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

Primary Purpose

Pain, Chronic

Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Reiki Protocol Hand Placement Procedures
Sponsored by
Landstuhl Regional Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pain, Chronic focused on measuring Reiki, Chronic Pain, Military

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Landstuhl Regional Medical Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

One Group Study Arm

Arm Description

One group study arm assesses pre Reiki and post Reiki intervention measures

Outcomes

Primary Outcome Measures

Pain Description, Relief and Interference with Daily Life (via Brief Pain Inventory)
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

Sensory and Affective Pain Perception (via McGill Pain Questionnaire)
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.
Current Pain Level (Defense and Veteran Pain Rating Scale)
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).
Impression of current pain's affect on sleep, mood and stress (via DoD/VA Pain Supplemental Questionnaire)
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.
Impression of Improvement (via Patient Global Impression of Improvement Scale Questionnaire) Patient Global Impression of Improvement Scale
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.
Knowledge About Reiki (via Reiki Knowledge Assessment Questionnaire)
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.
Willingness to inform other about Reiki and to continue treatments (via Reiki Post Study Questionnaire)
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.

Full Information

First Posted
April 17, 2017
Last Updated
September 9, 2017
Sponsor
Landstuhl Regional Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT03173872
Brief Title
The Acceptance of Reiki Therapy as a Complementary and Alternative Option for the Management of Chronic Pain
Official Title
The Acceptance of Reiki Therapy as a Complementary and Alternative Option for the Management of Chronic Pain
Study Type
Interventional

2. Study Status

Record Verification Date
September 2017
Overall Recruitment Status
Completed
Study Start Date
April 6, 2017 (Actual)
Primary Completion Date
May 31, 2017 (Actual)
Study Completion Date
May 31, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Landstuhl Regional Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Chronic
Keywords
Reiki, Chronic Pain, Military

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
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)
Allocation
N/A
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
One Group Study Arm
Arm Type
Experimental
Arm Description
One group study arm assesses pre Reiki and post Reiki intervention measures
Intervention Type
Procedure
Intervention Name(s)
Reiki Protocol Hand Placement Procedures
Intervention Description
Ten Reiki hand placement procedures will last 3 minutes each for a total Reiki session lasting 30 minutes long.
Primary Outcome Measure Information:
Title
Pain Description, Relief and Interference with Daily Life (via Brief Pain Inventory)
Description
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]).
Time Frame
From baseline measure to up to 3 weeks
Secondary Outcome Measure Information:
Title
Sensory and Affective Pain Perception (via McGill Pain Questionnaire)
Description
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.
Time Frame
From baseline measure to up to 3 weeks
Title
Current Pain Level (Defense and Veteran Pain Rating Scale)
Description
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).
Time Frame
From baseline measure to up to 3 weeks
Title
Impression of current pain's affect on sleep, mood and stress (via DoD/VA Pain Supplemental Questionnaire)
Description
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.
Time Frame
From baseline measure to up to 3 weeks
Title
Impression of Improvement (via Patient Global Impression of Improvement Scale Questionnaire) Patient Global Impression of Improvement Scale
Description
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.
Time Frame
At mid-point measure and again at 3 weeks
Title
Knowledge About Reiki (via Reiki Knowledge Assessment Questionnaire)
Description
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.
Time Frame
From baseline measure to up to 3 weeks
Title
Willingness to inform other about Reiki and to continue treatments (via Reiki Post Study Questionnaire)
Description
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.
Time Frame
At the conclusion of 3 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Has chronic pain (defined as pain that lasts 3 months or more since first onset). 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. Is affiliated with at least one of the 13 installations within the Kaiserslautern Military Community area Is eligible to receive healthcare at Landstuhl Regional Medical Center Is 18 years and older Can read and speak English Is able to commit to 6 treatments (approximately 2-3 weeks) Exclusion Criteria: 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 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
MeLisa A Gantt, PhD
Organizational Affiliation
Gantt Clinical Research Institute LLC
Official's Role
Principal Investigator
Facility Information:
Facility Name
Landstuhl Regional Medical Center
City
Landstuhl
ZIP/Postal Code
09018
Country
Germany

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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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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