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- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico 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.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
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.
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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Kahramanmaraş
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Kahramanmaraş, Kahramanmaraş, Turquía (Türkiye), 46050
- Kahramanmaraş
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Descripción
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.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Sin intervención: Grupo de control
No se aplicará ninguna intervención al grupo de control.
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Experimental: Intervetion group
In the intervention group, su-jok seed therapy will be applied to the su-jok reflection zones on the hands.
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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.
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Comparador de placebos: 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.
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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.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Systolic Blood Pressure
Periodo de tiempo: baseline, 15 minutes, 60 minutes, 4 hours after intervention
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Hemodynamic response measured by systolic blood pressure
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baseline, 15 minutes, 60 minutes, 4 hours after intervention
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Heart Rate (Pulse Rate)
Periodo de tiempo: baseline, 15 minutes, 60 minutes, 4 hours after intervention
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Heart rate measured in beats per minute
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baseline, 15 minutes, 60 minutes, 4 hours after intervention
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Oxygen Saturation (SpO₂)
Periodo de tiempo: baseline, 15 minutes, 60 minutes, 4 hours after intervention
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Peripheral oxygen saturation
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baseline, 15 minutes, 60 minutes, 4 hours after intervention
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Body Temperature
Periodo de tiempo: baseline, 15 minutes, 60 minutes, 4 hours after intervention
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Core body temperature
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baseline, 15 minutes, 60 minutes, 4 hours after intervention
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Respiratory Rate
Periodo de tiempo: baseline, 15 minutes, 60 minutes, 4 hours after intervention
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Number of breaths per minute
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baseline, 15 minutes, 60 minutes, 4 hours after intervention
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Richmond Agitation-Sedation Scale (RASS)
Periodo de tiempo: baseline, 1 hour, 4 hours after intervention
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Negative scores indicate sedation, positive scores indicate agitation
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baseline, 1 hour, 4 hours after intervention
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Behavioral Pain Scale (BPS)
Periodo de tiempo: baseline, 1 hour, 4 hours after intervention
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Higher scores indicate more severe pain
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baseline, 1 hour, 4 hours after intervention
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Hemodynamic Stability Index (Systolic/Diastolic Blood Pressure Change)
Periodo de tiempo: baseline, 15 minutes, 60 minutes, 4 hours after intervention
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Change in systolic and diastolic blood pressure from baseline to post-intervention measurements.
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baseline, 15 minutes, 60 minutes, 4 hours after intervention
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Oxygenation Trend (SpO₂ Change Over Time)
Periodo de tiempo: baseline, 15 minutes, 60 minutes, 4 hours after intervention
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hanges in peripheral oxygen saturation over the intervention period.
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baseline, 15 minutes, 60 minutes, 4 hours after intervention
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Heart Rate Variability (Clinical Pulse Trend)
Periodo de tiempo: baseline, 15 minutes, 60 minutes, 4 hours after intervention
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Changes in heart rate measured in beats per minute during and after intervention.
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baseline, 15 minutes, 60 minutes, 4 hours after intervention
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Sedation-Agitation Level Stability (RASS Trend)
Periodo de tiempo: baseline, 1 hour, 4 hours after intervention
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Changes in Richmond Agitation-Sedation Scale (RASS) scores over time indicating sedation or agitation level.
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baseline, 1 hour, 4 hours after intervention
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Pain Intensity Change (Behavioral Pain Scale Trend)
Periodo de tiempo: baseline, 1 hour, 4 hours after intervention
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Changes in Behavioral Pain Scale (BPS) scores indicating pain severity over time.
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baseline, 1 hour, 4 hours after intervention
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Respiratory Stability (Respiratory Rate Change)
Periodo de tiempo: baseline, 15 minutes, 60 minutes, 4 hours after intervention
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Changes in respiratory rate indicating respiratory stability during intervention.
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baseline, 15 minutes, 60 minutes, 4 hours after intervention
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Temperature Stability
Periodo de tiempo: baseline, 15 minutes, 60 minutes, 4 hours after intervention
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hanges in body temperature over time following intervention.
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baseline, 15 minutes, 60 minutes, 4 hours after intervention
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Non-pharmacological Intervention Effectiveness (Overall Clinical Stability Score)
Periodo de tiempo: baseline, 4 hours after intervention
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Composite assessment of physiological stability based on vital signs and sedation/pain scores.
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baseline, 4 hours after intervention
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Silla de estudio: NERMİN OLGUN, Prof. Dr., Hasan Kalyoncu University
- Investigador principal: MELTEM KALAYCI, Hasan Kalyoncu University
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- HKU-LEE-MK-01
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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