Mersin University Institute of Health Sciences
Mersin, Turkey (Türkiye)
NCT Number: NCT07815184
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.
This study is active but is not currently recruiting participants.
Notify Me18 year and older
All sexes
Interventional
Not applicable
Mersin, Turkey (Türkiye)
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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
No interventions will be performed on patients in the control group; they will receive routine nursing care before and after the endoscopy.
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.
Time frame: From 45 minutes before endoscopy to 15 minutes after completion of endoscopy.
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.
Time frame: From 45 minutes before endoscopy to 15 minutes after completion of endoscopy.
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.
Time frame: From 45 minutes before endoscopy to 15 minutes after completion of endoscopy.
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.
Time frame: From 45 minutes before endoscopy to 15 minutes after completion of endoscopy.
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.
Time frame: From 45 minutes before endoscopy to 15 minutes after completion of endoscopy.
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.
Time frame: From 45 minutes before endoscopy to 15 minutes after completion of endoscopy.
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.
Mersin University
Other
The Effect of Pre-Endoscopy Box Breathing and Real-Time Physiological Feedback on Stress, Comfort, and Vital Signs
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