The Effect of 4-7-8 Breathing Exercises on Pain, Comfort, and Satisfaction During Intramuscular Injection
Procedural Pain
What this study involves
The registry does not currently label this study as recruiting. Ask about its status before planning a screening visit.
- Study type
- Interventional
- Phase
- Not applicable
- Age range
- 18 years - 65 years
- Sex eligible
- All sexes
- Healthy volunteers
- Not accepted
- Participants
- 140 Actual
These are starting points, not an eligibility decision. The research team must review the full requirements.
About the research
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.
Read the full description
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.
Who may be able to participate?
The list below is the sponsor’s full registry wording. It can include conditions, prior treatment, test results and other requirements. A match in search does not mean you qualify.
Inclusion Criteria:
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 informed consent.
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. Body mass index (BMI) below 18.5 kg/m² or ≥30 kg/m². Inability to understand and follow the study instructions.
Understand screeningTreatment, groups and participation
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- Assignment
- Random assignment
- Masking
- Double masked
Control group
no intervention
4 7 8 breath exercise group
4 7 8 breath exercise
Other: 4 7 8 breath exercise
4 7 8 breath exercise OTHER
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.
What researchers are measuring
Outcome measures describe what is being studied. They are not proof that a treatment works.
Primary measures
Pain Scores Assessed by Visual Analog Scale (VAS)
Time frame: Immediately after intramuscular injection (post-injection) (Day 1)
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.
Secondary measures
Post-Injection Satisfaction Scale Scores
Time frame: Immediately after intramuscular injection (post-injection) (Day 1)
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.
Comfort Scale for Injection
Time frame: Immediately after intramuscular injection (post-injection) (Day 1)
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.
Injection Fear Scale Scores
Time frame: Assessment of the fear of injection experienced by the participants before the procedure.
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.
Review the complete result tables and limitations in the official record.
Open official results ↗Research locations (1)
The overall study status and a local site’s status can differ. Confirm that location’s availability before traveling.
1 locations
Atatürk Sanatoryum Eğitim ve Araştırma HastanesiAnkara, Turkey (Türkiye)Status unknown
Study team and timeline
- Lead sponsor
- Saglik Bilimleri Universitesi
- Study start
- Jul 1, 2026 Actual
- Primary completion
- Oct 30, 2026 Actual
- Study completion
- Oct 30, 2026 Actual
- First posted
- Nov 10, 2026 Actual
- Last updated
- Nov 10, 2026 Actual
Official study contacts
No central contact is listed. Check the locations and the official record.
Official study title
The Effect of 4-7-8 Breathing Exercises on Pain, Comfort, and Satisfaction During Intramuscular Injection in Adults: A Randomized Controlled Trial
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Source: ClinicalTrials.gov API v2. Information is submitted by sponsors and investigators. NLM does not approve the safety or science of all listed studies. Registry disclaimer.
Retrieved: Nov 11, 2026 · Last registry update: Nov 10, 2026