Reiki in Symptom Management of Hemodialysis Patients

April 25, 2023 updated by: Ulviye Özcan Yüce, Osmaniye Korkut Ata University

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
64

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Osmaniye, Turkey, 80000
        • Osmaniye Korkut Ata University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Reiki
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
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
No Intervention: Control
No intervention was made in the control group (n=32).

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change from baseline Dialysis Symptom Index at a week
Time Frame: Within 1 hour of first admission. -A week later
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change from Sodium values at a week
Time Frame: Within one week of first application
In this section there is Sodium value required for eliminating fluid-electrolyte imbalances. The observed sodium is expected to be 136 -144 mmol/L.
Within one week of first application
Change from Potassium values at a week
Time Frame: Within one week of first application
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
Within one week of first application
Change from Calcium values at a week
Time Frame: Within one week of first application
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
Within one week of first application
Change from Chloride values at a week
Time Frame: Within one week of first application
In this section there is Chloride value required for eliminating fluid-electrolyte imbalances. The observed Chloride is expected to be 97 - 105 mmol/L
Within one week of first application
Change from Magnesium values at a week
Time Frame: Within one week of first application
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
Within one week of first application
Change from Phosphate values at a week
Time Frame: Within one week of first application
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
Within one week of first application
Change from urea values at a week
Time Frame: Within one week of first application
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
Within one week of first application
Change from Hemoglobin values at a week
Time Frame: Within one week of first application
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
Within one week of first application
Change from Hematocrit values at a week
Time Frame: Within one week of first application
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%
Within one week of first application

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Osmaniye Korkut Ata University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 7, 2022

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 13, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 8, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 29, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 25, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 27, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 27, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 25, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2022/02/12-E.54558

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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