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Prospective randomized controlled study to investigate the effect of Yokukansan on perioperative anxiety and pain.

Prospective randomized controlled study to investigate the effect of Yokukansan on perioperative anxiety and pain. - Prospective randomized controlled study to investigate the effect of Yokukansan on perioperative anxiety and pain.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000028998
Enrollment
80
Registered
2017-09-10
Start date
2017-08-17
Completion date
Unknown
Last updated
2026-06-29

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

Conditions

breast cancer patients

Interventions

Yokukansan group take 2.5 g of yokukansan before asleep on the previous day and 2hr before the surgery on the operation day. Control group take nothing.

Sponsors

Niigata university Guraduate school of medical and dental sciences
Lead Sponsor

Eligibility

Sex/Gender
Female

Inclusion criteria

Inclusion criteria: Patients who undergo total breast excision and sentinel lymph node biopsy, or breast partial resection and sentinel lymph node biopsy

Exclusion criteria

Exclusion criteria: patients who -disagree to participate in this study -ASA-physical status =/>4 -Body Mass Index=/>30kg/m2 -has difficulty for communication (eg. patient suffered from dementia, has mental retardation, can not understand Japanese) -has allergy for the drugs that will use in this study -is suffering from pain -is received anxiolytic or antipsychotic medication. -is received analgesics or opioid medication -whom the examiner assume inadequate to participate in this study

Design outcomes

Primary

MeasureTime frame
subjective evaluation items: HADS( Hospital anxiety and depression scale) objective evaluation items: salivaly amylase activity

Secondary

MeasureTime frame
STAI(State Trait Anxiety Inventory) QoR (quality of recovery) score VAS score of pain

Countries

Japan

Contacts

Public ContactMoegi Tanaka

Niigata university Guraduate school of medical and dental sciences division of Anesthesiology

moett@med.niigata-u.ac.jp025-227-2328

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026