| CTRI Number |
CTRI/2026/04/108396 [Registered on: 15/04/2026] Trial Registered Prospectively |
| Last Modified On: |
05/06/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Energy conservation ] |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Energy Saving for Better Living in Dialysis Patients at AIIMS, New Delhi. |
|
Scientific Title of Study
|
A Quasi experimental study to evaluate effectiveness of energy conservation intervention on fatigue, symptoms burden and quality of life among patients on maintenance hemodialysis at AIIMS, New Delhi. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Ayushi Sharma |
| Designation |
M.Sc Student |
| Affiliation |
College of Nursing,AIIMS,New Delhi |
| Address |
College of Nursing
Porta cabin 2
AIIMS New Delhi
South
DELHI
110029
India |
| Phone |
8219491525 |
| Fax |
|
| Email |
ayushisharma20016@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Manju A K Rajora |
| Designation |
Associate Professor |
| Affiliation |
College of Nursing,AIIMS,New Delhi |
| Address |
College of Nursing, AIIMS Delhi
South
DELHI
110029
India |
| Phone |
9870260036 |
| Fax |
|
| Email |
manjuakrajora@aiims.edu |
|
Details of Contact Person
Public Query
|
| Name |
Ayushi Sharma |
| Designation |
M.Sc Student |
| Affiliation |
College of Nursing,AIIMS,New Delhi |
| Address |
College of Nursing
Porta cabin 2
AIIMS New Delhi
South
DELHI
110029
India |
| Phone |
8219491525 |
| Fax |
|
| Email |
ayushisharma20016@gmail.com |
|
|
Source of Monetary or Material Support
|
| ALL INDIA Institute of Medical Sciences(AIIMS),Ansari Nagar, New Delhi,110029,India-Infrastructural support only |
|
|
Primary Sponsor
|
| Name |
Ayushi Sharma |
| Address |
Porta cabin 2 College of Nursing AIIMS New Delhi 110029 India |
| 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 |
| Dr Manju A K Rajora |
AIIMS New Delhi |
Dialysis Unit Ward Block
South
DELHI |
9870260036
manjuakrajora@aiims.edu |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTE ETHICS COMMITTEE FOR POST GRADUATE RESEARCH, ALL INDIA INSTITUTE OF MEDICAL SCIENCES, NEW DELHI 110029 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N18||Chronic kidney disease (CKD), |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Energy Conservation Intervention |
Introduction of Fatigue
Causes of Fatigue
Energy Conservation
Strategy 1
Planning
Identifying activities that consume more energy (Cooking, Bathing).
Organizing daily activities
Simplifying daily tasks.
Strategy 2
Prioritizing
Prioritizing activities according to individual needs
Differentiating activities into: must do, can do later, and can ask for help.
Strategy 3
Pacing
Emphasizing the importance of adequate rest periods.
Breaking large tasks into smaller steps.
Alternating activity with rest.
Strategy 4
Positioning & Environmental Modification
Teaching correct body mechanics.
Demonstrating proper positioning during activities
Environmental modification to reduce energy expenditure.
|
| Comparator Agent |
N/A |
N/A |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients who are on maintenance hemodialysis for at least 3 months
Able to understand Hindi or English
Willing to participate
|
|
| ExclusionCriteria |
| Details |
Patients with acute kidney injury, peritoneal dialysis or acute illness.
Diagnosed with severe cognitive impairment
Currently enrolled in other fatigue management programs
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess the effectiveness of energy conservation intervention on fatigue among patient on maintenance hemodialysis at AIIMS New Delhi |
Week 1 Baseline
Week 3 Post intervention
Week 6 Follow up |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To assess effectiveness of energy conservation intervention on symptom burden among patients on MHD.
2. To assess effectiveness of energy conservation intervention on quality of life among patients on MHD.
3. To find out the relationship between fatigue and symptom burden among patients on MHD.
4.To find out the relationship between symptom burden and quality of life among patients on MHD.
5.To find out the association between fatigue, symptom burden and quality of life with selected demographical & clinical variables.
|
4 time |
|
|
Target Sample Size
|
Total Sample Size="42"
Sample Size from India="42"
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)
|
01/08/2026 |
| 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="5"
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
Modification(s)
|
A Quasi experimental study to evaluate effectiveness of energy conservation intervention on fatigue, symptoms burden and quality of life among patients on maintenance hemodialysis at AIIMS, New Delhi.The study aims to evaluate the effectiveness of energy conservation intervention on fatigue, symptom burden, and quality of life among patients undergoing maintenance hemodialysis at AIIMS, New Delhi.The study population will include adult patients aged 18-85 years receiving maintenance hemodialysis who meet the inclusion criteria. Eligible participants attending the hemodialysis unit will be recruited using convenience sampling. Data collection will be carried out over six weeks, with baseline, mid-intervention, and post-intervention assessments.Data will be collected using standardized tools. The energy conservation intervention will be delivered through structured group-based educational sessions focusing on planning, prioritization, pacing, positioning, and environmental modification. The findings of the study are expected to provide evidence on the effectiveness of energy conservation strategies in reducing fatigue, lowering symptom burden, and improving quality of life among patients on maintenance hemodialysis. |