Clinical trial NCT02207764: Reiki as a Complementary Therapy: A Pilot Study
Official title: Reiki as a Complementary Therapy: A Pilot Study
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Hematologic Malignancy
Lead sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Sponsor class: OTHER
First posted: 2014-08-04
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: stress level: patient report
timeFrame: baseline: prior to Reiki intervention
measure: stress level: patient report
timeFrame: post intervention: immediately after Reiki
Secondary outcomes:
measure: salivary alpha amylase
timeFrame: baseline
measure: salivary alpha amylase
timeFrame: post intervention (after Reiki- 15 minutes from baseline)
measure: salivary alpha amylase
timeFrame: pre bone marrow biopsy (immediately before bone marrow is done, same day as Reiki)
measure: salivary alpha amylase
timeFrame: post bone marrow biopsy (immediately after bone marrow is done, same day as Reiki)
measure: salivary alpha amylase
timeFrame: 20 minutes post bone marrow biopsy
measure: salivary cortisol
timeFrame: baseline
measure: salivary cortisol
timeFrame: post intervention (after Reiki- 15 minutes from baseline)
measure: salivary cortisol
timeFrame: pre bone marrow biopsy (immediately before bone marrow is done, same day as Reiki)
measure: salivary cortisol
timeFrame: post bone marrow biopsy (immediately after bone marrow is done, same day as Reiki)
measure: salivary cortisol
timeFrame: 20 minutes post bone marrow biopsy
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins Hospital
state: Maryland
Study officials:
affiliation: Johns Hopkins University
name: Jennifer Day, PhD
role: PRINCIPAL_INVESTIGATOR
References: