NCT05833451

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
64

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 7, 2022

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 13, 2022

Completed
25 days until next milestone

Study Completion

Last participant's last visit for all outcomes

July 8, 2022

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

March 29, 2023

Completed
29 days until next milestone

First Posted

Study publicly available on registry

April 27, 2023

Completed
Last Updated

April 27, 2023

Status Verified

April 1, 2023

Enrollment Period

3 months

First QC Date

March 29, 2023

Last Update Submit

April 25, 2023

Conditions

Keywords

nursinghemodialysisReikiureahemodialysis symptoms

Outcome Measures

Primary Outcomes (1)

  • Change from baseline Dialysis Symptom Index at a week

    The Dialysis Symptom Index was used to investigate the therapeutic effect of Reiki on hemodialysis-related symptoms. The index consists of 30 items to evaluate physical and emotional symptoms and the severity of these symptoms. Participants are asked to define the presence of each symptom they experienced in the last week as Yes or No, and they are also report how much symptoms they experience affect them on a five-point Likert type scale (1 = not at all bothersome, 5 = very much bothersome). The lowest score to be obtained from the index is 0, the highest score is 150, and higher scores indicate more dialysis symptoms. In order to reach the Primary Outcome Measure, it was aimed that the Dialysis Symptom Index total scores of the individuals in the intervention group were lower in the final measurement than in the first measurement.

    Within 1 hour of first admission. -A week later

Secondary Outcomes (9)

  • Change from Sodium values at a week

    Within one week of first application

  • Change from Potassium values at a week

    Within one week of first application

  • Change from Calcium values at a week

    Within one week of first application

  • Change from Chloride values at a week

    Within one week of first application

  • Change from Magnesium values at a week

    Within one week of first application

  • +4 more secondary outcomes

Study Arms (2)

Reiki

EXPERIMENTAL

The participants in the Reiki group (n=32) were given Reiki remotely for 60 minutes by two certified practitioners who completed the second level Reiki training with a Master degree Reiki instructor according to the Usui method.

Other: Reiki

Control

NO INTERVENTION

No intervention was made in the control group (n=32).

Interventions

ReikiOTHER

Reiki, one of integrative practices, is an energy therapy involving the use of energy that flows naturally from the hands of the practitioner to strengthen the body's ability to heal itself in order to increase well-being. Reiki improves well-being in many areas, ensures that blood and lymph circulation is maintained properly, regulates blood pressure and pulse rate by stimulating the autonomic nervous system, increases comfort, reduces depression and anxiety levels. In this way, Reiki facilitates physical and mental relaxation and promotes health

Reiki

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Osmaniye Korkut Ata University

Osmaniye, 80000, Turkey (Türkiye)

Location

Related Publications (14)

  • 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.

    PMID: 22626821BACKGROUND
  • 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.

    PMID: 34437444BACKGROUND
  • 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.

    PMID: 32032397BACKGROUND
  • 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.

    PMID: 33186220BACKGROUND
  • 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.

    PMID: 34175022BACKGROUND
  • 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.

    PMID: 26500179BACKGROUND
  • 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.

    PMID: 32017699BACKGROUND
  • 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.

    PMID: 24529536BACKGROUND
  • 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.

    PMID: 15010101BACKGROUND
  • 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.

    BACKGROUND
  • 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

    BACKGROUND
  • 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.

    PMID: 31638407BACKGROUND
  • 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.

    PMID: 30170509BACKGROUND
  • 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

    BACKGROUND

MeSH Terms

Interventions

Therapeutic Touch

Intervention Hierarchy (Ancestors)

Mind-Body TherapiesComplementary TherapiesTherapeuticsSpiritual Therapies

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD., Assist. Prof.

Study Record Dates

First Submitted

March 29, 2023

First Posted

April 27, 2023

Study Start

March 7, 2022

Primary Completion

June 13, 2022

Study Completion

July 8, 2022

Last Updated

April 27, 2023

Record last verified: 2023-04

Locations