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ISRCTN
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ISRCTN13039379
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ClinicalTrials.gov identifier
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Public title
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Healing therapy in a gastroenterology outpatients
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Scientific title
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A randomised controlled trial of healing therapy in a gastroenterology outpatient setting
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Acronym
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N/A
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Serial number at source
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DSS01
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Study hypothesis
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Principle question:
Does healing therapy in addition to usual management impact on symptoms in individuals with irritable bowel syndrome (IBS) and inflammatory bowel disease (IBD, specifically ulcerative colitis), compared to normal management alone?
Secondary question:
Does healing therapy in addition to usual management impact on an individual's quality of life, compared to usual management alone?
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Lay summary
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Ethics approval
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The Black Country Research Ethics Committee approved on the 11th June 2010 (ref: 10/H1202/36)
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Study design
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Pragmatic single centre randomised controlled trial
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Countries of recruitment
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United Kingdom
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Disease/condition/study domain
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Irritable bowel syndrome (IBS), inflammatory bowel disease (IBD), ulcerative colitis
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Participants - inclusion criteria
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1. Over 18 years of age, either sex
2. Attending clinic with a clinician diagnosis of IBS (confirmed by ROME II criteria) or with a clinician diagnosis of ulcerative colitis
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Participants - exclusion criteria
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1. Already receiving healing, Reiki or other similar complementary treatments elsewhere (or having done so in the previous 12 months)
2. Unable to give fully informed consent due to learning disability, mental illness or other reason
3. Pregnant
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Anticipated start date
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19/07/2010
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Anticipated end date
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01/07/2012
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Status of trial
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Ongoing |
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Patient information material
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Not available in web format, please use the contact details below to request a patient information sheet
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Target number of participants
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200
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Interventions
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Obtaining consent and allocation of patients to study arms (1 interview at start of trial lasting 30 minutes):
1. Intervention: healing therapy, patient to attend 5 weekly 30 minute sessions (held in consecutive weeks)
2. Control: waiting list will undergo therapy sessions after 12 weeks
After this questionnaire data (1 baseline; 3 follow-up questionnaires completed each lasting 15 minutes) and qualitative semi-structured interviews (potentially 2 interviews, depending on selection, each lasting 1 hour) will take place.
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Primary outcome measure(s)
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Change in Measure Yourself Medical Outcome Profile (MYMOP) score at week 6 and 12. This well validated individualised patient-centred instrument developed by researchers working in the study of alternative and complementary therapies.
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Secondary outcome measure(s)
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1. Change in disease specific quality of life scores at week 6 and 12. Appropriate disease specific tools will be used for patients with IBS (Irritable Bowel Syndrome Quality of Life Instrument [IBS-QOL]) and IBD (Inflammatory Bowel Disease Questionnaire [IBDQ]) and change in arm assessed for each disease type separately.
2. Change in disease specific symptom scores at weeks 6 and 12 will also be compared using the Birmingham IBS symptom questionnaire and modified version of the Simple Clinical Colitis Activity Index (SCCAI)
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Sources of funding
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Big Lottery Fund (UK) (ref: C811A1336)
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Trial website
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Publications
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Contact name
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Dr
Sukhdev
Singh
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Address
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Gastroenterology
Good Hope Hospital
Rectory Road
Sutton Coldfield
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City/town
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Birmingham
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Zip/Postcode
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B75 7RR
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Country
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United Kingdom
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Sponsor
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Heart of England NHS Foundation Trust (UK)
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Address
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c/o June DelaRue
Research & Development Directorate
Birmingham Heartlands Hospital
Bordesley Green
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City/town
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Birmingham
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Zip/Postcode
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B9 5SS
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Country
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United Kingdom
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Sponsor website:
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http://www.heartofengland.nhs.uk/
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Date applied
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05/07/2010
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Last edited
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16/07/2010
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Date ISRCTN assigned
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16/07/2010
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