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The Acceptance of Reiki Therapy as a Complementary and Alternative Option for the Management of Chronic Pain

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ClinicalTrials.gov Identifier: NCT03173872
Recruitment Status : Completed
First Posted : June 2, 2017
Last Update Posted : September 12, 2017
Sponsor:
Information provided by (Responsible Party):
Dr MeLisa Gantt, Landstuhl Regional Medical Center

Brief Summary:

For the past few years, the military has been looking for an innovative way to decrease the use of opioids for chronic pain. This has prompted military treatment facilities to begin integrating complementary and/or alternative medicine modalities into their conventional plans of care. Reiki, a bio-field energy therapy, is one such modality. The purpose of this prospective repeated measure study is to: 1) introduce the concept Reiki therapy to military healthcare beneficiaries experiencing chronic pain, 2) assess pain outcome after receiving six treatments of Reiki therapy, and 3) assess participant's impression of Reiki therapy as a possible complementary and/or alternative option for the management of chronic pain.

Thirty military healthcare beneficiaries with the complaint of chronic pain will receive a brief introduction to Reiki therapy followed by six 30-minute Reiki sessions provided by trained Reiki Level 1 Practitioner. Participant's knowledge of Reiki will be assessed using pre and post questionnaires; pain will be assessed using the Brief Pain Inventory, Defense Veterans Pain Rating Scale, DoD (Department of Defense) VA (Veteran's Administration) Pain Supplementary Questionnaire, McGill Pain Questionnaire and pain medication diaries; and participant's impression will be assessed using the Patient Global Impression of Improvement Scale and along with a post study questionnaire. If it is found that Reiki therapy helped in decreasing chronic pain outcomes, this treatment modality may be added to Landstuhl Regional Medical (LRMC) Pain Clinic's pool of complementary and alternative medicine options.


Condition or disease Intervention/treatment Phase
Pain, Chronic Procedure: Reiki Protocol Hand Placement Procedures Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Intervention Model: Single Group Assignment
Intervention Model Description: A short prospective, exploratory one group study to assess the acceptance of Reiki in 30 military healthcare beneficiaries, by comparing pre and post Reiki intervention measures.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Acceptance of Reiki Therapy as a Complementary and Alternative Option for the Management of Chronic Pain
Actual Study Start Date : April 6, 2017
Actual Primary Completion Date : May 31, 2017
Actual Study Completion Date : May 31, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Chronic Pain

Arm Intervention/treatment
Experimental: One Group Study Arm
One group study arm assesses pre Reiki and post Reiki intervention measures
Procedure: Reiki Protocol Hand Placement Procedures
Ten Reiki hand placement procedures will last 3 minutes each for a total Reiki session lasting 30 minutes long.




Primary Outcome Measures :
  1. Pain Description, Relief and Interference with Daily Life (via Brief Pain Inventory) [ Time Frame: From baseline measure to up to 3 weeks ]
    This instrument assesses the time relation sensory component of pain intensity (average over the last week, worst and least, and present pain) using a numeric rating scale (0 [No pain] to 10 [Pain as bad as you can imagine]), percentage of pain relief (0 [No relief] to 100% [Complete relief]), and 7 pain interferences concerning work, activity, mood, enjoyment, sleep, walk and relationships are assessed using 0-10 numeric scales (0 [No interference] to 10 [Complete interference]).


Secondary Outcome Measures :
  1. Sensory and Affective Pain Perception (via McGill Pain Questionnaire) [ Time Frame: From baseline measure to up to 3 weeks ]
    This instrument is a brief screening tool for pain and has 3 subscales: Sensory (11 word items), Affective (4 word items), and a composite Evaluative score. Fifteen words represent acute, intermittent and chronic pains, and are scored on a four-point Likert-type scale from 0 = none to 3 = severe. A total score of 45 is possible by summing the Sensory and Affective subscales and scoring them separately.

  2. Current Pain Level (Defense and Veteran Pain Rating Scale) [ Time Frame: From baseline measure to up to 3 weeks ]
    A Likert Scale graphic tool to describe one's "current" level of pain. The score ranges from 0 "no pain" to 10 "as bad as it could be nothing else matter". The scale is also colored coated depicting Mild 1-3 (Green), Moderate 4-7 (Yellow) and Severe 8-10 (Red).

  3. Impression of current pain's affect on sleep, mood and stress (via DoD/VA Pain Supplemental Questionnaire) [ Time Frame: From baseline measure to up to 3 weeks ]
    This 4-item Likert Scale instrument is used in conjunction with the Defense and Veteran Pain Rating Scale to measure the biopsychosocial impact of "current" pain level on four areas… activity sleep mood and stress.

  4. Impression of Improvement (via Patient Global Impression of Improvement Scale Questionnaire) Patient Global Impression of Improvement Scale [ Time Frame: At mid-point measure and again at 3 weeks ]
    This instrument consists of a 7-point Likert scale with 1 = "very much improved" to 7 = "very much worse" to capture overall changes related to a study medication or intervention.

  5. Knowledge About Reiki (via Reiki Knowledge Assessment Questionnaire) [ Time Frame: From baseline measure to up to 3 weeks ]
    This 5-item questionnaire to measure the participant's knowledge about Reiki. The instrument asks five of the most commonly missed questions regarding Reiki…the definition, history, credentials of practitioner, origin and usage.

  6. Willingness to inform other about Reiki and to continue treatments (via Reiki Post Study Questionnaire) [ Time Frame: At the conclusion of 3 weeks ]
    This 5-item questionnaire assesses the participant's impression of Reiki, their willingness to tell a family member, friend or co-worker about the therapy; and their thought of Reiki being offered a permanent treatment option at their healthcare facility.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Has chronic pain (defined as pain that lasts 3 months or more since first onset).
  2. Is receiving a stable pain medication regimen (defined as a regimen that has not increased 10% to 20% in the past week prior to enrollment), if on pain medication.
  3. Is affiliated with at least one of the 13 installations within the Kaiserslautern Military Community area
  4. Is eligible to receive healthcare at Landstuhl Regional Medical Center
  5. Is 18 years and older
  6. Can read and speak English
  7. Is able to commit to 6 treatments (approximately 2-3 weeks)

Exclusion Criteria:

  1. Have had surgery or a painful procedure in the last 30 days or are being scheduled for any surgeries or painful procedures during the duration of the study
  2. Already have a working knowledge (e.g., credentialed Reiki Level I, II or III Practitioner or Reiki Master) of Reiki or have had Reiki therapy in the past

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03173872


Locations
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Germany
Landstuhl Regional Medical Center
Landstuhl, Germany, 09018
Sponsors and Collaborators
Landstuhl Regional Medical Center
Investigators
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Principal Investigator: MeLisa A Gantt, PhD Gantt Clinical Research Institute LLC

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Responsible Party: Dr MeLisa Gantt, LTC (Ret.) MeLisa Gantt, Landstuhl Regional Medical Center
ClinicalTrials.gov Identifier: NCT03173872     History of Changes
Other Study ID Numbers: M-10617
First Posted: June 2, 2017    Key Record Dates
Last Update Posted: September 12, 2017
Last Verified: September 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Dr MeLisa Gantt, Landstuhl Regional Medical Center:
Reiki
Chronic Pain
Military

Additional relevant MeSH terms:
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Chronic Pain
Pain
Neurologic Manifestations
Signs and Symptoms