Ignite Creation Date:
2024-05-06 @ 8:03 PM
Last Modification Date:
2024-10-26 @ 3:19 PM
Study NCT ID:
NCT06237738
Status:
COMPLETED
Last Update Posted:
2024-02-01
First Post:
2024-01-12
Brief Title:
Impact of Stress Balls on Cannulation Pain in Hemodialysis A Randomized Study
Sponsor:
Hasan Kalyoncu University
Organization:
Hasan Kalyoncu University
Study Overview
Official Title:
The Effect of Stress Ball Use on Invasive Pain Associated With Cannulation in Hemodialysis Patients A Randomized Controlled Single-Blind Study
Status:
COMPLETED
Status Verified Date:
2024-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 studys design methodology and ethical standards will be transparently registered on ClinicalTrialsgov 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 studys 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
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 studys design methodology and ethical standards will be transparently registered on ClinicalTrialsgov 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 studys 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
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 hospitals 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 Declarations principles Ethical approval was obtained from the local ethics committee and informed consent was secured from all participants The studys design methodology and ethical considerations were transparently registered on ClinicalTrialsgov
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
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 hospitals 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 Declarations principles Ethical approval was obtained from the local ethics committee and informed consent was secured from all participants The studys design methodology and ethical considerations were transparently registered on ClinicalTrialsgov
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None