[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT05979610":3,"trial-entities:NCT05979610":169,"trial-summary:NCT05979610":177},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":26,"study_type":28,"primary_purpose":29,"phases":30,"enrollment_info":32,"interventions":35,"primary_outcomes":41,"secondary_outcomes":46,"sex":70,"minimum_age":71,"maximum_age":17,"healthy_volunteers":72,"eligibility_criteria":73,"std_ages":85,"locations":88,"central_contacts":107,"overall_officials":112,"references":114,"see_also_links":168},"NCT05979610","HCI158391","Using Reiki Therapy to Improve Symptoms Associated With Brachytherapy in Patients With Gynecological Malignancies","Reiki-Brachy: An Interventional Treatment Trial Using Reiki Therapy to Improve Symptoms Associated With Brachytherapy in Patients With Gynecological Malignancies","RECRUITING","2027-06","2026-05","2026-05-11","2023-11-14","University of Utah","OTHER",true,"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.\n\nParticipants 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.\n\nResearchers 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.",null,[19,20,21,22,23,24,25],"Gynecologic Neoplasm","Brachytherapy","Therapeutic Touch","Endometrial Cancer","Cervical Cancer","Vaginal Cancer","Vulvar Cancer",[27],"Reiki","INTERVENTIONAL","TREATMENT",[31],"PHASE2",{"count":33,"type":34},70,"ESTIMATED",[36],{"type":14,"name":37,"description":38,"armGroupLabels":39},"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:\n\n* The patient will be in a quiet clinic room lying in the supine position with calming music playing and aromatherapy if the patient chooses.\n* 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.\n* 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.\n* The Reiki therapist may use different techniques, such as hand movements or visualization.",[40],"Reiki Therapy",[42],{"measure":43,"description":44,"timeFrame":45},"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.\n\nThe 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",[47,50,53,55,58,61,64,67],{"measure":48,"description":49,"timeFrame":45},"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.\n\nThe 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.",{"measure":51,"description":52,"timeFrame":45},"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.\n\nThe 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\").",{"measure":54,"description":49,"timeFrame":45},"Comparison between the treatment groups of the change in anxiety from Assessment 1 to Assessment 3 as measured by the Visual Analog Scale - Pain.",{"measure":56,"description":57,"timeFrame":45},"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.\n\nThe 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\u002Fno impairment) to 21 (abnormal\u002Fsevere impairment.)",{"measure":59,"description":60,"timeFrame":45},"Respiratory Rate","To compare the change in physiological measurements between subjects receiving Reiki therapy and the standard of care control arm during brachytherapy treatment.\n\nA 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.",{"measure":62,"description":63,"timeFrame":45},"Heart Rate","To compare the change in physiological measurements between subjects receiving Reiki therapy and the standard of care control arm during brachytherapy treatment.\n\nA 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.",{"measure":65,"description":66,"timeFrame":45},"Blood Pressure","To compare the change in physiological measurements between subjects receiving Reiki therapy and the standard of care control arm during brachytherapy treatment.\n\nA 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.",{"measure":68,"description":69,"timeFrame":45},"Oxygen Saturation","To compare the change in physiological measurements between subjects receiving Reiki therapy and the standard of care control arm during brachytherapy treatment.\n\nA 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.","FEMALE","18 Years",false,{"inclusion":74,"exclusion":81,"raw_text":84},[75,76,77,78,79,80],"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\u002For 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.",[82,83],"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.","Inclusion Criteria:\n\n* Subject aged ≥ 18 years.\n* Pathologically confirmed malignancy of the endometrium, cervix, vagina or vulva.\n* Eligible to undergo brachytherapy treatment as an outpatient procedure.\n* Able to read and understand English and\u002For Spanish.\n* Able to provide informed consent and willing to sign an approved consent form that conforms to federal and institutional guidelines.\n* Willing to participate in either the Reiki therapy or standard of care arm regardless of treatment assignment.\n\nExclusion Criteria:\n\n* Prior brachytherapy treatment for a gynecological malignancy.\n* 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.",[86,87],"ADULT","OLDER_ADULT",[89],{"facility":90,"status":8,"city":91,"state":92,"zip":93,"country":94,"contacts":95,"geoPoint":104},"Huntsman Cancer Institute","Salt Lake City","Utah","84112","United States",[96,101],{"name":97,"role":98,"phone":99,"email":100},"Elyse D'Astous","CONTACT","801-587-4323","Elyse.DAstous@hci.utah.edu",{"name":102,"role":103},"Lindsay Burt, MD","PRINCIPAL_INVESTIGATOR",{"lat":105,"lon":106},40.76078,-111.89105,[108],{"name":109,"role":98,"phone":110,"email":111},"David Samuel","801-587-4713","David.Samuel@hci.utah.edu",[113],{"name":102,"affiliation":90,"role":103},[115,119,122,125,128,131,134,137,140,143,146,149,152,155,158,160,162,165],{"pmid":116,"type":117,"citation":118},"30665713","BACKGROUND","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\u002Fj.brachy.2018.11.009. Epub 2019 Jan 18.",{"pmid":120,"type":117,"citation":121},"26876955","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\u002Fj.ijrobp.2015.12.363. Epub 2015 Dec 29.",{"pmid":123,"type":117,"citation":124},"30292512","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\u002Fj.radi.2018.06.002. Epub 2018 Jul 18.",{"pmid":126,"type":117,"citation":127},"6536502","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\u002F\u002F0278-6133.3.6.535.",{"pmid":129,"type":117,"citation":130},"19507459","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":132,"type":117,"citation":133},"15154151","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":135,"type":117,"citation":136},"14713325","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\u002F1534735403259064.",{"pmid":138,"type":117,"citation":139},"10836918","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\u002F0003-4819-132-11-200006060-00009.",{"pmid":141,"type":117,"citation":142},"24582620","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\u002Fj.pmn.2013.07.008. Epub 2014 Feb 28.",{"pmid":144,"type":117,"citation":145},"27194823","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\u002Fmedarh.2016.70.142-147. Epub 2016 Apr 1.",{"pmid":147,"type":117,"citation":148},"30247960","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\u002FOct;24(9-10):968-973. doi: 10.1089\u002Facm.2018.0192.",{"pmid":150,"type":117,"citation":151},"32147038","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\u002Fj.ctim.2020.102318. Epub 2020 Jan 17.",{"pmid":153,"type":117,"citation":154},"24105356","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\u002F1534735413503547. Epub 2013 Oct 7.",{"pmid":156,"type":117,"citation":157},"12652885","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.",{"type":117,"citation":159},"Health NCfCaI: Reiki. https:\u002F\u002Fwww.nccih.nih.gov\u002Fhealth\u002Freiki, 2018",{"type":117,"citation":161},"Benali K: The Experience of Pain and Anxiety in Cervical Cancer Patients Undergoing Multiple Fraction High-Dose Rate Brachytherapy: A Prospective Observational Study. Journal of Cancer Therapy 13:405-416, 2022",{"pmid":163,"type":117,"citation":164},"17351024","Tsang KL, Carlson LE, Olson K. Pilot crossover trial of Reiki versus rest for treating cancer-related fatigue. Integr Cancer Ther. 2007 Mar;6(1):25-35. doi: 10.1177\u002F1534735406298986.",{"pmid":166,"type":117,"citation":167},"25646186","Breitbart W, Rosenfeld B, Pessin H, Applebaum A, Kulikowski J, Lichtenthal WG. Meaning-centered group psychotherapy: an effective intervention for improving psychological well-being in patients with advanced cancer. J Clin Oncol. 2015 Mar 1;33(7):749-54. doi: 10.1200\u002FJCO.2014.57.2198. Epub 2015 Feb 2.",[],{"nct_id":4,"conditions":170,"biomarkers":176},[171,172,173,174,175],"Cervical Carcinoma","Endometrial Carcinoma","Female Reproductive System Neoplasm","Vaginal Carcinoma","Vulvar Carcinoma",[],{"nct_id":4,"found":15,"summary":178,"prompt_version":188},{"design":179,"status":180,"heading":181,"summary":182,"follow_up":183,"word_count":184,"commitments":185,"compensation":186,"drugs_mentioned":187},"This is an open-label, randomized, controlled clinical trial planning to enroll 70 participants. Participants will be randomly assigned to either receive Reiki therapy or usual care.","completed","Reiki Therapy for Gynecological Cancers During Brachytherapy","This study is exploring whether Reiki therapy can help improve symptoms like anxiety and pain for women with gynecological cancers (like endometrial or cervical cancer) who are receiving brachytherapy. Brachytherapy is a type of radiation therapy where a device is placed inside or near the tumor. Participants will either receive a session of Reiki therapy or usual care during the wait time for their brachytherapy. Researchers will compare these two groups to see if Reiki therapy impacts anxiety, pain, and depression. You may be able to join if you are an adult woman with a confirmed gynecological cancer, are having brachytherapy as an outpatient, and can read English or Spanish. The study aims to measure changes in anxiety over 4 months.","Participants will be followed up at three months after their first brachytherapy treatment, with the primary endpoint measured at 4 months.",121,"You would receive a Reiki therapy session or usual care during your brachytherapy wait time. You will also complete questionnaires on the day of your first brachytherapy and at a three-month follow-up.","Not stated in the trial record.",[37],"v2"]