- ICH GCP
- US-Register für klinische Studien
- Klinische Studie NCT07646002
Effectiveness of Balloon Blowing and Deep Breathing Exercise on Increasing Peripheral Oxygen Saturation in Patients With Chronic Obstructive Pulmonary Disease
This study aims to determine the effect of Balloon Blowing and Deep Breathing Exercise on Increasing Peripheral Oxygen Saturation in Patients with Chronic Obstructive Pulmonary Disease. The main question it aims to answer is:
1. What is the effect of balloon blowing breathing exercise on peripheral oxygen saturation in Chronic Obstructive Pulmonary Disease patients? Participants performed the exercise on the day agreed upon with the researcher. Respondents performed balloon-blowing breathing exercises twice daily for 7 days. These exercises consisted of deep breathing exercises followed by a slow balloon-blowing technique in three cycles per session, with a 1-minute rest interval between cycles. Each cycle included a deep breath for 3-4 seconds, a breath hold for 2-3 seconds, and a slow breath into the balloon for 5-8 seconds, repeated four times. Oxygen saturation was measured after the intervention on the seventh day to assess the effect of the exercise on peripheral oxygen saturation.
Researchers compared the intervention and control groups to determine whether there was a significant difference between respondents who performed deep breathing exercises and balloon-blowing (intervention) and those who performed only deep breathing exercises (control).
Studienübersicht
Status
Bedingungen
Intervention / Behandlung
Detaillierte Beschreibung
The research process was guided by the CONSORT Statement for RCTs. The process involved registration, allocation, follow-up, and analysis. The recruitment process began with a feasibility assessment for potential respondents. This process was carried out when the patient conducted a phase 2 pulmonary rehabilitation evaluation.
Researchers initially reviewed patient data through medical records, reviewing ID, color code, age, gender, medical history, patient condition, and location of residence. Patients' communication skills were assessed during the evaluation.
The inclusion criteria for this study were patients aged 18-60 years, diagnosed with mild to moderate COPD, or with other medical conditions but a history of COPD, able and calm to follow instructions to inhale using the balloon blowing technique, and willing to be studied with informed consent. Exclusion criteria included patients with severe shortness of breath, patients on respiratory support, and abnormal hemoglobin levels. Dropout criteria included discontinuation of the study and respondents not undergoing the appropriate intervention. The collected respondents were then randomly assigned using envelopes, dividing them into two groups: 23 respondents in the intervention group and 23 respondents in the control group.
Studientyp
Einschreibung (Tatsächlich)
Phase
- Unzutreffend
Kontakte und Standorte
Studienorte
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Special Region of Aceh
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Banda Aceh, Special Region of Aceh, Indonesien, 32126
- dr. Zainoel Abidin Regional General Hospital
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Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
- Erwachsene
Akzeptiert gesunde Freiwillige
Beschreibung
Inclusion Criteria:
- Patients aged 18-60 years, diagnosed with mild to moderate COPD, or with other medical conditions but a history of COPD, able and calm to follow instructions to inhale using the balloon blowing technique, and willing to be studied with informed consent.
Exclusion Criteria:
- Patients with severe shortness of breath, patients on respiratory support, and abnormal hemoglobin levels. Dropout criteria included discontinuation of the study and respondents not undergoing the appropriate intervention.
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Behandlung
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Single
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
|
Experimental: Intervention Group
Performed Balloon-blowing and Deep breathing exercises
|
Respondents performed balloon-blowing breathing exercises twice daily for 7 days.
These exercises consisted of deep breathing exercises followed by a slow balloon-blowing technique in three cycles per session, with a 1-minute rest interval between cycles.
Each cycle included a deep breath for 3-4 seconds, a breath hold for 2-3 seconds, and a slow breath into the balloon for 5-8 seconds, repeated four times.
|
|
Experimental: Control Group
Performed only deep breathing exercises
|
The participants performed deep breathing exercises twice daily for 7 days.
The exercises consisted of three cycles of deep breathing only per session, with a 1-minute rest interval between cycles.
Each cycle included a deep breath in for 3-4 seconds, a breath hold for 2-3 seconds, and a slow exhalation for 5-8 seconds, repeated four times.
|
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Peripheral Oxygen Saturation
Zeitfenster: Day 1 & Day 7
|
Peripheral oxygen saturation was measured using a Braun brand pulse oximeter after the intervention on the first and seventh days to assess the effect of the exercise.
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Day 1 & Day 7
|
Mitarbeiter und Ermittler
Sponsor
Ermittler
- Studienstuhl: Chairul Huda, Master & Postgraduate Program, Indonesia University
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn (Tatsächlich)
Primärer Abschluss (Tatsächlich)
Studienabschluss (Tatsächlich)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Tatsächlich)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- 770/Litbang
Plan für individuelle Teilnehmerdaten (IPD)
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Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
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