NCT05252377

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable pain

Timeline
Completed

Started Jan 2022

Shorter than P25 for not_applicable pain

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 5, 2022

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

February 14, 2022

Completed
9 days until next milestone

First Posted

Study publicly available on registry

February 23, 2022

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2022

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2022

Completed
Last Updated

September 9, 2022

Status Verified

September 1, 2022

Enrollment Period

3 months

First QC Date

February 14, 2022

Last Update Submit

September 8, 2022

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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.

    At the end of the every dialysis session during one month (3 hemodialysis sessions are done every week)]

Study Arms (2)

Breathing Exercise Group

EXPERIMENTAL

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.

Other: Breathing Exercise

Control Group

NO INTERVENTION

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.

Interventions

1. The patient will be asked to close their eyes 2. He will be asked to relax his head and neck in a semi-sitting position in bed 3. The patient will be asked to breathe through the nose for 3 seconds by counting 4. Then he will be told to hold his breath for 3 seconds 5. As the last step, he will be asked to breathe out again in 3 seconds.

Breathing Exercise Group

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Demiroglu Bilim University

Istanbul, 34384, Turkey (Türkiye)

Location

Related Publications (3)

  • 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.

    PMID: 31797508BACKGROUND
  • 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.

    PMID: 23743153BACKGROUND
  • 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.

    PMID: 15835412BACKGROUND

MeSH Terms

Conditions

PainArteriovenous Fistula

Interventions

Breathing Exercises

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsArteriovenous MalformationsVascular MalformationsCardiovascular AbnormalitiesCardiovascular DiseasesVascular FistulaVascular DiseasesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesFistulaPathological Conditions, Anatomical

Intervention Hierarchy (Ancestors)

Mind-Body TherapiesComplementary TherapiesTherapeuticsExercise Movement TechniquesPhysical Therapy Modalities

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

February 14, 2022

First Posted

February 23, 2022

Study Start

January 5, 2022

Primary Completion

April 1, 2022

Study Completion

May 1, 2022

Last Updated

September 9, 2022

Record last verified: 2022-09

Data Sharing

IPD Sharing
Will not share

Locations