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NCT05979610PHASE2Recruiting

Using Reiki Therapy to Improve Symptoms Associated With Brachytherapy in Patients With Gynecological Malignancies

University of Utah

Start Date

11/14/2023

Completion Date

6/1/2027

Summary

The goal of this open label, randomized, controlled clinical trial is to assess the benefits of providing Reiki therapy to subjects receiving their first brachytherapy treatment for gynecological malignancies. Participants will either receive a session of Reiki therapy or usual care during the standard wait time between the placement of the brachytherapy device and brachytherapy treatment. Questionnaires will be administered at various time points on the day of the participant's first brachytherapy treatment as well as at the three month follow-up time point. Researchers will compare the intervention (Reiki therapy) and control (usual care) groups to assess the impact of the Reiki therapy on anxiety, pain, state anxiety, depression, and physiological measurements.

Eligibility Criteria

Age Range: 18 years to No maximum

Inclusion Criteria: * Subject aged ≥ 18 years. * Pathologically confirmed malignancy of the endometrium, cervix, vagina or vulva. * Eligible to undergo brachytherapy treatment as an outpatient procedure. * Able to read and understand English and/or Spanish. * Able to provide informed consent and willing to sign an approved consent form that conforms to federal and institutional guidelines. * Willing to participate in either the Reiki therapy or standard of care arm regardless of treatment assignment. Exclusion Criteria: * Prior brachytherapy treatment for a gynecological malignancy. * Medical, psychiatric, cognitive, or other conditions that may compromise the subject's ability to understand the subject information, give informed consent, comply with the study protocol or complete the study.

Interventions

OTHER

Reiki therapy

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Conditions

Gynecologic NeoplasmBrachytherapyTherapeutic TouchEndometrial CancerCervical CancerVaginal CancerVulvar Cancer

Locations

Huntsman Cancer Institute

Salt Lake City, Utah 84112

United States