Reiki-Brachy: An Interventional Treatment Trial Using Reiki Therapy to Improve Symptoms Associated With Brachytherapy in Patients With Gynecological Malignancies

Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Interventional
Study Phase: Phase 2
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
Participation Requirements
Sex: Female
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
United States
Utah
Huntsman Cancer Institute
RECRUITING
Salt Lake City
Contact Information
Primary
David Samuel
David.Samuel@hci.utah.edu
801-587-4713
Time Frame
Start Date: 2023-10-09
Estimated Completion Date: 2027-04-01
Participants
Target number of participants: 68
Treatments
Experimental: 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.
No_intervention: 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.
Sponsors
Leads: University of Utah

This content was sourced from clinicaltrials.gov