AnxietyNCT07917585
Effect of the 4-7-8 Breathing Technique Before Central Venous Catheter Insertion
A study testing 4-7-8 breathing technique in people with Anxiety and Pain, run by Mersin University at 1 site in Turkey (Türkiye).
Trial summary
Purpose: This study aims to evaluate the effect of the 4-7-8 breathing technique applied before central venous catheter (CVC) insertion on patients' anxiety, pain, and vital signs. Design: A single-center, randomized controlled experimental study. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Anxiety, Pain, Vital Sign Evaluation
- What is being tested?
- 4-7-8 breathing technique
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Mar 2025to 30 Jan 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 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients scheduled for their first planned central venous catheter (CVC) insertion
- Patients over 18 years of age
- Patients with a stable general clinical condition
Who cannot join
- Patients who underwent emergency CVC insertion
- Patients who used another breathing technique or complementary method prior to the procedure
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of the 4-7-8 Breathing Technique Before Central Venous Catheter Insertion on Anxiety, Vital Signs, and Pain: A Randomized Controlled Trial
Purpose: This study aims to evaluate the effect of the 4-7-8 breathing technique applied before central venous catheter (CVC) insertion on patients' anxiety, pain, and vital signs.
Design: A single-center, randomized controlled experimental study. Methods: The study plans to recruit adult patients undergoing CVC insertion. Participants will be randomly allocated to either the 4-7-8 breathing intervention group or the standard-care control group. The intervention group will perform the 4-7-8 breathing technique before the CVC insertion procedure, whereas the control group will receive routine standard care. Data will be collected using a participant information form, State-Trait Anxiety Inventory, Visual Analog Scale (VAS) for pain, and a vital signs follow-up form. Statistical analyses will include independent-samples and paired-samples t-tests, the Mann-Whitney U test, and the Wilcoxon signed-rank test to compare the groups
Read the detailed description
Introduction and Rationale:
Central venous catheter (CVC) insertion is an invasive procedure that often induces high levels of anxiety and acute pain in patients. Elevated anxiety can negatively impact vital signs and the overall patient experience. Non-pharmacological interventions, such as controlled breathing techniques, offer non-invasive ways to manage these symptoms. This study aims to evaluate the prospective effect of the 4-7-8 breathing technique applied prior to CVC insertion on patients' anxiety levels, pain perception, and vital signs.
Study Protocol and Interventions:
Adult patients scheduled for CVC insertion will be assessed for eligibility based on the inclusion and exclusion criteria. Eligible participants will be randomly assigned to either the intervention group or the control group.
- Intervention Group: Participants in this group will be trained in the 4-7-8 breathing technique by a researcher. They will perform this structured breathing pattern immediately before the CVC insertion procedure.
- Control Group: Participants will receive the standard pre-procedural routine care specified by the institution.
Data Collection and Outcomes:
Data will be gathered at specific intervals (before and after the procedure) using four distinct tools: a participant information form to capture demographic variables, the State-Trait Anxiety Inventory to measure situational anxiety, the Visual Analog Scale (VAS) to assess post-procedural pain, and a standardized vital signs form to track blood pressure, heart rate, and respiratory rate.
Statistical Analysis Plan:
All collected data will be analyzed using statistical software. Continuous variables will be evaluated for normal distribution. To compare the clinical outcomes and baseline characteristics between the intervention and control groups, independent-samples t-tests or Mann-Whitney U tests will be utilized. Paired-samples t-tests or Wilcoxon signed-rank tests will be conducted for within-group pre- and post-intervention comparisons.
- Conditions
- Anxiety, Pain, Vital Sign Evaluation, 4-7-8 Breathing Technique
- Being tested
- 4-7-8 breathing technique
- Keywords
- pain, anxiety, vital sign, 4-7-8 Breathing Technique
- Medical subject headings
- Anxiety Disorders, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
4-7-8 breathing techniqueBehavioural
4-7-8 breathing technique
| Study group | Role | What they receive |
|---|---|---|
| intervention group | Experimental | Participants will practice the 4-7-8 breath technique before central venous catheter placement. Participants will also receive routine clinical care. Receives: Behavioral: 4-7-8 breathing technique |
| Control group | No intervention | Participants receive routine clinical care prior to central venous catheter placement; the 4-7-8 breath technique is not practiced. |
What is being measured
The primary outcome is the main question the study is designed to answer.
State Anxiety Level
Measured using the State-Trait Anxiety Inventory (STAI-S). The score ranges from 20 to 80, with higher scores indicating higher levels of anxiety. The outcome will be reported as the change in anxiety scores from baseline to immediately after the 4-7-8 breathing technique.
Measured: Baseline (pre-procedure) and immediately after the 4-7-8 breathing technique
Pain
Measured using the Visual Analog Scale (VAS), where scores range from 0 (no pain) to 10 (worst possible pain). The outcome will be reported as the change in pain scores from baseline to immediately after the CVC insertion procedure.
Measured: Baseline (pre-procedure) and immediately after the CVC insertion procedure.
Secondary outcomes (4)
Systolic Blood Pressure
Measured using a standardized non-invasive blood pressure monitor. The outcome will be reported as the change in systolic blood pressure from baseline to immediately after the 4-7-8 breathing technique.
Measured: Baseline (pre-procedure) and immediately after the 4-7-8 breathing technique.
Diastolic Blood Pressure
Measured in mmHg using a standardized non-invasive blood pressure monitor. The outcome will be reported as the change in diastolic blood pressure from baseline to immediately after the 4-7-8 breathing technique.
Measured: Baseline (pre-procedure) and immediately after the 4-7-8 breathing technique.
Heart Rate
Measured as beats per minute.
Measured: Baseline (pre-procedure) and immediately after the 4-7-8 breathing technique. The outcome will be reported as the change in heart rate from baseline to immediately after the 4-7-8 breathing technique.
Respiratory Rate
Measured as breaths per minute. The outcome will be reported as the change in respiratory rate from baseline to immediately after the 4-7-8 breathing technique.
Measured: Baseline (pre-procedure) and immediately after the 4-7-8 breathing technique.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2026
- Study start1 Mar 2025
- Primary completion1 Oct 2025
- Study completion30 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnxietyStudies of the same condition, open and under way.
- More trials run by Mersin UniversityThe sponsor's other registered studies.
- 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
- Model description
- Participants will be randomly assigned to one of the two study groups in a 1:1 ratio using a parallel design. The intervention group will practice the structured 4-7-8 breathing technique immediately before the central venous catheter (CVC) insertion procedure. The control group will receive the standard pre-procedural routine care as per institutional guidelines.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mersin University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Birgul Vural Dogru, Mersin University
- Investigators
- Birgül Vural Doğru, Study director, Mersin UniversityEsra Köse, PhD, Study director, Mersin University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07917585
- Sponsor's protocol ID
- 2024-1039
- Status last verified
- Oct 2026
- First submitted
- 26 Oct 2026
- Last updated
- 4 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: ndividual participant data will not be shared because of patient confidentiality and privacy concerns. The data contain sensitive clinical information, and sharing them could pose a risk to participant privacy. The study findings will be disseminated through scientific publications.
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of the 4-7-8 Breathing Technique Before Central Venous Catheter Insertion on Anxiety, Vital Signs, and Pain: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07917585
- Acronym / sponsor ID
- 2024-1039
- Conditions
- Anxiety, Pain, Vital Sign Evaluation, 4-7-8 Breathing Technique
- Keywords
- pain, anxiety, vital sign, 4-7-8 Breathing Technique
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Mersin UniversityUniversity, hospital or other
- Study start
- 1 Mar 2025 (actual)
- Primary completion
- 1 Oct 2025 (actual)
- Study completion
- 30 Jan 2026 (actual)
- First posted
- 4 Nov 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.
Purpose: This study aims to evaluate the effect of the 4-7-8 breathing technique applied before central venous catheter (CVC) insertion on patients' anxiety, pain, and vital signs.
Design: A single-center, randomized controlled experimental study. Methods: The study plans to recruit adult patients undergoing CVC insertion. Participants will be randomly allocated to either the 4-7-8 breathing intervention group or the standard-care control group. The intervention group will perform the 4-7-8 breathing technique before the CVC insertion procedure, whereas the control group will receive routine standard care. Data will be collected using a participant information form, State-Trait Anxiety Inventory, Visual Analog Scale (VAS) for pain, and a vital signs follow-up form. Statistical analyses will include independent-samples and paired-samples t-tests, the Mann-Whitney U test, and the Wilcoxon signed-rank test to compare the groups
Detailed description
Introduction and Rationale:
Central venous catheter (CVC) insertion is an invasive procedure that often induces high levels of anxiety and acute pain in patients. Elevated anxiety can negatively impact vital signs and the overall patient experience. Non-pharmacological interventions, such as controlled breathing techniques, offer non-invasive ways to manage these symptoms. This study aims to evaluate the prospective effect of the 4-7-8 breathing technique applied prior to CVC insertion on patients' anxiety levels, pain perception, and vital signs.
Study Protocol and Interventions:
Adult patients scheduled for CVC insertion will be assessed for eligibility based on the inclusion and exclusion criteria. Eligible participants will be randomly assigned to either the intervention group or the control group.
- Intervention Group: Participants in this group will be trained in the 4-7-8 breathing technique by a researcher. They will perform this structured breathing pattern immediately before the CVC insertion procedure.
- Control Group: Participants will receive the standard pre-procedural routine care specified by the institution.
Data Collection and Outcomes:
Data will be gathered at specific intervals (before and after the procedure) using four distinct tools: a participant information form to capture demographic variables, the State-Trait Anxiety Inventory to measure situational anxiety, the Visual Analog Scale (VAS) to assess post-procedural pain, and a standardized vital signs form to track blood pressure, heart rate, and respiratory rate.
Statistical Analysis Plan:
All collected data will be analyzed using statistical software. Continuous variables will be evaluated for normal distribution. To compare the clinical outcomes and baseline characteristics between the intervention and control groups, independent-samples t-tests or Mann-Whitney U tests will be utilized. Paired-samples t-tests or Wilcoxon signed-rank tests will be conducted for within-group pre- and post-intervention comparisons.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Participants will be randomly assigned to one of the two study groups in a 1:1 ratio using a parallel design. The intervention group will practice the structured 4-7-8 breathing technique immediately before the central venous catheter (CVC) insertion procedure. The control group will receive the standard pre-procedural routine care as per institutional guidelines.
| Arm | Type | Receives |
|---|---|---|
| intervention group | Experimental | Behavioral: 4-7-8 breathing techniqueParticipants will practice the 4-7-8 breath technique before central venous catheter placement. Participants will also receive routine clinical care. |
| Control group | No intervention | –Participants receive routine clinical care prior to central venous catheter placement; the 4-7-8 breath technique is not practiced. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients scheduled for their first planned central venous catheter (CVC) insertion
- Patients over 18 years of age
- Patients with a stable general clinical condition
Key exclusion criteria (2 listed)
- Patients who underwent emergency CVC insertion
- Patients who used another breathing technique or complementary method prior to the procedure
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 |
|---|---|---|
| 4-7-8 breathing technique4-7-8 breathing technique | Behavioural | intervention group |
Primary outcome
State Anxiety Level
Time frame: Baseline (pre-procedure) and immediately after the 4-7-8 breathing technique
Measured using the State-Trait Anxiety Inventory (STAI-S). The score ranges from 20 to 80, with higher scores indicating higher levels of anxiety. The outcome will be reported as the change in anxiety scores from baseline to immediately after the 4-7-8 breathing technique.
Pain
Time frame: Baseline (pre-procedure) and immediately after the CVC insertion procedure.
Measured using the Visual Analog Scale (VAS), where scores range from 0 (no pain) to 10 (worst possible pain). The outcome will be reported as the change in pain scores from baseline to immediately after the CVC insertion procedure.
4 secondary outcomes
Systolic Blood Pressure
Time frame: Baseline (pre-procedure) and immediately after the 4-7-8 breathing technique.
Diastolic Blood Pressure
Time frame: Baseline (pre-procedure) and immediately after the 4-7-8 breathing technique.
Heart Rate
Time frame: Baseline (pre-procedure) and immediately after the 4-7-8 breathing technique. The outcome will be reported as the change in heart rate from baseline to immediately after the 4-7-8 breathing technique.
Respiratory Rate
Time frame: Baseline (pre-procedure) and immediately after the 4-7-8 breathing technique.
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 4 Nov 2026.
- Individual participant dataSharing planned: No. ndividual participant data will not be shared because of patient confidentiality and privacy concerns. The data contain sensitive clinical information, and sharing them could pose a risk to participant privacy. The study findings will be disseminated through scientific publications.
Related trials for Anxiety
Recruiting
Marine Lipids Ease Painful TMD
Temporomandibular Disorder (TMD)
Not yet recruitingObservational study
Soap-and-Water Bed Bath Versus Disposable Wipe Bath in the Same ICU Patients
Critical Illness, Pain
Recruiting
Peer-Mentor Support for Vulnerable Patients With Atrial Fibrillation
Atrial Fibrillation
Not yet recruiting
Effects of Oxygen Cage Support During Cataract Surgery
Cataract
Not yet recruiting
Feasibility of a Web-based Single-session Intervention Combined With Ecological Momentary Assessment and Intervention for Patients With Complex Posttraumatic Stress Disorder Awaiting Inpatient Treatment
PTSD - Post Traumatic Stress Disorder, Depression
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.
Birgül Vural Doğru study director
Mersin University
Esra Köse, PhD study director
Mersin University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 4-7-8 breathing technique in people with Anxiety and Pain, run by Mersin 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 3 inclusion and 2 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 4 Nov 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?
State Anxiety Level (time frame: Baseline (pre-procedure) and immediately after the 4-7-8 breathing technique). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 4 Nov 2026.