Arteriovenous Fistula PainNCT06862687
Arteriovenous Fistula Pain and Cold Application
A study testing Cooling Spray and Cold Aloe Vera Gel Application in people with Arteriovenous Fistula Pain, run by Ataturk University at 1 site in Turkey (Türkiye).
Trial summary
TThis study was designed as a single-group comparative prospective intervention study. The aim of the study was to assess the effectiveness of different pain management interventions during AVF cannulation. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Arteriovenous Fistula Pain
- What is being tested?
- Cooling Spray and Cold Aloe Vera Gel Application
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 May 2024to 1 Dec 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Over 18 and under 65 years old
- Literate
- Have an arteriovenous fistula (AVF)
- Undergoing hemodialysis (HD) treatment at least twice a week
- No allergy to aloe vera
- No communication barriers and/or psychiatric disorders
Who cannot join
- Diagnosed with malignancy
- Having any sensory problems that prevent the assessment of perception and pain
- Using any analgesic preparations
- Having a vascular access other than AVF
- Patients in whom AVF cannulation is not successful in a single attempt
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Atatürk Research Hospital
Erzurum, Yakutiye, 25000
About this study
Official title: The Effect of Cold Application Using Two Different Methods on Arteriovenous Fistula Pain
TThis study was designed as a single-group comparative prospective intervention study. The aim of the study was to assess the effectiveness of different pain management interventions during AVF cannulation. The effects of pain management methods such as cooling spray, aloe vera gel, and the standard procedure on pain levels, and which intervention was more effective in reducing pain compared to the standard procedure, were investigated.
The study included patients over 18 and under 65 years old, undergoing hemodialysis, having an AVF, literate, without an aloe vera allergy, and without communication barriers or psychiatric disorders.
Read more
The main research questions were defined as follows: Did different pain management methods (cooling spray, aloe vera gel, and standard procedure) affect pain levels during AVF cannulation? Which intervention was more effective in reducing pain levels? The primary hypotheses were defined as The application of cooling spray and aloe vera gel would reduce pain levels more than the standard procedure.
The researchers compared pain levels after each intervention to determine which one was more effective. Three different interventions (cooling spray, aloe vera gel, and standard procedure) were applied to participants in sequence, and pain levels were assessed after each intervention using the Visual Analog Scale (VAS). Additionally, feedback from participants regarding each intervention was collected.
- Conditions
- Arteriovenous Fistula Pain
- Being tested
- Cooling Spray, Cold Aloe Vera Gel Application, Standard Procedure (Control Condition)
- Keywords
- Arteriovenous Fistula, cold application, Hemodialysis, Kidney Failure, Pain
- Medical subject headings
- Arteriovenous Fistula, Renal Insufficiency, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cooling SprayOther
A cooling spray containing propan-butane-pentane was applied 25 cm from the cannulation site until mild whitening/frosting appeared.
The standard AVF cannulation procedure was performed. Pain levels were measured immediately after the procedure using VAS.
Cold Aloe Vera Gel ApplicationOther
1 ml of cold aloe vera gel was applied to a 5x5 cm area over the fistula site. The standard AVF cannulation procedure was conducted. Pain levels were assessed post-procedure using VAS.
Standard Procedure (Control Condition)Other
No additional pain-relief intervention was applied. The nurse performed the standard AVF cannulation procedure, including hand hygiene, thrill assessment, and site disinfection.
Pain levels were assessed immediately after cannulation using the Visual Analog Scale (VAS).
| Study group | Role | What they receive |
|---|---|---|
| Single Group Assignment | Active comparator | Three different interventions (cooling spray, aloe vera gel, and standard procedure) were applied to participants in sequence Receives: Other: Cooling Spray; Other: Cold Aloe Vera Gel Application; Other: Standard Procedure (Control Condition) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Level (VAS - Visual Analog Scale)
The pain level experienced by patients after AVF cannulation was assessed using the VAS (0-10 scale).
Pain scores were recorded and compared across all three interventions. Lower VAS scores indicate greater effectiveness of the intervention in pain reduction. n this scale, patients are asked to describe their pain using numbers, where "0" represents no pain and "10" indicates the highest, unbearable pain.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2025
- Study start1 May 2024
- Primary completion15 Jul 2024
- Study completion1 Dec 2024
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 Arteriovenous Fistula PainStudies of the same condition, open and under way.
- More trials run by Ataturk 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ataturk University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mehtap KAVURMACI, Ataturk University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06862687
- Sponsor's protocol ID
- B.30.2.ATA.0.01.00/300
- Status last verified
- Mar 2025
- First submitted
- 27 Feb 2025
- Last updated
- 11 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Thompson J, Steinheiser MM, Hotchkiss JB, Davis J, DeVries M, Frate K, Helm R, Jungkans CW, Kakani S, Lau S, Lindell K, Landrum KM, McQuillan KA, Shannon DJ, Wuerz L, Pitts S. Standards of care for peripheral intravenous catheters: evidence-based expert consensus. Br J Nurs. 2024 Nov 21;33(21):S32-S46. doi: 10.12968/bjon.2024.0422.
PubMed 39585227
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Cold Application Using Two Different Methods on Arteriovenous Fistula Pain
- ClinicalTrials.gov ID
- NCT06862687
- Acronym / sponsor ID
- B.30.2.ATA.0.01.00/300
- Conditions
- Arteriovenous Fistula Pain
- Keywords
- Arteriovenous Fistula, cold application, Hemodialysis, Kidney Failure, Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Ataturk UniversityUniversity, hospital or other
- Study start
- 1 May 2024 (actual)
- Primary completion
- 15 Jul 2024 (actual)
- Study completion
- 1 Dec 2024 (actual)
- First posted
- 6 Mar 2025 (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.
TThis study was designed as a single-group comparative prospective intervention study. The aim of the study was to assess the effectiveness of different pain management interventions during AVF cannulation. The effects of pain management methods such as cooling spray, aloe vera gel, and the standard procedure on pain levels, and which intervention was more effective in reducing pain compared to the standard procedure, were investigated.
The study included patients over 18 and under 65 years old, undergoing hemodialysis, having an AVF, literate, without an aloe vera allergy, and without communication barriers or psychiatric disorders.
The main research questions were defined as follows: Did different pain management methods (cooling spray, aloe vera gel, and standard procedure) affect pain levels during AVF cannulation? Which intervention was more effective in reducing pain levels? The primary hypotheses were defined as The application of cooling spray and aloe vera gel would reduce pain levels more than the standard procedure.
The researchers compared pain levels after each intervention to determine which one was more effective. Three different interventions (cooling spray, aloe vera gel, and standard procedure) were applied to participants in sequence, and pain levels were assessed after each intervention using the Visual Analog Scale (VAS). Additionally, feedback from participants regarding each intervention was collected.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single Group Assignment | Active comparator | Other: Cooling Spray, Other: Cold Aloe Vera Gel Application, Other: Standard Procedure (Control Condition)Three different interventions (cooling spray, aloe vera gel, and standard procedure) were applied to participants in sequence |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Over 18 and under 65 years old
- Literate
- Have an arteriovenous fistula (AVF)
- Undergoing hemodialysis (HD) treatment at least twice a week
- No allergy to aloe vera
Key exclusion criteria (5 listed)
- Diagnosed with malignancy
- Having any sensory problems that prevent the assessment of perception and pain
- Using any analgesic preparations
- Having a vascular access other than AVF
- Patients in whom AVF cannulation is not successful in a single attempt
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 |
|---|---|---|
| Cooling SprayA cooling spray containing propan-butane-pentane was applied 25 cm from the cannulation site until mild whitening/frosting appeared. The standard AVF cannulation procedure was performed. Pain levels were measured immediately after the procedure using VAS. | Other | Single Group Assignment |
| Cold Aloe Vera Gel Application1 ml of cold aloe vera gel was applied to a 5x5 cm area over the fistula site. The standard AVF cannulation procedure was conducted. Pain levels were assessed post-procedure using VAS. | Other | Single Group Assignment |
| Standard Procedure (Control Condition)No additional pain-relief intervention was applied. The nurse performed the standard AVF cannulation procedure, including hand hygiene, thrill assessment, and site disinfection. Pain levels were assessed immediately after cannulation using the Visual Analog Scale (VAS). | Other | Single Group Assignment |
Primary outcome
Pain Level (VAS - Visual Analog Scale)
Time frame: 3 months
The pain level experienced by patients after AVF cannulation was assessed using the VAS (0-10 scale). Pain scores were recorded and compared across all three interventions. Lower VAS scores indicate greater effectiveness of the intervention in pain reduction. n this scale, patients are asked to describe their pain using numbers, where "0" represents no pain and "10" indicates the highest, unbearable pain.
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 11 Mar 2025.
- Results publication: PubMed 39585227Thompson J, Steinheiser MM, Hotchkiss JB, Davis J, DeVries M, Frate K, Helm R, Jungkans CW, Kakani S, Lau S, Lindell K, Landrum KM, McQuillan KA, Shannon DJ, Wuerz L, Pitts S. Standards of care for peripheral intravenous catheters: evidence-based expert consensus. Br J Nurs. 2024 Nov 21;33(21):S32-S46. doi: 10.12968/bjon.2024.0422.
- 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 Cooling Spray and Cold Aloe Vera Gel Application in people with Arteriovenous Fistula Pain, run by Ataturk 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 6 inclusion and 5 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 11 Mar 2025. 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 (VAS - Visual Analog Scale) (time frame: 3 months). 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 NCT06862687, 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 11 Mar 2025.