An interventional study of Diaphragmatic Breathing Exercises in Breath Exercise, State Anxiety and Adult Patients, sponsored by Eastern Mediterranean University. Active, not recruiting at 1 site in Cyprus. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-11-10.
Sponsored by Eastern Mediterranean University · Not applicable, Interventional, and Other
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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.
Gastroscopy is a widely used and gold-standard endoscopic procedure in the diagnosis and treatment of upper gastrointestinal tract diseases. It plays a significant role in the early diagnosis and treatment of these diseases by allowing direct visualization of the esophagus, stomach, and duodenum (Areia et al., 2025; Bazerbachi et al., 2023) . However, gastroscopy is often perceived by patients as an uncomfortable and frightening procedure; this perception can lead to anxiety in the pre-procedure period (Çelik et al., 2022; Hua et al., 2025) .
The literature reports that pre-gastroscopy anxiety is quite common. A large-sample study of 1242 patients undergoing upper gastrointestinal endoscopy indicated that 52.7% of patients experienced significant anxiety before the procedure ( Yarbaş et al., 2025). The same study showed that female gender and the presence of chronic diseases were associated with high anxiety levels; however, previous gastroscopy experience or knowledge about the procedure did not significantly reduce anxiety. Similarly, another study of individuals undergoing gastroscopy without sedation highlighted that patients had moderate state anxiety scores, and that procedural tolerance decreased as anxiety levels increased (Yang et al., 2024). These findings demonstrate that pre-gastroscopy anxiety is a common occurrence and directly impacts patient compliance and procedural quality.
Several factors contribute to anxiety in patients during the pre-gastroscopy period. Anxiety often stems from insufficient information about endoscopy, fear of the procedure, pain and discomfort, the development of complications, loss of control, or inadequate attention during the procedure ( Nasution , 2022, Helba 2024 ). A study by Farooq et al. reported a correlation between high pre-gastroscopy anxiety levels and the risk of panic and fear during the procedure ( Farooq et al., 2025). Another study indicated that patients assessed with a Visual Analog Scale (VAS) before endoscopy had fear levels above seven ( Khan et al., 2023). It is noted that anxiety and fear experienced by patients during the pre-gastroscopy preparation period prolong the procedure time and affect the anesthesia dose, leading to undesirable outcomes ( Liu 2025, Sargın 2020). Emotional responses such as anxiety and fear experienced during the pre-gastroscopy period negatively impact the patient's comfort during the procedure and cause a physiological stress response due to autonomic nervous system activation. Sympathetic responses such as tachycardia, hypertension, and increased respiratory rate, which develop in relation to anxiety, can lead to transient changes in vital signs (Karpuzcu et al. 2025 ) . Although gastroscopy is generally a safe procedure, a large proportion of complications occurring during and after the procedure are reported to be related to cardiopulmonary complications and sedation ( Waddingham et al., 2022). Therefore, the application of safe and non-invasive interventions that help reduce anxiety and fear and support the stabilization of vital signs in the pre-gastroscopy period is considered a critical requirement for patient safety ( Bisschops et al., 2025).
In recent years, there has been an increase in research on the effectiveness of non-pharmacological interventions in reducing anxiety before gastroscopy and other invasive procedures. The literature indicates that methods such as informational training, visual aids, music therapy, aromatherapy, and relaxation techniques have a positive impact on patient satisfaction ( Khan et al., 2023; Mohamed et al., 2025; Calderon Martinez et al., 2025). In this context, another non-pharmacological method that has a positive impact on patient outcomes before invasive procedures is breathing exercises. Breathing exercises are noteworthy due to their applicability, low cost, and low risk of side effects. It is emphasized that breathing exercises have a regulatory effect on the autonomic nervous system, positively influencing vital signs such as heart rate, blood pressure, and respiratory rate ( Garg et al., 2023; Herawati et al., 2023; Ismail et al., 2025).
Numerous studies in the literature have examined the effects of breathing exercises on anxiety in different clinical groups ( Gauthier , 2023; Bulut, 2023). Çoban's (2025) study on cancer survivors highlighted that breathing exercise training reduced fear of cancer recurrence and improved mental well-being. Aktaş's (2022) randomized controlled trial with bariatric surgery patients showed that the 4-7-8 breathing technique significantly reduced situational anxiety. Similarly, other studies in surgical patients report that breathing exercises reduce anxiety levels and positively affect sleep quality and the healing process (Bulut \& Karabulut, 2023; Lu et al., 2022). These findings support the idea that breathing exercises are an effective intervention not only on psychological but also on physiological parameters.
Although high rates of anxiety are reported in patients before gastroscopy, it is emphasized that this issue is not sufficiently considered in clinical practice ( Hua et al., 2025). This situation necessitates the adoption of a holistic care approach and the strengthening of nursing interventions in the pre-gastroscopy period (Yang, 2025). Nurses, as healthcare professionals who interact most with patients in the pre-procedure period, have a key role in anxiety management. Breathing exercises are considered an effective method that can be easily integrated into nursing care, increases patient participation, and supports self-management ( Herawati et al., 2023). A literature review revealed that there are limited studies that address the effects of pre-gastroscopy breathing exercises on situational anxiety, vital signs, and fear variables together. The aim of this research is to examine the effect of pre-procedure breathing exercises on anxiety levels, fear, and vital signs in adult patients undergoing gastroscopy. The aim of this study is to contribute to evidence-based practices aimed at reducing anxiety and fear before gastroscopy, increasing patient compliance, and to provide a scientific basis for healthcare professionals regarding the integration of breathing exercises into clinical practice.
7,207 studies on the registry are indexed under Anxiety Disorders; 1,682 are open to participants now.
This study's enrollment of 64 is below the median of 80 across 6,062 interventional studies indexed under Anxiety Disorders.
Browse Anxiety Disorders studies →Eastern Mediterranean University is the lead sponsor of 141 studies on the registry; 17 are open to participants now.
Compared within Anxiety Disorders, the registry's first condition term, which may not be this study's main condition. Counted across the registry records on this site, refreshed daily. How we classify →
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Exclusion Criteria:
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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.
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.
Eligible patients scheduled for gastroscopy will provide written informed consent and be randomly assigned to the intervention or control group. Before the procedure, all participants will complete the Personal Data Collection Form, State Anxiety Scale (SAS), Visual Analog Scale for Fear (VAS-Fear), and baseline vital signs will be recorded. The intervention group will perform a standardized 10-minute diaphragmatic breathing exercise, while the control group will receive routine care only. Immediately after the intervention or waiting period, anxiety, fear, and vital signs will be reassessed to evaluate the effects of diaphragmatic breathing before gastroscopy.
Other: Diaphragmatic Breathing Exercises
Eligible patients scheduled for gastroscopy who meet the inclusion criteria will receive verbal and written information about the study and provide written informed consent before participation. Participants will be assigned a unique study identification number and randomly allocated to the intervention or control group. Approximately 30 minutes before the procedure, all participants will complete the Personal Data Collection Form, the State Anxiety Scale (SAS), and the Visual Analog Scale for Fear (VAS-Fear). Baseline vital signs, including pulse, systolic and diastolic blood pressure, respiratory rate, and oxygen saturation (SpO₂), will be recorded. Participants in the control group will receive routine pre-procedural care without breathing exercises or relaxation techniques. After a 20-minute waiting period, the SAS, VAS-Fear, and vital signs will be reassessed and recorded as post-test measurements.
Participants 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.
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).
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.
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).
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).
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).
Change in Respiratory Rate
Respiratory rate will be measured in breaths per minute before and after the intervention. The change in respiratory 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).
Change in Oxygen Saturation (SpO₂)
Peripheral oxygen saturation (SpO₂) will be measured as a percentage (%) before and after the intervention. The change in oxygen saturation 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).
Plan to share: No
Ran from Jul 2026 to primary completion in Oct 2026, 2 months.
Of 3,841 non-industry interventional studies with no phase under Anxiety Disorders, half reached primary completion within 12 months of starting (the median), counting those still running; a quarter within 5 and three quarters within 28. This study's 2 months is below that.
Counting every sponsor, half of 3,943 studies reached it within 12 months; a quarter within 5 and three quarters within 28.
Since we started tracking on Sep 25, 2026, the dates moved once, on Nov 10, 2026: primary completion Sep 2026 → Oct 2026 and completion Oct 2026 → Nov 2026.
Earlier changes are on the record history on ClinicalTrials.gov ↗
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 ↗
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