HemodialysisNCT07427875
Breathing Exercises for Pain and Anxiety During Arteriovenous Fistula Cannulation
A study testing Guided 4-7-8 Breathing Exercise, Guided Diaphragmatic Breathing Exercise and routine care in people with Hemodialysis and Arteriovenous Fistula Cannulation, run by Emine Kaplan Serin at 1 site in Turkey (Türkiye).
Trial summary
This study aims to evaluate the effects of guided 4-7-8 and diaphragmatic breathing exercises performed during arteriovenous fistula cannulation on pain, anxiety, and comfort levels in patients undergoing hemodialysis treatment. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Hemodialysis, Arteriovenous Fistula Cannulation, Breathing Exercises
- What is being tested?
- Guided 4-7-8 Breathing Exercise, Guided Diaphragmatic Breathing Exercise and routine care
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 10 Feb 2026to 1 Apr 2026
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Be 18 years of age or older
- Have been receiving regular hemodialysis treatment for at least 6 months
- Undergo hemodialysis via an AV fistula
- Have the physical and cognitive ability to perform breathing exercises during cannulation
- Have a cognitive level sufficient to communicate
- Volunteer to participate in the study and sign the written informed consent form Exclusion criteria
Show all 12Show fewer
- Those with pain level 4 or higher
- Those using painkillers and antidepressants
- Those with a history of acute complications
- Patients using a vascular access route other than an AV fistula
- Those with severe cognitive impairment or a neurological disease that impairs communication
- Those with severe cardiopulmonary disease that may contraindicate breathing exercises Patients with an infection requiring contact isolation
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Mersin University Faculty of Nursing Çiftlikköy Campus 33343, Yenişehir / Mersin
Mersin, Yenişehir, 33000
About this study
Official title: The Effect of Guided 4-7-8 and Diaphragmatic Breathing Exercises During Arteriovenous Fistula Cannulation on Pain, Anxiety, and Comfort Levels in Hemodialysis Patients: A Randomized Controlled Trial
This study aims to evaluate the effects of guided 4-7-8 and diaphragmatic breathing exercises performed during arteriovenous fistula cannulation on pain, anxiety, and comfort levels in patients undergoing hemodialysis treatment. Hemodialysis patients often experience pain and anxiety during fistula cannulation, which can negatively affect the treatment process and patient comfort.
The study will be conducted as a three-arm randomized controlled trial. Participants will be randomly assigned to the 4-7-8 breathing exercise group, the diaphragmatic breathing exercise group, or the control group receiving usual care. In the intervention groups, breathing exercises will be performed with guidance before and during cannulation.
The study anticipates that breathing exercises will reduce pain and anxiety, increase comfort levels, and contribute as an easily applicable, side-effect-free method to nursing care. The findings are expected to support the use of non-pharmacological interventions in hemodialysis patients.
Read the detailed description
This study is a randomized controlled trial designed to evaluate the effects of non-pharmacological breathing exercises applied during arteriovenous fistula cannulation on pain, anxiety, and comfort levels in hemodialysis patients. The research will be conducted within routine clinical practice, and no additional invasive procedures will be performed beyond standard care.
During the study process, guided breathing exercises will be applied to patients in the intervention groups before and during arteriovenous fistula cannulation, which is routinely performed in the hemodialysis unit. Patients in the control group will continue to receive standard nursing care without any additional intervention. The breathing exercises used in this study are complementary nursing interventions that are easy to apply in clinical settings, cost-free, and associated with no known serious adverse effects.
All measurement tools used in the study are validated and reliable instruments, and the collected data will be used solely for research purposes. Participants' personal information will be kept confidential, data will be coded and analyzed anonymously, and no identifying information will be shared with third parties. Participation in the study is entirely voluntary, and participants may withdraw from the study at any time without providing a reason. Withdrawal from the study will not affect patients' ongoing treatment processes or their right to receive healthcare services.
The breathing exercises will be administered with careful consideration of patients' physical and cognitive conditions. If any clinical risk or contraindication to the breathing exercises is identified, the intervention will be discontinued immediately. Participant safety will be prioritized throughout the study, and appropriate clinical interventions will be provided promptly in the event of any discomfort or adverse situation.
The findings obtained from this study are expected to contribute evidence-based data to nursing care practices related to arteriovenous fistula cannulation in hemodialysis patients and to support the integration of effective non-pharmacological interventions into clinical practice.
- Conditions
- Hemodialysis, Arteriovenous Fistula Cannulation, Breathing Exercises, Pain, Anxiety, Comfort
- Being tested
- Guided 4-7-8 Breathing Exercise, Guided Diaphragmatic Breathing Exercise, routine care
- Medical subject headings
- Pain, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Guided 4-7-8 Breathing ExerciseBehavioural
Also called 4-7-8 Breathing Technique
Katılımcılar, rutin hemodiyaliz bakımına ek olarak, arteriyovenöz fistül kanülasyonu öncesinde ve sırasında rehberli 4-7-8 nefes egzersizi yapacaklardır. Bu teknik, 4 saniye boyunca burundan nefes almak, 7 saniye boyunca nefesini tutmak ve 8 saniye boyunca ağızdan yavaşça nefes vermekten oluşur. Egzersiz, her kanülasyon seansı sırasında standart bir protokole göre araştırmacıların rehberliğinde uygulanacaktır.
Guided Diaphragmatic Breathing ExerciseBehavioural
Also called Diaphragmatic Breathing Technique
Participants will perform guided diaphragmatic breathing exercises before and during arteriovenous fistula cannulation in addition to routine hemodialysis care. The intervention involves slow and deep breathing with diaphragmatic expansion, emphasizing abdominal movement rather than chest movement. The breathing exercises will be administered under researcher guidance according to a standardized protocol during each cannulation session.
routine careOther
Also called Usual Care
Participants in this group will receive routine nursing care during arteriovenous fistula cannulation according to standard clinical practice. No breathing exercise or additional intervention will be applied.
| Study group | Role | What they receive |
|---|---|---|
| 4-7-8 Breathing Exercise Group | Experimental | Participants in this experimental group will receive guided 4-7-8 breathing exercises before and during arteriovenous fistula cannulation in addition to routine hemodialysis care. The 4-7-8 breathing technique consists of inhaling through the nose for 4 seconds, holding the breath for 7 seconds, and exhaling slowly through the mouth for 8 seconds. The breathing exercises will be performed under researcher guidance according to a standardized protocol during each cannulation session. Receives: Behavioral: Guided 4-7-8 Breathing Exercise |
| Diaphragmatic Breathing Exercise Group | Experimental | Participants in this experimental group will receive guided diaphragmatic breathing exercises before and during arteriovenous fistula cannulation in addition to routine hemodialysis care. The intervention involves slow and deep breathing with diaphragmatic expansion, emphasizing abdominal movement rather than chest movement. The breathing exercises will be performed under researcher guidance according to a standardized protocol during each cannulation session. Receives: Behavioral: Guided Diaphragmatic Breathing Exercise |
| Control Group (Usual Care) | Other | Participants in this control group will receive routine nursing care during arteriovenous fistula cannulation according to standard clinical practice. No breathing exercise or additional intervention will be applied. Receives: Other: routine care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Anxiety level during arteriovenous fistula cannulation
State anxiety will be measured using the State-Trait Anxiety Inventory (STAI) state subscale. The subscale consists of 20 items rated on a four-point Likert scale. Total scores range from 20 to 80, with higher scores indicating greater anxiety. Anxiety will be assessed during arteriovenous fistula cannulation to evaluate the immediate effect of the intervention.
Measured: During arteriovenous fistula cannulation
Secondary outcomes (8)
Pain intensity during arteriovenous fistula cannulation
Pain intensity will be measured using the Visual Analog Scale (VAS). The scale ranges from 0 to 10, where 0 indicates no pain and 10 indicates the worst possible pain. Higher scores indicate greater pain intensity. Pain will be assessed during arteriovenous fistula cannulation to evaluate the effect of the intervention.
Measured: During arteriovenous fistula cannulation.
Systolic blood pressure
Time Frame: Pre-cannulation and post-cannulation Unit of Measure: mmHg
Description:
Higher values indicate higher blood pressure and potentially worse physiological response.
Measured: During arteriovenous fistula cannulation.
Diastolic blood pressure
Time Frame: Pre-cannulation and post-cannulation Unit of Measure: mmHg
Description:
Higher values indicate higher blood pressure and potentially worse physiological response.
Measured: During arteriovenous fistula cannulation
Heart rate
Time Frame: Pre-cannulation and post-cannulation Unit of Measure: beats per minute (bpm)
Measured: During arteriovenous fistula cannulation.
Respiratory rate
Time Frame: Pre-cannulation and post-cannulation Unit of Measure: breaths per minute
Measured: During arteriovenous fistula cannulation
Oxygen saturation
Time Frame: Pre-cannulation and post-cannulation Unit of Measure: percentage (%)
Measured: During arteriovenous fistula cannulation.
Body temperature
Time Frame: Pre-cannulation Unit of Measure: °C
Measured: During arteriovenous fistula cannulation
Body Mass Index (BMI)
Time Frame: Baseline Unit of Measure: kg/m²
Description:
BMI will be calculated using the formula: weight (kg) divided by height squared (m²). Height (meters) and weight (kilograms) are measured separately and combined to obtain a single reported value (kg/m²).
Measured: During arteriovenous fistula cannulation.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2026
- Study start10 Feb 2026
- Primary completion1 Apr 2026
- Study completion1 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for HemodialysisStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Emine Kaplan Serin
- Sponsor type
- University, hospital or other
- Collaborators
- Mersin University
- Responsible party
- Sponsor-investigator, Emine Kaplan Serin, Mersin University
- Investigators
- Emine KAPLAN SERİN, Associate Professor, Study director, Mersin University, Faculty of Nursing, Department of Internal Medicine Nursing, Mersin/ Türkiye.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07427875
- Sponsor's protocol ID
- 78017789/050.01.04/3392078
- Status last verified
- Feb 2026
- First submitted
- 8 Feb 2026
- Last updated
- 7 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared due to ethical considerations, protection of patient privacy, and the absence of participant consent for data sharing beyond the scope of this study.
Publications
İlgin, V. E., & Yayla, A. (2023). Effect of the 4-7-8 breathing technique on pain level and sleep quality of patients after laparoscopic bariatric surgery: A randomized controlled study. Bariatric Surgical Practice and Patient Care, 18, 225-232. https://doi.org/10.1089/bari.2022.0044
Serbest Baz, A. N. (2025). The effect of using the 4-7-8 breathing technique on postoperative shoulder pain and pulmonary functions after laparoscopic cholecystectomy (Unpublished doctoral dissertation). Mersin University.
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Guided 4-7-8 and Diaphragmatic Breathing Exercises During Arteriovenous Fistula Cannulation on Pain, Anxiety, and Comfort Levels in Hemodialysis Patients: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07427875
- Acronym / sponsor ID
- 78017789/050.01.04/3392078
- Conditions
- Hemodialysis, Arteriovenous Fistula Cannulation, Breathing Exercises, Pain, Anxiety, Comfort
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Emine Kaplan SerinUniversity, hospital or other
- Collaborators
- Mersin University
- Study start
- 10 Feb 2026 (actual)
- Primary completion
- 1 Apr 2026 (actual)
- Study completion
- 1 Apr 2026 (actual)
- First posted
- 23 Feb 2026 (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.
This study aims to evaluate the effects of guided 4-7-8 and diaphragmatic breathing exercises performed during arteriovenous fistula cannulation on pain, anxiety, and comfort levels in patients undergoing hemodialysis treatment. Hemodialysis patients often experience pain and anxiety during fistula cannulation, which can negatively affect the treatment process and patient comfort.
The study will be conducted as a three-arm randomized controlled trial. Participants will be randomly assigned to the 4-7-8 breathing exercise group, the diaphragmatic breathing exercise group, or the control group receiving usual care. In the intervention groups, breathing exercises will be performed with guidance before and during cannulation.
The study anticipates that breathing exercises will reduce pain and anxiety, increase comfort levels, and contribute as an easily applicable, side-effect-free method to nursing care. The findings are expected to support the use of non-pharmacological interventions in hemodialysis patients.
Detailed description
This study is a randomized controlled trial designed to evaluate the effects of non-pharmacological breathing exercises applied during arteriovenous fistula cannulation on pain, anxiety, and comfort levels in hemodialysis patients. The research will be conducted within routine clinical practice, and no additional invasive procedures will be performed beyond standard care.
During the study process, guided breathing exercises will be applied to patients in the intervention groups before and during arteriovenous fistula cannulation, which is routinely performed in the hemodialysis unit. Patients in the control group will continue to receive standard nursing care without any additional intervention. The breathing exercises used in this study are complementary nursing interventions that are easy to apply in clinical settings, cost-free, and associated with no known serious adverse effects.
All measurement tools used in the study are validated and reliable instruments, and the collected data will be used solely for research purposes. Participants' personal information will be kept confidential, data will be coded and analyzed anonymously, and no identifying information will be shared with third parties. Participation in the study is entirely voluntary, and participants may withdraw from the study at any time without providing a reason. Withdrawal from the study will not affect patients' ongoing treatment processes or their right to receive healthcare services.
The breathing exercises will be administered with careful consideration of patients' physical and cognitive conditions. If any clinical risk or contraindication to the breathing exercises is identified, the intervention will be discontinued immediately. Participant safety will be prioritized throughout the study, and appropriate clinical interventions will be provided promptly in the event of any discomfort or adverse situation.
The findings obtained from this study are expected to contribute evidence-based data to nursing care practices related to arteriovenous fistula cannulation in hemodialysis patients and to support the integration of effective non-pharmacological interventions into clinical practice.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 4-7-8 Breathing Exercise Group | Experimental | Behavioral: Guided 4-7-8 Breathing ExerciseParticipants in this experimental group will receive guided 4-7-8 breathing exercises before and during arteriovenous fistula cannulation in addition to routine hemodialysis care. The 4-7-8 breathing technique consists of inhaling through the nose for 4 seconds, holding the breath for 7 seconds, and exhaling slowly through the mouth for 8 seconds. The breathing exercises will be performed under researcher guidance according to a standardized protocol during each cannulation session. |
| Diaphragmatic Breathing Exercise Group | Experimental | Behavioral: Guided Diaphragmatic Breathing ExerciseParticipants in this experimental group will receive guided diaphragmatic breathing exercises before and during arteriovenous fistula cannulation in addition to routine hemodialysis care. The intervention involves slow and deep breathing with diaphragmatic expansion, emphasizing abdominal movement rather than chest movement. The breathing exercises will be performed under researcher guidance according to a standardized protocol during each cannulation session. |
| Control Group (Usual Care) | Other | Other: routine careParticipants in this control group will receive routine nursing care during arteriovenous fistula cannulation according to standard clinical practice. No breathing exercise or additional intervention will be applied. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Be 18 years of age or older
- Have been receiving regular hemodialysis treatment for at least 6 months
- Undergo hemodialysis via an AV fistula
- Have the physical and cognitive ability to perform breathing exercises during cannulation
- Have a cognitive level sufficient to communicate
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Guided 4-7-8 Breathing ExerciseAlso: 4-7-8 Breathing TechniqueKatılımcılar, rutin hemodiyaliz bakımına ek olarak, arteriyovenöz fistül kanülasyonu öncesinde ve sırasında rehberli 4-7-8 nefes egzersizi yapacaklardır. Bu teknik, 4 saniye boyunca burundan nefes almak, 7 saniye boyunca nefesini tutmak ve 8 saniye boyunca ağızdan yavaşça nefes vermekten oluşur. Egzersiz, her kanülasyon seansı sırasında standart bir protokole göre araştırmacıların rehberliğinde uygulanacaktır. | Behavioural | 4-7-8 Breathing Exercise Group |
| Guided Diaphragmatic Breathing ExerciseAlso: Diaphragmatic Breathing TechniqueParticipants will perform guided diaphragmatic breathing exercises before and during arteriovenous fistula cannulation in addition to routine hemodialysis care. The intervention involves slow and deep breathing with diaphragmatic expansion, emphasizing abdominal movement rather than chest movement. The breathing exercises will be administered under researcher guidance according to a standardized protocol during each cannulation session. | Behavioural | Diaphragmatic Breathing Exercise Group |
| routine careAlso: Usual CareParticipants in this group will receive routine nursing care during arteriovenous fistula cannulation according to standard clinical practice. No breathing exercise or additional intervention will be applied. | Other | Control Group (Usual Care) |
Primary outcome
Anxiety level during arteriovenous fistula cannulation
Time frame: During arteriovenous fistula cannulation
State anxiety will be measured using the State-Trait Anxiety Inventory (STAI) state subscale. The subscale consists of 20 items rated on a four-point Likert scale. Total scores range from 20 to 80, with higher scores indicating greater anxiety. Anxiety will be assessed during arteriovenous fistula cannulation to evaluate the immediate effect of the intervention.
8 secondary outcomes
Pain intensity during arteriovenous fistula cannulation
Time frame: During arteriovenous fistula cannulation.
Systolic blood pressure
Time frame: During arteriovenous fistula cannulation.
Diastolic blood pressure
Time frame: During arteriovenous fistula cannulation
Heart rate
Time frame: During arteriovenous fistula cannulation.
Respiratory rate
Time frame: During arteriovenous fistula cannulation
Oxygen saturation
Time frame: During arteriovenous fistula cannulation.
Body temperature
Time frame: During arteriovenous fistula cannulation
Body Mass Index (BMI)
Time frame: During arteriovenous fistula cannulation.
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 7 Apr 2026.
- Backgroundİlgin, V. E., & Yayla, A. (2023). Effect of the 4-7-8 breathing technique on pain level and sleep quality of patients after laparoscopic bariatric surgery: A randomized controlled study. Bariatric Surgical Practice and Patient Care, 18, 225-232. https://doi.org/10.1089/bari.2022.0044
- Results publicationSerbest Baz, A. N. (2025). The effect of using the 4-7-8 breathing technique on postoperative shoulder pain and pulmonary functions after laparoscopic cholecystectomy (Unpublished doctoral dissertation). Mersin University.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: No. Individual participant data will not be shared due to ethical considerations, protection of patient privacy, and the absence of participant consent for data sharing beyond the scope of this study.
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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.
Emine KAPLAN SERİN, Associate Professor study director
Mersin University, Faculty of Nursing, Department of Internal Medicine Nursing, Mersin/ Türkiye.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Guided 4-7-8 Breathing Exercise, Guided Diaphragmatic Breathing Exercise and routine care in people with Hemodialysis and Arteriovenous Fistula Cannulation, run by Emine Kaplan Serin 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 12 inclusion and 0 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 7 Apr 2026. 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?
Anxiety level during arteriovenous fistula cannulation (time frame: During arteriovenous fistula cannulation). 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 NCT07427875, which also lists 2 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 7 Apr 2026.