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Gynecologic NeoplasmPhase 2Reiki-BrachyNCT05979610

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

A Phase 2 study testing Reiki therapy in people with Gynecologic Neoplasm and Brachytherapy, run by University of Utah at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older, women only
What is being tested?
Reiki therapy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
70 participants
Where
1 siteUnited States
Study dates
14 Nov 2023to Jun 2027
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

United States1 site, 1 recruiting
  • Huntsman Cancer Institute

    Salt Lake City, Utah, 84112

    Elyse D'Astous, 801-587-4323, Elyse.DAstous@hci.utah.edu

    Lindsay Burt, MD

    Recruiting

Other trials in United States

About this study

Official title: 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.

Being tested
Reiki therapy
Keywords
Reiki
Medical subject headings
Genital Neoplasms, Female, Endometrial Neoplasms, Uterine Cervical Neoplasms, Vaginal Neoplasms, Vulvar Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Reiki therapyOther

    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.
Study groups in NCT05979610
Study groupRoleWhat they receive
Reiki TherapyExperimentalParticipants 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.
Receives: Other: Reiki therapy
Standard of CareNo interventionParticipants 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 being measured

The primary outcome is the main question the study is designed to answer.

  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").

    Measured: 4 months

Secondary outcomes (8)
  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.

    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.

    Measured: 4 months

  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.

    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").

    Measured: 4 months

  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.

    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.

    Measured: 4 months

  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.

    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.)

    Measured: 4 months

  5. Respiratory Rate

    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.

    Measured: 4 months

  6. Heart Rate

    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.

    Measured: 4 months

  7. Blood Pressure

    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 (systolic and diastolic) obtained before the placement of the brachytherapy device, after the placement of the brachytherapy device, and after Reiki therapy or standard of care.

    Measured: 4 months

  8. Oxygen Saturation

    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.

    Measured: 4 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Aug 2023
  2. Study start14 Nov 2023
  3. Primary completionDec 2026 (estimated)
  4. Study completionJun 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
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.
Masking
None (open label)
Enrolment
70 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05979610
Sponsor's protocol ID
158391
Acronym
Reiki-Brachy
Status last verified
May 2026
First submitted
28 Jul 2023
Last updated
14 Oct 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Holschneider CH, Petereit DG, Chu C, Hsu IC, Ioffe YJ, Klopp AH, Pothuri B, Chen LM, Yashar C. Brachytherapy: A critical component of primary radiation therapy for cervical cancer: From the Society of Gynecologic Oncology (SGO) and the American Brachytherapy Society (ABS). Brachytherapy. 2019 Mar-Apr;18(2):123-132. doi: 10.1016/j.brachy.2018.11.009. Epub 2019 Jan 18.

    PubMed 30665713
  • Kirchheiner K, Potter R, Tanderup K, Lindegaard JC, Haie-Meder C, Petric P, Mahantshetty U, Jurgenliemk-Schulz IM, Rai B, Cooper R, Dorr W, Nout RA; EMBRACE Collaborative Group. Health-Related Quality of Life in Locally Advanced Cervical Cancer Patients After Definitive Chemoradiation Therapy Including Image Guided Adaptive Brachytherapy: An Analysis From the EMBRACE Study. Int J Radiat Oncol Biol Phys. 2016 Apr 1;94(5):1088-98. doi: 10.1016/j.ijrobp.2015.12.363. Epub 2015 Dec 29.

    PubMed 26876955
  • Humphrey P, Bennett C, Cramp F. The experiences of women receiving brachytherapy for cervical cancer: A systematic literature review. Radiography (Lond). 2018 Nov;24(4):396-403. doi: 10.1016/j.radi.2018.06.002. Epub 2018 Jul 18.

    PubMed 30292512
  • Andersen BL, Karlsson JA, Anderson B, Tewfik HH. Anxiety and cancer treatment: response to stressful radiotherapy. Health Psychol. 1984;3(6):535-51. doi: 10.1037//0278-6133.3.6.535.

    PubMed 6536502
  • Kwekkeboom KL, Dendaas NR, Straub M, Bradley KA. Patterns of pain and distress during high-dose-rate intracavity brachytherapy for cervical cancer. J Support Oncol. 2009 May-Jun;7(3):108-14.

    PubMed 19507459
  • Cook CA, Guerrerio JF, Slater VE. Healing touch and quality of life in women receiving radiation treatment for cancer: a randomized controlled trial. Altern Ther Health Med. 2004 May-Jun;10(3):34-41. No abstract available.

    PubMed 15154151
  • Post-White J, Kinney ME, Savik K, Gau JB, Wilcox C, Lerner I. Therapeutic massage and healing touch improve symptoms in cancer. Integr Cancer Ther. 2003 Dec;2(4):332-44. doi: 10.1177/1534735403259064.

    PubMed 14713325
  • Astin JA, Harkness E, Ernst E. The efficacy of "distant healing": a systematic review of randomized trials. Ann Intern Med. 2000 Jun 6;132(11):903-10. doi: 10.7326/0003-4819-132-11-200006060-00009.

    PubMed 10836918
  • Thrane S, Cohen SM. Effect of Reiki therapy on pain and anxiety in adults: an in-depth literature review of randomized trials with effect size calculations. Pain Manag Nurs. 2014 Dec;15(4):897-908. doi: 10.1016/j.pmn.2013.07.008. Epub 2014 Feb 28.

    PubMed 24582620
  • Tabatabaee A, Tafreshi MZ, Rassouli M, Aledavood SA, AlaviMajd H, Farahmand SK. Effect of Therapeutic Touch in Patients with Cancer: a Literature Review. Med Arch. 2016 Apr;70(2):142-7. doi: 10.5455/medarh.2016.70.142-147. Epub 2016 Apr 1.

    PubMed 27194823
  • Gentile D, Boselli D, O'Neill G, Yaguda S, Bailey-Dorton C, Eaton TA. Cancer Pain Relief After Healing Touch and Massage. J Altern Complement Med. 2018 Sep/Oct;24(9-10):968-973. doi: 10.1089/acm.2018.0192.

    PubMed 30247960
  • Behzadmehr R, Dastyar N, Moghadam MP, Abavisani M, Moradi M. Effect of complementary and alternative medicine interventions on cancer related pain among breast cancer patients: A systematic review. Complement Ther Med. 2020 Mar;49:102318. doi: 10.1016/j.ctim.2020.102318. Epub 2020 Jan 17.

    PubMed 32147038
  • Fleisher KA, Mackenzie ER, Frankel ES, Seluzicki C, Casarett D, Mao JJ. Integrative Reiki for cancer patients: a program evaluation. Integr Cancer Ther. 2014 Jan;13(1):62-7. doi: 10.1177/1534735413503547. Epub 2013 Oct 7.

    PubMed 24105356
  • Miles P, True G. Reiki--review of a biofield therapy history, theory, practice, and research. Altern Ther Health Med. 2003 Mar-Apr;9(2):62-72.

    PubMed 12652885
  • Health NCfCaI: Reiki. https://www.nccih.nih.gov/health/reiki, 2018

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Reiki therapy in people with Gynecologic Neoplasm and Brachytherapy, run by University of Utah at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 14 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact David Samuel (801-587-4713, David.Samuel@hci.utah.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05979610, which also lists 18 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Oct 2026.

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