NCT02207764

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.

Trial Health

35
At Risk

Trial Health Score

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

Geographic Reach
1 country

1 active site

Status
withdrawn

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

First Submitted

Initial submission to the registry

July 29, 2014

Completed
6 days until next milestone

First Posted

Study publicly available on registry

August 4, 2014

Completed
28 days until next milestone

Study Start

First participant enrolled

September 1, 2014

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
Last Updated

December 23, 2014

Status Verified

July 1, 2014

Enrollment Period

1.2 years

First QC Date

July 29, 2014

Last Update Submit

December 19, 2014

Conditions

Outcome Measures

Primary Outcomes (2)

  • 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.

    baseline: prior to Reiki intervention

  • stress level: patient report

    Explore effectiveness of Reiki therapy as an adjuvant to conventional therapy in the management of stress and anxiety.

    post intervention: immediately after Reiki

Secondary Outcomes (10)

  • salivary alpha amylase

    baseline

  • salivary alpha amylase

    post intervention (after Reiki- 15 minutes from baseline)

  • salivary alpha amylase

    pre bone marrow biopsy (immediately before bone marrow is done, same day as Reiki)

  • salivary alpha amylase

    post bone marrow biopsy (immediately after bone marrow is done, same day as Reiki)

  • salivary alpha amylase

    20 minutes post bone marrow biopsy

  • +5 more secondary outcomes

Study Arms (2)

Reiki Intervention

EXPERIMENTAL

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.

Behavioral: Reiki

nursing presence control

NO INTERVENTION

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

Interventions

ReikiBEHAVIORAL

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.

Reiki Intervention

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Johns Hopkins Hospital

Baltimore, Maryland, 21287, United States

Location

MeSH Terms

Conditions

Hematologic Neoplasms

Interventions

Therapeutic Touch

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsHematologic DiseasesHemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Mind-Body TherapiesComplementary TherapiesTherapeuticsSpiritual Therapies

Study Officials

  • Jennifer Day, PhD

    Johns Hopkins University

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 29, 2014

First Posted

August 4, 2014

Study Start

September 1, 2014

Primary Completion

December 1, 2015

Last Updated

December 23, 2014

Record last verified: 2014-07

Locations