The Efficacy of Pharmacopuncture on Inpatients With Psychological Stress Caused by Traffic Accidents: A Practical Randomized Control Pilot Study
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Jaseng Medical Foundation
- Enrollment
- 50
- Locations
- 1
- Primary Endpoint
- Hospital Anxiety and Depression Scale(HADS)
Study Overview
Brief Summary
This study is a double blind, randomized controlled trail. Condition/disease: Psychological Stress treatment Intervention:Pharmacopuncture
Detailed Description
"Pharmacopuncture is a treatment that combines 2 of the most frequented Korean medicine treatment methods - traditional acupuncture and herbal medicine - by injecting herbal medicine extract at acupoints.
This treatment is known to be an important part of Korean medicine treatment. However, there has been no specific value for the effect of this treatment.
Therefore, the investigators are going to conduct a practical randomized controlled trials to verify the efficacy and safety of Pharmacopuncture on Psychological Stress. From October 2023 to December 2024, the investigators are going to collect 50 inpatients who are suffering from Psychological Stress with the HADS-A(Hospital Anxiety and Depression Scale-anxiety) or HADS-D(Hospital Anxiety and Depression Scale-Depression) over 8 after injury by traffic accident(TA). For experimental group(n=25), the investigators will conduct Pharamacopuncture on 5 mandatory acupoints and 3 additional acupoints if needed durling the hospitalization and other Korean medical treatment. For control group(n=25), just Korean medical treatment except Pharamacopuncture on mandatory acupoints and additional acupoints will be conducted.
For these two groups, the investigators will compare Psychological stress intensity scale: Hospital Anxiety and Depression Scale (HADS), NRS of Anxiety, NRS of Depression, NRS of Physical pain, Sleeping disorder intensity scale: Korean version of the Insomnia Severity Index(ISI-K), subjective stress scale caused by traumatic events: Revised Version of the Impact of Event Scale of Korea(IES-R-K), EuroQol 5-Dimension (EQ-5D-5L) and Patient Global Impression of Change (PGIC)."
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 19 Years to 69 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Patients aged 19-69 years on the date they sign the consent form.
- •Patients who are suffered by Psychological Stress that occurred within 3 days after traffic accident.
- •Patients who are hospitalized due to traffic accident.
- •Patients with HADS-A ≥ 8 or HADS-D ≥
- •Patients who provide consent to participate in the trial and return the informed consent form.
Exclusion Criteria
- •Patients with progressive neurological deficit or with serious neurological symptoms.
- •Patients with a specific serious disease that may interfere with the interpretation of the therapeutic effects or results: malignancy, spondylitis, inflammatory spondylitis, etc.
- •Patients who are taking steroids, immunosuppressants, mental illness drugs, or other drugs that may affect the results of the study.
- •Patients with medical history of brain disease or surgery due to trauma.
- •Patients who are addicted by drug or alcohol within the year.
- •If acupuncture is inadequate or unsafe: patients with hemorrhagic, receiving anticoagulants, severe diabetes and cardiovascular disease.
- •Patients who are pregnant or planning to become pregnant
- •Patients who are participated in clinical trials other than observational studies without therapeutic intervention.
- •Patients who are difficult to complete the research participation agreement
- •Other patients whose participation in the trial is judged by a researcher to be problematic
Arms & Interventions
Pharmacopucture on Acupoints Related to Psychological Stress
The Pharmacopucture group will recieve Pharmacopucture treatment durling the hospitalization. The mandatory acupoints are (Dan-jung(CV17), Jung-wan(CV12), Gi-hae(CV6), Gwan-won(CV4), Sin-mun(HT7). If needed, they will recieve additional acupoints are (So-hae(HT3), Jung-jeo(TE3), Sam-eumgyo(SP6). A trained doctor of Korean medicine with at least 3 years of clinical experience are going to conduct the pharmacopucture.
The Pharmacopucture group will also be treated with other Korean medical treatment everyday: acupuncture, chuna and Korean herbal medicine.
Intervention: Pharmacopuncture (Procedure)
Pharmacopucture on Acupoints Related to Psychological Stress
The Pharmacopucture group will recieve Pharmacopucture treatment durling the hospitalization. The mandatory acupoints are (Dan-jung(CV17), Jung-wan(CV12), Gi-hae(CV6), Gwan-won(CV4), Sin-mun(HT7). If needed, they will recieve additional acupoints are (So-hae(HT3), Jung-jeo(TE3), Sam-eumgyo(SP6). A trained doctor of Korean medicine with at least 3 years of clinical experience are going to conduct the pharmacopucture.
The Pharmacopucture group will also be treated with other Korean medical treatment everyday: acupuncture, chuna and Korean herbal medicine.
Intervention: Korean medical treatment (Procedure)
Korean medical treatment
The control group will receive Korean medical treatment everyday after hospitalization: acupuncture, chuna, pharmacoacupuncture(except on mandatory and additional acupoints) and Korean herbal medicine.
Intervention: Korean medical treatment (Procedure)
Outcomes
Primary Outcomes
Hospital Anxiety and Depression Scale(HADS)
Time Frame: Screeing day (day 1), Baseline (day2), Discharge 1 day, 15 days after admission day, 2 months after admission day
Hospital Anxiety and Depression Scale aims to measure symptoms of anxiety and depression. It is a self-rating scale developed to assess psychological distress in non-psychiatric patients. The HADS consists of 14 questions and each question is scored on a 4-point Likert scale(0=no problems, 3=severe problems) The odd numbers ask anxiety(HADS-A) and even number ask Depression(HADS-D). HADS-A (or HADS-D) cut-off score is 8 or above.
Secondary Outcomes
- Numeric Rating Scale of Depression(NRS of Depression)(From baseline(Day2) up to Discharge 1 day, Discharge 1 day, 15 days after admission day, 2 months after admission day)
- EuroQol 5-Dimension (EQ-5D)(Baseline(day2), Discharge 1 day, 15 days after admission day, 2 months after admission day)
- Korean version of the Insomnia Severity Index(ISI-K)(Baseline (day2), Discharge 1 day, 15 days after admission day, 2 months after admission day)
- Korean version of the Insomnia Severity Index(IES-R-K)(Baseline (day2), Discharge 1 day, 15 days after admission day, 2 months after admission day)
- Numeric Rating Scale of Anxiety (NRS of Anxiety)(From baseline(Day2) up to Discharge 1 day, 15 days after admission day, 2 months after admission day)
- Numeric Rating Scale of Physical pain(NRS of Physical pain)(From baseline(Day2) up to Discharge 1 day, Discharge 1 day, 15 days after admission day, 2 months after admission day)
- Patient Global Impression of Change (PGIC)(Discharge 1 day, 15 days after admission day, 2 months after admission day)