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Reiki as a Complementary Therapy: A Pilot Study

NCT ID: NCT02207764

Last Updated: 2014-12-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2014-09-30

Brief Summary

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This research is being done to test whether a complementary intervention, Reiki therapy, can provide added benefits to the standard patient care. Reiki is method for stress reduction that uses hand positions over and/or on the body to help people relax.

We are studying the effect of a 15-minute Reiki application compared to an intervention of nursing presence without Reiki. We hope to find if Reiki can assist in relieving stress, and improving patient outcomes. In the future we would like to offer complementary interventions as an adjunct to our standard care for patients.

Detailed Description

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This pilot study is designed to test if a complementary therapy, Reiki, has an effect on physiological and subjective measures of stress. This is a 2-arm randomized pilot study of the use of Reiki therapy prior to a stressful event with a convenience sample of 40 participants who are newly diagnosed hematologic malignancy patients on the inpatient service who will experience bone marrow aspirate post induction chemotherapy. Reiki therapy is a non-invasive complementary therapy that can be used in addition to the standard of care. The intervention group will receive a 15-minute Reiki session and the control group will receive 15 minutes of nursing presence. Each study arm includes a brief item questionnaire to rank subjective measures of pain, anxiety, and energy; saliva biological markers related to stress-reduction; and measures of blood pressure, heart rate, and respirations. The intervention group will receive a 15-minute intervention performed on the inpatient unit prior to the bone marrow aspirate procedure. Data will be collected from patients both before and after the intervention and before and after the bone marrow aspirate. We will collect saliva samples from the control group and baseline data including subjective measures of pain, anxiety and energy and measures of blood pressure, heart rate, and respirations. The study nurse will maintain presence in the control participant's room for 15-minutes after the initial measures.

Our research hypothesis is that there will be a change in the response to one or more parameters of physiological or subjective measures for those patients receiving a Reiki intervention when compared to those receiving standard of care plus the nurse presence in room.

The null hypothesis is there will be no difference in response between the groups.

Conditions

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Hematologic Malignancy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Reiki Intervention

Each study participant in the intervention group will receive one Reiki intervention by a registered nurse trained in Advanced Level Reiki through the Usui Shiki Ryoho method.

Group Type EXPERIMENTAL

Reiki

Intervention Type BEHAVIORAL

Each study participant in the intervention group will receive one Reiki intervention by a registered nurse trained in Advanced Level Reiki through the Usui Shiki Ryoho method.

nursing presence control

Each patient in the control group will receive usual care including the study nurse presence for the 15-minute period.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Reiki

Each study participant in the intervention group will receive one Reiki intervention by a registered nurse trained in Advanced Level Reiki through the Usui Shiki Ryoho method.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* Patients 18 and older admitted to hospital
* Speak English
* Able to give consent will be included.

Exclusion Criteria

* Patients who are under 18
* Non-English speaking
* Unable to consent
* Pregnant women
* Unwilling to join the study will be excluded
* Intensive Care Unit (ICU) patients and those patients scheduled to receive conscious sedation will be excluded.
* Each patient may join the pilot study only once
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jennifer Day, PhD

Role: PRINCIPAL_INVESTIGATOR

Johns Hopkins University

Locations

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Johns Hopkins Hospital

Baltimore, Maryland, United States

Site Status

Countries

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United States

Other Identifiers

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IRB00026755

Identifier Type: OTHER

Identifier Source: secondary_id

J1358

Identifier Type: -

Identifier Source: org_study_id