Cannulation-Related Pain in Dialysis Patients With Arteriovenous Fistula

Hemodialysis Access Clinical Trial

— AVF  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06236867
• Other study ID #: AU-SBE-SY-01
• Status: Completed
• Phase: N/A
• Start date: March 13, 2023
• Est. completion date: December 26, 2023

Study information

• Verified date: January 2024
• Source: Amasya University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 102
• Est. completion date: December 26, 2023
• Est. primary completion date: June 2, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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

Related Conditions & MeSH terms

• Arteriovenous Fistula
• Fistula
• Hemodialysis Access

Intervention

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.
• 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)
• 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.

Locations

Country	Name	City	State
Turkey	Amasya University Institute of Health Sciences	Amasya	Merkez

Sponsors (1)

Lead Sponsor	Collaborator
Sülayman YAMAN

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	One week= during 3rd dialysis sessions
Secondary	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".	After 3rd dialysis session (after one week)
Secondary	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.	through study completion, an average of 3rd month.