Impact of Kava Extract on Stress in Nurses

The Effect of Oral Kavalactones on Cortisol, Measures of Burnout, and Motivation in Nurses

This study tests if Kava extract can help reduce stress levels in nurses working in surgical services at the Mayo Clinic.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 200 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Mayo Clinic (other)
• Drugs / interventions: prednisone
• Locations: 1 site (Rochester, Minnesota)
• Trial ID: NCT06177535 on ClinicalTrials.gov

What this trial studies

This study evaluates the effects of Kava extract, a dietary supplement, on cortisol levels among surgical services nurses at the Mayo Clinic in Rochester, MN. Participants will be randomly assigned to receive either Kavalactones or a placebo. The goal is to determine if Kava can effectively reduce stress in this specific population of healthcare professionals. The study will include a thorough informed consent process to ensure participants understand their involvement.

Who should consider this trial

Good fit: Ideal candidates are surgical services nurses at the Mayo Clinic who are able to participate fully and are willing to use birth control if of childbearing potential.

Not a fit: Patients who are pregnant, nursing, or trying to conceive, as well as those with prior adverse reactions to kava, will not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a natural method for stress reduction among nursing professionals.

How similar studies have performed: While there is limited data on the specific use of Kava in nursing populations, other studies have shown potential benefits of Kava for stress reduction, indicating a promising avenue for exploration.

Eligibility criteria

Inclusion Criteria:

* Surgical services nurses at Mayo Clinic in Rochester, MN.
* Able to participate fully in all aspects of the study.
* Willing to use birth control for the duration of the study (if of childbearing potential).
* Understood and signed study informed consent.

Exclusion Criteria:

* Pregnant, nursing, or trying to conceive.
* Persons with a menstrual cycle who are not willing and able to use an approved contraceptive during the study (female sterilization (tubal ligation, hysterectomy), IUD or another implant, oral or injectable contraceptive, contraceptive patch/ring, diaphragm/cervical cap, male sterilization (vasectomy), male condom, female condom, sponge/spermicide) (Persons who do not have sex with men can participate without the use of an approved contraceptive).
* Use of kava or kava-containing products within the past 8 weeks.
* Any prior adverse reaction or known sensitivity or allergy to kava or related botanicals (peppers).
* Use of acetaminophen that cannot be discontinued or replaced with an NSAID during the study.
* Use of oral corticosteroids (e.g., hydrocortisone) or other steroids (e.g., prednisone).
* Alcohol use greater than 1 drink per day.
* Use of kratom within the past 8 weeks.
* Recent history of clinical depression or anxiety diagnosis.
* Known significant liver disease or dysfunction.
* Known significant kidney disease or dysfunction.
* Known Addison's or Cushing's Disease.
* Known catecholamine imbalance or medication use which influences catecholamine levels.
* History or current diagnosis of cancer (except for successfully treated basal cell carcinoma diagnosed less than 5 years prior to screening or cancer in full remission more than 5 years after diagnosis).
* Recent history or acute disease or unstable medical condition.
* Surgery planned during the course of the trial.
* A known history of any condition or factor judged by the investigator to preclude participation in the study or which might hinder adherence.

Where this trial is running

Rochester, Minnesota

• Mayo Clinic Minnesota — Rochester, Minnesota, United States (RECRUITING)

Study contacts

• Principal investigator: Brent Bauer, MD — Mayo Clinic
• Study coordinator: Jennifer Soderlind

Conditions: Stress, Nursing Professionals