Hemodialysis ComplicationNCT06332118
The Effect of Ice Massage on Pain, Ecchymosis, Hematoma and Patient Satisfaction
A study testing ice massage group in people with Hemodialysis Complication, run by Erzurum Technical University at 2 sites in Turkey (Türkiye).
Trial summary
The research was planned to measure pain, ecchymosis, hematoma and patient satisfaction with ice massage applied to the fistula before the arteriovenous fistula procedure in hemodialysis patients. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Hemodialysis Complication
- What is being tested?
- ice massage group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 2 sitesTurkey (Türkiye)
- Study dates
- 15 Apr 2024to 30 May 2024
- 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 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Conscious and oriented
- Communicable,
- Those who are 18 years or older,
- Hemodialysis treatment is applied via arteriovenous fistula,
- There are no signs of infection such as redness, swelling, or open wound in the area where the procedure will be performed,
- Patient: International Normalized Ratio: 2-3, Activated Partial Thromboplastin Time: 27-45 sec. Prothrombin Time: 11-16 sec. Thrombocyte: 125-350 m3
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- Can tolerate the application,
- 10 minutes before starting Hemodialysis treatment. vissual analog scale pain score was evaluated beforehand and vissual analog scale was ≥4.
- Patients who agree to participate in the study verbally and in writing will be included in the research.
Who cannot join
- Unconscious,
- Unable to communicate,
- Those who are under 18 years of age,
- Hemodialysis treatment is not applied via arteriovenous fistula,
- If there is any sign of infection such as redness, swelling, open wound in the area where cannulation will be performed,
- 10 minutes before starting hemodialysis treatment. vissual analog scale pain score was evaluated beforehand and vissual analog scale ≤ 4
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- Using any painkillers before the procedure on the same day,
- Patient: International Normalized Ratio: 2-3, Activated Partial Thromboplastin Time: 27-45 sec. Prothrombin Time: 11-16 sec. Thrombocyte: above 125-350 m3, prone to bleeding,
- Patients who cannot tolerate the application or do not want to participate in the study voluntarily will not be included in the research.
- Patients who cannot tolerate ice massage during the procedure will not be included in the study.
Trial locations and contacts
2 sites in 1 country.
Turkey (Türkiye)2 sites
Ercan Bakır
Erzurum, Yakutiye, 25010
Ercan Bakır, PhD, 05444252111, ercan.bakir@erzurum.edu.tr
Ercan Bakır, PhD, 05443047186, e.bakir02@gmail.com
Ercan Bakır
Erzurum, Yakutiye
About this study
Official title: The Effect of Ice Massage Applied Before Arteriovenous Fistula Cannulation Procedure on Pain, Ecchymosis, Hematoma and Patient Satisfaction in Hemodialysis Patients
The research was planned to measure pain, ecchymosis, hematoma and patient satisfaction with ice massage applied to the fistula before the arteriovenous fistula procedure in hemodialysis patients. Patients who agree to participate in the study will be given ice massage before the procedure and the relevant parameters will be measured.
Read the detailed description
Chronic renal failure is a condition that causes irreversible damage to kidney functions and prevents the excretion of metabolic wastes through urine. In the treatment of the disease; renal replacement therapies and kidney transplant options are available. The most commonly used treatment in end-stage renal failure patients is hemodialysis. Hemodialysis is performed through catheters and fistula channels. Patients receiving hemodialysis treatment through fistula are connected to the dialysis device. For this procedure, an injection occurs 2 or 3 times a week. It is a distressing situation for patients that needle insertion is painful during the procedure and that conditions such as ecchymosis and hematoma frequently occur afterwards. In this study, cold application was planned in a pre-test post-test design to evaluate pain, ecchymosis, hematoma and patient satisfaction. Volunteer participants who receive hemodialysis treatment through fistula will receive an ice massage for an average of 3-5 minutes on the fistula area where the needle will be inserted before the procedure.
- Conditions
- Hemodialysis Complication
- Being tested
- ice massage group
- Keywords
- Hemodialysis, ice massage, pain, hematoma, ecchymosis, patient satisfaction
- Medical subject headings
- Pain, Hematoma, Ecchymosis, Patient Satisfaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ice massage groupOther
Measurement surveys will be applied to obtain pre-test data from hemodialysis patients who meet the research criteria. After the preliminary test data are obtained, ice cubes prepared by the researchers before the needle insertion into the arteriovenous fistula for the hemodialysis procedure will be wrapped in a thin sponge and an ice massage will be applied to the needle insertion area of the patient in a direction that will not disrupt the circulation. This process will take approximately 3-5 minutes or the massage will be terminated when the patient feels drowsiness. In the next stage, the patient will undergo needle intervention for hemodialysis. At the end of this stage, the patient's pain will be evaluated. Patients will be re-evaluated at 24, 48 and 72 hours for ecchymosis and hematoma and relevant measurements will be provided.
| Study group | Role | What they receive |
|---|---|---|
| ice massage group | Experimental | Measurement surveys will be applied to obtain pre-test data from hemodialysis patients who meet the research criteria. After the preliminary test data are obtained, ice cubes prepared by the researchers before the needle insertion into the arteriovenous fistula for the hemodialysis procedure will be wrapped in a thin sponge and an ice massage will be applied to the needle insertion area of the patient in a direction that will not disrupt the circulation. This process will take approximately 3-5 minutes or the massage will be terminated when the patient feels drowsiness. In the next stage, the patient will undergo needle intervention for hemodialysis. At the end of this stage, the patient's pain will be evaluated. Patients will be re-evaluated at 24, 48 and 72 hours for ecchymosis and hematoma and relevant measurements will be provided. Receives: Other: ice massage group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain score
Vissual analog scale: The scale is rated between 0 points and 10 points. 0 indicates that the patient has no pain, and 10 indicates that the patient has unbearable pain. Patients report their pain status on a scale of 0 to 10 points.
Measured: 3 days
Secondary outcomes (3)
Ecchymosis degree
The area of the ecchymosis will be calculated in square millimeters with polyethylene millimetric plastic film (opsite flexigrid).
Measured: 3 days
Hematoma degree
The area of the hematoma will be calculated in square millimeters with polyethylene millimetric plastic film (opsite flexigrid).
Measured: 3 days
Patient satisfaction score
Numerical Satisfaction Scale: The scale is rated between 0 points and 10 points. 0 indicates that the patient is very dissatisfied, and 10 indicates that the patient is very satisfied. Patients report their satisfaction between 0 and 10 points.
Measured: 3 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2024
- Study start15 Apr 2024 (estimated)
- Primary completion15 May 2024 (estimated)
- Study completion30 May 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Hemodialysis ComplicationStudies 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
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- The research is quasi-experimental and relationship-seeking in a pretest-posttest format.
- Masking
- None (open label)
- Enrolment
- 35 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Erzurum Technical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ercan Bakır, Erzurum Technical University
- Investigators
- Ercan Bakır, PhD, Study director, erzurum tecnical university
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06332118
- Sponsor's protocol ID
- avf ice massage
- Status last verified
- Apr 2024
- First submitted
- 4 Mar 2024
- Last updated
- 2 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Koushki B, Khajeh M, Bagheri H, Talebi SS, Ebrahimi H. Comparing the Effect of Local Application of Peppermint and Cold Compresses on the Severity of Pain from Venipuncture in Dialysis Patients: A Parallel Randomized Clinical Trial Study. Saudi J Kidney Dis Transpl. 2023 Jul 1;34(4):288-296. doi: 10.4103/1319-2442.395444. Epub 2024 Feb 12.
PubMed 38345583Ghoreyshi Z, Amerian M, Amanpour F, Ebrahimi H. Evaluation and comparison of the effects of Xyla-P cream and cold compress on the pain caused by the cannulation of arteriovenous fistula in hemodialysis patients. Saudi J Kidney Dis Transpl. 2018 Mar-Apr;29(2):369-375. doi: 10.4103/1319-2442.229265.
PubMed 29657205Kesik G, Ozdemir L, Yildirim T, Jabrayilov J, Celiksoz G. Effects of warm or cold compresses applied to the legs during hemodialysis on cramps, fatigue, and patient comfort: A placebo-controlled randomized trial. Hemodial Int. 2023 Apr;27(2):117-125. doi: 10.1111/hdi.13070. Epub 2023 Feb 14.
PubMed 36788410Dehghan M, Hosseini SJ, Shahrbabaki PM, Forouzi MA, Roy C. The Effect of Acupressure and Cryotherapy on the Pain of Patients on Hemodialysis During Arteriovenous Fistula Cannulation: A Randomized Crossover Clinical Trial. Nephrol Nurs J. 2023 Mar-Apr;50(2):131-139.
PubMed 37074938Al Amer HS, Dator WL, Abunab HY, Mari M. Cryotherapy intervention in relieving arteriovenous fistula cannulation-related pain among hemodialysis patients at the King Khalid Hospital, Tabuk, Kingdom of Saudi Arabia. Saudi J Kidney Dis Transpl. 2017 Sep-Oct;28(5):1050-1056. doi: 10.4103/1319-2442.215141.
PubMed 28937062Bakir E, Karasu S, Nacak UA, Yilmaz Karabulutlu E, Turan GB. Effects of Ice Massage on Pain, Ecchymosis, Hematoma, and Patient Satisfaction When Applied Prior to Hemodialysis Arteriovenous Fistula Cannulation: A Crossover Trial. Hemodial Int. 2026 May 22. doi: 10.1111/hdi.70089. Online ahead of print.
PubMed 42173811
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Ice Massage Applied Before Arteriovenous Fistula Cannulation Procedure on Pain, Ecchymosis, Hematoma and Patient Satisfaction in Hemodialysis Patients
- ClinicalTrials.gov ID
- NCT06332118
- Acronym / sponsor ID
- avf ice massage
- Conditions
- Hemodialysis Complication
- Keywords
- Hemodialysis, ice massage, pain, hematoma, ecchymosis, patient satisfaction
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 35 participants (estimated)
- Lead sponsor
- Erzurum Technical UniversityUniversity, hospital or other
- Study start
- 15 Apr 2024 (estimated)
- Primary completion
- 15 May 2024 (estimated)
- Study completion
- 30 May 2024 (estimated)
- First posted
- 27 Mar 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.
The research was planned to measure pain, ecchymosis, hematoma and patient satisfaction with ice massage applied to the fistula before the arteriovenous fistula procedure in hemodialysis patients. Patients who agree to participate in the study will be given ice massage before the procedure and the relevant parameters will be measured.
Detailed description
Chronic renal failure is a condition that causes irreversible damage to kidney functions and prevents the excretion of metabolic wastes through urine. In the treatment of the disease; renal replacement therapies and kidney transplant options are available. The most commonly used treatment in end-stage renal failure patients is hemodialysis. Hemodialysis is performed through catheters and fistula channels. Patients receiving hemodialysis treatment through fistula are connected to the dialysis device. For this procedure, an injection occurs 2 or 3 times a week. It is a distressing situation for patients that needle insertion is painful during the procedure and that conditions such as ecchymosis and hematoma frequently occur afterwards. In this study, cold application was planned in a pre-test post-test design to evaluate pain, ecchymosis, hematoma and patient satisfaction. Volunteer participants who receive hemodialysis treatment through fistula will receive an ice massage for an average of 3-5 minutes on the fistula area where the needle will be inserted before the procedure.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- The research is quasi-experimental and relationship-seeking in a pretest-posttest format.
| Arm | Type | Receives |
|---|---|---|
| ice massage group | Experimental | Other: ice massage groupMeasurement surveys will be applied to obtain pre-test data from hemodialysis patients who meet the research criteria. After the preliminary test data are obtained, ice cubes prepared by the researchers before the needle insertion into the arteriovenous fistula for the hemodialysis procedure will be wrapped in a thin sponge and an ice massage will be applied to the needle insertion area of the patient in a direction that will not disrupt the circulation. This process will take approximately 3-5 minutes or the massage will be terminated when the patient feels drowsiness. In the next stage, the patient will undergo needle intervention for hemodialysis. At the end of this stage, the patient's pain will be evaluated. Patients will be re-evaluated at 24, 48 and 72 hours for ecchymosis and hematoma and relevant measurements will be provided. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Conscious and oriented
- Communicable,
- Those who are 18 years or older,
- Hemodialysis treatment is applied via arteriovenous fistula,
- There are no signs of infection such as redness, swelling, or open wound in the area where the procedure will be performed,
Key exclusion criteria (10 listed)
- Unconscious,
- Unable to communicate,
- Those who are under 18 years of age,
- Hemodialysis treatment is not applied via arteriovenous fistula,
- If there is any sign of infection such as redness, swelling, open wound in the area where cannulation will be performed,
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 |
|---|---|---|
| ice massage groupMeasurement surveys will be applied to obtain pre-test data from hemodialysis patients who meet the research criteria. After the preliminary test data are obtained, ice cubes prepared by the researchers before the needle insertion into the arteriovenous fistula for the hemodialysis procedure will be wrapped in a thin sponge and an ice massage will be applied to the needle insertion area of the patient in a direction that will not disrupt the circulation. This process will take approximately 3-5 minutes or the massage will be terminated when the patient feels drowsiness. In the next stage, the patient will undergo needle intervention for hemodialysis. At the end of this stage, the patient's pain will be evaluated. Patients will be re-evaluated at 24, 48 and 72 hours for ecchymosis and hematoma and relevant measurements will be provided. | Other | ice massage group |
Primary outcome
Pain score
Time frame: 3 days
Vissual analog scale: The scale is rated between 0 points and 10 points. 0 indicates that the patient has no pain, and 10 indicates that the patient has unbearable pain. Patients report their pain status on a scale of 0 to 10 points.
3 secondary outcomes
Ecchymosis degree
Time frame: 3 days
Hematoma degree
Time frame: 3 days
Patient satisfaction score
Time frame: 3 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Apr 2024.
- Background: PubMed 38345583Koushki B, Khajeh M, Bagheri H, Talebi SS, Ebrahimi H. Comparing the Effect of Local Application of Peppermint and Cold Compresses on the Severity of Pain from Venipuncture in Dialysis Patients: A Parallel Randomized Clinical Trial Study. Saudi J Kidney Dis Transpl. 2023 Jul 1;34(4):288-296. doi: 10.4103/1319-2442.395444. Epub 2024 Feb 12.
- Background: PubMed 29657205Ghoreyshi Z, Amerian M, Amanpour F, Ebrahimi H. Evaluation and comparison of the effects of Xyla-P cream and cold compress on the pain caused by the cannulation of arteriovenous fistula in hemodialysis patients. Saudi J Kidney Dis Transpl. 2018 Mar-Apr;29(2):369-375. doi: 10.4103/1319-2442.229265.
- Background: PubMed 36788410Kesik G, Ozdemir L, Yildirim T, Jabrayilov J, Celiksoz G. Effects of warm or cold compresses applied to the legs during hemodialysis on cramps, fatigue, and patient comfort: A placebo-controlled randomized trial. Hemodial Int. 2023 Apr;27(2):117-125. doi: 10.1111/hdi.13070. Epub 2023 Feb 14.
- Background: PubMed 37074938Dehghan M, Hosseini SJ, Shahrbabaki PM, Forouzi MA, Roy C. The Effect of Acupressure and Cryotherapy on the Pain of Patients on Hemodialysis During Arteriovenous Fistula Cannulation: A Randomized Crossover Clinical Trial. Nephrol Nurs J. 2023 Mar-Apr;50(2):131-139.
- Background: PubMed 28937062Al Amer HS, Dator WL, Abunab HY, Mari M. Cryotherapy intervention in relieving arteriovenous fistula cannulation-related pain among hemodialysis patients at the King Khalid Hospital, Tabuk, Kingdom of Saudi Arabia. Saudi J Kidney Dis Transpl. 2017 Sep-Oct;28(5):1050-1056. doi: 10.4103/1319-2442.215141.
- Derived from this study: PubMed 42173811Bakir E, Karasu S, Nacak UA, Yilmaz Karabulutlu E, Turan GB. Effects of Ice Massage on Pain, Ecchymosis, Hematoma, and Patient Satisfaction When Applied Prior to Hemodialysis Arteriovenous Fistula Cannulation: A Crossover Trial. Hemodial Int. 2026 May 22. doi: 10.1111/hdi.70089. Online ahead of print.
- Individual participant dataSharing planned: No
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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.
Ercan Bakır, PhD study director
erzurum tecnical university
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ice massage group in people with Hemodialysis Complication, run by Erzurum Technical University at 2 sites 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 9 inclusion and 10 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: status not confirmed, as of the sponsor's last update on 2 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ercan Bakır, PhD (05444252111, ercan.bakir@erzurum.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain score (time frame: 3 days). 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 NCT06332118, which also lists 6 linked publications.
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 2 Apr 2024.