Impact of Stress Balls on Cannulation Pain in Hemodialysis: A Randomized Study

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.

Conditions

• Pain
• Cannula Site Pain

Interventions

BEHAVIORAL

Stress Ball Use

The intervention in this study involves the use of stress balls provided to participants in the intervention group. These are specially designed medium-firm silicone balls intended for squeezing with the hand opposite the one receiving cannulation during hemodialysis sessions. The primary objective of this intervention is to offer a simple, non-pharmacological method to potentially alleviate the pain associated with the cannulation process. Participants are instructed to use the stress ball for a period of three minutes before the start of cannulation. This activity is hypothesized to focus the participant's attention and possibly reduce the perception of pain, contributing to a more comfortable and less distressing cannulation experience.

Sponsors & Collaborators

• Hasan Kalyoncu University

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2023-10-18

Primary Completion

2023-12-30

Completion

2023-12-30

Countries

• Turkey (Türkiye)

Study Locations