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.
Descripción general del estudio
Estado
Estado
Condiciones
Condiciones
Intervención / Tratamiento
Intervención / Tratamiento
Descripción detallada
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.
Tipo de estudio
Tipo de estudio
Inscripción (Estimado)
Inscripción
Fase
Fase
- No aplica
Contactos y Ubicaciones
Estudio Contacto
Estudio Contacto
- Nombre: Gamze Bozkul
- Número de teléfono: +903246000033
- Correo electrónico: gamze.bozkul@gmail.com
Copia de seguridad de contactos de estudio
- Nombre: GAMZE BOZKUL
- Correo electrónico: gamze.bozkul@gmail.com
Criterios de participación
Criterio de elegibilidad
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Descripción
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 de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Otro
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Cuadruplicar
Número de brazos
Armas e Intervenciones
Grupo de participantes/brazoGrupo de participantes/brazo |
Intervención / TratamientoIntervención / Tratamiento |
|---|---|
|
Experimental: 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.
|
|
Sin intervención: 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.
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Ansiedad
Periodo de tiempo: 12 meses
|
Se utilizó la escala de ansiedad del estado: en este estudio, se usó el DAQ, que está estructurado para medir los sentimientos momentáneos.
Su validez y confiabilidad turca fue realizada por Öner y Le Compte en 1983.
El DAQ consta de 20 preguntas en una escala Likert de cuatro puntos.
Las declaraciones en el DAQ se evalúan como en absoluto (1), un poco (2), mucho (3) y completamente (4).
En esta sección, las declaraciones se dividen en declaraciones directas e invertidas.
Declaraciones invertidas: 1 °, 2, 5, 5, 8, 8, 10, 11, 15, 16, 19, 20 °.
El puntaje total de las declaraciones invertidas se resta de la puntuación total de las declaraciones directas y el número 50, que es el valor invariante del DAQ, se agrega al valor obtenido y se calcula el puntaje DAQ.
El puntaje de escala varía entre 20-80 y un aumento en la puntuación indica un aumento en el nivel de ansiedad.
|
12 meses
|
|
Procedural Pain
Periodo de tiempo: 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
Periodo de tiempo: 12 months
|
This form is used to record pre-procedural and post-procedural pulmonary function test (PFT) parameters
|
12 months
|
Colaboradores e Investigadores
Patrocinador
Patrocinador
Investigadores
Investigadores
- Director de estudio: Gamze Bozkul, Tarsus University
Publicaciones y enlaces útiles
Publicaciones Generales
- 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
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Estimado)
Inicio del estudio
Finalización primaria (Estimado)
Finalización primaria
Finalización del estudio (Estimado)
Finalización del estudio
Fechas de registro del estudio
Enviado por primera vez
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Publicado por primera vez
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización publicada
Última actualización enviada que cumplió con los criterios de control de calidad
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
Otros números de identificación del estudio
- TU-BOZKUL-021
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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