Clinical trial NCT06107777: The Effectiveness of Pharmacopuncture on Psychological Stress
Official title: The Efficacy of Pharmacopuncture on Inpatients With Psychological Stress Caused by Traffic Accidents: A Practical Randomized Control Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Psychological Stress
Keywords: Psychological Stress
Pharmacopuncture
Lead sponsor: Jaseng Medical Foundation
Sponsor class: OTHER
First posted: 2023-10-30
Enrollment: 50
Sex: ALL
Minimum age (years): 19
Maximum age (years): 69
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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)."

Eligibility criteria: 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 ≥ 8.
* 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

Primary outcomes:
measure: Hospital Anxiety and Depression Scale(HADS)
timeFrame: Screeing day (day 1), Baseline (day2), Discharge 1 day, 15 days after admission day, 2 months after admission day
Secondary outcomes:
measure: Korean version of the Insomnia Severity Index(IES-R-K)
timeFrame: Baseline (day2), Discharge 1 day, 15 days after admission day, 2 months after admission day
measure: Korean version of the Insomnia Severity Index(ISI-K)
timeFrame: Baseline (day2), Discharge 1 day, 15 days after admission day, 2 months after admission day
measure: Numeric Rating Scale of Anxiety (NRS of Anxiety)
timeFrame: From baseline(Day2) up to Discharge 1 day, 15 days after admission day, 2 months after admission day
measure: Numeric Rating Scale of Depression(NRS of Depression)
timeFrame: From baseline(Day2) up to Discharge 1 day, Discharge 1 day, 15 days after admission day, 2 months after admission day
measure: Numeric Rating Scale of Physical pain(NRS of Physical pain)
timeFrame: From baseline(Day2) up to Discharge 1 day, Discharge 1 day, 15 days after admission day, 2 months after admission day
measure: EuroQol 5-Dimension (EQ-5D)
timeFrame: Baseline(day2), Discharge 1 day, 15 days after admission day, 2 months after admission day
measure: Patient Global Impression of Change (PGIC)
timeFrame: Discharge 1 day, 15 days after admission day, 2 months after admission day
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Jaseng Hospital of Korean Medicine
state: Gangnam-Gu
Study officials:
affiliation: Jaseng Medical Foundation
name: In-Hyuk Ha, phD
role: PRINCIPAL_INVESTIGATOR
References: