Cannulation-Related Pain in Dialysis Patients With Arteriovenous Fistula

NCT ID: NCT06236867

Last Updated: 2024-02-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

102 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-03-13

Study Completion Date

2023-12-26

Brief Summary

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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

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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

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Hemodialysis Access

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.
Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Outcome Assessors
The patients did the pain scoring without knowing which group they were in. Patients are blinded.

In order to prevent the groups from being affected by each other, a inspection curtain was placed between the dialysis machines during the applications.

The data were coded as A, B and C groups and sent for statistical analysis. The outcomes assesor doing the analysis here is blinded.

Study Groups

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Kaleidoscope Group

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.

Group Type EXPERIMENTAL

KaleidoscopeGroup

Intervention Type OTHER

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 Group

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).

Group Type EXPERIMENTAL

Ice Application Group

Intervention Type OTHER

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 Group

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.

Group Type EXPERIMENTAL

Control Group

Intervention Type OTHER

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.

Interventions

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KaleidoscopeGroup

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.

Intervention Type OTHER

Ice Application Group

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)

Intervention Type OTHER

Control Group

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.

Intervention Type OTHER

Other Intervention Names

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Experimental Experimental Experimental

Eligibility Criteria

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Inclusion Criteria

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,

Exclusion Criteria

* 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
Minimum Eligible Age

18 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sülayman YAMAN

OTHER

Sponsor Role lead

Responsible Party

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Sülayman YAMAN

Master Student

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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Amasya University İnstitute of Health Sciences

Amasya, Merkez, Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Other Identifiers

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AU-SBE-SY-01

Identifier Type: -

Identifier Source: org_study_id

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