Hemodialysis AccessAVFNCT06236867
Cannulation-Related Pain in Dialysis Patients With Arteriovenous Fistula
A study testing KaleidoscopeGroup and Ice Application Group in people with Hemodialysis Access, run by Sülayman YAMAN at 1 site in Turkey (Türkiye).
Trial summary
It was conducted to investigate the effect of ice application to the kaleidoscope and hoku point on the management of cannulization-related pain in patients receiving hemodialysis treatment. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Hemodialysis Access
- What is being tested?
- KaleidoscopeGroup and Ice Application Group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 102 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 13 Mar 2023to 26 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 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Comfortable reception of trill and murmur sound from arteriovenous fistula,
- over the age of 18 and no communication problems,
- Having a place and time orientation,
- No dizziness,
Who cannot join
- Hemodialysis of the patient with arteriovenous graft and/or central venous catheter
- Pharmacological application was made to relieve pain 30 minutes before AVF cannulation,
- The patient has a COVID - 19 infection
- Having visual, auditory and intellectual disabilities,
- Having a communication problem,
- Not willing and willing to participate in the study, as well as wanting to withdraw from the study at any stage of the study
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Amasya University İnstitute of Health Sciences
Amasya, Merkez, 05100
About this study
Official title: The Effect of Ice Application and Kaleidoscope Application on the Management of Cannulation-Related Pain in Dialysis Patients With Arteriovenous Fistula
It was conducted to investigate the effect of ice application to the kaleidoscope and hoku point on the management of cannulization-related pain in patients receiving hemodialysis treatment.
Read the detailed description
After obtaining the necessary permissions for the research, the patients who were followed up in the hemodialysis unit of X,Y, Z Hospitals were randomly divided into three groups (Kaleidoscope application, ice application and control group).
Patients were made to sign written voluntary consent forms by the researchers.After the patients were transferred to the randomized program for the arrival days and TC numbers for the dialysis session, they were assigned to the experimental and control groups.
The patients' pain levels were evaluated during 3 dialysis sessions.
- Conditions
- Hemodialysis Access
- Being tested
- KaleidoscopeGroup, Ice Application Group, Control Group
- Keywords
- Arteriovenous fistula, Nursing, Pain Management
- Medical subject headings
- Arteriovenous Fistula, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KaleidoscopeGroupOther
Also called Experimental
The group consists of 34 people. Pain level was measured during 3 dialysis sessions.In order for the patients in the kaleidoscope group to recognize the device and increase their compliance during the procedure, a practice was performed using the device before the AVF cannulation procedure. Kaleidoscope application was performed during cannulation.
Ice Application GroupOther
Also called Experimental
The group consists of 34 people. Pain level was measured during 3 dialysis sessions. Before, during and after AVF cannulation, VAS pain scores will be evaluated after cannulation without any intervention.Ice application application was made with non-melting ice molds to the area where the index finger and thumb of the hand with fistula are joined (HOKU point)
Control GroupOther
Also called Experimental
The group consists of 34 people. Pain level will be measured during 3 dialysis sessions. In the control group, the vital signs of the patients before AVF cannulation will be recorded.
| Study group | Role | What they receive |
|---|---|---|
| Kaleidoscope Group | Experimental | In order for the patients in the kaleidoscope group to recognize the device and increase their compliance during the procedure, a practice was performed using the device before the AVF cannulation procedure. Kaleidoscope application was performed during cannulation. Receives: Other: KaleidoscopeGroup |
| Ice Application Group | Experimental | Ice application application was made with non-melting ice molds to the area where the index finger and thumb of the hand with fistula are joined (HOKU point). Receives: Other: Ice Application Group |
| Control Group | Experimental | In the control group, the vital signs of the patients before AVF cannulation will be recorded. Before, during and after AVF cannulation, VAS pain scores will be evaluated after cannulation without any intervention. Receives: Other: Control Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
visual pain scale (min-max:0-10 point) (1 week= during 3rd dialysis sessions)
Evaluation of pain levels (minimum=0 points, maximum: 10 points) of experimental and control groups in the 1st, 2nd and 3rd dialysis sessions
The visual pain scale is minimum 0 and maximum 10 points. 0 means no pain, 10 means severe pain.
- st dialysis session= Visual analog pain scores during cannulation were evaluated without any application.
- nd and 3rd dialysis sessions: Ice application to the patient's hoku point was performed by the researcher for 1 min before the AVF cannulation procedure and during cannulation, and visual analog scale pain scores was filled in during cannulation.
Kaleidoscope application was performed to the patient for 5 minutes before AVF cannulation procedure and during cannulation. The visual analog scale pain score was filled in during cannulation.
Control Group:visual analog scale pain scores will be evaluated before, during and after AVF cannulation without any intervention after the procedure.
Measured: One week= during 3rd dialysis sessions
Secondary outcomes (2)
The evaluation of Ice Application and kaleidoscope application
Learning patient experiences regarding ice application and kaleidoscope application via Kaleidoscope Application Patient Experience Form, Patient Experience Form for Ice Application.
The answers of the participants to the questions in the evaluation forms (Kaleidoscope Application Patient Experience Form, Patient Experience Form for Ice Application) are presented as a percentage. They were asked to answer the questions asked in the form as "yes, no, partially".
Measured: After 3rd dialysis session (after one week)
Sociodemographic and disease-related characteristics
Comparison of sociodemographic characteristics (age, gender) with visual pain scale scores of the experimental and control groups.
Comparison of disease-related characteristics [Body mass index:weight and height will be combined to report BMI in kg/m^2 (weight in kilograms, height in meters=kg/m2), duration of dialysis (months), artery and vein needle size (14,15,16,17 gauge), duration of fistula use, region where the fistula is located)] with visual pain scale scores of the experimental and control groups.
NOTE:After the data in all dialysis centers were completed (within about three months), the analysis was performed.
Measured: through study completion, an average of 3rd month.
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 start13 Mar 2023
- Primary completion2 Jun 2023
- Study completion26 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hemodialysis AccessStudies 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- After obtaining the necessary permissions for the research, the patients who were followed up in the hemodialysis unit of X,Y, Z Hospitals were randomly divided into three groups (Kaleidoscope application, ice application and control group). Patients were made to sign written voluntary consent forms by the researchers.After the patients were transferred to the randomized program for the arrival days and TC numbers for the dialysis session, they were assigned to the experimental and control groups. The patients' pain levels were evaluated during 3 dialysis sessions. The pain level was evaluated without the procedure on the first day. 2 and 3. on the other hand, pain levels were evaluated after the interventions per day. The data in the research are; Patient Diagnosis Form, Numerical Rating Scale and Life Signs Follow-up Form and Kaleidoscope Application Patient Experience Form, It was collected using the Patient Experience Form Related to Ice Application.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 102 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sülayman YAMAN
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Sülayman YAMAN, Amasya University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06236867
- Sponsor's protocol ID
- AU-SBE-SY-01
- Acronym
- AVF
- Status last verified
- Jan 2024
- First submitted
- 27 Dec 2023
- Last updated
- 1 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The results will be shared when the author is requested for meta-analysis studies.
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 Ice Application and Kaleidoscope Application on the Management of Cannulation-Related Pain in Dialysis Patients With Arteriovenous Fistula
- ClinicalTrials.gov ID
- NCT06236867
- Acronym / sponsor ID
- AVF / AU-SBE-SY-01
- Conditions
- Hemodialysis Access
- Keywords
- Arteriovenous fistula, Nursing, Pain Management
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 102 participants (actual)
- Lead sponsor
- Sülayman YAMANUniversity, hospital or other
- Study start
- 13 Mar 2023 (actual)
- Primary completion
- 2 Jun 2023 (actual)
- Study completion
- 26 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.
It was conducted to investigate the effect of ice application to the kaleidoscope and hoku point on the management of cannulization-related pain in patients receiving hemodialysis treatment.
Detailed description
After obtaining the necessary permissions for the research, the patients who were followed up in the hemodialysis unit of X,Y, Z Hospitals were randomly divided into three groups (Kaleidoscope application, ice application and control group).
Patients were made to sign written voluntary consent forms by the researchers.After the patients were transferred to the randomized program for the arrival days and TC numbers for the dialysis session, they were assigned to the experimental and control groups.
The patients' pain levels were evaluated during 3 dialysis sessions.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
- Model description
- After obtaining the necessary permissions for the research, the patients who were followed up in the hemodialysis unit of X,Y, Z Hospitals were randomly divided into three groups (Kaleidoscope application, ice application and control group). Patients were made to sign written voluntary consent forms by the researchers.After the patients were transferred to the randomized program for the arrival days and TC numbers for the dialysis session, they were assigned to the experimental and control groups. The patients' pain levels were evaluated during 3 dialysis sessions. The pain level was evaluated without the procedure on the first day. 2 and 3. on the other hand, pain levels were evaluated after the interventions per day. The data in the research are; Patient Diagnosis Form, Numerical Rating Scale and Life Signs Follow-up Form and Kaleidoscope Application Patient Experience Form, It was collected using the Patient Experience Form Related to Ice Application.
| Arm | Type | Receives |
|---|---|---|
| Kaleidoscope Group | Experimental | Other: KaleidoscopeGroupIn order for the patients in the kaleidoscope group to recognize the device and increase their compliance during the procedure, a practice was performed using the device before the AVF cannulation procedure. Kaleidoscope application was performed during cannulation. |
| Ice Application Group | Experimental | Other: Ice Application GroupIce application application was made with non-melting ice molds to the area where the index finger and thumb of the hand with fistula are joined (HOKU point). |
| Control Group | Experimental | Other: Control GroupIn the control group, the vital signs of the patients before AVF cannulation will be recorded. Before, during and after AVF cannulation, VAS pain scores will be evaluated after cannulation without any intervention. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Comfortable reception of trill and murmur sound from arteriovenous fistula,
- over the age of 18 and no communication problems,
- Having a place and time orientation,
- No dizziness,
Key exclusion criteria (6 listed)
- Hemodialysis of the patient with arteriovenous graft and/or central venous catheter
- Pharmacological application was made to relieve pain 30 minutes before AVF cannulation,
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 |
|---|---|---|
| KaleidoscopeGroupAlso: ExperimentalThe group consists of 34 people. Pain level was measured during 3 dialysis sessions.In order for the patients in the kaleidoscope group to recognize the device and increase their compliance during the procedure, a practice was performed using the device before the AVF cannulation procedure. Kaleidoscope application was performed during cannulation. | Other | Kaleidoscope Group |
| Ice Application GroupAlso: ExperimentalThe group consists of 34 people. Pain level was measured during 3 dialysis sessions. Before, during and after AVF cannulation, VAS pain scores will be evaluated after cannulation without any intervention.Ice application application was made with non-melting ice molds to the area where the index finger and thumb of the hand with fistula are joined (HOKU point) | Other | Ice Application Group |
| Control GroupAlso: ExperimentalThe group consists of 34 people. Pain level will be measured during 3 dialysis sessions. In the control group, the vital signs of the patients before AVF cannulation will be recorded. | Other | Control Group |
Primary outcome
visual pain scale (min-max:0-10 point) (1 week= during 3rd dialysis sessions)
Time frame: One week= during 3rd dialysis sessions
Evaluation of pain levels (minimum=0 points, maximum: 10 points) of experimental and control groups in the 1st, 2nd and 3rd dialysis sessions The visual pain scale is minimum 0 and maximum 10 points. 0 means no pain, 10 means severe pain. 1. st dialysis session= Visual analog pain scores during cannulation were evaluated without any application. 2. nd and 3rd dialysis sessions: Ice application to the patient's hoku point was performed by the researcher for 1 min before the AVF cannulation procedure and during cannulation, and visual analog scale pain scores was filled in during cannulation. Kaleidoscope application was performed to the patient for 5 minutes before AVF cannulation procedure and during cannulation. The visual analog scale pain score was filled in during cannulation. Control Group:visual analog scale pain scores will be evaluated before, during and after AVF cannulation without any intervention after the procedure.
2 secondary outcomes
The evaluation of Ice Application and kaleidoscope application
Time frame: After 3rd dialysis session (after one week)
Sociodemographic and disease-related characteristics
Time frame: through study completion, an average of 3rd month.
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.
- Individual participant dataSharing planned: No. The results will be shared when the author is requested for meta-analysis studies.
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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 KaleidoscopeGroup and Ice Application Group in people with Hemodialysis Access, run by Sülayman YAMAN 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 4 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 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?
visual pain scale (min-max:0-10 point) (1 week= during 3rd dialysis sessions) (time frame: One week= during 3rd dialysis sessions). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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.