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

The Effect of Stress Ball Use on Invasive Pain Associated With Cannulation in Hemodialysis Patients: A Randomized, Controlled, Single-Blind Study

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.

Study Overview

• Status: Completed
• Conditions: Pain; Cannula Site Pain
• Intervention / Treatment: Behavioral: Stress Ball Use

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 64
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Sahinbey
    • Gaziantep, Sahinbey, Turkey, 27000
      • 25 Aralik State Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Adult patients (18 years or older)
• Visual Analog Scale (VAS) score of 1 or higher
• Willingness to participate in the study

Exclusion Criteria:

• Individuals with communication barriers such as severe hearing or cognitive impairments
• Patients with issues in the arm/hand where the stress ball would be used

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Stress Ball Intervention; Participants in this group were provided with stress balls to use during their hemodialysis sessions, specifically before the cannulation process. These stress balls, made from medium-firm, high-quality silicone, were utilized by squeezing with the hand opposite the one receiving cannulation. This activity, performed three minutes before the cannulation, aimed to reduce the levels of pain experienced by the participants. The use of stress balls was integrated into the regular hemodialysis routine, and participants consistently engaged in this practice before each cannulation over the course of the study. This intervention provided valuable insights into the effectiveness of simple, non-pharmacological methods for pain management in a clinical setting.	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.
No Intervention: Standard Care Control; Participants in the control group did not receive any additional intervention. They continued to receive standard care during their hemodialysis sessions, without the use of any extra tools like stress balls for pain management. This group served as a comparison point to assess the effectiveness of the intervention implemented in the experimental group. By maintaining their routine hemodialysis care, the control group provided essential data for evaluating the impact of the stress ball intervention. The completion of their participation in the study was crucial in establishing a baseline for pain levels during cannulation without any non-pharmacological interventions.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain Level Reduction Title: Pain Level Reduction Pain Level Reduction	The primary outcome measure was the reduction in pain levels as assessed by the Visual Analog Scale (VAS). This measure evaluated the effectiveness of the stress ball intervention in reducing the pain experienced by participants during the cannulation process in hemodialysis sessions.	Hemodialysis patients were monitored over a period of one month, encompassing twelve sessions.

Collaborators and Investigators

• Sponsor: Hasan Kalyoncu University

Study record dates

Study Major Dates

• Study Start (Actual): October 18, 2023
• Primary Completion (Actual): December 30, 2023
• Study Completion (Actual): December 30, 2023

Study Registration Dates

• First Submitted: January 12, 2024
• First Submitted That Met QC Criteria: January 25, 2024
• First Posted (Estimated): February 1, 2024

Study Record Updates

• Last Update Posted (Estimated): February 1, 2024
• Last Update Submitted That Met QC Criteria: January 25, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: Renal Dialysis; Cannulation; Pain Management; Arteriovenous Fistula; Pain Measurement
• Other Study ID Numbers: 2023-64

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No