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Reiki as a Complementary Therapy: A Pilot Study

Primary Purpose

Hematologic Malignancy

Status
Withdrawn
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Reiki
Sponsored by
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Hematologic Malignancy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Johns Hopkins Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Reiki Intervention

nursing presence control

Arm Description

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.

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

Outcomes

Primary Outcome Measures

stress level: patient report
Explore effectiveness of Reiki therapy as an adjuvant to conventional therapy in the management of stress and anxiety. Patients will be asked their stress level on a 1-10 scale before and after the Reiki intervention.
stress level: patient report
Explore effectiveness of Reiki therapy as an adjuvant to conventional therapy in the management of stress and anxiety.

Secondary Outcome Measures

salivary alpha amylase
Examine whether a complementary therapy, such as Reiki, has any effect on the indices of physiological and subjective measurements when compared with the standard of care including nurse presence.
salivary alpha amylase
Examine whether a complementary therapy, such as Reiki, has any effect on the indices of physiological and subjective measurements when compared with the standard of care including nurse presence.
salivary alpha amylase
Examine whether a complementary therapy, such as Reiki, has any effect on the indices of physiological and subjective measurements when compared with the standard of care including nurse presence.
salivary alpha amylase
Examine whether a complementary therapy, such as Reiki, has any effect on the indices of physiological and subjective measurements when compared with the standard of care including nurse presence.
salivary alpha amylase
Examine whether a complementary therapy, such as Reiki, has any effect on the indices of physiological and subjective measurements when compared with the standard of care including nurse presence.
salivary cortisol
Examine whether a complementary therapy, such as Reiki, has any effect on the indices of physiological and subjective measurements when compared with the standard of care including nurse presence.
salivary cortisol
Examine whether a complementary therapy, such as Reiki, has any effect on the indices of physiological and subjective measurements when compared with the standard of care including nurse presence.
salivary cortisol
Examine whether a complementary therapy, such as Reiki, has any effect on the indices of physiological and subjective measurements when compared with the standard of care including nurse presence.
salivary cortisol
Examine whether a complementary therapy, such as Reiki, has any effect on the indices of physiological and subjective measurements when compared with the standard of care including nurse presence.
salivary cortisol
Examine whether a complementary therapy, such as Reiki, has any effect on the indices of physiological and subjective measurements when compared with the standard of care including nurse presence.

Full Information

First Posted
July 29, 2014
Last Updated
December 19, 2014
Sponsor
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
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1. Study Identification

Unique Protocol Identification Number
NCT02207764
Brief Title
Reiki as a Complementary Therapy: A Pilot Study
Official Title
Reiki as a Complementary Therapy: A Pilot Study
Study Type
Interventional

2. Study Status

Record Verification Date
July 2014
Overall Recruitment Status
Withdrawn
Why Stopped
competing priorities at the organization
Study Start Date
September 2014 (undefined)
Primary Completion Date
December 2015 (Anticipated)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hematologic Malignancy

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Reiki Intervention
Arm Type
Experimental
Arm Description
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.
Arm Title
nursing presence control
Arm Type
No Intervention
Arm Description
Each patient in the control group will receive usual care including the study nurse presence for the 15-minute period.
Intervention Type
Behavioral
Intervention Name(s)
Reiki
Intervention Description
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.
Primary Outcome Measure Information:
Title
stress level: patient report
Description
Explore effectiveness of Reiki therapy as an adjuvant to conventional therapy in the management of stress and anxiety. Patients will be asked their stress level on a 1-10 scale before and after the Reiki intervention.
Time Frame
baseline: prior to Reiki intervention
Title
stress level: patient report
Description
Explore effectiveness of Reiki therapy as an adjuvant to conventional therapy in the management of stress and anxiety.
Time Frame
post intervention: immediately after Reiki
Secondary Outcome Measure Information:
Title
salivary alpha amylase
Description
Examine whether a complementary therapy, such as Reiki, has any effect on the indices of physiological and subjective measurements when compared with the standard of care including nurse presence.
Time Frame
baseline
Title
salivary alpha amylase
Description
Examine whether a complementary therapy, such as Reiki, has any effect on the indices of physiological and subjective measurements when compared with the standard of care including nurse presence.
Time Frame
post intervention (after Reiki- 15 minutes from baseline)
Title
salivary alpha amylase
Description
Examine whether a complementary therapy, such as Reiki, has any effect on the indices of physiological and subjective measurements when compared with the standard of care including nurse presence.
Time Frame
pre bone marrow biopsy (immediately before bone marrow is done, same day as Reiki)
Title
salivary alpha amylase
Description
Examine whether a complementary therapy, such as Reiki, has any effect on the indices of physiological and subjective measurements when compared with the standard of care including nurse presence.
Time Frame
post bone marrow biopsy (immediately after bone marrow is done, same day as Reiki)
Title
salivary alpha amylase
Description
Examine whether a complementary therapy, such as Reiki, has any effect on the indices of physiological and subjective measurements when compared with the standard of care including nurse presence.
Time Frame
20 minutes post bone marrow biopsy
Title
salivary cortisol
Description
Examine whether a complementary therapy, such as Reiki, has any effect on the indices of physiological and subjective measurements when compared with the standard of care including nurse presence.
Time Frame
baseline
Title
salivary cortisol
Description
Examine whether a complementary therapy, such as Reiki, has any effect on the indices of physiological and subjective measurements when compared with the standard of care including nurse presence.
Time Frame
post intervention (after Reiki- 15 minutes from baseline)
Title
salivary cortisol
Description
Examine whether a complementary therapy, such as Reiki, has any effect on the indices of physiological and subjective measurements when compared with the standard of care including nurse presence.
Time Frame
pre bone marrow biopsy (immediately before bone marrow is done, same day as Reiki)
Title
salivary cortisol
Description
Examine whether a complementary therapy, such as Reiki, has any effect on the indices of physiological and subjective measurements when compared with the standard of care including nurse presence.
Time Frame
post bone marrow biopsy (immediately after bone marrow is done, same day as Reiki)
Title
salivary cortisol
Description
Examine whether a complementary therapy, such as Reiki, has any effect on the indices of physiological and subjective measurements when compared with the standard of care including nurse presence.
Time Frame
20 minutes post bone marrow biopsy

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jennifer Day, PhD
Organizational Affiliation
Johns Hopkins University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Johns Hopkins Hospital
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287
Country
United States

12. IPD Sharing Statement

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Reiki as a Complementary Therapy: A Pilot Study

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