An interventional study of 4-7-8 breathing technique in Anxiety, Pain and Vital Sign Evaluation, sponsored by Mersin University. Completed at 1 site in Turkey (Türkiye). Open to participants aged 18 Years to 70 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-11-04.
Sponsored by Mersin University · Not applicable, Interventional, and Supportive care
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
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.
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.
10,054 studies on the registry are indexed under Pain; 1,649 are open to participants now.
This study's enrollment of 80 is above the median of 66 across 8,493 interventional studies indexed under Pain.
Browse Pain studies →Mersin University is the lead sponsor of 178 studies on the registry; 45 are open to participants now.
Compared within Pain, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Anxiety Disorders. The counts are of registry records indexed under each term, refreshed daily. How we classify →
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Participants will practice the 4-7-8 breath technique before central venous catheter placement. Participants will also receive routine clinical care.
Behavioral: 4-7-8 breathing technique
Participants receive routine clinical care prior to central venous catheter placement; the 4-7-8 breath technique is not practiced.
4-7-8 breathing technique
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.
Time frame: 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.
Time frame: Baseline (pre-procedure) and immediately after the CVC insertion procedure.
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.
Time frame: 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.
Time frame: Baseline (pre-procedure) and immediately after the 4-7-8 breathing technique.
Heart Rate
Measured as beats per minute.
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
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.
Time frame: Baseline (pre-procedure) and immediately after the 4-7-8 breathing technique.
Plan to share: 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.
No publications or documents are linked to this record.
Ran from Mar 2025 to primary completion in Oct 2025, 7 months.
Of 3,731 non-industry interventional studies with no phase under Pain, half reached primary completion within 10 months of starting (the median), counting those still running; a quarter within 4 and three quarters within 23. This study's 7 months is below that.
Counting every sponsor, half of 3,830 studies reached it within 10 months; a quarter within 4 and three quarters within 23.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is completed, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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