<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT02207764</url>
  </required_header>
  <id_info>
    <org_study_id>J1358</org_study_id>
    <secondary_id>IRB00026755</secondary_id>
    <nct_id>NCT02207764</nct_id>
  </id_info>
  <brief_title>Reiki as a Complementary Therapy: A Pilot Study</brief_title>
  <official_title>Reiki as a Complementary Therapy: A Pilot Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This research is being done to test whether a complementary intervention, Reiki therapy, can&#xD;
      provide added benefits to the standard patient care. Reiki is method for stress reduction&#xD;
      that uses hand positions over and/or on the body to help people relax.&#xD;
&#xD;
      We are studying the effect of a 15-minute Reiki application compared to an intervention of&#xD;
      nursing presence without Reiki. We hope to find if Reiki can assist in relieving stress, and&#xD;
      improving patient outcomes. In the future we would like to offer complementary interventions&#xD;
      as an adjunct to our standard care for patients.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This pilot study is designed to test if a complementary therapy, Reiki, has an effect on&#xD;
      physiological and subjective measures of stress. This is a 2-arm randomized pilot study of&#xD;
      the use of Reiki therapy prior to a stressful event with a convenience sample of 40&#xD;
      participants who are newly diagnosed hematologic malignancy patients on the inpatient service&#xD;
      who will experience bone marrow aspirate post induction chemotherapy. Reiki therapy is a&#xD;
      non-invasive complementary therapy that can be used in addition to the standard of care. The&#xD;
      intervention group will receive a 15-minute Reiki session and the control group will receive&#xD;
      15 minutes of nursing presence. Each study arm includes a brief item questionnaire to rank&#xD;
      subjective measures of pain, anxiety, and energy; saliva biological markers related to&#xD;
      stress-reduction; and measures of blood pressure, heart rate, and respirations. The&#xD;
      intervention group will receive a 15-minute intervention performed on the inpatient unit&#xD;
      prior to the bone marrow aspirate procedure. Data will be collected from patients both before&#xD;
      and after the intervention and before and after the bone marrow aspirate. We will collect&#xD;
      saliva samples from the control group and baseline data including subjective measures of&#xD;
      pain, anxiety and energy and measures of blood pressure, heart rate, and respirations. The&#xD;
      study nurse will maintain presence in the control participant's room for 15-minutes after the&#xD;
      initial measures.&#xD;
&#xD;
      Our research hypothesis is that there will be a change in the response to one or more&#xD;
      parameters of physiological or subjective measures for those patients receiving a Reiki&#xD;
      intervention when compared to those receiving standard of care plus the nurse presence in&#xD;
      room.&#xD;
&#xD;
      The null hypothesis is there will be no difference in response between the groups.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    competing priorities at the organization&#xD;
  </why_stopped>
  <start_date>September 2014</start_date>
  <primary_completion_date type="Anticipated">December 2015</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>stress level: patient report</measure>
    <time_frame>baseline: prior to Reiki intervention</time_frame>
    <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.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>stress level: patient report</measure>
    <time_frame>post intervention: immediately after Reiki</time_frame>
    <description>Explore effectiveness of Reiki therapy as an adjuvant to conventional therapy in the management of stress and anxiety.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>salivary alpha amylase</measure>
    <time_frame>baseline</time_frame>
    <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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>salivary alpha amylase</measure>
    <time_frame>post intervention (after Reiki- 15 minutes from baseline)</time_frame>
    <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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>salivary alpha amylase</measure>
    <time_frame>pre bone marrow biopsy (immediately before bone marrow is done, same day as Reiki)</time_frame>
    <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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>salivary alpha amylase</measure>
    <time_frame>post bone marrow biopsy (immediately after bone marrow is done, same day as Reiki)</time_frame>
    <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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>salivary alpha amylase</measure>
    <time_frame>20 minutes post bone marrow biopsy</time_frame>
    <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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>salivary cortisol</measure>
    <time_frame>baseline</time_frame>
    <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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>salivary cortisol</measure>
    <time_frame>post intervention (after Reiki- 15 minutes from baseline)</time_frame>
    <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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>salivary cortisol</measure>
    <time_frame>pre bone marrow biopsy (immediately before bone marrow is done, same day as Reiki)</time_frame>
    <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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>salivary cortisol</measure>
    <time_frame>post bone marrow biopsy (immediately after bone marrow is done, same day as Reiki)</time_frame>
    <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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>salivary cortisol</measure>
    <time_frame>20 minutes post bone marrow biopsy</time_frame>
    <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.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">0</enrollment>
  <condition>Hematologic Malignancy</condition>
  <arm_group>
    <arm_group_label>Reiki Intervention</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <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.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>nursing presence control</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Each patient in the control group will receive usual care including the study nurse presence for the 15-minute period.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Reiki</intervention_name>
    <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.</description>
    <arm_group_label>Reiki Intervention</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients 18 and older admitted to hospital&#xD;
&#xD;
          -  Speak English&#xD;
&#xD;
          -  Able to give consent will be included.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients who are under 18&#xD;
&#xD;
          -  Non-English speaking&#xD;
&#xD;
          -  Unable to consent&#xD;
&#xD;
          -  Pregnant women&#xD;
&#xD;
          -  Unwilling to join the study will be excluded&#xD;
&#xD;
          -  Intensive Care Unit (ICU) patients and those patients scheduled to receive conscious&#xD;
             sedation will be excluded.&#xD;
&#xD;
          -  Each patient may join the pilot study only once&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jennifer Day, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Johns Hopkins University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Johns Hopkins Hospital</name>
      <address>
        <city>Baltimore</city>
        <state>Maryland</state>
        <zip>21287</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>July 2014</verification_date>
  <study_first_submitted>July 29, 2014</study_first_submitted>
  <study_first_submitted_qc>July 31, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 4, 2014</study_first_posted>
  <last_update_submitted>December 19, 2014</last_update_submitted>
  <last_update_submitted_qc>December 19, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">December 23, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hematologic Neoplasms</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02207764
org study id: J1358
secondary id: IRB00026755
nct id: NCT02207764
lead sponsor: 
has dmc: Yes
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.
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.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: None (Open Label)
measure: stress level: patient report
time frame: baseline: prior to Reiki intervention
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.
measure: stress level: patient report
time frame: post intervention: immediately after Reiki
description: Explore effectiveness of Reiki therapy as an adjuvant to conventional therapy in the management of stress and anxiety.
measure: salivary alpha amylase
time frame: baseline
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.
measure: salivary alpha amylase
time frame: post intervention (after Reiki- 15 minutes from baseline)
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.
measure: salivary alpha amylase
time frame: pre bone marrow biopsy (immediately before bone marrow is done, same day as Reiki)
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.
measure: salivary alpha amylase
time frame: post bone marrow biopsy (immediately after bone marrow is done, same day as Reiki)
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.
measure: salivary alpha amylase
time frame: 20 minutes post bone marrow biopsy
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.
measure: salivary cortisol
time frame: baseline
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.
measure: salivary cortisol
time frame: post intervention (after Reiki- 15 minutes from baseline)
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.
measure: salivary cortisol
time frame: pre bone marrow biopsy (immediately before bone marrow is done, same day as Reiki)
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.
measure: salivary cortisol
time frame: post bone marrow biopsy (immediately after bone marrow is done, same day as Reiki)
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.
measure: salivary cortisol
time frame: 20 minutes post bone marrow biopsy
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.
arm group label: Reiki Intervention
arm group type: Experimental
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 group label: nursing presence control
arm group type: No Intervention
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: Reiki
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 group label: Reiki Intervention
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Jennifer Day, PhD
role: Principal Investigator
affiliation: Johns Hopkins University
facility: 
country: United States
responsible party type: Sponsor
mesh term: Hematologic Neoplasms