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

Официальное название

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

Обзор

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.

Вмешательства

• Другое 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

Первичные конечные точки

• 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. [Срок оценки: 4 months]

Вторичные конечные точки (8)

• Comparison between the treatment groups of the change in pain from Assessment 1 to Assessment 3 as measured by the Visual Analog Scale - Pain. [Срок оценки: 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. [Срок оценки: 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. [Срок оценки: 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. [Срок оценки: 4 months]
• Respiratory Rate [Срок оценки: 4 months]
• Heart Rate [Срок оценки: 4 months]
• Blood Pressure [Срок оценки: 4 months]
• Oxygen Saturation [Срок оценки: 4 months]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

США · 1 центр

• Huntsman Cancer Institute — Salt Lake City

Публикации

• 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. PMID 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 PMID 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. PMID 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. PMID 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. PMID 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. PMID 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. PMID 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. PMID 10836918

Идентификаторы

NCT: NCT05979610 · HCI158391

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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