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

May 6, 2026 updated by: University of Utah

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

70

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Utah
      • Salt Lake City, Utah, United States, 84112
        • Recruiting
        • Huntsman Cancer Institute
        • Principal Investigator:
          • Lindsay Burt, MD
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
Other: 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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Comparison between the treatment groups of the change in anxiety from Assessment 1 to Assessment 3 as measured by the 6-item Spielberger State Anxiety Scale.
Time Frame: 4 months

To assess the impact of Reiki therapy on anxiety in subjects undergoing brachytherapy treatment for gynecological malignancies compared to the usual care control arm.

The 6-item Spielberger State Anxiety Scale is a validated shortened version of the Spielberger State-Trait Anxiety Inventory (STAI) used to measure state anxiety. The scale utilizes a Likert scale with four response categories assigned numerical values from 1-4 ("not at all,""somewhat,""moderately," and "very much").
4 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Comparison between the treatment groups of the change in pain from Assessment 1 to Assessment 3 as measured by the Visual Analog Scale - Pain.
Time Frame: 4 months

To assess the impact of Reiki therapy on pain in subjects undergoing brachytherapy treatment for gynecological malignancies compared to the usual care control arm.

The Visual Analogue Scale (VAS) uses an 11-point scale ranging from 0 (no symptom) to 10 (worst possible symptom). Using the pain-VAS scoring system, 0 is considered no pain, 1 - 3 is considered mild, 4 - 6 is moderate to severe, 7 - 9 is very severe and 10 is categorized as worst possible pain.
4 months
Comparison between the treatment groups of the change in anxiety from Assessment 2 to Assessment 3 as measured by the 6-item Spielberger State Anxiety Scale.
Time Frame: 4 months

To assess the impact of Reiki therapy on pain in subjects undergoing brachytherapy treatment for gynecological malignancies compared to the usual care control arm.

The 6-item Spielberger State Anxiety Scale is a validated shortened version of the Spielberger State-Trait Anxiety Inventory (STAI) used to measure state anxiety. The scale utilizes a Likert scale with four response categories assigned numerical values from 1-4 ("not at all,""somewhat,""moderately," and "very much").
4 months
Comparison between the treatment groups of the change in anxiety from Assessment 1 to Assessment 3 as measured by the Visual Analog Scale - Pain.
Time Frame: 4 months

To assess the impact of Reiki therapy on pain in subjects undergoing brachytherapy treatment for gynecological malignancies compared to the usual care control arm.

The Visual Analogue Scale (VAS) uses an 11-point scale ranging from 0 (no symptom) to 10 (worst possible symptom). Using the pain-VAS scoring system, 0 is considered no pain, 1 - 3 is considered mild, 4 - 6 is moderate to severe, 7 - 9 is very severe and 10 is categorized as worst possible pain.
4 months
Comparison between the treatment groups of the change in state anxiety and depression from Assessment 1 to three month post-radiation as measured by the Hospital Anxiety and Depression Scale.
Time Frame: 4 months

To assess the impact of Reiki therapy on state anxiety and depression in subjects undergoing brachytherapy treatment for gynecological malignancies compared to the usual care control arm.

The Hospital Anxiety and Depression Scale (HADS) is a validated, self-assessment instrument used to identify caseness of anxiety disorders and depression in medical patients. It is comprised of 14 total questions, each of which are rated on a 4-point severity scale between zero (no impairment) and three (severe impairment). Total score range is 0 (normal/no impairment) to 21 (abnormal/severe impairment.)
4 months
Respiratory Rate
Time Frame: 4 months

To compare the change in physiological measurements between subjects receiving Reiki therapy and the standard of care control arm during brachytherapy treatment.

A comparison between the treatment groups of the change in physiological measurements assessed through respiratory rate obtained before the placement of the brachytherapy device, after the placement of the brachytherapy device, and after Reiki therapy or standard of care.
4 months
Heart Rate
Time Frame: 4 months

To compare the change in physiological measurements between subjects receiving Reiki therapy and the standard of care control arm during brachytherapy treatment.

A comparison between the treatment groups of the change in physiological measurements assessed through heart rate obtained before the placement of the brachytherapy device, after the placement of the brachytherapy device, and after Reiki therapy or standard of care.
4 months
Blood Pressure
Time Frame: 4 months

To compare the change in physiological measurements between subjects receiving Reiki therapy and the standard of care control arm during brachytherapy treatment.

A comparison between the treatment groups of the change in physiological measurements assessed through vitals blood pressure obtained before the placement of the brachytherapy device, after the placement of the brachytherapy device, and after Reiki therapy or standard of care.
4 months
Oxygen Saturation
Time Frame: 4 months

To compare the change in physiological measurements between subjects receiving Reiki therapy and the standard of care control arm during brachytherapy treatment.

A comparison between the treatment groups of the change in physiological measurements assessed through vitals oxygen saturation obtained before the placement of the brachytherapy device, after the placement of the brachytherapy device, and after Reiki therapy or standard of care.
4 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Utah

Investigators

  • Principal Investigator: Lindsay Burt, MD, Huntsman Cancer Institute/ University of Utah

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 14, 2023

Primary Completion (Estimated)

August 1, 2026

Study Completion (Estimated)

June 1, 2027

Study Registration Dates

First Submitted

July 28, 2023

First Submitted That Met QC Criteria

July 28, 2023

First Posted (Actual)

August 7, 2023

Study Record Updates

Last Update Posted (Actual)

May 11, 2026

Last Update Submitted That Met QC Criteria

May 6, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HCI158391

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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