Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT06237738 |
| Other study ID # |
2023-64 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
October 18, 2023 |
| Est. completion date |
December 30, 2023 |
Study information
| Verified date |
January 2024 |
| Source |
Hasan Kalyoncu University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
Background: Chronic kidney disease significantly impacts patients and their families, with a
portion requiring hemodialysis. Hemodialysis involves repeated vascular cannulation, often
causing moderate to severe pain. This planned study aims to investigate the efficacy of using
stress balls as a non-pharmacological intervention to reduce pain during cannulation in
hemodialysis patients.
Methods: This upcoming single-blind, randomized, controlled trial will involve 64 adult
patients undergoing hemodialysis, divided equally into an intervention group and a control
group. The intervention group will use stress balls during cannulation, while the control
group will receive standard care. Pain levels will be assessed using the Visual Analog Scale
(VAS), and additional socio-demographic and medical data will be collected through a
semi-structured questionnaire.
Objectives: The primary objective of this proposed study is to evaluate the effectiveness of
stress balls in reducing pain associated with cannulation in hemodialysis patients. The study
also aims to contribute to pain management strategies in this patient population.
Ethical Considerations: The study will adhere to the Helsinki Declaration principles and will
seek approval from the local ethics committee. Informed consent will be obtained from all
participants, and the study's design, methodology, and ethical standards will be
transparently registered on ClinicalTrials.gov prior to commencement.
Statistical Analysis: Data analysis will be planned using JAMOVI software. The primary
analysis will compare VAS scores between groups and over time using Robust ANOVA, with
adjustments for multiple comparisons.
Significance: This planned study addresses the need for non-pharmacological pain management
during hemodialysis cannulation. The findings are expected to enhance patient comfort and
adherence to dialysis regimens, ultimately improving their quality of life.
Background: Chronic kidney disease (CKD) has a significant impact on patients and their
families, with many eventually requiring hemodialysis treatment. Hemodialysis often involves
repeated vascular cannulation, which can cause moderate to severe pain. This study has been
conducted to investigate the efficacy of using stress balls as a non-pharmacological
intervention to reduce pain during cannulation in hemodialysis patients.
Methods: In this completed single-blind, randomized, controlled trial, 64 adult patients
undergoing hemodialysis were divided into two groups. The intervention group used stress
balls during cannulation, while the control group received standard care without the use of
stress balls. Pain levels were assessed using the Visual Analog Scale (VAS). Additionally,
socio-demographic and medical data were collected through a semi-structured questionnaire.
Objectives: The primary objective of the study was to evaluate the effectiveness of stress
balls in reducing pain associated with cannulation in hemodialysis patients. The study also
aimed to contribute to the development of pain management strategies for this patient
population.
Ethical Considerations: The study adhered to the principles of the Helsinki Declaration and
received approval from the local ethics committee. Informed consent was obtained from all
participants, ensuring transparency about the study's purpose, processes, and potential
risks.
Statistical Analysis: Data from the study were analyzed using JAMOVI software. The primary
analysis involved comparing VAS scores between the intervention and control groups over time
using Robust ANOVA, with adjustments for multiple comparisons.
Significance: The study addressed the need for non-pharmacological pain management methods
during hemodialysis cannulation.
Description:
Chronic kidney disease (CKD) is a critical health issue globally, affecting millions. Many
CKD patients require hemodialysis, involving arteriovenous fistula cannulation, which often
leads to moderate to severe pain. This pain can negatively impact patient compliance and
quality of life. Recognizing the potential benefits of non-pharmacological interventions,
this study was conducted to evaluate the effectiveness of stress balls in reducing pain
experienced during cannulation in hemodialysis patients.
The primary objective of this completed study was to determine whether the use of stress
balls during cannulation significantly reduces pain levels in hemodialysis patients, as
measured by the Visual Analog Scale (VAS).
In this single-blind, randomized, controlled trial conducted at a state hospital's
hemodialysis unit in Turkey, 64 adult patients undergoing hemodialysis were enrolled. These
patients, all with a VAS score of 1 or higher, were randomly assigned to either an
intervention group (using stress balls during cannulation) or a control group (receiving
standard care). The intervention group included patients attending sessions on Monday,
Wednesday, and Friday, while the control group comprised those attending on Tuesday,
Thursday, and Saturday. The intervention involved using the stress ball in the non-cannulated
hand for three minutes before cannulation.
Pain levels were measured using the VAS at each of the 12 sessions of cannulation for every
patient, providing comprehensive data on pain levels. A semi-structured questionnaire was
used to collect socio-demographic and medical data. The data were analyzed using JAMOVI
software, with Robust ANOVA employed for comparisons.
The study adhered strictly to the Helsinki Declaration's principles. Ethical approval was
obtained from the local ethics committee, and informed consent was secured from all
participants. The study's design, methodology, and ethical considerations were transparently
registered on ClinicalTrials.gov.
The study hypothesized that the use of stress balls would lead to a significant reduction in
pain levels during cannulation. This intervention was expected to provide a simple,
cost-effective, and accessible method to enhance patient comfort and adherence to
hemodialysis, thereby improving their overall quality of life.
The results of this study could significantly contribute to improved pain management
strategies for hemodialysis patients. Demonstrating the efficacy of stress balls as a
non-pharmacological intervention could offer a straightforward, economical, and accessible
approach to enhancing patient comfort during hemodialysis.
