DialysisNCT07662564
Thermotherapy for Reducing Pain During Arteriovenous Fistula Cannulation
A study testing Thermotherapy application in people with Dialysis and Pain, run by Istanbul University at 1 site in Turkey (Türkiye).
Trial summary
Arteriovenous fistula (AVF) cannulation is a routine procedure for people receiving haemodialysis and is frequently associated with pain. Thermotherapy has been reported as an effective non-pharmacological intervention for reducing AVF cannulation-related pain; however, the optimal application duration remains unclear. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- What is being tested?
- Thermotherapy application
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 51 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 6 Apr 2026to 15 Jun 2026
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients aged 18 years and older
- Patients who received hemodialysis (HD) treatment with an arteriovenous fistula (AVF) for at least 3 months
- Patients receiving HD treatment 3 days a week for 4 hours each session
- Patients with a pain score of ⩾1 during AVF cannulation, measured by a visual analog scale (VAS)
- Patients able to communicate in Turkish
- Patients without psychiatric disorders that impair communication
- Patients who agreed to participate in the study
Who cannot join
- Patients who were known to present difficulties with fistula cannulation (requiring multiple cannulations)
- Patients with a history of hematoma or stenosis in the arteriovenous fistula (AVF)
- Patients with an infection at the fistula site
- Patients who took painkillers within 3 hours prior to treatment
- Hypersensitivity reactions and circulatory disorders due to thermotherapy
- Sensory or cognitive impairment preventing a proper assessment of pain
- Patients who did not wish to participate in the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Optimal Time of Thermotherapy for Reducing Arteriovenous Fistula Cannulation Related Pain: A Three-Arm, Placebo-Controlled, Randomized Trial
Arteriovenous fistula (AVF) cannulation is a routine procedure for people receiving haemodialysis and is frequently associated with pain. Thermotherapy has been reported as an effective non-pharmacological intervention for reducing AVF cannulation-related pain; however, the optimal application duration remains unclear.
Read the detailed description
Thermotherapy is the therapeutic application of any substance to the body that adds heat to the body resulting in increased tissue temperature. Thermotherapy increases tissue tem-perature, blood flow, metabolism, and connective tissue extensibility. Some of the benefits provided by topical heat therapy may be mediated di¬rectly in the brain. Functional brain imag¬ing research has revealed central ef¬fects of non-noxious skin warming with increased activation of the thalamus and posterior insula of the brain. In addition, innocuous tactile stimulation of the skin activates the thalamus and S2 region of the cerebral cortex. These direct effects on the brain may mitigate the sensation of pain in the brain, thereby providing pain relief. Two studies were found in the literature evaluating the effect of thermotherapy on fistula-related cannulation pain. In both studies, thermotherapy treatment was found to be effective in reducing pain. Although it is stated in the literature that thermotherapy can be applied for 5-30 minutes , research shows that it is applied for 15 minutes, 10 minutes and 20 minutes. Thermotherapy was administered in three sessions, and in one session. This randomized controlled trial was conducted to evaluate the effectiveness of different application durations (5 and 10 minutes) of thermotherapy on reducing pain during AVF cannulation for long period (12 dialysis sessions). Investigators hypothesized that the 5 minutes thermotherapy is the optimal time to alleviate the patients' fistula cannulation related pain.
- Being tested
- Thermotherapy application
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Thermotherapy applicationOther
Heated hot pack was hold for 5 or 10 minutes on the AVF cannulation area.
| Study group | Role | What they receive |
|---|---|---|
| Heated hot pack 5 minutes | Experimental | Heated hot pack was hold for 5 minutes on the AVF cannulation area. After 5 minutes the area was cleaned with a disinfection and cannulation was done by the nurse. Receives: Other: Thermotherapy application |
| Heated hot pack 10 minutes | Experimental | Heated hot pack was hold for 10 minutes on the AVF cannulation area. After 10 minutes the area was cleaned with a disinfection and cannulation was done by the nurse. Receives: Other: Thermotherapy application |
| Placebo Group | No intervention | Not heated hot pack was hold for 10 minutes on the AVF cannulation area. After 10 minutes the area was cleaned with a disinfection and cannulation was done by the nurse. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline Fistula Cannulation Related Pain
It will be assessed six times at the end of the dialysis session with Visual Analogue Scale. Visual Analogue Scale ranging from 0 (no pain) to 10 (worst pain). Pain increases the score increases. The high point describes bad outcome
Measured: Up to 2 weeks (3 hemodialysis sessions in a week)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2026
- Study start6 Apr 2026
- Primary completion15 May 2026
- Study completion15 Jun 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for DialysisStudies of the same condition, open and under way.
- More trials run by Istanbul UniversityThe sponsor's other registered studies.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nurten Ozen, Istanbul University
- Investigators
- NURTEN ÖZEN, Professor, Principal investigator, Istanbul University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07662564
- Sponsor's protocol ID
- 2026/22
- Status last verified
- Aug 2026
- First submitted
- 17 Jun 2026
- Last updated
- 6 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Abramson DI, Chu LS, Tuck S Jr, Lee SW, Richardson G, Levin M. Effect of tissue temperatures and blood flow on motor nerve conduction velocity. JAMA. 1966 Dec 5;198(10):1082-8. No abstract available.
PubMed 5953385Back Y, Lee Y. Optimal Time of Thermotherapy for Reducing Pain, Anxiety, and Side Effects in Arteriovenous Fistula Puncture Patients: A Randomized Controlled Trial. Int J Environ Res Public Health. 2020 Sep 29;17(19):7147. doi: 10.3390/ijerph17197147.
PubMed 33003591
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimal Time of Thermotherapy for Reducing Arteriovenous Fistula Cannulation Related Pain: A Three-Arm, Placebo-Controlled, Randomized Trial
- ClinicalTrials.gov ID
- NCT07662564
- Acronym / sponsor ID
- 2026/22
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- Istanbul UniversityUniversity, hospital or other
- Study start
- 6 Apr 2026 (actual)
- Primary completion
- 15 May 2026 (actual)
- Study completion
- 15 Jun 2026 (actual)
- First posted
- 23 Jun 2026 (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.
Arteriovenous fistula (AVF) cannulation is a routine procedure for people receiving haemodialysis and is frequently associated with pain. Thermotherapy has been reported as an effective non-pharmacological intervention for reducing AVF cannulation-related pain; however, the optimal application duration remains unclear.
Detailed description
Thermotherapy is the therapeutic application of any substance to the body that adds heat to the body resulting in increased tissue temperature. Thermotherapy increases tissue tem-perature, blood flow, metabolism, and connective tissue extensibility. Some of the benefits provided by topical heat therapy may be mediated di¬rectly in the brain. Functional brain imag¬ing research has revealed central ef¬fects of non-noxious skin warming with increased activation of the thalamus and posterior insula of the brain. In addition, innocuous tactile stimulation of the skin activates the thalamus and S2 region of the cerebral cortex. These direct effects on the brain may mitigate the sensation of pain in the brain, thereby providing pain relief. Two studies were found in the literature evaluating the effect of thermotherapy on fistula-related cannulation pain. In both studies, thermotherapy treatment was found to be effective in reducing pain. Although it is stated in the literature that thermotherapy can be applied for 5-30 minutes , research shows that it is applied for 15 minutes, 10 minutes and 20 minutes. Thermotherapy was administered in three sessions, and in one session. This randomized controlled trial was conducted to evaluate the effectiveness of different application durations (5 and 10 minutes) of thermotherapy on reducing pain during AVF cannulation for long period (12 dialysis sessions). Investigators hypothesized that the 5 minutes thermotherapy is the optimal time to alleviate the patients' fistula cannulation related pain.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Heated hot pack 5 minutes | Experimental | Other: Thermotherapy applicationHeated hot pack was hold for 5 minutes on the AVF cannulation area. After 5 minutes the area was cleaned with a disinfection and cannulation was done by the nurse. |
| Heated hot pack 10 minutes | Experimental | Other: Thermotherapy applicationHeated hot pack was hold for 10 minutes on the AVF cannulation area. After 10 minutes the area was cleaned with a disinfection and cannulation was done by the nurse. |
| Placebo Group | No intervention | –Not heated hot pack was hold for 10 minutes on the AVF cannulation area. After 10 minutes the area was cleaned with a disinfection and cannulation was done by the nurse. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Patients aged 18 years and older
- Patients who received hemodialysis (HD) treatment with an arteriovenous fistula (AVF) for at least 3 months
- Patients receiving HD treatment 3 days a week for 4 hours each session
- Patients with a pain score of ⩾1 during AVF cannulation, measured by a visual analog scale (VAS)
- Patients able to communicate in Turkish
Key exclusion criteria (7 listed)
- Patients who were known to present difficulties with fistula cannulation (requiring multiple cannulations)
- Patients with a history of hematoma or stenosis in the arteriovenous fistula (AVF)
- Patients with an infection at the fistula site
- Patients who took painkillers within 3 hours prior to treatment
- Hypersensitivity reactions and circulatory disorders due to thermotherapy
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 |
|---|---|---|
| Thermotherapy applicationHeated hot pack was hold for 5 or 10 minutes on the AVF cannulation area. | Other | Heated hot pack 10 minutes, Heated hot pack 5 minutes |
Primary outcome
Change From Baseline Fistula Cannulation Related Pain
Time frame: Up to 2 weeks (3 hemodialysis sessions in a week)
It will be assessed six times at the end of the dialysis session with Visual Analogue Scale. Visual Analogue Scale ranging from 0 (no pain) to 10 (worst pain). Pain increases the score increases. The high point describes bad outcome
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 6 Aug 2026.
- Background: PubMed 5953385Abramson DI, Chu LS, Tuck S Jr, Lee SW, Richardson G, Levin M. Effect of tissue temperatures and blood flow on motor nerve conduction velocity. JAMA. 1966 Dec 5;198(10):1082-8. No abstract available.
- Results publication: PubMed 33003591Back Y, Lee Y. Optimal Time of Thermotherapy for Reducing Pain, Anxiety, and Side Effects in Arteriovenous Fistula Puncture Patients: A Randomized Controlled Trial. Int J Environ Res Public Health. 2020 Sep 29;17(19):7147. doi: 10.3390/ijerph17197147.
- 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.
NURTEN ÖZEN, Professor principal investigator
Istanbul University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Thermotherapy application in people with Dialysis and Pain, run by Istanbul 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 7 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 6 Aug 2026. 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?
Change From Baseline Fistula Cannulation Related Pain (time frame: Up to 2 weeks (3 hemodialysis sessions in a week)). 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 NCT07662564, which also lists 2 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 6 Aug 2026.