Breath ExerciseNCT07781943
The Effect of Diaphragmatic Breathing Exercises Before Gastroscopy on Anxiety, Fear, and Vital Signs
A study testing Diaphragmatic Breathing Exercises in people with Breath Exercise and State Anxiety, run by Eastern Mediterranean University at 1 site in Cyprus.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Breath Exercise, State Anxiety, Adult Patients
- What is being tested?
- Diaphragmatic Breathing Exercises
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 siteCyprus
- Study dates
- 31 Jul 2026to 30 Oct 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
- Inability to complete the intervention because of unexpected changes in the timing of the gastroscopy procedure.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Sevinç Taştan, Prof. Dr. contact
Cyprus1 site, 1 recruiting
- Recruiting
Famagusta State Hospital
Famagusta
Cemal Cevheroğlu, Dr., +90 548 886 7788, info.gmdh@gov.ct.tr
Şerife Ünal, RN, +90 533 858 5829, info.gmdh@gov.ct.tr
About this study
Official title: The Effect of Diaphragmatic Breathing Exercises Performed Prior to Diagnostic Gastroscopy on Anxiety, Fear, and Vital Signs in Adult Patients: A Randomized Controlled 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.
Read the detailed description
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.
- Conditions
- Breath Exercise, State Anxiety, Adult Patients, Vital Signs Monitoring, Fear
- Being tested
- Diaphragmatic Breathing Exercises
- Keywords
- Gastroscopy, Fear, State Anxiety, Vital Signs, Breathing Exercise, endoscopy, GI endoscopy
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diaphragmatic Breathing ExercisesOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Breathing Exercise | Experimental | 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. Receives: Other: Diaphragmatic Breathing Exercises |
| Control | No intervention | 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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 (6)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2026
- Study start31 Jul 2026
- Primary completion30 Sep 2026 (estimated)
- Study completion30 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (24)Papers the sponsor has linked to this study.
- Other trials for Breath ExerciseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 64 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Eastern Mediterranean University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sevinç Taştan, Principal investigator, Eastern Medditerranian University, Faculty Of Health Sciences, Nursing Department
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07781943
- Sponsor's protocol ID
- AY-BreathE.2027-01
- Status last verified
- Jul 2026
- First submitted
- 29 Jul 2026
- Last updated
- 24 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Potter, P. A., Perry, A. G., Stockert, P. A., Hall, A., Astle, B. J., & Duggleby, W. (2018). Canadian fundamentals of nursing (6th ed.). Mosby Canada. (ss.3203 - 3204)
Berman, A., Snyder, S. J., & Frandsen, G. (2022). Kozier & Erb's fundamentals of nursing: Concepts, process, and practice (11th ed.). Pearson. (ss.964 - 980)
Aslan K, Ozer Z, Yontem MK. Effect of Virtual Reality on Pain, Anxiety, and Vital Signs in Endoscopy. Pain Manag Nurs. 2025 Aug;26(4):e371-e380. doi: 10.1016/j.pmn.2024.11.009. Epub 2025 Jan 13.
PubMed 39809653Karpuzcu HC, Yarbas G, Catalbas R, Atli NA, Erdogan C. The effect of pre-procedural anxiety level on the quality of upper GI endoscopy in non-sedated patients: "can the need for sedation be predicted?". Ther Adv Gastroenterol. 2025 Apr 16;18:17562848251333025. doi: 10.1177/17562848251333025. eCollection 2025.
PubMed 40297209Ismail AMA, El Gressy NSSA, Hegazy MD, Ahmed OSM, Elfahl AMA. Effects of diaphragmatic breathing exercise on sleeping quality, cortisol, cardiovascular autonomic functions, depression, and fatigue: a randomized-controlled trial in women with systemic sclerosis. Reumatologia. 2025 Apr 30;63(2):89-96. doi: 10.5114/reum/200193. eCollection 2025.
PubMed 40485947Kiyak R, Taskin G. Beyond hemodynamics: environmental and psychosocial predictors of anxiety in emergency patients with gastrointestinal bleeding. Front Psychol. 2025 Oct 22;16:1668976. doi: 10.3389/fpsyg.2025.1668976. eCollection 2025.
PubMed 41200048Khan AA, Ali A, Khan AS, Shafi Y, Masud M, Irfan F, Abaidullah S. Effects of visual aid on state anxiety, fear and stress level in patients undergoing endoscopy: a randomized controlled trial. Ann Med. 2023 Dec;55(1):1234-1243. doi: 10.1080/07853890.2023.2191000.
PubMed 37078544Yarbas G, Karpuzcu HC, Catalbas R, Erdogan C. Exploring Anxiety Triggers in Non-sedated Upper Gastrointestinal Endoscopy: A Prospective Analysis. Dig Dis Sci. 2025 Dec;70(12):4099-4112. doi: 10.1007/s10620-025-09216-3. Epub 2025 Jul 24.
PubMed 40707757Ozkan O, Korkut S. Effect of Breathing Exercise During Peripheral Venous Catheterization on Pain, Anxiety, and Patient Satisfaction: A Randomized Controlled Trial. J Perianesth Nurs. 2024 Aug;39(4):630-637. doi: 10.1016/j.jopan.2023.11.006. Epub 2024 Feb 29.
PubMed 38430076Liu, Z., Gao, F., Jin, J., Wang, W., Zhao, X., Liang, Q., ... & Wei, L. (2025). Effect of biomechanics-correlated integrated nursing mode of physician and nursing on operation process, intraoperative and postoperative adverse reactions and resuscitation quality of elderly patients with painless gastroscopy. Molecular & Cellular Biomechanics, 22(1). https://doi.org/10.62617/mcb948
Farooq, M. A., Uzair, M., Mansoor, H., Asghar, A., Siddique, M., & Yasin, M. A. (2025). Impact of pre-procedure anxiety on the outcome of upper gastro-intestinal endoscopy: A study at CMH Lahore. Pakistan Armed Forces Medical Journal, 75(Suppl-6), S841-S845. https://doi.org/10.51253/pafmj.v75iSUPPL-6.6126
Helba, K. M., Abdelaziz, A. L., Selim, M. F., & Salem, F. A. (2024). Effect of Nursing Instructions on Clinical Outcomes for Patients Undergoing Upper Gastrointestinal Endoscopy. Tanta Scientific Nursing Journal, 33(2), 223-244. https://doi.org/10.21608/tsnj.2024.351226
Nasution, N. (2022). Knowledge Relationship With Level Anxiety In Patients Who Will Endoscopic Performance In General Hospital Dr. Zainoel Abidin Government Aceh 2022. Science Midwifery, 10(5), 3929-3933. https://doi.org/10.35335/midwifery.v10i5.921
Waddingham W, Kamran U, Kumar B, Trudgill NJ, Tsiamoulos ZP, Banks M. Complications of diagnostic upper Gastrointestinal endoscopy: common and rare - recognition, assessment and management. BMJ Open Gastroenterol. 2022 Dec;9(1):e000688. doi: 10.1136/bmjgast-2021-000688.
PubMed 36572454Sargin M, Uluer M. The effect of pre-procedure anxiety on sedative requirements for sedation during upper gastrointestinal endoscopy. Turk J Surg. 2020 Dec 29;36(4):368-373. doi: 10.47717/turkjsurg.2020.4532. eCollection 2020 Dec.
PubMed 33778396
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Diaphragmatic Breathing Exercises Performed Prior to Diagnostic Gastroscopy on Anxiety, Fear, and Vital Signs in Adult Patients: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07781943
- Acronym / sponsor ID
- AY-BreathE.2027-01
- Conditions
- Breath Exercise, State Anxiety, Adult Patients, Vital Signs Monitoring, Fear
- Keywords
- Gastroscopy, Fear, State Anxiety, Vital Signs, Breathing Exercise, endoscopy, GI endoscopy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 64 participants (estimated)
- Lead sponsor
- Eastern Mediterranean UniversityUniversity, hospital or other
- Study start
- 31 Jul 2026 (actual)
- Primary completion
- 30 Sep 2026 (estimated)
- Study completion
- 30 Oct 2026 (estimated)
- First posted
- 24 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Breathing Exercise | Experimental | Other: Diaphragmatic Breathing ExercisesEligible 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. |
| Control | No intervention | –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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
- Inability to complete the intervention because of unexpected changes in the timing of the gastroscopy procedure.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Diaphragmatic Breathing ExercisesParticipants 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. | Other | Intervention Breathing Exercise |
Primary outcome
Change in State Anxiety Score
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).
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.
6 secondary outcomes
Changes in Fear Score
Time frame: Baseline (approximately 30 minutes before gastroscopy) and immediately before the gastroscopy procedure.
Change in Pulse Rate
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
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
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
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)
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).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2026.
- BackgroundPotter, P. A., Perry, A. G., Stockert, P. A., Hall, A., Astle, B. J., & Duggleby, W. (2018). Canadian fundamentals of nursing (6th ed.). Mosby Canada. (ss.3203 - 3204)
- BackgroundBerman, A., Snyder, S. J., & Frandsen, G. (2022). Kozier & Erb's fundamentals of nursing: Concepts, process, and practice (11th ed.). Pearson. (ss.964 - 980)
- Results publication: PubMed 39809653Aslan K, Ozer Z, Yontem MK. Effect of Virtual Reality on Pain, Anxiety, and Vital Signs in Endoscopy. Pain Manag Nurs. 2025 Aug;26(4):e371-e380. doi: 10.1016/j.pmn.2024.11.009. Epub 2025 Jan 13.
- Results publication: PubMed 40297209Karpuzcu HC, Yarbas G, Catalbas R, Atli NA, Erdogan C. The effect of pre-procedural anxiety level on the quality of upper GI endoscopy in non-sedated patients: "can the need for sedation be predicted?". Ther Adv Gastroenterol. 2025 Apr 16;18:17562848251333025. doi: 10.1177/17562848251333025. eCollection 2025.
- Results publication: PubMed 40485947Ismail AMA, El Gressy NSSA, Hegazy MD, Ahmed OSM, Elfahl AMA. Effects of diaphragmatic breathing exercise on sleeping quality, cortisol, cardiovascular autonomic functions, depression, and fatigue: a randomized-controlled trial in women with systemic sclerosis. Reumatologia. 2025 Apr 30;63(2):89-96. doi: 10.5114/reum/200193. eCollection 2025.
- Results publication: PubMed 41200048Kiyak R, Taskin G. Beyond hemodynamics: environmental and psychosocial predictors of anxiety in emergency patients with gastrointestinal bleeding. Front Psychol. 2025 Oct 22;16:1668976. doi: 10.3389/fpsyg.2025.1668976. eCollection 2025.
- Results publication: PubMed 37078544Khan AA, Ali A, Khan AS, Shafi Y, Masud M, Irfan F, Abaidullah S. Effects of visual aid on state anxiety, fear and stress level in patients undergoing endoscopy: a randomized controlled trial. Ann Med. 2023 Dec;55(1):1234-1243. doi: 10.1080/07853890.2023.2191000.
- Results publication: PubMed 40707757Yarbas G, Karpuzcu HC, Catalbas R, Erdogan C. Exploring Anxiety Triggers in Non-sedated Upper Gastrointestinal Endoscopy: A Prospective Analysis. Dig Dis Sci. 2025 Dec;70(12):4099-4112. doi: 10.1007/s10620-025-09216-3. Epub 2025 Jul 24.
- Results publication: PubMed 38430076Ozkan O, Korkut S. Effect of Breathing Exercise During Peripheral Venous Catheterization on Pain, Anxiety, and Patient Satisfaction: A Randomized Controlled Trial. J Perianesth Nurs. 2024 Aug;39(4):630-637. doi: 10.1016/j.jopan.2023.11.006. Epub 2024 Feb 29.
- Results publicationLiu, Z., Gao, F., Jin, J., Wang, W., Zhao, X., Liang, Q., ... & Wei, L. (2025). Effect of biomechanics-correlated integrated nursing mode of physician and nursing on operation process, intraoperative and postoperative adverse reactions and resuscitation quality of elderly patients with painless gastroscopy. Molecular & Cellular Biomechanics, 22(1). https://doi.org/10.62617/mcb948
- Results publicationFarooq, M. A., Uzair, M., Mansoor, H., Asghar, A., Siddique, M., & Yasin, M. A. (2025). Impact of pre-procedure anxiety on the outcome of upper gastro-intestinal endoscopy: A study at CMH Lahore. Pakistan Armed Forces Medical Journal, 75(Suppl-6), S841-S845. https://doi.org/10.51253/pafmj.v75iSUPPL-6.6126
- Results publicationHelba, K. M., Abdelaziz, A. L., Selim, M. F., & Salem, F. A. (2024). Effect of Nursing Instructions on Clinical Outcomes for Patients Undergoing Upper Gastrointestinal Endoscopy. Tanta Scientific Nursing Journal, 33(2), 223-244. https://doi.org/10.21608/tsnj.2024.351226
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Sevinç Taştan, Prof. Dr. contact
Sevinç Taştan principal investigator
Eastern Medditerranian University, Faculty Of Health Sciences, Nursing Department
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Diaphragmatic Breathing Exercises in people with Breath Exercise and State Anxiety, run by Eastern Mediterranean University at 1 site in Cyprus.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 24 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Cyprus. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Aynur Yüksel, Bachelors (+90 533 867 1705, aynuryuksel05@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in State Anxiety Score (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).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07781943, which also lists 24 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Aug 2026; AzTrials last refreshed its copy on 26 Oct 2026.