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Renal DialysisNCT05833451

Reiki in Symptom Management of Hemodialysis Patients

A study testing Reiki in people with Renal Dialysis, run by Osmaniye Korkut Ata University at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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

Who is it for?
Ages 18 years and older
Conditions the study is for
Renal Dialysis
What is being tested?
Reiki
Could I receive a placebo?
No, everyone receives an active treatment
How many people
64 participants
Where
1 siteTurkey (Türkiye)
Study dates
7 Mar 2022to 8 Jul 2022
Phase
Interventional
Are there results?
None posted in the registry

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
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site

  • Osmaniye Korkut Ata University

    Osmaniye, 80000

Other trials in Turkey (Türkiye)

About this study

Official title: Is Reiki Effective In Coping With the Symptoms Experienced by Patients Undergoing Hemodialysis?: Single-Blind Randomized Controlled Trial

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

Read the 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.

Conditions
Renal Dialysis
Being tested
Reiki
Keywords
nursing, hemodialysis, Reiki, urea, hemodialysis symptoms

What participants receive

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

  • 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

Study groups in NCT05833451
Study groupRoleWhat they receive
ReikiExperimentalThe 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.
Receives: Other: Reiki
ControlNo interventionNo intervention was made in the control group (n=32).

What is being measured

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

  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.

    Measured: Within 1 hour of first admission. -A week later

Secondary outcomes (9)

  1. Change from Sodium values at a week

    In this section there is Sodium value required for eliminating fluid-electrolyte imbalances. The observed sodium is expected to be 136 -144 mmol/L.

    Measured: Within one week of first application

  2. Change from Potassium values at a week

    In this section there is Potassium value required for eliminating fluid-electrolyte imbalances. The observed sodium is expected to be 3.7 - 5.1 mmol/L

    Measured: Within one week of first application

  3. Change from Calcium values at a week

    In this section there is Calcium value required for eliminating fluid-electrolyte imbalances. The observed Calcium is expected to be 8.5 -10.2 mg/dL

    Measured: Within one week of first application

  4. Change from Chloride values at a week

    In this section there is Chloride value required for eliminating fluid-electrolyte imbalances. The observed Chloride is expected to be 97 - 105 mmol/L

    Measured: Within one week of first application

  5. Change from Magnesium values at a week

    In this section there is Magnesium value required for eliminating fluid-electrolyte imbalances. The observed Magnesium is expected to be 1.7- 2.2 mg/dL

    Measured: Within one week of first application

  6. Change from Phosphate values at a week

    In this section there is Phosphate value required for eliminating fluid-electrolyte imbalances. The observed Phosphate is expected to be 2.5- 4.8 mg/dL

    Measured: Within one week of first application

  7. Change from urea values at a week

    In this section there is urea value required for eliminating fluid-electrolyte imbalances. The observed urea is expected to be 1.8 to 7.1 mmol

    Measured: Within one week of first application

  8. Change from Hemoglobin values at a week

    In this section there is Hemoglobin value required for preventing anemia. The observed Hemoglobin is expected to be Male (ages 15+): 13.0 - 17.0 g/dL; Female (ages 15+): 11.5 - 15.5 g/dL

    Measured: Within one week of first application

  9. Change from Hematocrit values at a week

    This section contains the Hematocrit value, which should be in the appropriate range to prevent fluid imbalance and anemia. The observed Hematocrit is expected to be Male: 40 - 55%; Female: 36 - 48%

    Measured: Within one week of first application

Timeline

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

  1. First posted27 Apr 2023
  2. Study start7 Mar 2022
  3. Primary completion13 Jun 2022
  4. Study completion8 Jul 2022

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 N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
64 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05833451
Sponsor's protocol ID
2022/02/12-E.54558
Status last verified
Apr 2023
First submitted
29 Mar 2023
Last updated
27 Apr 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • 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.

    PubMed 22626821

  • 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.

    PubMed 34437444

  • 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.

    PubMed 32032397

  • 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.

    PubMed 33186220

  • 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.

    PubMed 34175022

  • 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.

    PubMed 26500179

  • 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.

    PubMed 32017699

  • 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.

    PubMed 24529536

  • 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.

    PubMed 15010101

  • 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.

  • 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

  • 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.

    PubMed 31638407

  • 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.

    PubMed 30170509

  • 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

Questions about this trial

What is this clinical trial studying?

A study testing Reiki in people with Renal Dialysis, run by Osmaniye Korkut Ata University at 1 site in Turkey (Türkiye).

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 4 inclusion and 3 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: finished, as of the sponsor's last update on 27 Apr 2023. 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 Turkey (Türkiye). 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.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change from baseline Dialysis Symptom Index at a week (time frame: Within 1 hour of first admission. -A week later). 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 NCT05833451, which also lists 14 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 27 Apr 2023.

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