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

NCT ID: NCT05979610

Last Updated: 2025-04-01

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 68 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-10-09
• Study Completion Date: 2027-04-01

Brief 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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Reiki Therapy

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.

Group Type: EXPERIMENTAL

Reiki therapy

Intervention Type: OTHER

Reiki therapy is a form of energy healing that originated in Japan. It involves the transfer of energy from the Reiki practitioner to the recipient through the hands, with the goal of promoting physical, emotional, and spiritual well-being. Below is a general outline of the process of Reiki therapy, which may vary slightly depending on the needs of the recipient:

• The patient will be in a quiet clinic room lying in the supine position with calming music playing and aromatherapy if the patient chooses.
• The Reiki therapist will place their hands on or near the recipient's body. The Reiki therapist may use a series of hand positions that correspond to different energy centers in the body.
• During the treatment, the practitioner channels energy into the recipient's body through their hands. The patient may feel a sense of warmth, tingling, or relaxation.
• The Reiki therapist may use different techniques, such as hand movements or visualization.

Standard of Care

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Reiki therapy

Reiki therapy is a form of energy healing that originated in Japan. It involves the transfer of energy from the Reiki practitioner to the recipient through the hands, with the goal of promoting physical, emotional, and spiritual well-being. Below is a general outline of the process of Reiki therapy, which may vary slightly depending on the needs of the recipient:

• The patient will be in a quiet clinic room lying in the supine position with calming music playing and aromatherapy if the patient chooses.
• The Reiki therapist will place their hands on or near the recipient's body. The Reiki therapist may use a series of hand positions that correspond to different energy centers in the body.
• During the treatment, the practitioner channels energy into the recipient's body through their hands. The patient may feel a sense of warmth, tingling, or relaxation.
• The Reiki therapist may use different techniques, such as hand movements or visualization.

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

University of Utah

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Lindsay Burt, MD

Role: PRINCIPAL_INVESTIGATOR

Huntsman Cancer Institute/ University of Utah

Locations

Huntsman Cancer Institute

Salt Lake City, Utah, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

David Samuel

Role: CONTACT

David.Samuel@hci.utah.edu

801-587-4713

Facility Contacts

Elyse D'Astous

Role: primary

Elyse.DAstous@hci.utah.edu

801-587-4323

Other Identifiers

HCI158391

Identifier Type: -

Identifier Source: org_study_id