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Breathing Exercise and Invasive Pain at Hemodialysis Patients

Primary Purpose

Pain, Arteriovenous Fistula, Breathing Exercise

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Breathing Exercise
Sponsored by
Istanbul Demiroglu Bilim University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Pain

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Hemodialysis treatment with arteriovenous for at least 3 months
  • Hemodialysis treatment is applied for 3 days and 4 hours a week.
  • Between the ages of 18-65
  • Pain score ≥ 2 as assessed by Visual Analogue Scale during cannulation of the arteriovenous fistula
  • Absence of advanced heart failure, asthma and chronic obstructive pulmonary disease
  • Able to communicate in Turkish
  • Not having any psychiatric disorder that prevents communication
  • Agreeing to participate in the research

Exclusion Criteria:

  • Inability to do breathing exercises properly
  • Presence of infection, edema and scar tissue in the area where the arteriovenous fistula is located
  • Using pain medication before hemodialysis treatment
  • Two or more cannulation attempts for arteriovenous fistula in the same session
  • Presence of neuropathy and peripheral vascular disease
  • Pregnancy
  • Withdrawal from the study at any stage of the research

Sites / Locations

  • Demiroglu Bilim University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Breathing Exercise Group

Control Group

Arm Description

Breathing exercise program; It was prepared by the researchers in accordance with the literature and based on the studies in which breathing exercise was applied to reduce invasive pain experienced during cannulation, blood collection and postoperative pain. Patients will be given an exercise based on rhythmic breathing. The exercise will be started before the cannulation application, the patient will be told to perform the breathing exercise twice, and he will be asked to continue doing the breathing exercise until the cannulation process is completed. The patient will wait by taking five normal breaths between each breathing exercise. The patient will be told that he can count by using his fingers in the steps he is asked to count up to three.

No intervention will be made by the researcher on the patients in this group, and a pain assessment will be made by the nurse in charge of dialysis immediately after the cannulation procedure by the dialysis nurse working in the unit.

Outcomes

Primary Outcome Measures

Change From Baseline Invasive Pain at 12 Dialysis Session
It will be assessed total 12 times at the end of the dialysis session with Visual Analogue. Pain intensity measured on a Visual Analog Scale with scores ranging from 0 - 10. Pain increases as the score increases. The high point describes bad outcome.

Secondary Outcome Measures

Full Information

First Posted
February 14, 2022
Last Updated
September 8, 2022
Sponsor
Istanbul Demiroglu Bilim University
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1. Study Identification

Unique Protocol Identification Number
NCT05252377
Brief Title
Breathing Exercise and Invasive Pain at Hemodialysis Patients
Official Title
Investigation of the Effect of Breathing Exercise on Invasive Pain Associated With Arteriovenous Fistula Cannulation in Hemodialysis Patients.
Study Type
Interventional

2. Study Status

Record Verification Date
September 2022
Overall Recruitment Status
Completed
Study Start Date
January 5, 2022 (Actual)
Primary Completion Date
April 1, 2022 (Actual)
Study Completion Date
May 1, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Istanbul Demiroglu Bilim 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
Non-pharmacological approaches applied in the prevention of invasive pain due to cannulation in patients treated with arteriovenous fistula and hemodialysis; It is also a cost-effective method that prevents the patient from feeling pain from the application. Breathing exercises are a method that can be easily applied before the cannulation procedure. Although it is seen that there are limited number of studies on the subject in the literature, it was observed that the duration of breathing exercise application was short (two weeks) in one study and the duration was not specified in the other.
Detailed Description
An average of 312 cannulations per year is performed in a patient who is treated for chronic hemodialysis and has arteriovenous fistula. Patients state that they experience moderate to severe pain at a rate of 57-60.9% when accessing the arteriovenous. In cases where access to the fistula cannot be achieved at one time, patients may experience pain due to; patients experience non-compliance with dialysis treatment and their quality of life is adversely affected. This situation causes an increase in the mortality rate, especially with cardiovascular and respiratory system complications. In recent years, breathing exercise, which is one of the methods of distraction, has been used to reduce the invasive pain experienced during blood collection and cannulation procedures. By increasing lung ventilation with breathing, the amount of oxygen entering the body is maximized, and this causes relaxation in the patient. This relaxation also causes the person to relax and reduce the pain they will feel. Although studies have found that breathing exercise is effective in reducing invasive pain; No information was given about the exercise method and duration. Although in practice, holding the patient's breath during venipuncture and performing the cannulation procedure while giving it is a method frequently applied by the nurse, no study with high evidence supporting the situation has been found in the literature.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Arteriovenous Fistula, Breathing Exercise

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
100 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Breathing Exercise Group
Arm Type
Experimental
Arm Description
Breathing exercise program; It was prepared by the researchers in accordance with the literature and based on the studies in which breathing exercise was applied to reduce invasive pain experienced during cannulation, blood collection and postoperative pain. Patients will be given an exercise based on rhythmic breathing. The exercise will be started before the cannulation application, the patient will be told to perform the breathing exercise twice, and he will be asked to continue doing the breathing exercise until the cannulation process is completed. The patient will wait by taking five normal breaths between each breathing exercise. The patient will be told that he can count by using his fingers in the steps he is asked to count up to three.
Arm Title
Control Group
Arm Type
No Intervention
Arm Description
No intervention will be made by the researcher on the patients in this group, and a pain assessment will be made by the nurse in charge of dialysis immediately after the cannulation procedure by the dialysis nurse working in the unit.
Intervention Type
Other
Intervention Name(s)
Breathing Exercise
Intervention Description
The patient will be asked to close their eyes He will be asked to relax his head and neck in a semi-sitting position in bed The patient will be asked to breathe through the nose for 3 seconds by counting Then he will be told to hold his breath for 3 seconds As the last step, he will be asked to breathe out again in 3 seconds.
Primary Outcome Measure Information:
Title
Change From Baseline Invasive Pain at 12 Dialysis Session
Description
It will be assessed total 12 times at the end of the dialysis session with Visual Analogue. Pain intensity measured on a Visual Analog Scale with scores ranging from 0 - 10. Pain increases as the score increases. The high point describes bad outcome.
Time Frame
At the end of the every dialysis session during one month (3 hemodialysis sessions are done every week)]

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Hemodialysis treatment with arteriovenous for at least 3 months Hemodialysis treatment is applied for 3 days and 4 hours a week. Between the ages of 18-65 Pain score ≥ 2 as assessed by Visual Analogue Scale during cannulation of the arteriovenous fistula Absence of advanced heart failure, asthma and chronic obstructive pulmonary disease Able to communicate in Turkish Not having any psychiatric disorder that prevents communication Agreeing to participate in the research Exclusion Criteria: Inability to do breathing exercises properly Presence of infection, edema and scar tissue in the area where the arteriovenous fistula is located Using pain medication before hemodialysis treatment Two or more cannulation attempts for arteriovenous fistula in the same session Presence of neuropathy and peripheral vascular disease Pregnancy Withdrawal from the study at any stage of the research
Facility Information:
Facility Name
Demiroglu Bilim University
City
Istanbul
ZIP/Postal Code
34384
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
31797508
Citation
Alzaatreh MY, Abdalrahim MS. Management Strategies for Pain Associated with Arteriovenous Fistula Cannulation: An Integrative Literature Review. Hemodial Int. 2020 Jan;24(1):3-11. doi: 10.1111/hdi.12803. Epub 2019 Dec 3.
Results Reference
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PubMed Identifier
23743153
Citation
Aitken E, McLellan A, Glen J, Serpell M, Mactier R, Clancy M. Pain resulting from arteriovenous fistulae: prevalence and impact. Clin Nephrol. 2013 Nov;80(5):328-33. doi: 10.5414/CN107917.
Results Reference
background
PubMed Identifier
15835412
Citation
Crespo Montero R, Rivero Arellano F, Contreras Abad MD, Martinez Gomez A, Fuentes Galan MI. Pain degree and skin damage during arterio-venous fistula puncture. EDTNA ERCA J. 2004 Oct-Dec;30(4):208-12. doi: 10.1111/j.1755-6686.2004.tb00369.x.
Results Reference
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Breathing Exercise and Invasive Pain at Hemodialysis Patients

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