Pain, ChronicNCT03173872
The Acceptance of Reiki Therapy as a Complementary and Alternative Option for the Management of Chronic Pain
A study testing Reiki Protocol Hand Placement Procedures in people with Pain, Chronic, run by Landstuhl Regional Medical Center at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Pain, Chronic
- What is being tested?
- Reiki Protocol Hand Placement Procedures
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteGermany
- Study dates
- 6 Apr 2017to 31 May 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
- Being tested
- Reiki Protocol Hand Placement Procedures
- Keywords
- Reiki, Chronic Pain, Military
- Medical subject headings
- Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Reiki Protocol Hand Placement ProceduresProcedure or surgery
Ten Reiki hand placement procedures will last 3 minutes each for a total Reiki session lasting 30 minutes long.
| Study group | Role | What they receive |
|---|---|---|
| One Group Study Arm | Experimental | One group study arm assesses pre Reiki and post Reiki intervention measures Receives: Procedure: Reiki Protocol Hand Placement Procedures |
What is being measured
The primary outcome is the main question the study is designed to answer.
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]).
Measured: From baseline measure to up to 3 weeks
Secondary outcomes (6)
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.
Measured: From baseline measure to up to 3 weeks
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).
Measured: 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)
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.
Measured: 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
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.
Measured: At mid-point measure and again at 3 weeks
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.
Measured: From baseline measure to up to 3 weeks
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.
Measured: At the conclusion of 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2017
- Study start6 Apr 2017
- Primary completion31 May 2017
- Study completion31 May 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain, ChronicStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- 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)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Landstuhl Regional Medical Center
- Sponsor type
- US federal agency
- Responsible party
- Principal investigator, Dr MeLisa Gantt, Landstuhl Regional Medical Center
- Investigators
- MeLisa A Gantt, PhD, Principal investigator, Gantt Clinical Research Institute LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03173872
- Sponsor's protocol ID
- M-10617
- Status last verified
- Sep 2017
- First submitted
- 17 Apr 2017
- Last updated
- 12 Sep 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 12 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Acceptance of Reiki Therapy as a Complementary and Alternative Option for the Management of Chronic Pain
- ClinicalTrials.gov ID
- NCT03173872
- Acronym / sponsor ID
- M-10617
- Conditions
- Pain, Chronic
- Keywords
- Reiki, Chronic Pain, Military
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Landstuhl Regional Medical CenterUS federal agency
- Study start
- 6 Apr 2017 (actual)
- Primary completion
- 31 May 2017 (actual)
- Study completion
- 31 May 2017 (actual)
- First posted
- 2 Jun 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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.
| Arm | Type | Receives |
|---|---|---|
| One Group Study Arm | Experimental | Procedure: Reiki Protocol Hand Placement ProceduresOne group study arm assesses pre Reiki and post Reiki intervention measures |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Reiki Protocol Hand Placement ProceduresTen Reiki hand placement procedures will last 3 minutes each for a total Reiki session lasting 30 minutes long. | Procedure or surgery | One Group Study Arm |
Primary outcome
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]).
6 secondary outcomes
Sensory and Affective Pain Perception (via McGill Pain Questionnaire)
Time frame: From baseline measure to up to 3 weeks
Current Pain Level (Defense and Veteran Pain Rating Scale)
Time frame: 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)
Time frame: 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
Time frame: At mid-point measure and again at 3 weeks
Knowledge About Reiki (via Reiki Knowledge Assessment Questionnaire)
Time frame: From baseline measure to up to 3 weeks
Willingness to inform other about Reiki and to continue treatments (via Reiki Post Study Questionnaire)
Time frame: At the conclusion of 3 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Sep 2017.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
MeLisa A Gantt, PhD principal investigator
Gantt Clinical Research Institute LLC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Reiki Protocol Hand Placement Procedures in people with Pain, Chronic, run by Landstuhl Regional Medical Center at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Sep 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain Description, Relief and Interference with Daily Life (via Brief Pain Inventory) (time frame: From baseline measure to up to 3 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Sep 2017.