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

NCT03173872 | Completed

• 1 other identifier: M-10617
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Pain, Chronic

Keywords

Reiki; Chronic Pain; Military

Outcome Measures

Primary Outcomes (1)

• 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 \[Complete interference\]).

  From baseline measure to up to 3 weeks

Secondary Outcomes (6)

• Sensory and Affective Pain Perception (via McGill Pain Questionnaire)

  From baseline measure to up to 3 weeks

• Current Pain Level (Defense and Veteran Pain Rating Scale)

  From baseline measure to up to 3 weeks

• Impression of current pain's affect on sleep, mood and stress (via DoD/VA Pain Supplemental Questionnaire)

  From baseline measure to up to 3 weeks

• Impression of Improvement (via Patient Global Impression of Improvement Scale Questionnaire) Patient Global Impression of Improvement Scale

  At mid-point measure and again at 3 weeks

• Knowledge About Reiki (via Reiki Knowledge Assessment Questionnaire)

  From baseline measure to up to 3 weeks

Study Arms (1)

One Group Study Arm

EXPERIMENTAL

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

Procedure: Reiki Protocol Hand Placement Procedures

Interventions

Reiki Protocol Hand Placement Procedures PROCEDURE

Ten Reiki hand placement procedures will last 3 minutes each for a total Reiki session lasting 30 minutes long.

One Group Study Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Landstuhl Regional Medical Center: lead

Study Sites (1)

Landstuhl Regional Medical Center

Landstuhl, 09018, Germany

Location

MeSH Terms

Conditions

Chronic Pain

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• MeLisa A Gantt, PhD

  Gantt Clinical Research Institute LLC

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: FED
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: LTC (Ret.) MeLisa Gantt

Model Details: 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.

Study Record Dates

• First Submitted: April 17, 2017
• First Posted: June 2, 2017
• Study Start: April 6, 2017
• Primary Completion: May 31, 2017
• Study Completion: May 31, 2017
• Last Updated: September 12, 2017

Record last verified: 2017-09

Locations

DE (1)