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Completed

NCT Number: NCT06236867

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.

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Key information

Conditions

Hemodialysis Access Agnosia Arteriovenous Fistula Arteriovenous Malformations Cardiovascular Abnormalities Cardiovascular Diseases Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Fistula Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Perceptual Disorders Signs and Symptoms Vascular Diseases Vascular Fistula Vascular Malformations

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Amasya University İnstitute of Health Sciences

Amasya, Merkez, 05100, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

KaleidoscopeGroup

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.

Other names: Experimental

Ice Application Group

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)

Other names: Experimental

Control Group

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.

Other names: Experimental

Primary outcomes

  1. 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.

    • 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.

Secondary outcomes

  1. 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".

  2. 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.

Sponsors and collaborators

Lead sponsor

Sülayman YAMAN

Other

Registry information

Official study title

The Effect of Ice Application and Kaleidoscope Application on the Management of Cannulation-Related Pain in Dialysis Patients With Arteriovenous Fistula

Acronym: AVF

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Feb 1, 2024
Registry last updated
Feb 1, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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