The Effect of Diaphragmatic Breathing Exercises Before Gastroscopy on Anxiety, Fear, and Vital Signs

NCT07781943 | Recruiting

• 1 other identifier: AY-BreathE.2027-01
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

Brief 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). 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.

Conditions

Breath Exercise; State Anxiety; Adult Patients; Vital Signs Monitoring; Fear

Keywords

Gastroscopy; Fear; State Anxiety; Vital Signs; Breathing Exercise; endoscopy; GI endoscopy

Outcome Measures

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.

  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

  Baseline (approximately 30 minutes before gastroscopy) and immediately before the gastroscopy procedure.

• Change in Pulse Rate

  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

  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

  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

  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).

Study Arms (2)

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.

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.

Interventions

Diaphragmatic Breathing Exercises OTHER

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.

Intervention Breathing Exercise

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Eastern Mediterranean University: lead

Study Sites (1)

Famagusta State Hospital

Famagusta, Cyprus

RECRUITING

Related Publications (24)

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  BACKGROUND

• Berman, A., Snyder, S. J., & Frandsen, G. (2022). Kozier & Erb's fundamentals of nursing: Concepts, process, and practice (11th ed.). Pearson. (ss.964 - 980)

  BACKGROUND

• 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.

  PMID: 39809653 RESULT

• 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.

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• 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.

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• 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.

  PMID: 41200048 RESULT

• 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.

  PMID: 37078544 RESULT

• 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.

  PMID: 40707757 RESULT

• 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.

  PMID: 38430076 RESULT

• 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

  RESULT

• 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

  RESULT

• 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

  RESULT

• 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

  RESULT

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  PMID: 36572454 RESULT

• 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.

  PMID: 33778396 RESULT

• Lu HB, Liu X, Wang YQ, Cao HP, Ma RC, Yin YY, Song CY, Yang TT, Xie J. Active Cycle of Breathing Technique: A Respiratory Modality to Improve Perioperative Outcomes in Patients With Lung Cancer. Clin J Oncol Nurs. 2022 Apr 1;26(2):176-182. doi: 10.1188/22.CJON.176-182.

  PMID: 35302551 RESULT

• Herawati I, Mat Ludin AF, M M, Ishak I, Farah NMF. Breathing exercise for hypertensive patients: A scoping review. Front Physiol. 2023 Jan 25;14:1048338. doi: 10.3389/fphys.2023.1048338. eCollection 2023.

  PMID: 36760529 RESULT

• Gauthier F, Gunes U. The effect of music therapy and breathing exercise on anxiety and pain in patients undergoing coronary angiography: A randomized controlled study. Nurs Crit Care. 2024 Nov;29(6):1325-1333. doi: 10.1111/nicc.13145. Epub 2024 Sep 16.

  PMID: 39279717 RESULT

• Garg P, Mendiratta A, Banga A, Bucharles A, Victoria P, Kamaraj B, Qasba RK, Bansal V, Thimmapuram J, Pargament R, Kashyap R. Effect of breathing exercises on blood pressure and heart rate: A systematic review and meta-analysis. Int J Cardiol Cardiovasc Risk Prev. 2023 Dec 27;20:200232. doi: 10.1016/j.ijcrp.2023.200232. eCollection 2024 Mar.

  PMID: 38179185 RESULT

• Yang Y, Xia Q, Wu L, Luo R, Huang H, Lyu Q, Wang F. Examination tolerance, pre-examination anxiety, knowledge needs and cooperation in gastroscopic examinees: A prospective, correlational analysis in a health screening population. Nurs Open. 2024 Aug;11(8):e70006. doi: 10.1002/nop2.70006.

  PMID: 39161133 RESULT

• Bulut G, Karabulut N. The Effects of Breathing Exercises on Patients Having Laparoscopic Cholecystectomy Surgery. Clin Nurs Res. 2023 May;32(4):805-814. doi: 10.1177/10547738231154130. Epub 2023 Feb 9.

  PMID: 36759970 RESULT

• Hua F, Chang L, Chun LX. Prevalence and correlates of depression and depression-anxiety in patients receiving gastroscopy. Front Psychiatry. 2025 Aug 28;16:1585083. doi: 10.3389/fpsyt.2025.1585083. eCollection 2025.

  PMID: 40950769 RESULT

• Areia M, Esposito G, Leclercq P, Romanczyk M, Zessner-Spitzenberg J, Delgado Guillena PG, Monged A, Honrubia Lopez R, Uchima H, Ruiz Ballesteros EJ, Panarese A, Reis de Oliveira LA, Afify S, Bisschops R, Ferlitsch M; External Voting Panel. Performance measures for upper gastrointestinal endoscopy: a European Society of Gastrointestinal Endoscopy (ESGE) Quality Improvement Initiative - Update 2025. Endoscopy. 2025 Nov;57(11):1268-1297. doi: 10.1055/a-2674-4912. Epub 2025 Sep 11.

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  PMID: 37059158 RESULT

MeSH Terms

Conditions

Anxiety Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Study Officials

• Sevinç Taştan

  Eastern Medditerranian University, Faculty Of Health Sciences, Nursing Department

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Aynur Yüksel, Bachelors

CONTACT

+90 533 867 1705; aynuryuksel05@gmail.com

Sevinç Taştan, Prof. Dr.

CONTACT

sevinc.tastan@emu.edu.tr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 29, 2026
• First Posted: August 24, 2026
• Study Start: July 31, 2026
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): October 30, 2026
• Last Updated: August 24, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

CY (1)