Using Reiki Therapy to Improve Symptoms Associated With Brachytherapy in Patients With Gynecological Malignancies (Reiki-Brachy)

Utah System of Higher Education (USHE)

Status and phase: Enrolling; Phase 2

Conditions: Endometrial Cancer; Gynecologic Neoplasm; Vulvar Cancer; Therapeutic Touch; Vaginal Cancer; Brachytherapy; Cervical Cancer

Treatments: Other: Reiki therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT05979610

HCI158391

Details and patient eligibility

About

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.

Enrollment: 68 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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68 participants in 2 patient groups

Reiki Therapy

Experimental group

Description:

Participants randomized to Arm 1 will receive a session of Reiki therapy during the standard wait time between the placement of the brachytherapy device and their first brachytherapy treatment.

Treatment:

Other: Reiki therapy

Standard of Care

No Intervention group

Description:

Participants randomized to the standard of care control arm will be asked to remain in a clinic room during the standard waiting period between the placement of the brachytherapy device and the start of brachytherapy treatment. Participants may participate in any activity other than Reiki therapy during this time. Participants may be accompanied by a family member or friend.