Breathing ExercisesNCT07815184
Box Breathing and Physiological Feedback Before Endoscopy
A study testing Box Breathing Exercise and Real-Time Physiological Feedback and Routine Maintenance in people with Breathing Exercises and Physiological Feedback, run by Mersin University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breathing Exercises, Physiological Feedback, Stress
- What is being tested?
- Box Breathing Exercise and Real-Time Physiological Feedback and Routine Maintenance
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Feb 2026to 15 Sep 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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,
Show all 10Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Mersin University Institute of Health Sciences
Mersin
About this study
Official title: The Effect of Pre-Endoscopy Box Breathing and Real-Time Physiological Feedback on Stress, Comfort, and Vital Signs
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.
Read the detailed description
This study is a two-group randomized controlled trial designed to evaluate the effects of box breathing exercises and real-time physiological feedback-administered prior to the endoscopy procedure-on patients' stress levels, comfort levels, and vital signs. The research will be conducted within the scope of routine clinical practice, and no additional invasive procedures beyond standard nursing care will be performed. During the study, patients in the intervention group will receive guided box breathing exercises and real-time physiological feedback in addition to standard nursing care prior to the endoscopy. Patients in the control group will continue to receive standard nursing care without any additional interventions.
The box breathing exercise employed in this study is a non-pharmacological nursing intervention that is easy to implement in clinical settings, low-cost, and free of known serious side effects. Real-time physiological feedback will enable the monitoring of changes in patients' physiological indicators during the procedure and the provision of appropriate feedback to the patient. All measurement tools used in the study have proven validity and reliability, and the data obtained will be used solely for research purposes. Participants' personal information will be kept confidential; data will be analyzed using coding, and personally identifiable information will not be shared with third parties.
Participation in the study is entirely voluntary, and participants may withdraw at any time without providing a reason. A decision to withdraw from the study will not affect the participants' endoscopy procedures or their right to access healthcare services. The box breathing exercise will be administered with due consideration of the participants' physical and cognitive conditions. The practice will be terminated immediately should any dizziness, shortness of breath, discomfort, or other adverse reactions occur during the exercise. Participant safety will be prioritized throughout the study, and any necessary clinical assessment and intervention will be provided without delay in the event of discomfort or an adverse incident.
The findings of this study are expected to provide evidence-based data for nursing care practices aimed at managing patient stress and comfort during the pre-endoscopy period, and to support the integration of non-pharmacological interventions-such as box breathing exercises and real-time physiological feedback-into clinical practice.
- Conditions
- Breathing Exercises, Physiological Feedback, Stress, Endoscopy, Patient Comfort
- Being tested
- Box Breathing Exercise and Real-Time Physiological Feedback, Routine Maintenance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Box Breathing Exercise and Real-Time Physiological FeedbackOther
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
Routine MaintenanceOther
No interventions will be performed on patients in the control group; they will receive routine nursing care before and after the endoscopy.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Box Breathing Exercise and Real-Time Physiological Feedback |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From 45 minutes before endoscopy to 15 minutes after completion of endoscopy.
Secondary outcomes (6)
Comfort Level
Patients' comfort levels will be assessed via face-to-face interviews using the General Comfort Questionnaire-Short Form (GCQ-SF). Measurements will be taken 45 minutes prior to the endoscopy procedure (1st measurement), immediately after the intervention (2nd measurement), and 15 minutes after the completion of the endoscopy procedure (3rd measurement). Changes in comfort levels between the study and control groups will be compared.
Measured: From 45 minutes before endoscopy to 15 minutes after completion of endoscopy.
Systolic Blood Pressure
The patients' systolic blood pressure will be measured using the hospital's digital blood pressure monitor. Measurements will be taken 45 minutes before the endoscopy procedure (1st measurement), immediately after the intervention (2nd measurement), and 15 minutes after the completion of the endoscopy procedure (3rd measurement). Changes in the study and control groups will be compared.
Measured: From 45 minutes before endoscopy to 15 minutes after completion of endoscopy.
Diastolic Blood Pressure
Patients' diastolic blood pressure will be measured using the hospital's digital blood pressure monitor. Measurements will be taken 45 minutes before the endoscopy procedure (1st measurement), immediately after the intervention (2nd measurement), and 15 minutes after the completion of the endoscopy procedure (3rd measurement). Changes in the study and control groups will be compared.
Measured: From 45 minutes before endoscopy to 15 minutes after completion of endoscopy.
Heart Rate
The patients' heart rates will be measured using the hospital's digital blood pressure monitor. Measurements will be taken 45 minutes before the endoscopy procedure (1st measurement), immediately after the intervention (2nd measurement), and 15 minutes after the completion of the endoscopy procedure (3rd measurement). Changes in the study and control groups will be compared.
Measured: From 45 minutes before endoscopy to 15 minutes after completion of endoscopy.
Respiratory Rate
Patients' respiratory rates will be measured by observing chest movements for one minute using the researcher's digital watch. Measurements will be taken 45 minutes prior to the endoscopy procedure (1st measurement), immediately after the intervention (2nd measurement), and 15 minutes after the completion of the endoscopy procedure (3rd measurement). Changes in the study and control groups will be compared.
Measured: From 45 minutes before endoscopy to 15 minutes after completion of endoscopy.
Oxygen Saturation Value
Patients' oxygen saturation levels will be measured using the hospital's pulse oximeter. Measurements will be taken 45 minutes prior to the endoscopy procedure (1st measurement), immediately after the intervention (2nd measurement), and 15 minutes after the completion of the endoscopy procedure (3rd measurement). Changes in the study and control groups will be compared.
Measured: From 45 minutes before endoscopy to 15 minutes after completion of endoscopy.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2026
- Study start15 Feb 2026
- Primary completion15 Sep 2026 (estimated)
- Study completion15 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Breathing ExercisesStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mersin University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yasemin ÇAYİR, Mersin University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07815184
- Sponsor's protocol ID
- 78017789/050.01.04/3392075
- Status last verified
- Sep 2026
- First submitted
- 5 Sep 2026
- Last updated
- 11 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared due to ethical considerations, protection of patient privacy, and the absence of participant consent for data sharing beyond the scope of this study.
Publications
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
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Pre-Endoscopy Box Breathing and Real-Time Physiological Feedback on Stress, Comfort, and Vital Signs
- ClinicalTrials.gov ID
- NCT07815184
- Acronym / sponsor ID
- 78017789/050.01.04/3392075
- Conditions
- Breathing Exercises, Physiological Feedback, Stress, Endoscopy, Patient Comfort
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Mersin UniversityUniversity, hospital or other
- Study start
- 15 Feb 2026 (actual)
- Primary completion
- 15 Sep 2026 (estimated)
- Study completion
- 15 Sep 2026 (estimated)
- First posted
- 11 Sep 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.
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.
Detailed description
This study is a two-group randomized controlled trial designed to evaluate the effects of box breathing exercises and real-time physiological feedback-administered prior to the endoscopy procedure-on patients' stress levels, comfort levels, and vital signs. The research will be conducted within the scope of routine clinical practice, and no additional invasive procedures beyond standard nursing care will be performed. During the study, patients in the intervention group will receive guided box breathing exercises and real-time physiological feedback in addition to standard nursing care prior to the endoscopy. Patients in the control group will continue to receive standard nursing care without any additional interventions.
The box breathing exercise employed in this study is a non-pharmacological nursing intervention that is easy to implement in clinical settings, low-cost, and free of known serious side effects. Real-time physiological feedback will enable the monitoring of changes in patients' physiological indicators during the procedure and the provision of appropriate feedback to the patient. All measurement tools used in the study have proven validity and reliability, and the data obtained will be used solely for research purposes. Participants' personal information will be kept confidential; data will be analyzed using coding, and personally identifiable information will not be shared with third parties.
Participation in the study is entirely voluntary, and participants may withdraw at any time without providing a reason. A decision to withdraw from the study will not affect the participants' endoscopy procedures or their right to access healthcare services. The box breathing exercise will be administered with due consideration of the participants' physical and cognitive conditions. The practice will be terminated immediately should any dizziness, shortness of breath, discomfort, or other adverse reactions occur during the exercise. Participant safety will be prioritized throughout the study, and any necessary clinical assessment and intervention will be provided without delay in the event of discomfort or an adverse incident.
The findings of this study are expected to provide evidence-based data for nursing care practices aimed at managing patient stress and comfort during the pre-endoscopy period, and to support the integration of non-pharmacological interventions-such as box breathing exercises and real-time physiological feedback-into clinical practice.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| control group | Experimental | Other: Routine MaintenanceNo interventions will be performed on patients in the control group; they will receive routine nursing care before and after the endoscopy. |
| study group | Experimental | Other: Box Breathing Exercise and Real-Time Physiological FeedbackThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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,
Key exclusion criteria (10 listed)
- 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,
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 |
|---|---|---|
| Box Breathing Exercise and Real-Time Physiological FeedbackA 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 | Other | study group |
| Routine MaintenanceNo interventions will be performed on patients in the control group; they will receive routine nursing care before and after the endoscopy. | Other | control group |
Primary outcome
Stress Level
Time frame: From 45 minutes before endoscopy to 15 minutes after completion of endoscopy.
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.
6 secondary outcomes
Comfort Level
Time frame: From 45 minutes before endoscopy to 15 minutes after completion of endoscopy.
Systolic Blood Pressure
Time frame: From 45 minutes before endoscopy to 15 minutes after completion of endoscopy.
Diastolic Blood Pressure
Time frame: From 45 minutes before endoscopy to 15 minutes after completion of endoscopy.
Heart Rate
Time frame: From 45 minutes before endoscopy to 15 minutes after completion of endoscopy.
Respiratory Rate
Time frame: From 45 minutes before endoscopy to 15 minutes after completion of endoscopy.
Oxygen Saturation Value
Time frame: From 45 minutes before endoscopy to 15 minutes after completion of endoscopy.
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 11 Sep 2026.
- Results publication: PubMed 33778396Sargin 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.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: No. Individual participant data will not be shared due to ethical considerations, protection of patient privacy, and the absence of participant consent for data sharing beyond the scope of this study.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Box Breathing Exercise and Real-Time Physiological Feedback and Routine Maintenance in people with Breathing Exercises and Physiological Feedback, run by Mersin University at 1 site in Turkey (Türkiye).
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 8 inclusion and 10 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: under way, not looking for participants, as of the sponsor's last update on 11 Sep 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 Turkey (Türkiye). 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Stress Level (time frame: From 45 minutes before endoscopy to 15 minutes after completion of endoscopy.). 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 NCT07815184, which also lists 1 linked publication.
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 11 Sep 2026.