- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05971134
Acupressure and Fistula Needle Insert Pain Management
The Effect of Acupressure Applied to Different Fistula Area on Fistula Needle Insert Pain: A Randomized Clinical Trial
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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Türkiye
-
Ankara, Türkiye, Turkey, 109861
- Baskent University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: experimental group
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.
|
Acupressure was applied to the LI4 acupuncture point for 3 minutes by the researcher for the intervention group
|
|
No Intervention: Control Group
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Numeric Rating Scale was used to determine the severity of acute pain experienced by patients during fistula needle insertion.
Time Frame: 1 week
|
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".
|
1 week
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Assistant prof. GÜLAY TURGAY, Baskent University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pathologic Processes
- Urologic Diseases
- Disease Attributes
- Renal Insufficiency
- Pathological Conditions, Anatomical
- Chronic Disease
- Female Urogenital Diseases
- Female Urogenital Diseases and Pregnancy Complications
- Urogenital Diseases
- Male Urogenital Diseases
- Kidney Diseases
- Renal Insufficiency, Chronic
- Fistula
Other Study ID Numbers
- Acupressure
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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