- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning 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.
Studieöversikt
Status
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Inskrivning (Beräknad)
Fas
- Inte tillämpbar
Kontakter och platser
Studiekontakt
- Namn: Gamze Bozkul
- Telefonnummer: +903246000033
- E-post: gamze.bozkul@gmail.com
Studera Kontakt Backup
- Namn: GAMZE BOZKUL
- E-post: gamze.bozkul@gmail.com
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
- Vuxen
- Äldre vuxen
Tar emot friska volontärer
Beskrivning
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.
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Övrig
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Fyrdubbla
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: 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.
|
|
Inget ingripande: 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.
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Ångest
Tidsram: 12 månader
|
Den statliga ångestskalan: I denna studie användes DAQ, som är strukturerad för att mäta tillfälliga känslor,.
Dess turkiska giltighet och tillförlitlighet genomfördes av Öer och Le Compte 1983.
DAQ består av 20 frågor på en fyra-punkts Likert-skala.
Uttalningarna i DAQ utvärderas som inte alls (1), lite (2), mycket (3) och helt (4).
I detta avsnitt är uttalandena uppdelade i direkta och omvända uttalanden.
Inverterade uttalanden: 1: a, 2: a, 5: e, 5: e, 8: e, 8: e, 10: e, 11: e, 15: e, 16: e 19, 20: e artiklar.
Den totala poängen för de omvända uttalandena dras från den totala poängen för de direkta uttalandena och numret 50, som är det invarierade värdet för DAQ, läggs till det erhållna värdet och DAQ -poängen beräknas.
Skalpoängen sträcker sig mellan 20-80 och en ökning av poängen indikerar en ökning av ångestnivån.
|
12 månader
|
|
Procedural Pain
Tidsram: 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
Tidsram: 12 months
|
This form is used to record pre-procedural and post-procedural pulmonary function test (PFT) parameters
|
12 months
|
Samarbetspartners och utredare
Sponsor
Utredare
- Studierektor: Gamze Bozkul, Tarsus University
Publikationer och användbara länkar
Allmänna publikationer
- 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
Studieavstämningsdatum
Studera stora datum
Studiestart (Beräknad)
Primärt slutförande (Beräknad)
Avslutad studie (Beräknad)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- TU-BOZKUL-021
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