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Trial Title:
Using Reiki Therapy to Improve Symptoms Associated With Brachytherapy in Patients With Gynecological Malignancies
NCT ID:
NCT05979610
Condition:
Gynecologic Neoplasm
Brachytherapy
Therapeutic Touch
Endometrial Cancer
Cervical Cancer
Vaginal Cancer
Vulvar Cancer
Conditions: Official terms:
Endometrial Neoplasms
Vulvar Neoplasms
Vaginal Neoplasms
Genital Neoplasms, Female
Conditions: Keywords:
Reiki
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Intervention model description:
Subjects who meet all criteria for enrollment will be randomly assigned to receive Reiki
therapy (Arm 1) or usual care (Arm 2) using block randomization. Subjects will be
randomized through the OnCore system in a 1:1 ratio to Arm 1 or Arm 2 and stratified by
treatment type (multichannel vaginal cylinder (MCVC) and vaginal cylinder vs. all other
treatment modalities). Randomization will not be blinded.
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Other
Intervention name:
Reiki therapy
Description:
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.
Arm group label:
Reiki Therapy
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.
Criteria for 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.
Gender:
Female
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Huntsman Cancer Institute
Address:
City:
Salt Lake City
Zip:
84112
Country:
United States
Status:
Recruiting
Contact:
Last name:
Elyse D'Astous
Phone:
801-587-4323
Email:
Elyse.DAstous@hci.utah.edu
Investigator:
Last name:
Lindsay Burt, MD
Email:
Principal Investigator
Start date:
October 9, 2023
Completion date:
April 1, 2027
Lead sponsor:
Agency:
University of Utah
Agency class:
Other
Source:
University of Utah
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05979610
