HemolysisNCT06144801
The Effect of Coolsense Method on Pain and Comfort in Hemodialysis Patients
A study testing CoolSense Group in people with Hemolysis and Complementary Therapy, run by Karadeniz Technical University at 1 site in Turkey (Türkiye).
Trial summary
This study aimed to investigate the impact of the CoolSense method on arteriovenous fistula cannulation pain and the comfort levels of hemodialysis patients. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Hemolysis, Complementary Therapy, Pain
- What is being tested?
- CoolSense Group
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 20 Feb 2023to 20 Aug 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 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- For the patient:
- Being 18 years of age or older,
- Receiving HD treatment through the fistula,
- Being conscious and able to communicate with no impairment in mental or cognitive functions,
- Taking sedatives or analgesics at least 6 hours ago,
- Having no diabetes-related neuropathy,
- Having no alcohol or narcotic dependence.
Who cannot join
- Refusing to participate in the study,
- Being 18 years of age or younger,
- Receiving dialysis treatment through a catheter,
- Having diabetes mellitus for more than 10 years or no diabetes-related neuropathy,
- Having a history of addiction or diagnosed psychological disorders,
- Having an unstable hemodynamic status.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Coolsense Method on Arteriovenous Fistula Cannulation Pain and Comfort in Hemodialysis Patients: A Single Blind Randomized Controlled Study
This study aimed to investigate the impact of the CoolSense method on arteriovenous fistula cannulation pain and the comfort levels of hemodialysis patients.
Read the detailed description
Pain is a sensation of unease that arises in response to intense stimulation of nerve endings throughout the body. It impacts individuals on various dimensions (emotional, social, physical, etc.), often leading to feelings of anxiety and fear. Pain is recognized as a subjective experience, influenced by factors such as age and previous pain encounters, shaping an individual's perception of pain. During their hospitalization, patients may undergo painful procedures repeatedly over an extended period, which can lead to increased complications, prolonged hospital stays, and even a decline in overall health. Furthermore, pain symptoms can reduce compliance with hemodialysis (HD) treatment, impacting the quality of life and comfort of HD patients.
Effective nursing care interventions must prioritize the needs of patients and ensure their comfort and well-being. Comfort is regarded as the foundation of high-quality nursing care. Literature suggests that identifying and managing symptoms resulting from illness or treatment can enhance patients' comfort levels. Moreover, nurses, in their independent role, can effectively minimize pain and prevent potential complications by employing non-pharmacological treatment methods, especially in managing pain symptoms. Non-pharmacological methods are advantageous due to their affordability, applicability across all age groups, ease of use, and cleanliness. In this context, cold application stands out as one of the most effective non-pharmacological treatments for alleviating pain symptoms.
Cold application mitigates pain through two primary mechanisms. Firstly, it indirectly induces an analgesic effect by reducing swelling, edema, and muscle spasms caused by trauma or inflammation. Secondly, it directly contributes to analgesia by altering the conduction of peripheral nerves. Additionally, cold application leads to a decrease in the conduction velocity of unmyelinated nerve fibers responsible for transmitting painful stimuli, thereby diminishing pain perception. In the relevant literature concerning the application of cold therapy, there is a noticeable scarcity of international studies focusing on the CoolSense device, which has demonstrated local anesthetic effects preceding medical procedures in recent years. Furthermore, there is currently no international or national study available that assesses the impact of the CoolSense device on the pain experienced during arteriovenous fistula cannulation in hemodialysis (HD) patients. In light of this gap in research, this study aimed to investigate the influence of the CoolSense Method on arteriovenous fistula cannulation pain and the comfort levels of HD patients.
- Conditions
- Hemolysis, Complementary Therapy, Pain, Comfort
- Being tested
- CoolSense Group
- Keywords
- CoolSense, Hemodialysis, Arteriovenous Fistula, Cannulation, Pain
- Medical subject headings
- Hemolysis, Pain, Arteriovenous Fistula
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CoolSense GroupDevice
Patients in the CoolSense group received a CoolSense device that had been pre-chilled in the freezer for a minimum of one hour. The cover of the CoolSense device was removed, and the arteriovenous fistula, whose metal tip had been cleaned with batikon, was brought into contact with the area where the arteriovenous fistula cannulation would occur. This contact was maintained for 5 seconds, involving circular movements, and the fistula cannulation took place promptly.
| Study group | Role | What they receive |
|---|---|---|
| CoolSense Group | Experimental | The responsible researcher carried out the application of the CoolSense device and filled out the patient information form before the arteriovenous fistula cannulation. Meanwhile, the application of the VCS and GCS was conducted both before and after the CoolSense device's application, with the latter occurring after the arteriovenous fistula cannulation. The nephrology charge nurse was responsible for these measurements, using a single device located at the patient's bedside. Receives: Device: CoolSense Group |
| Control Group | No intervention | Patients in the control group underwent routine HD arteriovenous fistula cannulation and received HD treatment following the hospital's established protocol. Data collection tools were only administered to the participants before and after the study. |
What is being measured
The primary outcome is the main question the study is designed to answer.
The The Verbal Category Scale
The Scale is a pain assessment tool based on the patient's selection of the most appropriate word to describe their pain state. Patients rate their pain on a 0-4 point scale, where 0 point indicates "no pain," 1 point indicates "mild pain," 2 points indicate "severe pain," 3 points indicate "very severe pain," and 4 points indicate "unbearable pain".
It was determined that the pain decreased after CoolsenSe application.
Measured: 1 Day
The General Comfort Scale
It employs a four-point Likert-type scale, encompassing three sub-dimensions (relief, relaxation, and superiority-coping with problems) and 48 items. In this study, a score of 1 indicates a low comfort level, while a score of 4 represents a high comfort level.
It was determined that comfort increased after CoolsenSe application.
Measured: 1 Day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2023
- Study start20 Feb 2023
- Primary completion31 Jul 2023
- Study completion20 Aug 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 HemolysisStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- To determine the sample, power analysis was utilized. With an effect size of 0.80 and a targeted test power of 0.80 (80%), the sample size was computed as 42 patients in total (21 for each group) for both the CoolSense group and the control group. This calculation was performed using the G\*Power 3.1.9.6 software, with a significance level of α=0.05, considering the absence of prior experimental studies investigating pain scores in this context. Accounting for potential issues such as participant withdrawal or study-related mortality, each group was increased by 20%, resulting in a total of 50 patients, with 25 patients in each group.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karadeniz Technical University
- Sponsor type
- University, hospital or other
- Collaborators
- Gümüşhane Universıty
- Responsible party
- Principal investigator, Hatice Demirağ, Ph.D, Karadeniz Technical University
- Investigators
- Hatice Demirağ, Assist Prof., Principal investigator, Gümüşhane Universıty
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06144801
- Sponsor's protocol ID
- RCS10042017
- Status last verified
- Nov 2023
- First submitted
- 14 Nov 2023
- Last updated
- 22 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: We don't want yet.
Publications
Demirag H, Kulakac N. The effect of using a local skin cooling device on arteriovenous fistula cannulation pain and comfort level of patients on hemodialysis: A single-blind randomized controlled study. Hemodial Int. 2025 Jan;29(1):47-55. doi: 10.1111/hdi.13190. Epub 2024 Oct 28.
PubMed 39467833
Study at a glance
From the registry record, last updated by the sponsor on 22 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Coolsense Method on Arteriovenous Fistula Cannulation Pain and Comfort in Hemodialysis Patients: A Single Blind Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT06144801
- Acronym / sponsor ID
- RCS10042017
- Conditions
- Hemolysis, Complementary Therapy, Pain, Comfort
- Keywords
- CoolSense, Hemodialysis, Arteriovenous Fistula, Cannulation, Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Karadeniz Technical UniversityUniversity, hospital or other
- Collaborators
- Gümüşhane Universıty
- Study start
- 20 Feb 2023 (actual)
- Primary completion
- 31 Jul 2023 (actual)
- Study completion
- 20 Aug 2023 (actual)
- First posted
- 22 Nov 2023 (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.
This study aimed to investigate the impact of the CoolSense method on arteriovenous fistula cannulation pain and the comfort levels of hemodialysis patients.
Detailed description
Pain is a sensation of unease that arises in response to intense stimulation of nerve endings throughout the body. It impacts individuals on various dimensions (emotional, social, physical, etc.), often leading to feelings of anxiety and fear. Pain is recognized as a subjective experience, influenced by factors such as age and previous pain encounters, shaping an individual's perception of pain. During their hospitalization, patients may undergo painful procedures repeatedly over an extended period, which can lead to increased complications, prolonged hospital stays, and even a decline in overall health. Furthermore, pain symptoms can reduce compliance with hemodialysis (HD) treatment, impacting the quality of life and comfort of HD patients.
Effective nursing care interventions must prioritize the needs of patients and ensure their comfort and well-being. Comfort is regarded as the foundation of high-quality nursing care. Literature suggests that identifying and managing symptoms resulting from illness or treatment can enhance patients' comfort levels. Moreover, nurses, in their independent role, can effectively minimize pain and prevent potential complications by employing non-pharmacological treatment methods, especially in managing pain symptoms. Non-pharmacological methods are advantageous due to their affordability, applicability across all age groups, ease of use, and cleanliness. In this context, cold application stands out as one of the most effective non-pharmacological treatments for alleviating pain symptoms.
Cold application mitigates pain through two primary mechanisms. Firstly, it indirectly induces an analgesic effect by reducing swelling, edema, and muscle spasms caused by trauma or inflammation. Secondly, it directly contributes to analgesia by altering the conduction of peripheral nerves. Additionally, cold application leads to a decrease in the conduction velocity of unmyelinated nerve fibers responsible for transmitting painful stimuli, thereby diminishing pain perception. In the relevant literature concerning the application of cold therapy, there is a noticeable scarcity of international studies focusing on the CoolSense device, which has demonstrated local anesthetic effects preceding medical procedures in recent years. Furthermore, there is currently no international or national study available that assesses the impact of the CoolSense device on the pain experienced during arteriovenous fistula cannulation in hemodialysis (HD) patients. In light of this gap in research, this study aimed to investigate the influence of the CoolSense Method on arteriovenous fistula cannulation pain and the comfort levels of HD patients.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- To determine the sample, power analysis was utilized. With an effect size of 0.80 and a targeted test power of 0.80 (80%), the sample size was computed as 42 patients in total (21 for each group) for both the CoolSense group and the control group. This calculation was performed using the G*Power 3.1.9.6 software, with a significance level of α=0.05, considering the absence of prior experimental studies investigating pain scores in this context. Accounting for potential issues such as participant withdrawal or study-related mortality, each group was increased by 20%, resulting in a total of 50 patients, with 25 patients in each group.
| Arm | Type | Receives |
|---|---|---|
| CoolSense Group | Experimental | Device: CoolSense GroupThe responsible researcher carried out the application of the CoolSense device and filled out the patient information form before the arteriovenous fistula cannulation. Meanwhile, the application of the VCS and GCS was conducted both before and after the CoolSense device's application, with the latter occurring after the arteriovenous fistula cannulation. The nephrology charge nurse was responsible for these measurements, using a single device located at the patient's bedside. |
| Control Group | No intervention | –Patients in the control group underwent routine HD arteriovenous fistula cannulation and received HD treatment following the hospital's established protocol. Data collection tools were only administered to the participants before and after the study. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Being 18 years of age or older,
- Receiving HD treatment through the fistula,
- Being conscious and able to communicate with no impairment in mental or cognitive functions,
- Taking sedatives or analgesics at least 6 hours ago,
- Having no diabetes-related neuropathy,
Key exclusion criteria (6 listed)
- Refusing to participate in the study,
- Being 18 years of age or younger,
- Receiving dialysis treatment through a catheter,
- Having diabetes mellitus for more than 10 years or no diabetes-related neuropathy,
- Having a history of addiction or diagnosed psychological disorders,
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 |
|---|---|---|
| CoolSense GroupPatients in the CoolSense group received a CoolSense device that had been pre-chilled in the freezer for a minimum of one hour. The cover of the CoolSense device was removed, and the arteriovenous fistula, whose metal tip had been cleaned with batikon, was brought into contact with the area where the arteriovenous fistula cannulation would occur. This contact was maintained for 5 seconds, involving circular movements, and the fistula cannulation took place promptly. | Device | CoolSense Group |
Primary outcome
The The Verbal Category Scale
Time frame: 1 Day
The Scale is a pain assessment tool based on the patient's selection of the most appropriate word to describe their pain state. Patients rate their pain on a 0-4 point scale, where 0 point indicates "no pain," 1 point indicates "mild pain," 2 points indicate "severe pain," 3 points indicate "very severe pain," and 4 points indicate "unbearable pain". It was determined that the pain decreased after CoolsenSe application.
The General Comfort Scale
Time frame: 1 Day
It employs a four-point Likert-type scale, encompassing three sub-dimensions (relief, relaxation, and superiority-coping with problems) and 48 items. In this study, a score of 1 indicates a low comfort level, while a score of 4 represents a high comfort level. It was determined that comfort increased after CoolsenSe application.
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 22 Nov 2023.
- Derived from this study: PubMed 39467833Demirag H, Kulakac N. The effect of using a local skin cooling device on arteriovenous fistula cannulation pain and comfort level of patients on hemodialysis: A single-blind randomized controlled study. Hemodial Int. 2025 Jan;29(1):47-55. doi: 10.1111/hdi.13190. Epub 2024 Oct 28.
- Individual participant dataSharing planned: No. We don't want yet.
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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.
Hatice Demirağ, Assist Prof. principal investigator
Gümüşhane Universıty
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CoolSense Group in people with Hemolysis and Complementary Therapy, run by Karadeniz Technical 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 7 inclusion and 6 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 22 Nov 2023. 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?
The The Verbal Category Scale (time frame: 1 Day). The study lists 2 primary outcomes in all. 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 NCT06144801, 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 22 Nov 2023.