PainNCT05252377
Breathing Exercise and Invasive Pain at Hemodialysis Patients
A study testing Breathing Exercise in people with Pain and Arteriovenous Fistula, run by Istanbul Demiroglu Bilim University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Pain, Arteriovenous Fistula, Breathing Exercise
- What is being tested?
- Breathing Exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 5 Jan 2022to 1 May 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Investigation of the Effect of Breathing Exercise on Invasive Pain Associated With Arteriovenous Fistula Cannulation in Hemodialysis Patients.
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.
Read the 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.
- Conditions
- Pain, Arteriovenous Fistula, Breathing Exercise
- Being tested
- Breathing Exercise
- Medical subject headings
- Pain, Arteriovenous Fistula
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Breathing ExerciseOther
- 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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At the end of the every dialysis session during one month (3 hemodialysis sessions are done every week)]
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2022
- Study start5 Jan 2022
- Primary completion1 Apr 2022
- Study completion1 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul Demiroglu Bilim University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nurten Ozen, Istanbul Demiroglu Bilim University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05252377
- Sponsor's protocol ID
- 2021-20-02
- Status last verified
- Sep 2022
- First submitted
- 14 Feb 2022
- Last updated
- 9 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 31797508Aitken 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.
PubMed 23743153Crespo 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.
PubMed 15835412
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Effect of Breathing Exercise on Invasive Pain Associated With Arteriovenous Fistula Cannulation in Hemodialysis Patients.
- ClinicalTrials.gov ID
- NCT05252377
- Acronym / sponsor ID
- 2021-20-02
- Conditions
- Pain, Arteriovenous Fistula, Breathing Exercise
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Istanbul Demiroglu Bilim UniversityUniversity, hospital or other
- Study start
- 5 Jan 2022 (actual)
- Primary completion
- 1 Apr 2022 (actual)
- Study completion
- 1 May 2022 (actual)
- First posted
- 23 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Breathing Exercise Group | Experimental | Other: Breathing ExerciseBreathing 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. |
| 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Breathing Exercise1. 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. | Other | Breathing Exercise Group |
Primary outcome
Change From Baseline Invasive Pain at 12 Dialysis Session
Time frame: At the end of the every dialysis session during one month (3 hemodialysis sessions are done every week)]
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2022.
- Background: PubMed 31797508Alzaatreh 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.
- Background: PubMed 23743153Aitken 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.
- Background: PubMed 15835412Crespo 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Breathing Exercise in people with Pain and Arteriovenous Fistula, run by Istanbul Demiroglu Bilim University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change From Baseline Invasive Pain at 12 Dialysis Session (time frame: At the end of the every dialysis session during one month (3 hemodialysis sessions are done every week)]). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05252377, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Sep 2022.