Cannulation-Related Pain in Dialysis Patients With Arteriovenous Fistula

NCT06236867 | Completed

• 1 other identifier: AU-SBE-SY-01
• Study Type: interventional
• Target: 102
• Locations: 1 country
• Sites: 1

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.

Conditions

Hemodialysis Access

Keywords

Arteriovenous fistula; Nursing; Pain Management

Outcome Measures

Primary Outcomes (1)

• 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. 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 Outcomes (2)

• The evaluation of Ice Application and kaleidoscope application

  After 3rd dialysis session (after one week)

• Sociodemographic and disease-related characteristics

  through study completion, an average of 3rd month.

Study Arms (3)

Kaleidoscope Group

EXPERIMENTAL

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

Ice Application Group

EXPERIMENTAL

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

Control Group

EXPERIMENTAL

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

Interventions

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.

Also known as: Experimental

Kaleidoscope Group

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)

Also known as: Experimental

Ice Application Group

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.

Also known as: Experimental

Control Group

Eligibility Criteria

• Age: 18 Years - 100 Years
• Gender Eligibility Details: Over age the 18
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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,

You may not qualify if:

• 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

Sponsors & Collaborators

• Sülayman YAMAN: lead

Study Sites (1)

Amasya University İnstitute of Health Sciences

Amasya, Merkez, 05100, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Arteriovenous Fistula; Agnosia

Interventions

Control Groups

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Master Student

Model Details: 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.

Study Record Dates

• First Submitted: December 27, 2023
• First Posted: February 1, 2024
• Study Start: March 13, 2023
• Primary Completion: June 2, 2023
• Study Completion: December 26, 2023
• Last Updated: February 1, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)