliation |
SPHE College of nursing gharuan mohali punjab |
| Address |
room no. 23, 2nd floor, SPHE, College of Nursing, Gharuan, Mohali
Rupnagar
PUNJAB
140413
India |
| Phone |
|
| Fax |
|
| Email |
bindyadhiman93@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
RAJESH KUMAR SHYORAN |
| Designation |
Nursing Officer |
| Affiliation |
GMCH 32 Chandigarh |
| Address |
RICU department of Nursing Area no. 52, 5th floor, A block, GMCH, Sector 32, Chandigarh
Chandigarh
CHANDIGARH
160047
India |
| Phone |
7837914560 |
| Fax |
|
| Email |
shyoranrajesh@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
RAJESH KUMAR SHYORAN |
| Designation |
Nursing Officer |
| Affiliation |
GMCH 32 chandigarh |
| Address |
RICU Department of Nursing Area 52 A Block Gmch Level 5th Sector 32 Chandigarh
Chandigarh
CHANDIGARH
160047
India |
| Phone |
7837914560 |
| Fax |
|
| Email |
shyoranrajesh@gmail.com |
|
|
Source of Monetary or Material Support
|
| CIVIL HOSPITAL PHASE 6 District MOHALI, state Punjab India, pin 160056 |
|
|
Primary Sponsor
|
| Name |
SPHE College of nursing |
| Address |
SPHE College of Nursing, Gharuan Mohali Punjab India pin 140413 |
| Type of Sponsor |
Other [Nil] |
|
|
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 |
| SMO |
civil hospital |
Phase 6, Nephro Ward Level 2 Block A, Mohali, Punjab, India 160056
Rupnagar
PUNJAB |
7837914560
bindyadhiman93@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| NOC From civil Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N189||Chronic kidney disease, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
control group |
No intervention, only routine treatment given |
| Intervention |
Supportive Educative Nursing System |
The Supportive Educative Nursing System booklet is given that contains four modules, including infection control, diet, fluid and electrolytes, managing complications, and treatment adherence, and assess after 15 days. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
All hemodialysis patients |
|
| ExclusionCriteria |
| Details |
1. Patients who will not be willing to participate.
2. Not Available at the time of data collection.
3. Unconscious patients
|
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Assessment of self-care efficacy |
baseline, 7th day and 15th day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
effect of supportive educative
nursing system |
on the 7th and 15th day |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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
|
Phase 2 |
|
Date of First Enrollment (India)
|
10/02/2026 |
| 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="0"
Months="2"
Days="5" |
|
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
|
this is a randomized controlled trial that is to determine the effect of a supportive educative nursing system based on Orem’s nursing theory on self-care efficacy among patients undergoing hemodialysis at a selected hospital of Mohali, Punjab. for this researcher, estimate approximately 60 samples in experimental and control groups.
|