Reiki as a Complementary Therapy: A Pilot Study

Hematologic Malignancy Clinical Trial

Official title:

Reiki as a Complementary Therapy: A Pilot Study

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02207764
• Other study ID #: J1358
• Secondary ID: IRB00026755
• Status: Withdrawn
• Phase: N/A
• First received: July 29, 2014
• Last updated: December 19, 2014
• Start date: September 2014

Study information

• Verified date: July 2014
• Source: Sidney Kimmel Comprehensive Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Hematologic Malignancy

Intervention

Behavioral:
• 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.

Locations

Country	Name	City	State
United States	Johns Hopkins Hospital	Baltimore	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
Sidney Kimmel Comprehensive Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	No
Secondary	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.	baseline	No
Secondary	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.	post intervention (after Reiki- 15 minutes from baseline)	No
Secondary	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.	pre bone marrow biopsy (immediately before bone marrow is done, same day as Reiki)	No
Secondary	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.	post bone marrow biopsy (immediately after bone marrow is done, same day as Reiki)	No
Secondary	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.	20 minutes post bone marrow biopsy	No
Secondary	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.	baseline	No
Secondary	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.	post intervention (after Reiki- 15 minutes from baseline)	No
Secondary	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.	pre bone marrow biopsy (immediately before bone marrow is done, same day as Reiki)	No
Secondary	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.	post bone marrow biopsy (immediately after bone marrow is done, same day as Reiki)	No
Secondary	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.	20 minutes post bone marrow biopsy	No