The Effect of Diaphragmatic Breathing Exercises Before Gastroscopy on Anxiety, Fear, and Vital Signs
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorEastern Mediterranean University
About this trial
Gastroscopy, performed as an invasive procedure for the diagnosis and treatment of upper gastrointestinal tract diseases, is often perceived by patients as an unpleasant and frightening experience, leading to anxiety (Hua et al., 2025). The onset of anxiety reduces procedure tolerance and negatively affects patient compliance (Yang et al., 2024). Factors such as pain, fear of complications, loss of control, and inadequate information are frequently cited as contributors to pre-gastroscopy anxiety (Helba, 2024). Anxiety triggers general stress responses-such as tachycardia, hypertension, and respiratory changes-associated with autonomic nervous system activation, and it impacts sedation requirements and cardiopulmonary risks (Liu, 2025). Breathing exercises, a non-pharmacological intervention, are widely recognized in the literature as effective in alleviating anxiety and fostering positive outcomes in patients (Aktaş, 2022; Bulut \& Karabulut, 2023). Breathing exercises stand out as a safe, low-cost method that modulates autonomic nervous system activity (Herawati et al., 2023). This study examines the effects of diaphragmatic breathing exercises performed prior to gastroscopy on anxiety, fear, and vital signs. The results of this study will establish a scientific foundation for healthcare professionals regarding the clinical application of breathing exercises and contribute to evidence-based practices aimed at reducing pre-gastroscopy anxiety and fear while enhancing personal coping.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Adults aged 18 years or older.
Scheduled to undergo diagnostic gastroscopy.
Medically eligible for gastroscopy (ASA Physical Status < III or suitable according to the institution's sedation protocol).
Able to read and understand the study information and questionnaires. Willing to provide written informed consent.
Disqualifiers
Cardiac, pulmonary, or other clinical conditions for which the attending physician considers breathing exercises inappropriate.
Diagnosed anxiety disorder or psychotic disorder.
Development of severe dizziness, syncope, severe dyspnea, chest pain, nausea, marked discomfort, or significant breathing irregularity during the breathing intervention.
Withdrawal of consent or unwillingness to continue participation.
Trial design
Design model
Parallel
Treatments tested in this trial
Diaphragmatic Breathing Exercises
Other interventionParticipants will perform a standardized breathing intervention consisting of pursed-lip breathing followed by diaphragmatic breathing. First, participants will complete 1 minute of pursed-lip breathing by inhaling deeply through the nose and exhaling slowly through slightly pursed lips to improve expiratory control and prepare for diaphragmatic breathing. They will then perform four sets of 10 diaphragmatic breaths. Each breathing cycle will include inhalation through the nose for 3-5 seconds, a 2-second pause, and controlled exhalation through the mouth for 6-7 seconds, with 30-60-second rest periods between sets. The total intervention will last approximately 10 minutes. Participants will be monitored throughout the session, instructed to focus on their breathing, and the intervention will be stopped if discomfort occurs.
Treatment groups
64 Participants
are divided into 2 treatment groupsGroup A: Intervention Breathing ExerciseExperimental treatment 1 intervention
Group B: ControlNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
Change in State Anxiety Score
State anxiety will be assessed using the State-Trait Anxiety Inventory - State Anxiety Scale (SAS). The scale consists of 20 items and has a total score ranging from 20 to 80. Higher scores indicate higher levels of state anxiety, representing a worse outcome. The primary outcome is the change in SAS score from baseline to post-intervention assessment. Participants will complete the SAS approximately 30 minutes before gastroscopy (baseline) and again immediately after the intervention in the intervention group or after the equivalent 20-minute waiting period in the control group. Changes in scores will be compared between the intervention and control groups to evaluate the effectiveness of diaphragmatic breathing exercises.
Time frame
Baseline (approximately 30 minutes before gastroscopy) and immediately before the gastroscopy procedure (approximately 20 minutes after baseline, following the intervention or routine waiting period).Secondary outcomes
1
Changes in Fear Score
Fear will be assessed using the Visual Analog Scale for Fear (VAS-Fear). The scale ranges from 0 to 10 cm, where 0 indicates no fear and 10 indicates an unbearable level of fear. Higher scores indicate greater fear and therefore a worse outcome. The secondary outcome is the change in VAS-Fear score from baseline to immediately before the gastroscopy procedure. Higher scores indicate greater fear. The change in fear score from baseline to post-intervention will be compared between the intervention and control groups.
Time frame
Baseline (approximately 30 minutes before gastroscopy) and immediately before the gastroscopy procedure.2
Change in Pulse Rate
Pulse rate will be measured in beats per minute (bpm) before and after the intervention. The change in pulse rate from baseline to post-intervention assessment will be compared between the intervention and control groups to evaluate the physiological effects of diaphragmatic breathing.
Time frame
Baseline (approximately 30 minutes before gastroscopy) and post-intervention assessment (immediately after the intervention or after a 20-minute waiting period in the control group).3
Changes in Systolic Blood Pressure
Systolic blood pressure will be measured in millimeters of mercury (mmHg) before and after the intervention. The change in systolic blood pressure from baseline to post-intervention assessment will be compared between the intervention and control groups to evaluate the physiological effects of diaphragmatic breathing.
Time frame
Baseline (approximately 30 minutes before gastroscopy) and post-intervention assessment (immediately after the intervention or after a 20-minute waiting period in the control group).4
Changes in Diastolic Blood Pressure
Diastolic blood pressure will be measured in millimeters of mercury (mmHg) before and after the intervention. The change in diastolic blood pressure from baseline to post-intervention assessment will be compared between the intervention and control groups to evaluate the physiological effects of diaphragmatic breathing.
Time frame
Baseline (approximately 30 minutes before gastroscopy) and post-intervention assessment (immediately after the intervention or after a 20-minute waiting period in the control group).Sponsors and contacts
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Source ClinicalTrials.gov