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NCT Number: NCT05979610

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.

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Key information

Conditions

Gynecologic Neoplasm Brachytherapy Cervical Cancer Endometrial Cancer Endometrial Neoplasms Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Genital Neoplasms, Female Neoplasms Neoplasms by Site Therapeutic Touch Urogenital Diseases Urogenital Neoplasms Uterine Cervical Diseases Uterine Cervical Neoplasms Uterine Diseases Uterine Neoplasms Vaginal Cancer Vaginal Diseases Vaginal Neoplasms Vulvar Cancer Vulvar Diseases Vulvar Neoplasms

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

Huntsman Cancer Institute

Salt Lake City, Utah, 84112, United States

Location status: Recruiting

Location contact

Elyse D'Astous

CONTACT

[email protected]

801-587-4323

Lindsay Burt, MD

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

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.

    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").

Secondary outcomes

  1. 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.

  2. 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").

  3. 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. 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.)

  5. 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.

  6. 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.

  7. 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.

  8. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

David Samuel

CONTACT

[email protected]

801-587-4713

Sponsors and collaborators

Lead sponsor

University of Utah

Other

Registry information

Official study title

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

Acronym: Reiki-Brachy

Important dates

Study start
2023
Primary completion
2026
Study completion
2027
First posted
Aug 7, 2023
Registry last updated
May 11, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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