Clinical trial NCT03173872: 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
Overall status: COMPLETED
Phase: NA
Conditions: Pain, Chronic
Keywords: Reiki
Chronic Pain
Military
Lead sponsor: Landstuhl Regional Medical Center
Sponsor class: FED
First posted: 2017-06-02
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
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.
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: Pain Description, Relief and Interference with Daily Life (via Brief Pain Inventory)
timeFrame: From baseline measure to up to 3 weeks
Secondary outcomes:
measure: Sensory and Affective Pain Perception (via McGill Pain Questionnaire)
timeFrame: From baseline measure to up to 3 weeks
measure: Current Pain Level (Defense and Veteran Pain Rating Scale)
timeFrame: From baseline measure to up to 3 weeks
measure: Impression of current pain's affect on sleep, mood and stress (via DoD/VA Pain Supplemental Questionnaire)
timeFrame: From baseline measure to up to 3 weeks
measure: Impression of Improvement (via Patient Global Impression of Improvement Scale Questionnaire) Patient Global Impression of Improvement Scale
timeFrame: At mid-point measure and again at 3 weeks
measure: Knowledge About Reiki (via Reiki Knowledge Assessment Questionnaire)
timeFrame: From baseline measure to up to 3 weeks
measure: Willingness to inform other about Reiki and to continue treatments (via Reiki Post Study Questionnaire)
timeFrame: At the conclusion of 3 weeks
Other outcomes:
Locations:
city: Landstuhl
country: Germany
facility: Landstuhl Regional Medical Center
Study officials:
affiliation: Gantt Clinical Research Institute LLC
name: MeLisa A Gantt, PhD
role: PRINCIPAL_INVESTIGATOR
References: