An interventional study of 4 7 8 breath exercise in Procedural Pain, sponsored by Saglik Bilimleri Universitesi. Completed at 1 site in Turkey (Türkiye). Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-11-10.
Sponsored by Saglik Bilimleri Universitesi · Not applicable, Interventional, and Supportive care
The aim of this study is to evaluate the effects of 4-7-8 breathing exercises performed before and during intramuscular injection on pain intensity, patient comfort, and satisfaction in adults using a randomized controlled trial design.
The aim of this study is to evaluate the effects of 4-7-8 breathing exercises performed before and during intramuscular injection on pain intensity, patient comfort, and satisfaction in adults using a randomized controlled trial design.Participants in the intervention group received a verbal explanation of how to perform the 4-7-8 breathing exercise before intramuscular injection, followed by a demonstration accompanied by an instructional video.Participants in the control group received standard intramuscular injections without any additional breathing exercises.
241 studies on the registry are indexed under Pain, Procedural; 64 are open to participants now.
This study's enrollment of 140 is above the median of 90 across 227 interventional studies indexed under Pain, Procedural.
Browse Pain, Procedural studies →Saglik Bilimleri Universitesi is the lead sponsor of 453 studies on the registry; 140 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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.
Patients aged 18 years or older. Patients presenting to the green-zone treatment unit of the emergency department.
Patients scheduled to receive a single-dose intramuscular injection of diclofenac sodium (75 mg/3 mL) into the ventrogluteal site, as prescribed by a physician.
Ability to read and write in Turkish. Cognitive ability to understand and follow the study instructions. Willingness to participate in the study and provision of written .
Exclusion Criteria:
Acute or chronic respiratory diseases. Neuromuscular disorders affecting respiratory function or respiratory muscles. Respiratory symptoms that could interfere with the performance of the breathing exercise.
History of dizziness, syncope, or hyperventilation. Diagnosed panic disorder or anxiety disorder. Uncontrolled hypertension, severe cardiovascular disease, or arrhythmia. Pregnancy or breastfeeding. Use of analgesics, nonsteroidal anti-inflammatory drugs, sedatives, anxiolytics, or muscle relaxants within 24 hours before the injection.
Lesions, infection, hematoma, or edema at the injection site. (BMI) below 18.5 kg/m² or ≥30 kg/m². Inability to understand and follow the study instructions.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
no intervention
4 7 8 breath exercise
Other: 4 7 8 breath exercise
Participants in the intervention group received a verbal explanation of how to perform the 4-7-8 breathing exercise before intramuscular injection, and the procedure was demonstrated using an instructional video. The exercise consisted of three phases: inhaling for four seconds, holding the breath for seven seconds, and exhaling slowly and in a controlled manner for eight seconds. Participants performed eight repetitions under the researcher's supervision, and their ability to perform the exercise was assessed. Standard intramuscular injection was initiated once participants demonstrated the ability to perform the exercise. The breathing exercise began before the injection and continued throughout the injection procedure.
Pain Scores Assessed by Visual Analog Scale (VAS)
Pain intensity will be assessed using the Visual Analogue Scale (VAS), ranging from 0 (no pain) to 10 (worst imaginable pain). Higher scores indicate greater pain intensity.
Time frame: Immediately after intramuscular injection (post-injection) (Day 1)
Post-Injection Satisfaction Scale Scores
Post-Injection Satisfaction Scale The Post-Injection Satisfaction Scale (PISS), developed by Yıldız and ve Çiftçi, was used to assess patients' satisfaction with the injection procedure. The scale is a 5-point Likert-type structure rated from 1=Not at all satisfied to 5=Very satisfied. The scale consists of two dimensions: 'Satisfaction with the Practitioner' (Items 5-9) and 'Satisfaction with the Procedure' (Items 1-4). Scoring is based on the average of the items, with the lowest possible score being 1 and the highest possible score being 5. As the score increases, the patient's satisfaction level also increases.
Time frame: Immediately after intramuscular injection (post-injection) (Day 1)
Comfort Scale for Injection
Comfort Scale for Injection (CTSI): The Comfort Scale for Injection was developed by Yıldız et al. 2024 to assess comfort levels related to injection procedures (Yildiz et al., 2024). It consists of 10 items rated on a 5-point Likert scale (1 = strongly disagree, 5 = strongly agree). Higher scores indicate greater comfort.
Time frame: Immediately after intramuscular injection (post-injection) (Day 1)
Injection Fear Scale Scores
Fear of Injection Scale (FIS): The Fear of Injection Scale was developed by Yıldız and Çiftçi (2023) to assess individuals' fear related to injection procedures (Yıldız \& Çiftçi, 2023). The scale consists of 14 items rated on a 5-point Likert scale. Higher scores indicate greater fear.
Time frame: Assessment of the fear of injection experienced by the participants before the procedure.
Plan to share: Yes — The data supporting the findings of this study are available from the corresponding author upon reasonable request, subject to ethical approval and applicable data protection requirements.
Supporting information: Study protocol, Informed consent form
No publications or documents are linked to this record.
Ran from Jul 2026 to primary completion in Oct 2026, 3 months.
Of 141 non-industry interventional studies with no phase under Pain, Procedural, half reached primary completion within 7 months of starting (the median), counting those still running; a quarter within 3 and three quarters within 15. This study's 3 months is below that.
Counting every sponsor, half of 141 studies reached it within 7 months; a quarter within 3 and three quarters within 15.
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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