This phase II trial assess the benefits of using Reiki therapy with standard of care brachytherapy treatment to promote relaxation and reduce the stress and anxiety that patients may experience with gynecological malignancies. Anxiety, distress and pain are all well-known symptoms in patients with cancer undergoing treatment. Brachytherapy is often used in the treatment of gynecological cancers but some studies have shown that brachytherapy is a greater stressor to patients than chemotherapy, surgery, or external radiation. Reiki is a complementary (a non-mainstream therapy used in addition to usual medicine) therapy developed in Japan to promote relaxation to reduce stress and anxiety. Reiki is not being studied as a treatment for cancer. Reiki therapy practitioners focus on removing energy blocks and promoting the flow of energy for the good of the recipient. This study may help researchers learn if Reiki therapy can improve anxiety, pain and distress in patients with gynecological malignancies compared to usual care alone.
Additional locations may be listed on ClinicalTrials.gov for NCT05979610.
Locations matching your search criteria
United States
Utah
Salt Lake City
Huntsman Cancer Institute/University of UtahStatus: Active
Contact: Lindsay M. Burt
Phone: 801-585-0255
PRIMARY OBJECTIVE:
I. To assess the impact of Reiki therapy on anxiety in subjects undergoing brachytherapy treatment for gynecological malignancies compared to the usual care control arm.
SECONDARY OBJECTIVES:
I. To assess the impact of Reiki therapy on pain in subjects undergoing brachytherapy treatment for gynecological malignancies compared to the usual care control arm.
II. To assess the impact of Reiki therapy on anxiety in subjects undergoing brachytherapy treatment for gynecological malignancies compared to the usual care control arm.
III. To assess the impact of Reiki therapy on pain in subjects undergoing brachytherapy treatment for gynecological malignancies compared to the usual care control arm.
IV. To assess the impact of Reiki therapy on state anxiety and depression in subjects undergoing brachytherapy treatment for gynecological malignancies compared to the usual care control arm.
VI. To compare the change in physiological measurements between subjects receiving Reiki therapy and the standard of care control arm during brachytherapy treatment.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM I: Patients receive a session of Reiki therapy for 30-60 minutes during the standard wait time between the placement of the brachytherapy device and their first brachytherapy treatment.
ARM II: Patients remain in a clinic room during the standard waiting period between the placement of the brachytherapy device and the start of brachytherapy treatment.
After completion of study treatment, patients are followed up at 3 months.
Lead OrganizationHuntsman Cancer Institute/University of Utah
Principal InvestigatorLindsay M. Burt
