Effect of Box Breathing Exercise on Anxiety, Pain, and Pulmonary Function Tests in Patients Undergoing Colonoscopy
Effect of Box Breathing Exercise on Anxiety, Pain, and Pulmonary Function Tests in Patients Undergoing Colonoscopy: Randomized Controlled Trial
This study is a prospective, randomized controlled clinical trial designed to determine the effect of box breathing exercises on anxiety, pain, and pulmonary function in patients undergoing colonoscopy. Data will be collected using the Participant Characteristics Form, State Anxiety Inventory (SAI), Visual Analog Scale (VAS), and Pulmonary Function Test Monitoring Form. Patients scheduled for colonoscopy who meet the inclusion criteria will be informed about the study, and written informed consent will be obtained.
Upon arrival at the endoscopy unit, all participants will complete the Participant Characteristics Form and the State Anxiety Inventory (SAI) under the supervision of researcher MA. Baseline pulmonary function tests will be performed using the Contec SP-10 Spirometer (China).
After confirming eligibility and obtaining written informed consent, researcher GB will notify researcher YG, who will determine the participant's group allocation and communicate it to GB according to the randomization sequence.
Before the procedure, 34 patients allocated to the intervention group will receive the box breathing intervention, whereas 34 patients in the control group will receive routine pre-procedural care.
Patients in the intervention group will receive instruction from researcher GB on the box breathing technique (4-4-4-4 breathing) upon arrival at the endoscopy unit. The exercise consists of inhaling through the nose for 4 seconds, holding the breath for 4 seconds, exhaling slowly through the mouth for 4 seconds, and holding the breath again for 4 seconds, constituting one complete cycle. Participants will be instructed to continue practicing this breathing exercise until they are transferred to the procedure room.
Participants in the control group will receive the unit's standard pre-procedural care. As part of routine practice, vital signs are assessed before the procedure. To maintain patient privacy, participants remove their clothing and wear a surgical gown. After being positioned in the left lateral position, petroleum jelly is applied to the anal region, and the colonoscopy is performed using a flexible colonoscope. All colonoscopy procedures will be performed by the same gastroenterology specialist to ensure procedural consistency.
Immediately after the procedure, the State Anxiety Inventory (SAI), Visual Analog Scale (VAS), and Pulmonary Function Test Monitoring Form will be administered by researcher MA.
Przegląd badań
Status
Warunki
Interwencja / Leczenie
Szczegółowy opis
This study is a prospective, randomized controlled clinical trial designed to determine the effect of box breathing exercises on anxiety, pain, and pulmonary function in patients undergoing colonoscopy. Data will be collected using the Participant Characteristics Form, State Anxiety Inventory (SAI), Visual Analog Scale (VAS), and Pulmonary Function Test Monitoring Form. Patients scheduled for colonoscopy who meet the inclusion criteria will be informed about the study, and written informed consent will be obtained.
Upon arrival at the endoscopy unit, all participants will complete the Participant Characteristics Form and the State Anxiety Inventory (SAI) under the supervision of researcher MA. Baseline pulmonary function tests will be performed using the Contec SP-10 Spirometer (China).
After confirming eligibility and obtaining written informed consent, researcher GB will notify researcher YG, who will determine the participant's group allocation and communicate it to GB according to the randomization sequence.
Before the procedure, 34 patients allocated to the intervention group will receive the box breathing intervention, whereas 34 patients in the control group will receive routine pre-procedural care.
Patients in the intervention group will receive instruction from researcher GB on the box breathing technique (4-4-4-4 breathing) upon arrival at the endoscopy unit. The exercise consists of inhaling through the nose for 4 seconds, holding the breath for 4 seconds, exhaling slowly through the mouth for 4 seconds, and holding the breath again for 4 seconds, constituting one complete cycle. Participants will be instructed to continue practicing this breathing exercise until they are transferred to the procedure room.
Participants in the control group will receive the unit's standard pre-procedural care. As part of routine practice, vital signs are assessed before the procedure. To maintain patient privacy, participants remove their clothing and wear a surgical gown. After being positioned in the left lateral position, petroleum jelly is applied to the anal region, and the colonoscopy is performed using a flexible colonoscope. All colonoscopy procedures will be performed by the same gastroenterology specialist to ensure procedural consistency.
Immediately after the procedure, the State Anxiety Inventory (SAI), Visual Analog Scale (VAS), and Pulmonary Function Test Monitoring Form will be administered by researcher MA. Data will be analyzed using statistical software. Participants' descriptive characteristics will be summarized using mean ± standard deviation, median (minimum-maximum), frequencies, and percentages, as appropriate. Qualitative variables recorded in the patient follow-up form will be categorized and converted into quantitative data, and the results will be presented as frequencies and percentages.
Typ studiów
Zapisy (Szacowany)
Faza
- Nie dotyczy
Kontakty i lokalizacje
Kontakt w sprawie studiów
- Nazwa: Gamze Bozkul
- Numer telefonu: +903246000033
- E-mail: gamze.bozkul@gmail.com
Kopia zapasowa kontaktu do badania
- Nazwa: GAMZE BOZKUL
- E-mail: gamze.bozkul@gmail.com
Kryteria uczestnictwa
Kryteria kwalifikacji
Wiek uprawniający do nauki
- Dorosły
- Starszy dorosły
Akceptuje zdrowych ochotników
Opis
Inclusion Criteria:
- are 18 years of age or older;
- are scheduled to undergo colonoscopy;
- are conscious, oriented, and able to cooperate;
- provide written informed consent to participate in the study;
- are able to speak and understand Turkish; and
- have no physical disabilities that would interfere with study participation.
Exclusion Criteria:
- decline to participate or choose to withdraw from the study;
- have a chronic respiratory disease;
- have chest pain;
- have nasal abnormalities (e.g., nasal septal deviation) or adenoid hypertrophy -that may affect ventilation;
- have previously practiced box breathing exercises; or
- have chronic pain.
Plan studiów
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Inny
- Przydział: Randomizowane
- Model interwencyjny: Przydział równoległy
- Maskowanie: Poczwórny
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
|---|---|
|
Eksperymentalny: Experimental group
Patients in the intervention group will receive instruction from researcher GB on the box breathing technique (4-4-4-4 breathing) upon arrival at the endoscopy unit.
The exercise consists of inhaling through the nose for 4 seconds, holding the breath for 4 seconds, exhaling slowly through the mouth for 4 seconds, and holding the breath again for 4 seconds, constituting one complete cycle.
Participants will be instructed to continue practicing this breathing exercise until they are transferred to the procedure room.
|
Patients in the intervention group will receive instruction from researcher GB on the box breathing technique (4-4-4-4 breathing) upon arrival at the endoscopy unit.
The exercise consists of inhaling through the nose for 4 seconds, holding the breath for 4 seconds, exhaling slowly through the mouth for 4 seconds, and holding the breath again for 4 seconds, constituting one complete cycle.
Participants will be instructed to continue practicing this breathing exercise until they are transferred to the procedure room.
|
|
Brak interwencji: Control group
Participants in the control group will receive the unit's standard pre-procedural care.
As part of routine practice, vital signs are assessed before the procedure.
To maintain patient privacy, participants remove their clothing and wear a surgical gown.
After being positioned in the left lateral position, petroleum jelly is applied to the anal region, and the colonoscopy is performed using a flexible colonoscope.
All colonoscopy procedures will be performed by the same gastroenterology specialist to ensure procedural consistency.
|
Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Lęk
Ramy czasowe: 12 miesięcy
|
Skala lęku stanowego: w tym badaniu zastosowano DAQ, który jest ustrukturyzowany do pomiaru chwilowych uczuć.
Jego turecka ważność i niezawodność zostały przeprowadzone przez Önera i LE Compte w 1983 r.
DAQ składa się z 20 pytań w czteropunktowej skali Likerta.
Oświadczenia w DAQ są oceniane jako wcale nie (1), trochę (2), dużo (3) i całkowicie (4).
W tej sekcji oświadczenia są podzielone na bezpośrednie i odwrócone oświadczenia.
Oświadczenia odwrócone: 1, 2, 5, 5, 8, 8, 10, 11, 15, 16, 19, 20 pozycja.
Całkowity wynik odwróconych instrukcji jest odejmowany od całkowitego wyniku instrukcji bezpośrednich, a liczba 50, która jest niezmienną wartością DAQ, jest dodawana do uzyskanej wartości i obliczany wynik DAQ.
Wynik skali waha się między 20-80, a wzrost wyniku wskazuje na wzrost poziomu lęku.
|
12 miesięcy
|
|
Procedural Pain
Ramy czasowe: 12 months
|
It is a scale that provides a subjective assessment of pain on a horizontal or vertical line from 0 (no pain at all)-10 (very severe pain) to evaluate the level of pain
|
12 months
|
|
Pulmonary function test
Ramy czasowe: 12 months
|
This form is used to record pre-procedural and post-procedural pulmonary function test (PFT) parameters
|
12 months
|
Współpracownicy i badacze
Sponsor
Śledczy
- Dyrektor Studium: Gamze Bozkul, Tarsus University
Publikacje i pomocne linki
Publikacje ogólne
- Balban MY, Neri E, Kogon MM, Weed L, Nouriani B, Jo B, Holl G, Zeitzer JM, Spiegel D, Huberman AD. Brief structured respiration practices enhance mood and reduce physiological arousal. Cell Rep Med. 2023 Jan 17;4(1):100895. doi: 10.1016/j.xcrm.2022.100895. Epub 2023 Jan 10.
- Chen J, Peng LH, Min S. Implementation of perioperative breathing exercises and its effect on postoperative pulmonary complications and long-term prognosis in elderly patients undergoing laparoscopic colorectal surgery: A randomized controlled trial. Clin Rehabil. 2022 Sep;36(9):1229-1243. doi: 10.1177/02692155221097762. Epub 2022 May 29.
- 14. Šantek, N., Režić-Palaversa, T., Vilč, B., Mayer, L., Šoštarić, M., Mrzljak, A., ... & Cigrovski-Berković, M. (2023). Single session preoperative breathing exercise education may influence postoperative outcomes in open colorectal cancer surgery. Libri oncologici: Croatian journal of oncology, 51(2-3), 76-84. https://doi.org/10.20471/LO.2023.51.02-03.12
- 12. Küçükakça Çelik, G., Gümüş, K., Taylan, S., & Ertural, F. (2025). The relationship between preprocedure anxiety level and postprocedure abdominal pain and distention in patients undergoing colonoscopy: A descriptive study. Lokman Hekim Health Sciences, 5(3), 305-311. https://doi.org/10.14744/lhhs.2025.49607
Daty zapisu na studia
Główne daty studiów
Rozpoczęcie studiów (Szacowany)
Zakończenie podstawowe (Szacowany)
Ukończenie studiów (Szacowany)
Daty rejestracji na studia
Pierwszy przesłany
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy wysłany (Rzeczywisty)
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia weryfikacja
Więcej informacji
Terminy związane z tym badaniem
Słowa kluczowe
Dodatkowe istotne warunki MeSH
Inne numery identyfikacyjne badania
- TU-BOZKUL-021
Plan dla danych uczestnika indywidualnego (IPD)
Planujesz udostępniać dane poszczególnych uczestników (IPD)?
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Bada produkt urządzenia regulowany przez amerykańską FDA
Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .