Effect of Healing on Rheumatoid Arthritis (RAhealing)
Primary Purpose
Rheumatoid Arthritis
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Healing
Sham healing
Sponsored by
About this trial
This is an interventional health services research trial for Rheumatoid Arthritis
Eligibility Criteria
Inclusion Criteria:
- Patients with rheumatoid arthritis in a stable medication the past 3 months written informed consent
Exclusion Criteria:
- Not able to arrange own transport, language problems
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Sham Comparator
No Intervention
Arm Label
Healing
Sham healing
Control
Arm Description
patients receive healing while blindfolded and with hearing protector. The healer is behind a screen and not allowed to speak with the subject.
Same design of room as with the healing, while in this case a student is behind the screen
Business as usual in the third arm
Outcomes
Primary Outcome Measures
DAS28
Secondary Outcome Measures
Colour Doppler fraction
Full Information
NCT ID
NCT00967395
First Posted
August 26, 2009
Last Updated
January 5, 2012
Sponsor
Henning Bliddal
Collaborators
The IMK Foundation, The Danish Rheumatism Association, Oak Foundation
1. Study Identification
Unique Protocol Identification Number
NCT00967395
Brief Title
Effect of Healing on Rheumatoid Arthritis
Acronym
RAhealing
Official Title
Effect of Healing on Rheumatoid Arthritis: a Three-arm Double-blind, Randomized, Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
January 2012
Overall Recruitment Status
Completed
Study Start Date
January 2008 (undefined)
Primary Completion Date
January 2009 (Actual)
Study Completion Date
September 2009 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Henning Bliddal
Collaborators
The IMK Foundation, The Danish Rheumatism Association, Oak Foundation
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The hypothesis is that healing may influence the patient's general status by altering psychological as well as other body functions of importance for the rheumatoid arthritis. This is tested in a three group design with a control group and two groups receiving healing with or without a healer present. The study is randomized and double blind.
Detailed Description
The central claim of healers is that this process facilitates self-healing in the patient. Spiritual healing includes several categories, including 'therapeutic touch' and 'intercessory prayer', and the healing may be attributed to God, spirits, universal forces or energies, biological healing energies residing in the healer, or self-healing powers or energies thought to reside latent in the healed organism. The highly controversial hypothesized effects of distant or spiritual healing contradict our traditional sense of reality and are in conflict with what is generally viewed as being in correspondence with modern science.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rheumatoid Arthritis
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
90 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Healing
Arm Type
Experimental
Arm Description
patients receive healing while blindfolded and with hearing protector. The healer is behind a screen and not allowed to speak with the subject.
Arm Title
Sham healing
Arm Type
Sham Comparator
Arm Description
Same design of room as with the healing, while in this case a student is behind the screen
Arm Title
Control
Arm Type
No Intervention
Arm Description
Business as usual in the third arm
Intervention Type
Other
Intervention Name(s)
Healing
Other Intervention Name(s)
"active healing"
Intervention Description
Healing in our study is given be a healer "no-touch", who just has to be present in the room.
Intervention Type
Other
Intervention Name(s)
Sham healing
Other Intervention Name(s)
"placebo healing"
Intervention Description
Sham Healing in our study is given be a student "no-touch", who just has to be present in the room.
Primary Outcome Measure Information:
Title
DAS28
Time Frame
8 weeks follow-up
Secondary Outcome Measure Information:
Title
Colour Doppler fraction
Time Frame
8 weeks follow-up
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients with rheumatoid arthritis in a stable medication the past 3 months written informed consent
Exclusion Criteria:
Not able to arrange own transport, language problems
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bente Danneskiold-Samsøe, Professor
Organizational Affiliation
Frederiksberg University Hospital
Official's Role
Study Director
12. IPD Sharing Statement
Learn more about this trial
Effect of Healing on Rheumatoid Arthritis
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