| CTRI Number |
CTRI/2026/01/100192 [Registered on: 02/01/2026] Trial Registered Prospectively |
| Last Modified On: |
02/01/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Ice Therapy application] |
| Study Design |
Non-randomized, Active Controlled Trial |
|
Public Title of Study
|
Effectiveness of ice therapy on pain during arteriovenous fistula cannulation among patients undergoing hemodialysis at a hemodialysis center |
|
Scientific Title of Study
|
Effectiveness of ice therapy on pain during arteriovenous fistula cannulation among patients undergoing hemodialysis at dialysis center |
| Trial Acronym |
NA |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Srijana Ghimire |
| Designation |
PhD scholar |
| Affiliation |
Noida International University |
| Address |
Noida International University, Plot 1, Sector-17 A, Yamuna Expressway, Sector 17A, Gautam Budh Nagar, Uttar Pradesh 203201
New Delhi
DELHI
203201
India |
| Phone |
8745862200 |
| Fax |
|
| Email |
srijananeupane95@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Dipak Sethi |
| Designation |
Dean School of Nursing |
| Affiliation |
Noida International University |
| Address |
Noida International University, Plot 1, Sector-17 A, Yamuna Expressway, Sector 17A, Gautam Budh Nagar, Uttar Pradesh 203201
New Delhi
DELHI
203201
India |
| Phone |
9988963832 |
| Fax |
|
| Email |
dir.son@niu.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Srijana Ghimire |
| Designation |
PhD scholar |
| Affiliation |
Noida International University |
| Address |
Noida International University, Plot 1, Sector-17 A, Yamuna Expressway, Sector 17A, Gautam Budh Nagar, Uttar Pradesh 203201
New Delhi
DELHI
203201
India |
| Phone |
8745862200 |
| Fax |
|
| Email |
srijananeupane95@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Srijana Ghimire |
| Address |
Noida International University, Plot 1, Sector-17 A, Yamuna Expressway, Sector 17A, Gautam Budh Nagar, Uttar Pradesh 203201. |
| Type of Sponsor |
Private medical college |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India
Nepal |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Sunil Panta |
Hemodialysis unit, Bharatpur Hospital, Nepal |
Bharatpur 10, Chitwan Nepal
|
056597003
info@bharatpurhospital.gov.np |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| NIIMS/IEC |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N185||Chronic kidney disease, stage 5, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Ice therapy |
A quasi-experimental research design (Post-test control group design) will be used to evaluate the effectiveness of ice therapy on pain during AV fistula cannulation. |
| Comparator Agent |
Regular care |
No intervention during maintenance for hemodialysis patients. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
All patients aged 18 years to 99 years who will be undergoing hemodialysis. Have a healthy arteriovenous fistula access with good function (no sign of infection, success of canula in one time prick.
Had a negative cold provocation test (A negative cold provocation test means that the test did not detect any abnormalities in blood flow or temperature in the fingers) with a single successful fistula cannulation attempt.
Analgesics or sedatives are not used within 6 hours before hemodialysis.
Those willing to participate in the study will be included
|
|
| ExclusionCriteria |
| Details |
Numbness and hematoma of the puncture site.
Severe illness and those who cannot verbally communicate.
Sampling
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Pain relief |
Single-point pain assessment done after cannulation |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nil |
Nil |
|
|
Target Sample Size
|
Total Sample Size="140"
Sample Size from India="140"
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)
|
15/02/2026 |
| 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="1"
Months="6"
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
|
A quasi-experimental research design, a post-test control group design, will be used. The aim of the study is to evaluate the effectiveness of ice therapy on pain during AV fistula cannulation. The study population will be maintenance hemodialysis patients. All patients will be screened to meet the inclusion criteria. Age 18 above, had a negative cold provocation test, a single successful fistula cannulation attempt, and analgesics or sedatives are not used within 6 hours before hemodialysis will be included. Ice therapy will be applied on the huge point of the contralateral arm for 10 minutes before fistula cannulation and 2 minutes after conutinue then assess the pain by using the pain rating scale. A total of 140 patients (70 experimental and 70 control group) will be included in the study. |