- ICH GCP
- US-Register für klinische Studien
- Klinische Studie NCT07632781
THE EFFECT OF SU-JOK THERAPY APPLIED TO INTENSİVE CARE PATIENTS UNDER MECHANICVENTILATION SUPPORT
THE EFFECT OF SU-JOK THERAPY APPLIED TO INTENSIVE CARE PATIENTS UNDER MECHANICAL VENTILATION SUPPORT ON PAIN AND PHYSIOLOGICAL PARAMETERS.
Studienübersicht
Status
Bedingungen
Intervention / Behandlung
Detaillierte Beschreibung
Mechanical ventilation (MV), one of the most common treatment methods in Intensive Care Units (ICUs), is a critical treatment approach to ensure adequate respiratory function in patients.
Although mechanical ventilation is a life-saving treatment method in ICUs, it can cause many physiological and psychological problems for patients. Furthermore, excessive exposure to physical, psychosocial, and environmental stressors can affect the patient's autonomic response and vital parameters (tachycardia, hypertension, tachypnea), leading to hemodynamic instability
The World Health Organization (WHO) defines Integrated, Complementary, and Alternative Medicine Practices as the provision of healthcare services that are not part of a country's own tradition or conventional medicine and are not fully integrated into the dominant healthcare system In intensive care patients, non-pharmacological methods such as aromatherapy, music therapy, massage, reflexology, acupressure, and Reiki are used as complementary and alternative treatments. Su Jok, one of these non-pharmacological methods, is an alternative treatment method based on traditional Korean medicine. Su Jok is a treatment method that uses the feet and hands, derived from the Korean words Su (hand) and Jok (foot). In the literature, it is argued that nurses can apply Su Jok therapy as an integrative method in symptom management due to its simplicity of application, lack of side effects, and non-invasiveness, which is similar to the philosophy of integrative nursing. Looking at the literature, very few studies on Su Jok therapy have been found. No studies have been found in the literature regarding the effect of Su Jok therapy on intensive care patients and patients on mechanical ventilation support.
Studientyp
Einschreibung (Tatsächlich)
Phase
- Unzutreffend
Kontakte und Standorte
Studienorte
-
-
Kahramanmaraş
-
Kahramanmaraş, Kahramanmaraş, Türkei (türkiye), 46050
- Kahramanmaraş
-
-
Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
- Erwachsene
- Älterer Erwachsener
Akzeptiert gesunde Freiwillige
Beschreibung
Inclusion Criteria:
Patients who are in intensive care,
- Patients receiving IMV support,
- Patients who were admitted to the ICU from the start date of the study and are planned to be monitored for at least 24 hours,
- Patients without any problems in the area where Su-Jok will be applied,
- Patients with GCS > 3, RASS between +1 and +4, BPS > 3
Exclusion Criteria:
• Patients in the ward,
- Patients with any problems such as fungal infections or wounds in the area where Su Jok will be applied,
- Patients with a GCS of 3,
- Patients not receiving IMV support will not be included in the study.
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Behandlung
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Single
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
|
Kein Eingriff: Kontrollgruppe
Auf die Kontrollgruppe wird keine Intervention angewendet.
|
|
|
Experimental: Intervetion group
In the intervention group, su-jok seed therapy will be applied to the su-jok reflection zones on the hands.
|
In the intervention group, the reflex zones on the hands were identified with a probe.
Buckwheat seeds were fixed to these areas with adhesive tape and massaged.
The seeds remained in place for 4 hours.
After 2 hours, these areas were stimulated with a 1-2 minute massage.
Measurements were recorded on a data collection form.
The application was carried out for 3 days.
|
|
Placebo-Komparator: Placebo group
In the placebo group, su-jok seed therapy will be applied to areas on the hands that are different from the reflection zones.
|
In the placebo group, reflex zones on the hand were identified using a probe.
Buckwheat seeds were fixed to a different area near these zones with a seed patch and massaged.
The seeds remained in place for 4 hours.
After 2 hours, these areas were stimulated with a 1-2 minute massage.
Measurements were recorded on a data collection form.
The application was carried out for 3 days.
|
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Systolic Blood Pressure
Zeitfenster: baseline, 15 minutes, 60 minutes, 4 hours after intervention
|
Hemodynamic response measured by systolic blood pressure
|
baseline, 15 minutes, 60 minutes, 4 hours after intervention
|
|
Heart Rate (Pulse Rate)
Zeitfenster: baseline, 15 minutes, 60 minutes, 4 hours after intervention
|
Heart rate measured in beats per minute
|
baseline, 15 minutes, 60 minutes, 4 hours after intervention
|
|
Oxygen Saturation (SpO₂)
Zeitfenster: baseline, 15 minutes, 60 minutes, 4 hours after intervention
|
Peripheral oxygen saturation
|
baseline, 15 minutes, 60 minutes, 4 hours after intervention
|
|
Body Temperature
Zeitfenster: baseline, 15 minutes, 60 minutes, 4 hours after intervention
|
Core body temperature
|
baseline, 15 minutes, 60 minutes, 4 hours after intervention
|
|
Respiratory Rate
Zeitfenster: baseline, 15 minutes, 60 minutes, 4 hours after intervention
|
Number of breaths per minute
|
baseline, 15 minutes, 60 minutes, 4 hours after intervention
|
|
Richmond Agitation-Sedation Scale (RASS)
Zeitfenster: baseline, 1 hour, 4 hours after intervention
|
Negative scores indicate sedation, positive scores indicate agitation
|
baseline, 1 hour, 4 hours after intervention
|
|
Behavioral Pain Scale (BPS)
Zeitfenster: baseline, 1 hour, 4 hours after intervention
|
Higher scores indicate more severe pain
|
baseline, 1 hour, 4 hours after intervention
|
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Hemodynamic Stability Index (Systolic/Diastolic Blood Pressure Change)
Zeitfenster: baseline, 15 minutes, 60 minutes, 4 hours after intervention
|
Change in systolic and diastolic blood pressure from baseline to post-intervention measurements.
|
baseline, 15 minutes, 60 minutes, 4 hours after intervention
|
|
Oxygenation Trend (SpO₂ Change Over Time)
Zeitfenster: baseline, 15 minutes, 60 minutes, 4 hours after intervention
|
hanges in peripheral oxygen saturation over the intervention period.
|
baseline, 15 minutes, 60 minutes, 4 hours after intervention
|
|
Heart Rate Variability (Clinical Pulse Trend)
Zeitfenster: baseline, 15 minutes, 60 minutes, 4 hours after intervention
|
Changes in heart rate measured in beats per minute during and after intervention.
|
baseline, 15 minutes, 60 minutes, 4 hours after intervention
|
|
Sedation-Agitation Level Stability (RASS Trend)
Zeitfenster: baseline, 1 hour, 4 hours after intervention
|
Changes in Richmond Agitation-Sedation Scale (RASS) scores over time indicating sedation or agitation level.
|
baseline, 1 hour, 4 hours after intervention
|
|
Pain Intensity Change (Behavioral Pain Scale Trend)
Zeitfenster: baseline, 1 hour, 4 hours after intervention
|
Changes in Behavioral Pain Scale (BPS) scores indicating pain severity over time.
|
baseline, 1 hour, 4 hours after intervention
|
|
Respiratory Stability (Respiratory Rate Change)
Zeitfenster: baseline, 15 minutes, 60 minutes, 4 hours after intervention
|
Changes in respiratory rate indicating respiratory stability during intervention.
|
baseline, 15 minutes, 60 minutes, 4 hours after intervention
|
|
Temperature Stability
Zeitfenster: baseline, 15 minutes, 60 minutes, 4 hours after intervention
|
hanges in body temperature over time following intervention.
|
baseline, 15 minutes, 60 minutes, 4 hours after intervention
|
|
Non-pharmacological Intervention Effectiveness (Overall Clinical Stability Score)
Zeitfenster: baseline, 4 hours after intervention
|
Composite assessment of physiological stability based on vital signs and sedation/pain scores.
|
baseline, 4 hours after intervention
|
Mitarbeiter und Ermittler
Sponsor
Ermittler
- Studienstuhl: NERMİN OLGUN, Prof. Dr., Hasan Kalyoncu University
- Hauptermittler: MELTEM KALAYCI, Hasan Kalyoncu 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
- HKU-LEE-MK-01
Plan für individuelle Teilnehmerdaten (IPD)
Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?
Arzneimittel- und Geräteinformationen, Studienunterlagen
Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .