Condition category
Skin and Connective Tissue Diseases
Date applied
05/10/2007
Date assigned
19/12/2007
Last edited
08/04/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Tessa Frost

ORCID ID

Contact details

Dermatology Department
Torbay Hospital
Lawes Bridge
Torquay
TQ2 7AA
United Kingdom
+44 1803 654 869
tessa.frost@nhs.net

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

RAP study 2007

Study information

Scientific title

A randomised controlled pilot study to assess the benefit of using Reiki to treat chronic plaque psoriasis

Acronym

RAP

Study hypothesis

That the use of Reiki healing treament of moderate to severe psoriasis is measurably effective and the same results are able to be reproduced by any Reiki II practitioner.

Ethics approval

Ethics approval received from the Devon and Torbay Research Ethics Committee (REC) on the 4th October 2007 (ref: 07/H0202/108).

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Condition

Chronic plaque psoriasis

Intervention

Arm A: conventional topical treatment (as per current local practice may include the following: emollients, vitamin D creams and ointments [calcipotriol etc.], tar preparations [Alphosyl and Exorex] and topical steroids or combinations of the above - applied twice daily as per instructions per standard practice, dependant on the topical treatment of choice) and five Reiki treatments given over a 3 month period.

Arm B: five consecutive reiki treatments only over 3 months but advised to continue using moisturisers.

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

1. Physical Assessment: using the Psoriasis Area and Severity Index (PASI) assessment tool, validated by photographic evidence
2. Quality of Life Assessments with Dermatology Life Quality Index (DLQI) to show to which degree the psoriasis affects the patient's normal activities
3. Psychological assessment (12-item General Health Questionnaire [GHQ12]) to show if there has been any general improvement in the quality of life, regardless of the state of psoriasis
4. Health Economics Assessment

Secondary outcome measures

1. The Healing Assessment (HA) 1.1 will identify any possible trends in psychological triggers
2. The Healing Assessment (HA) 2.1 will be used to assess the relevance of any unusual experiences during treatment and to note the areas of the body which the healer feels may require extra attention

Overall trial start date

15/10/2007

Overall trial end date

30/09/2009

Reason abandoned

Eligibility

Participant inclusion criteria

1. Patients who suffer from stable chronic plaque psoriasis that would be appropriate for treatment by topical agents
2. Informed consent
3. Adults aged 18 years or over, male or female

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

30

Participant exclusion criteria

1. Pregnant women
2. Patients with severe disease
3. Patients with unstable psoriasis and putular psoriasis
4. Patients who have already experienced healing
5. Unable to give informed consent

Recruitment start date

15/10/2007

Recruitment end date

30/09/2009

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Dermatology Department
Torquay
TQ2 7AA
United Kingdom

Sponsor information

Organisation

South Devon Healthcare NHS Foundation Trust (UK)

Sponsor details

Torbay Hospital
Lawes Bridge
Torquay
TQ2 7AA
United Kingdom
+44 1803 656635
sdhct.research@nhs.net

Sponsor type

Government

Website

http://www.sdhct.nhs.uk/

Funders

Funder type

Charity

Funder name

Newton Abbott Hospital League of Friends (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes

08/04/2016: No publications found, verifying study status with principal investigator