PainNCT06237738
Impact of Stress Balls on Cannulation Pain in Hemodialysis: A Randomized Study
A study testing Stress Ball Use in people with Pain and Cannula Site Pain, run by Hasan Kalyoncu University at 1 site in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pain, Cannula Site Pain
- What is being tested?
- Stress Ball Use
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 18 Oct 2023to 30 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patients (18 years or older)
- Visual Analog Scale (VAS) score of 1 or higher
- Willingness to participate in the study
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
25 Aralik State Hospital
Gaziantep, Sahinbey, 27000
About this study
Official title: 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.
Read more
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.
Read the 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.
- Conditions
- Pain, Cannula Site Pain
- Being tested
- Stress Ball Use
- Keywords
- Pain Management, Renal Dialysis, Cannulation, Arteriovenous Fistula, Pain Measurement
- Medical subject headings
- Pain, Agnosia, Arteriovenous Fistula
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stress Ball UseBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Stress Ball Intervention | Experimental | 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. Receives: Behavioral: Stress Ball Use |
| Standard Care Control | No intervention | 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 being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Hemodialysis patients were monitored over a period of one month, encompassing twelve sessions.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2024
- Study start18 Oct 2023
- Primary completion30 Dec 2023
- Study completion30 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This single-blind, randomized, controlled clinical trial evaluated the effectiveness of stress balls in alleviating cannulation-related pain in adults undergoing hemodialysis. The study, which targeted a sample size of 64 based on G\*Power analysis for a 95% confidence interval and 80% power with an expected effect size of 0.68, successfully distributed participants into two equal groups of 32: an experimental group and a control group. Participants, aged 18 and above and experiencing a pain level of 1 or more on the Visual Analog Scale (VAS), were randomly assigned to either group. The experimental group utilized stress balls in their non-cannulating hand for three minutes before cannulation during their Monday, Wednesday, and Friday sessions, while the control group, attending on Tuesday, Thursday, and Saturday, received standard care. Data collection encompassed VAS pain level measurements and socio-demographic and medical information gathered via a semi-structured questionnaire.
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hasan Kalyoncu University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, BETÜL TOSUN, PhD, Hasan Kalyoncu University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06237738
- Sponsor's protocol ID
- 2023-64
- Status last verified
- Jan 2024
- First submitted
- 12 Jan 2024
- Last updated
- 1 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Tosun B, Berse S, Dirgar E, Ozen N. Effect of stress ball use on cannulation-related invasive pain in Hemodialysis patients: a randomized controlled, single-blind study. BMC Nephrol. 2025 Mar 20;26(1):140. doi: 10.1186/s12882-025-04071-w.
PubMed 40114094
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Stress Ball Use on Invasive Pain Associated With Cannulation in Hemodialysis Patients: A Randomized, Controlled, Single-Blind Study
- ClinicalTrials.gov ID
- NCT06237738
- Acronym / sponsor ID
- 2023-64
- Conditions
- Pain, Cannula Site Pain
- Keywords
- Pain Management, Renal Dialysis, Cannulation, Arteriovenous Fistula, Pain Measurement
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Hasan Kalyoncu UniversityUniversity, hospital or other
- Study start
- 18 Oct 2023 (actual)
- Primary completion
- 30 Dec 2023 (actual)
- Study completion
- 30 Dec 2023 (actual)
- First posted
- 1 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
- Model description
- This single-blind, randomized, controlled clinical trial evaluated the effectiveness of stress balls in alleviating cannulation-related pain in adults undergoing hemodialysis. The study, which targeted a sample size of 64 based on G*Power analysis for a 95% confidence interval and 80% power with an expected effect size of 0.68, successfully distributed participants into two equal groups of 32: an experimental group and a control group. Participants, aged 18 and above and experiencing a pain level of 1 or more on the Visual Analog Scale (VAS), were randomly assigned to either group. The experimental group utilized stress balls in their non-cannulating hand for three minutes before cannulation during their Monday, Wednesday, and Friday sessions, while the control group, attending on Tuesday, Thursday, and Saturday, received standard care. Data collection encompassed VAS pain level measurements and socio-demographic and medical information gathered via a semi-structured questionnaire.
| Arm | Type | Receives |
|---|---|---|
| Stress Ball Intervention | Experimental | Behavioral: Stress Ball UseParticipants 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. |
| Standard Care Control | No intervention | –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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adult patients (18 years or older)
- Visual Analog Scale (VAS) score of 1 or higher
- Willingness to participate in the study
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Stress Ball UseThe 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. | Behavioural | Stress Ball Intervention |
Primary outcome
Pain Level Reduction Title: Pain Level Reduction Pain Level Reduction
Time frame: Hemodialysis patients were monitored over a period of one month, encompassing twelve sessions.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Feb 2024.
- Derived from this study: PubMed 40114094Tosun B, Berse S, Dirgar E, Ozen N. Effect of stress ball use on cannulation-related invasive pain in Hemodialysis patients: a randomized controlled, single-blind study. BMC Nephrol. 2025 Mar 20;26(1):140. doi: 10.1186/s12882-025-04071-w.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Stress Ball Use in people with Pain and Cannula Site Pain, run by Hasan Kalyoncu University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain Level Reduction Title: Pain Level Reduction Pain Level Reduction (time frame: Hemodialysis patients were monitored over a period of one month, encompassing twelve sessions.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06237738, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Feb 2024.