Clinical trial NCT05833451: Reiki in Symptom Management of Hemodialysis Patients
Official title: Is Reiki Effective In Coping With the Symptoms Experienced by Patients Undergoing Hemodialysis?: Single-Blind Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Renal Dialysis
Keywords: nursing
hemodialysis
Reiki
urea
hemodialysis symptoms
Lead sponsor: Osmaniye Korkut Ata University
Sponsor class: OTHER
First posted: 2023-04-27
Enrollment: 64
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: This study aims to investigate the effect of Reiki applied to individuals receiving hemodialysis treatment on hemodialysis-related symptoms and hematological indicators.

Detailed description: The study has a pretest-posttest randomized controlled design and it was carried out between March and July 2022 with 64 patients over the age of 18 who received hemodialysis treatment for at least 15 days in the dialysis unit of state hospitals in two different cities. Data were collected using the Patient Information Form, the Dialysis Symptom Index (DSI), and the follow-up chart including erythrocyte (RBC), hemoglobin (HGB), hematocrit (HCT), serum urea, creatinine, sodium (Na), potassium (K), phosphorus (P), and calcium (Ca) values. While the distance Reiki intervention was applied to each of the patients in the Reiki group for 60 minutes, no intervention was made in the control group. One week after the intervention, the DSI was re-administered to the patients in the posttest, and hematology and biochemistry results were recorded.

Eligibility criteria: Inclusion Criteria:

* To be over 18 years of age,
* To have received hemodialysis treatment for at least 15 days,
* To volunteer to participate in the study,
* To be able to answer the given forms and questionnaires

Exclusion Criteria:

* To be a Reiki practitioner or trainer,
* To have attended any energy therapy session before,
* Using other complementary and integrative medicine practices at the time of the application.

Primary outcomes:
measure: Change from baseline Dialysis Symptom Index at a week
timeFrame: Within 1 hour of first admission. -A week later
Secondary outcomes:
measure: Change from Sodium values at a week
timeFrame: Within one week of first application
measure: Change from Potassium values at a week
timeFrame: Within one week of first application
measure: Change from Calcium values at a week
timeFrame: Within one week of first application
measure: Change from Chloride values at a week
timeFrame: Within one week of first application
measure: Change from Magnesium values at a week
timeFrame: Within one week of first application
measure: Change from Phosphate values at a week
timeFrame: Within one week of first application
measure: Change from urea values at a week
timeFrame: Within one week of first application
measure: Change from Hemoglobin values at a week
timeFrame: Within one week of first application
measure: Change from Hematocrit values at a week
timeFrame: Within one week of first application
Other outcomes:
Locations:
city: Osmaniye
country: Turkey
facility: Osmaniye Korkut Ata University
Study officials:
References:
citation: Duranton F, Cohen G, De Smet R, Rodriguez M, Jankowski J, Vanholder R, Argiles A; European Uremic Toxin Work Group. Normal and pathologic concentrations of uremic toxins. J Am Soc Nephrol. 2012 Jul;23(7):1258-70. doi: 10.1681/ASN.2011121175. Epub 2012 May 24.
citation: Lu PH, Yu MC, Wei MJ, Kuo KL. The Therapeutic Strategies for Uremic Toxins Control in Chronic Kidney Disease. Toxins (Basel). 2021 Aug 17;13(8):573. doi: 10.3390/toxins13080573.
citation: Yu IC, Fang JT, Tsai YF. Exploring demands of hemodialysis patients in Taiwan: A two-step cluster analysis. PLoS One. 2020 Feb 7;15(2):e0228259. doi: 10.1371/journal.pone.0228259. eCollection 2020.
citation: Zarantonello D, Rhee CM, Kalantar-Zadeh K, Brunori G. Novel conservative management of chronic kidney disease via dialysis-free interventions. Curr Opin Nephrol Hypertens. 2021 Jan;30(1):97-107. doi: 10.1097/MNH.0000000000000670.
citation: Kalantar-Zadeh K, Jafar TH, Nitsch D, Neuen BL, Perkovic V. Chronic kidney disease. Lancet. 2021 Aug 28;398(10302):786-802. doi: 10.1016/S0140-6736(21)00519-5. Epub 2021 Jun 24.
citation: Vanholder RC, Eloot S, Glorieux GL. Future Avenues to Decrease Uremic Toxin Concentration. Am J Kidney Dis. 2016 Apr;67(4):664-76. doi: 10.1053/j.ajkd.2015.08.029. Epub 2015 Oct 21.
citation: Li PK, Garcia-Garcia G, Lui SF, Andreoli S, Fung WW, Hradsky A, Kumaraswami L, Liakopoulos V, Rakhimova Z, Saadi G, Strani L, Ulasi I, Kalantar-Zadeh K. Kidney health for everyone everywhere - from prevention to detection and equitable access to care. Clin Nephrol. 2020 Mar;93(3):111-122. doi: 10.5414/CNWKDEditorial.
citation: Komenda P, Ferguson TW, Macdonald K, Rigatto C, Koolage C, Sood MM, Tangri N. Cost-effectiveness of primary screening for CKD: a systematic review. Am J Kidney Dis. 2014 May;63(5):789-97. doi: 10.1053/j.ajkd.2013.12.012. Epub 2014 Feb 12.
citation: Weisbord SD, Fried LF, Arnold RM, Rotondi AJ, Fine MJ, Levenson DJ, Switzer GE. Development of a symptom assessment instrument for chronic hemodialysis patients: the Dialysis Symptom Index. J Pain Symptom Manage. 2004 Mar;27(3):226-40. doi: 10.1016/j.jpainsymman.2003.07.004.
citation: Daniel P. Wirth, R. J. Chang, W. S. Eidelman & J. B. Paxton, Hematological Indicators of Complementary Healing Intervention, Complementary Therapies in Medicine 4 (996), pp. 4-20.
citation: Önsöz HB, Usta Yeşilbalkan Ö. Reliability and validity of the Turkish version of the dialysis symptom index in chronic hemodialysis patients. Turkish Nephrology, Dialysis and Transplantation Journal 2013; 22(1): 60-67
citation: Dyer NL, Baldwin AL, Rand WL. A Large-Scale Effectiveness Trial of Reiki for Physical and Psychological Health. J Altern Complement Med. 2019 Dec;25(12):1156-1162. doi: 10.1089/acm.2019.0022. Epub 2019 Oct 22.
citation: Zins S, Hooke MC, Gross CR. Reiki for Pain During Hemodialysis: A Feasibility and Instrument Evaluation Study. J Holist Nurs. 2019 Jun;37(2):148-162. doi: 10.1177/0898010118797195. Epub 2018 Aug 31.
citation: Muhith A, Hidayaah N, Faizah I, Sari, RY, Hartadi H. The Effect of Reiki Therapy on Posttraumatic Growth (Ptg) Among Chronic Renal Failure Patients Through Hemodialysis. Nurse and Health: Journal Keperawatan. 2021, 10(2): 190-200. http://ejournal-kertacendekia.id/index.php/nhjk/index