- ICH GCP
- US Clinical Trials Registry
- Clinical Trial 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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Kahramanmaraş
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Kahramanmaraş, Kahramanmaraş, Turkey (Türkiye), 46050
- Kahramanmaraş
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
No Intervention: Control group
No intervention will be applied to the control group.
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|
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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.
|
|
Placebo Comparator: 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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Systolic Blood Pressure
Time Frame: 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)
Time Frame: baseline, 15 minutes, 60 minutes, 4 hours after intervention
|
Heart rate measured in beats per minute
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baseline, 15 minutes, 60 minutes, 4 hours after intervention
|
|
Oxygen Saturation (SpO₂)
Time Frame: baseline, 15 minutes, 60 minutes, 4 hours after intervention
|
Peripheral oxygen saturation
|
baseline, 15 minutes, 60 minutes, 4 hours after intervention
|
|
Body Temperature
Time Frame: baseline, 15 minutes, 60 minutes, 4 hours after intervention
|
Core body temperature
|
baseline, 15 minutes, 60 minutes, 4 hours after intervention
|
|
Respiratory Rate
Time Frame: 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)
Time Frame: 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)
Time Frame: baseline, 1 hour, 4 hours after intervention
|
Higher scores indicate more severe pain
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baseline, 1 hour, 4 hours after intervention
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Hemodynamic Stability Index (Systolic/Diastolic Blood Pressure Change)
Time Frame: 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)
Time Frame: 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)
Time Frame: 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
|
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Sedation-Agitation Level Stability (RASS Trend)
Time Frame: 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)
Time Frame: 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)
Time Frame: baseline, 15 minutes, 60 minutes, 4 hours after intervention
|
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
Time Frame: baseline, 15 minutes, 60 minutes, 4 hours after intervention
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hanges in body temperature over time following intervention.
|
baseline, 15 minutes, 60 minutes, 4 hours after intervention
|
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Non-pharmacological Intervention Effectiveness (Overall Clinical Stability Score)
Time Frame: baseline, 4 hours after intervention
|
Composite assessment of physiological stability based on vital signs and sedation/pain scores.
|
baseline, 4 hours after intervention
|
Collaborators and Investigators
Sponsor
Investigators
- Study Chair: NERMİN OLGUN, Prof. Dr., Hasan Kalyoncu University
- Principal Investigator: MELTEM KALAYCI, Hasan Kalyoncu University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- HKU-LEE-MK-01
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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