Box Breathing and Physiological Feedback Before Endoscopy

NCT07815184 | Active Not Recruiting

• 1 other identifier: 78017789/050.01.04/3392075
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to evaluate the effects of box breathing exercises and real-time physiological feedback-administered alongside standard nursing care prior to endoscopy-on patients' stress levels, comfort levels, and vital signs. Endoscopy procedures can induce pre-procedural stress and anxiety in patients, potentially affecting their comfort and physiological status. The study will be conducted as a two-group randomized controlled trial. Participants will be randomly assigned to either the study group or the control group. In addition to standard nursing care, the study group will receive guided box breathing exercises and real-time physiological feedback before the endoscopy. The control group will receive only standard nursing care. The study will assess the impact of the intervention on patients' stress levels, comfort levels, and vital signs. It is hypothesized that box breathing exercises and real-time physiological feedback will reduce stress levels, enhance patient comfort, and positively influence vital signs. The findings are expected to contribute to the development of non-pharmacological nursing interventions for managing patient stress and comfort during the pre-endoscopy period.

Conditions

Breathing Exercises; Physiological Feedback; Stress; Endoscopy; Patient Comfort

Outcome Measures

Primary Outcomes (1)

• Stress Level

  Patients' stress levels will be assessed using the Visual Analog Scale (VAS). VAS measurements will be taken at three different times: 45 minutes before the endoscopy procedure without intervention (measurement 1), 30 minutes before the endoscopy procedure immediately after box breathing exercises and immediate physiological feedback (measurement 2), and 15 minutes after the completion of the endoscopy procedure (measurement 3). Changes in VAS scores in the study and control groups will be compared.

  From 45 minutes before endoscopy to 15 minutes after completion of endoscopy.

Secondary Outcomes (6)

• Comfort Level

  From 45 minutes before endoscopy to 15 minutes after completion of endoscopy.

• Systolic Blood Pressure

  From 45 minutes before endoscopy to 15 minutes after completion of endoscopy.

• Diastolic Blood Pressure

  From 45 minutes before endoscopy to 15 minutes after completion of endoscopy.

• Heart Rate

  From 45 minutes before endoscopy to 15 minutes after completion of endoscopy.

• Respiratory Rate

  From 45 minutes before endoscopy to 15 minutes after completion of endoscopy.

Study Arms (2)

control group

EXPERIMENTAL

No interventions will be performed on patients in the control group; they will receive routine nursing care before and after the endoscopy.

Other: Routine Maintenance

study group

EXPERIMENTAL

The intervention planned for the study group consists of box breathing exercises and real-time physiological feedback. The researcher will administer the box breathing exercise-developed in accordance with the literature-and real-time physiological feedback to the patient. The breathing exercise will be conducted by the researcher, who has received training and holds a certification in this area; furthermore, the administration of breathing exercises falls within the scope of nursing interventions that nurses are authorized to perform. For individuals in the study group, the researcher will administer the box breathing exercise and real-time physiological feedback in the endoscopy preparation room 30 minutes prior to the endoscopy procedure. The duration of the box breathing exercise is approximately six to seven minutes. During the exercise, the environment will be ensured to be quiet, at room temperature, and well-ventilated.

Other: Box Breathing Exercise and Real-Time Physiological Feedback

Interventions

Box Breathing Exercise and Real-Time Physiological Feedback OTHER

A pulse oximeter will be attached to the patient's finger so they can instantly see or sense the relaxing effect. The patient will be asked to monitor changes in their pulse and oxygen levels in relation to their breathing and level of relaxation. The following statement will be made to the patient: "We are now going to do a few minutes of breathing exercises. This exercise will help relax your body, regulate your heart rate, increase your oxygen levels, and help you feel more at ease before the upcoming procedure. All you need to do is follow my breathing instructions and observe your pulse and oxygen levels on the device attached to your finger." Box Breathing Technique (3-4 minutes) Each cycle consists of: inhale for 4 seconds - hold for 4 seconds - exhale for 4 seconds - hold for 4 seconds. Box Breathing Exercise (to be repeated 6-8 times) "Take a deep breath in through your nose 1…2…3…4. Hold your breath 1…2…3…4. Now, exhale slowly 1…2…3…4. Hold your breath out 1…2…3...4

study group

Routine Maintenance OTHER

No interventions will be performed on patients in the control group; they will receive routine nursing care before and after the endoscopy.

control group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Individuals who present to the Endoscopy Unit of Mersin City Training and Research Hospital between February 15 and September 15, 2026,
• Are aged 18 years or older,
• Are literate in Turkish,
• Are undergoing a scheduled (non-emergency) endoscopy procedure for the first time,
• Do not receive any analgesic or anesthetic medication before or during the procedure,
• Have no diagnosis of, nor are receiving medical treatment for, an anxiety disorder,
• Have no cognitive, affective, or verbal impairments that would hinder communication,
• And agree to participate in the study will be included.

You may not qualify if:

• The following individuals will be excluded,
• Those who have previously undergone endoscopy,
• Those who have used analgesics within the last 24 hours,
• Those scheduled for endoscopy with sedation,
• Those using other complementary methods (yoga, reflexology, acupuncture, etc.) during the procedure,
• Patients with unstable general condition or vital signs,
• Those unable to perform breathing exercises due to severe cognitive impairment or psychiatric illness,
• Patients regularly using beta-blockers or antiarrhythmic drugs-making the interpretation of physiological parameters difficult,
• Pregnant individuals,
• Individuals who do not consent to participate in the study.

Sponsors & Collaborators

• Mersin University: lead

Study Sites (1)

Mersin University Institute of Health Sciences

Mersin, Turkey (Türkiye)

Location

Related Publications (1)

• 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

Related Links

• Related Info

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: This study is a prospective, parallel-group, single-center, randomized controlled experimental trial conducted to evaluate the effects of box breathing exercises and real-time physiological feedback-administered prior to endoscopy-on patients' stress levels, comfort, and vital signs.

Study Record Dates

• First Submitted: September 5, 2026
• First Posted: September 11, 2026
• Study Start: February 15, 2026
• Primary Completion: September 15, 2026
• Study Completion: September 15, 2026
• Last Updated: September 11, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)