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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.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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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.

Aynur Yüksel, Bachelors contact

+90 533 867 1705

aynuryuksel05@gmail.com

Sevinç Taştan, Prof. Dr. contact

sevinc.tastan@emu.edu.tr

Cyprus1 site, 1 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

    Recruiting

Other trials in Cyprus

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.

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 groups in NCT07781943
Study groupRoleWhat they receive
Intervention Breathing ExerciseExperimentalEligible 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
ControlNo interventionEligible 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.

  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.

    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)
  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.

    Measured: 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.

    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).

  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.

    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).

  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.

    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).

  5. 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).

  6. 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.

  1. First posted24 Aug 2026
  2. Study start31 Jul 2026
  3. Primary completion30 Sep 2026 (estimated)
  4. Study completion30 Oct 2026 (estimated)

Resources

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)
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 39809653
  • Karpuzcu 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 40297209
  • Ismail 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 40485947
  • Kiyak 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 41200048
  • Khan 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 37078544
  • Yarbas 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 40707757
  • Ozkan 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 38430076
  • Liu, 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 36572454
  • Sargin 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

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.

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