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

NCT05979610 | Recruiting Phase 2 DMC

• 1 other identifier: HCI158391
• Study Type: interventional
• Target: 68
• Locations: 1 country
• Sites: 1

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

Keywords

Reiki

Outcome Measures

Primary Outcomes (1)

• 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.

  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 Outcomes (4)

• Comparison between the treatment groups of the change in pain from Assessment 1 to Assessment 3 as measured by the Visual Analog Scale - 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.

  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.

  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.

  4 months

Study Arms (2)

Reiki Therapy

EXPERIMENTAL

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

Standard of Care

NO INTERVENTION

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.

Interventions

Reiki therapy 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.

Reiki Therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Utah: lead

Study Sites (1)

Huntsman Cancer Institute

Salt Lake City, Utah, 84112, United States

RECRUITING

MeSH Terms

Conditions

Genital Neoplasms, Female; Endometrial Neoplasms; Uterine Cervical Neoplasms; Vaginal Neoplasms; Vulvar Neoplasms

Interventions

Therapeutic Touch

Condition Hierarchy (Ancestors)

Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Uterine Neoplasms; Uterine Diseases; Uterine Cervical Diseases; Vaginal Diseases; Vulvar Diseases

Intervention Hierarchy (Ancestors)

Mind-Body Therapies; Complementary Therapies; Therapeutics; Spiritual Therapies

Study Officials

• Lindsay Burt, MD

  Huntsman Cancer Institute/ University of Utah

  PRINCIPAL INVESTIGATOR

Central Study Contacts

David Samuel

CONTACT

801-587-4713; David.Samuel@hci.utah.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: July 28, 2023
• First Posted: August 7, 2023
• Study Start: October 9, 2023
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): April 1, 2027
• Last Updated: March 23, 2026

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)