- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT07728890
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.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
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.
Type d'étude
Inscription (Estimé)
Phase
- N'est pas applicable
Contacts et emplacements
Coordonnées de l'étude
- Nom: Gamze Bozkul
- Numéro de téléphone: +903246000033
- E-mail: gamze.bozkul@gmail.com
Sauvegarde des contacts de l'étude
- Nom: GAMZE BOZKUL
- E-mail: gamze.bozkul@gmail.com
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
La description
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 d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Autre
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Quadruple
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: 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.
|
|
Aucune intervention: 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.
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Anxiété
Délai: 12 mois
|
L'échelle d'anxiété de l'État: dans cette étude, le DAQ, qui est structuré pour mesurer les sentiments momentanés, a été utilisé.
Sa validité turque et sa fiabilité ont été menées par Öner et Le Compte en 1983.
Le DAQ se compose de 20 questions sur une échelle de Likert à quatre points.
Les instructions dans le DAQ sont évaluées comme non du tout (1), un peu (2), beaucoup (3) et complètement (4).
Dans cette section, les déclarations sont divisées en déclarations directes et inversées.
Déclarations inversées: 1er, 2e, 5e, 5e, 8e, 8e, 10e, 11e, 15e, 16e, 19e, 20e éléments.
Le score total des instructions inversées est soustraite du score total des instructions directes et le nombre 50, qui est la valeur invariante du DAQ, est ajouté à la valeur obtenue et le score DAQ est calculé.
Le score d'échelle varie entre 20 et 80 et une augmentation du score indique une augmentation du niveau d'anxiété.
|
12 mois
|
|
Procedural Pain
Délai: 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
Délai: 12 months
|
This form is used to record pre-procedural and post-procedural pulmonary function test (PFT) parameters
|
12 months
|
Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Directeur d'études: Gamze Bozkul, Tarsus University
Publications et liens utiles
Publications générales
- 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
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Estimé)
Achèvement primaire (Estimé)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- TU-BOZKUL-021
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
Informations sur les médicaments et les dispositifs, documents d'étude
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