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Clinical trials evaluating the effect of cranial electrotherapy stimulation (CES) for anxiety and stress reduction

Randomized Controlled, Double-blinded, Active-controlled designed clinical trial evaluating The effects of cranial electrotherapy stimulation(CES) in treatment anxiety and stress.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CRIS
Registry ID
KCT0004065
Enrollment
60
Registered
2019-06-14
Start date
2017-02-15
Completion date
Unknown
Last updated
2019-06-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Medical Device : Experimental group: 50 minutes of Active CES, once everyday, for 3 weeks. Apply bi-phase pulse below 1mA. For the first application, apply music to half of the group and not the other

Sponsors

Hallym University Medical Center- Chuncheon
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1) Participants with Anxiety, Stress-relate disorder self-report score higher then four. 2) Men and women aged 19 to 65. 3) Those who are able to read and understand subject explanations and agreements, and who have the language ability to respond to the questionnaire. 4) Those who have voluntarily participated in the clinical trial and have agreed to the written consent of the subject and are able to participate in the entire period of the clinical trial.

Exclusion criteria

Exclusion criteria: 1) Except Anxiety disorder, according to the Diagnostic and Statistical Manual of Mental Disorders, fourth edition (DSM-IV) dignosed Axis I. 2) Primary diagnosis of alcohol or substance abuse 3) diagnosed with bipolar or psychotic major depressive disorder 4) attempted suicide before 6 months of screening 5) A person who is rated at 6 or more in suicidal tendency 6) A person judged to have problems with electroencephalography (EEG) or Alternating Current (AC) stimulation electrodes due to deformity of the scalp, inflammation reaction or other dermatological problems. 7) Have a contraindication about CES equipment(ex, A metal board is Inserted in the head). 8) A history of epilepsy and family history 9) Those with serious clinical impairment of cardiovascular, digestive, respiratory, endocrine, and central nervous system 10) Those who participated in other clinical trials within 30 days from the screening date 11) Female subjects likely to become pregnant 12) Pregnant or lactating women 13) In addition to the above, persons with clinical symptoms who are judged medically by the person in charge of testing or who are considered inappropriate for this test

Design outcomes

Primary

MeasureTime frame
SRI(Stress Response Instrument);HAM-A(Hamilton Anxiety Rating Scale), STAI(State-Trait Anxiety Inventory)

Secondary

MeasureTime frame
HAM-D(Hamilton Depression Rating Scale), BDI(Beck Depression Inventory);Wisconsin Card Sorting Test;(PQSI)Pittsburgh Sleep Quality Index;Suicidality Scale;WHOQOL-BREF(Korean Version of WHO Quality of Life Scale Abbreviated Version);CGISI(clinician-rated Clinical Global Impression-Severity of Illness scale);qEEG (quantitative electroencephalography);EEG Coherence

Countries

Korea, Republic of

Contacts

Public ContactJiheon Kim

Hallym University Medical Center- Chuncheon

ros205@daum.net+82-33-240-5739

Outcome results

None listed

Source: CRIS (via WHO ICTRP) · Data processed: Feb 4, 2026