Cannulation-Related Pain in Dialysis Patients With Arteriovenous Fistula

Not Applicable

Completed

• Conditions: Hemodialysis Access
• Interventions: Other: Control Group; Other: KaleidoscopeGroup; Other: Ice Application Group

• Registration Number: NCT06236867
• Lead Sponsor: Sülayman YAMAN

Brief 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.

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 Timeline

• Study Start: 2023-03-13
• Primary Completion: 2023-06-02
• Study Completion: 2023-12-26
• Study First Submitted: 2023-12-27
• Status Verified: 2024-01
• Study First Submitted QC: 2024-01-30
• Last Update Submitted: 2024-01-30
• Study First Posted: 2024-02-01
• Last Update Posted: 2024-02-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 102

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control Group	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.
Kaleidoscope Group	KaleidoscopeGroup	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 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).

Primary Outcome Measures

Name	Time	Method
visual pain scale (min-max:0-10 point) (1 week= during 3rd dialysis sessions)	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.

Secondary Outcome Measures

Name	Time	Method
Sociodemographic and disease-related characteristics	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.
The evaluation of Ice Application and kaleidoscope application	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".

Trial Locations

Locations (1)

Amasya University İnstitute of Health Sciences; 🇹🇷 Amasya, Merkez, Turkey