Cannulation-Related Pain in Dialysis Patients With Arteriovenous Fistula (AVF)

January 30, 2024 updated by: Sülayman YAMAN

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.

Study Overview

Status

Completed

Conditions

Intervention / 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 Type

Interventional

Enrollment (Actual)

102

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
    • Merkez
      • Amasya, Merkez, Turkey, 05100
        • Amasya University İnstitute of Health Sciences

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Other: 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.
Other Names:
  • Experimental
Experimental: 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).
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)
Other Names:
  • Experimental
Experimental: 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.
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.
Other Names:
  • Experimental

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
One week= during 3rd dialysis sessions

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The evaluation of Ice Application and kaleidoscope application
Time Frame: After 3rd dialysis session (after one week)

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".
After 3rd dialysis session (after one week)
Sociodemographic and disease-related characteristics
Time Frame: through study completion, an average of 3rd month.

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.
through study completion, an average of 3rd month.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sülayman YAMAN

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 13, 2023

Primary Completion (Actual)

June 2, 2023

Study Completion (Actual)

December 26, 2023

Study Registration Dates

First Submitted

December 27, 2023

First Submitted That Met QC Criteria

January 30, 2024

First Posted (Estimated)

February 1, 2024

Study Record Updates

Last Update Posted (Estimated)

February 1, 2024

Last Update Submitted That Met QC Criteria

January 30, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AU-SBE-SY-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

The results will be shared when the author is requested for meta-analysis studies.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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