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Acupressure and Fistula Needle Insert Pain Management

Primary Purpose

Chronic Kidney Disease Stage 5 (Disorder)

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Acupreesure applied
Sponsored by
Baskent University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Chronic Kidney Disease Stage 5 (Disorder)

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria 18 years or older have brescia-cimino, snuff-box or antecubital fistula speak Turkish have hemodialysis(HD) treatment three times a week have not used analgesics in the last 6 hours had no pain who volunteered to participate in the study. Exclusion Criteria With aneurysmatic fistula had soft tissue damage infection in extremities has coagulations and bleeding problems.

Sites / Locations

  • Baskent University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

experimental group

Control Group

Arm Description

Intervention group 1 consisted of patients with brescia-cimino fistula Intervention group 2 consisted of patients with snuff-box fistula Intervention group 3 consisted of patients with antecubital fistula.

Control group 1 consisted of patients with brescia-cimino fistula Control group 2 consisted of patients with snuff-box fistula Control group 3 consisted of patients with antecubital fistula.

Outcomes

Primary Outcome Measures

Numeric Rating Scale was used to determine the severity of acute pain experienced by patients during fistula needle insertion.
The pain severity of the patient is determined with the Numeric Rating Scale. NRS includes numbers from 0 to 10. The meaning of the number "0" on the scale is "I have no pain" and the number "10" means "I have very severity pain".

Secondary Outcome Measures

Full Information

First Posted
July 18, 2023
Last Updated
July 31, 2023
Sponsor
Baskent University
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1. Study Identification

Unique Protocol Identification Number
NCT05971134
Brief Title
Acupressure and Fistula Needle Insert Pain Management
Official Title
The Effect of Acupressure Applied to Different Fistula Area on Fistula Needle Insert Pain: A Randomized Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Completed
Study Start Date
October 1, 2022 (Actual)
Primary Completion Date
February 1, 2023 (Actual)
Study Completion Date
July 1, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Baskent University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Introduction: This study was conducted to determine the effectiveness of acupressure application on Hegu (LI4) point on the severity of acute pain caused by fistula needle in patients with brescia-cimino, snuff-box and antecubital fistula. Methods: This study was randomized control study which was conducted with 66 intervention and 65 control participants. The participants in the intervention group were divided into 3 groups according to the fistula area. Data were collected using Descriptive Information Form and pain scale.
Detailed Description
This study is determined that finger acupuncture at L14 point reduces the severity of pain felt by the patient during fistula needle insertion. Acute pain during puncture of arteriovenous fistula is a common problem in hemodialysis patients. Moreover, patients experience this acute pain three times a week. Accordingly, acupressure applied to the L4 acupuncture point can be considered as an effective, simple and low-cost non-pharmacological method to reduce acute pain during needle insertion in patients. Since this application is non-invasive and does not carry the risk of complications, it can be taught to patients and/or nurses to contribute to the management of acute pain. In addition, in this article, we examined the effect of acupressure applied only to the LI4 acupuncture point on pain intensity during fistula needle insertion, therefore, we suggest designing different studies with different acupuncture points (effective in reducing pain).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Kidney Disease Stage 5 (Disorder)

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
131 (Actual)

8. Arms, Groups, and Interventions

Arm Title
experimental group
Arm Type
Experimental
Arm Description
Intervention group 1 consisted of patients with brescia-cimino fistula Intervention group 2 consisted of patients with snuff-box fistula Intervention group 3 consisted of patients with antecubital fistula.
Arm Title
Control Group
Arm Type
No Intervention
Arm Description
Control group 1 consisted of patients with brescia-cimino fistula Control group 2 consisted of patients with snuff-box fistula Control group 3 consisted of patients with antecubital fistula.
Intervention Type
Behavioral
Intervention Name(s)
Acupreesure applied
Intervention Description
Acupressure was applied to the LI4 acupuncture point for 3 minutes by the researcher for the intervention group
Primary Outcome Measure Information:
Title
Numeric Rating Scale was used to determine the severity of acute pain experienced by patients during fistula needle insertion.
Description
The pain severity of the patient is determined with the Numeric Rating Scale. NRS includes numbers from 0 to 10. The meaning of the number "0" on the scale is "I have no pain" and the number "10" means "I have very severity pain".
Time Frame
1 week

10. Eligibility

Sex
All
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria 18 years or older have brescia-cimino, snuff-box or antecubital fistula speak Turkish have hemodialysis(HD) treatment three times a week have not used analgesics in the last 6 hours had no pain who volunteered to participate in the study. Exclusion Criteria With aneurysmatic fistula had soft tissue damage infection in extremities has coagulations and bleeding problems.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Assistant prof. GÜLAY TURGAY
Organizational Affiliation
Baskent University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Baskent University
City
Ankara
State/Province
Türkiye
ZIP/Postal Code
109861
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
After the article is published

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Acupressure and Fistula Needle Insert Pain Management

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