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Completed

NCT Number: NCT06107777

The Effectiveness of Pharmacopuncture on Psychological Stress

This study is a double blind, randomized controlled trail. Condition/disease: Psychological Stress treatment Intervention:Pharmacopuncture

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Key information

Age range

19 year–69 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Jaseng Hospital of Korean Medicine

Seoul, Gangnam-Gu, 135-896, South Korea

About this study

"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)."

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Pharmacopuncture

Procedure

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.

Korean medical treatment

Procedure

acupuncture treatment, chuna, pharmacoacupuncture, Korean herbal medicine

Primary outcomes

  1. 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

  1. Korean version of the Insomnia Severity Index(IES-R-K)

    Time frame: Baseline (day2), Discharge 1 day, 15 days after admission day, 2 months after admission day

    IES-R-K is the Korean version of impact of event scale revised. It was designed as a measure of post-traumatic stress disorder (PTSD) symptoms, and is a short, easily administered self-report questionnaire. It has 22 items and a cut-off score of 33 or above.

  2. Korean version of the Insomnia Severity Index(ISI-K)

    Time frame: Baseline (day2), Discharge 1 day, 15 days after admission day, 2 months after admission day

    ISI-K is a Korean version of Insomnia Severity Index. It was designed as a brief screening tool for insomnia and has the seven-item questionnaire asks respondents to rate the nature and symptoms of their sleep problems using a Likert-type scale.

  3. Numeric Rating Scale of Anxiety (NRS of Anxiety)

    Time frame: From baseline(Day2) up to Discharge 1 day, 15 days after admission day, 2 months after admission day

    NRS is a pain scale in which the patient indicates their subjective pain as a whole number from 0 to 10. The participant is asked to report their Anxiety using NRS, where 0 indicates 'no pain or discomfort' and 10 indicates 'the most severe pain and discomfort imaginable'.

  4. Numeric Rating Scale of Depression(NRS of Depression)

    Time frame: From baseline(Day2) up to Discharge 1 day, Discharge 1 day, 15 days after admission day, 2 months after admission day

    NRS is a pain scale in which the patient indicates their subjective pain as a whole number from 0 to 10. The participant is asked to report their Depression using NRS, where 0 indicates 'no pain or discomfort' and 10 indicates 'the most severe pain and discomfort imaginable'.

  5. Numeric Rating Scale of Physical pain(NRS of Physical pain)

    Time frame: From baseline(Day2) up to Discharge 1 day, Discharge 1 day, 15 days after admission day, 2 months after admission day

    NRS is a pain scale in which the patient indicates their subjective pain as a whole number from 0 to 10. The participant is asked to report their Physical pain and discomfort using NRS, where 0 indicates 'no pain or discomfort' and 10 indicates 'the most severe pain and discomfort imaginable'.

  6. EuroQol 5-Dimension (EQ-5D)

    Time frame: Baseline(day2), Discharge 1 day, 15 days after admission day, 2 months after admission day

    The EQ-5D is a method of indirectly calculating the weights of certain health states for quality of life after a multidimensional investigation of health states, and is the most widely used instrument for this purpose. The EQ-5D consists of 5 questions about current health state (mobility, self-care, usual activities, pain, anxiety/depression), and each question is scored on a 5-point Likert scale (1=no problems, 3=moderate problems, 5=severe problems). In this study, the investigators will use the Korean version of the EQ-5D, which has been demonstrated to be valid.

  7. Patient Global Impression of Change (PGIC)

    Time frame: Discharge 1 day, 15 days after admission day, 2 months after admission day

    The PGIC is an index that assesses improvements in functional limitation caused by whiplash injury. Participants rate the improvement in functional limitations after treatment on a 7-point Likert scale (1=Very much improved, 4=No change, 7=Very much worse). This index was originally developed for use in Psychology, but is currently used in various other medical fields to assess improvements in pain.

Sponsors and collaborators

Lead sponsor

Jaseng Medical Foundation

Other

Registry information

Official study title

The Efficacy of Pharmacopuncture on Inpatients With Psychological Stress Caused by Traffic Accidents: A Practical Randomized Control Pilot Study

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Oct 30, 2023
Registry last updated
Aug 6, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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