Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
DSS01
Study information
Scientific title
A randomised controlled trial of healing therapy in a gastroenterology outpatient setting
Acronym
Study hypothesis
Principal question:
Does healing therapy in addition to usual management impact on symptoms in individuals with irritable bowel syndrome (IBS) and inflammatory bowel disease (IBD), 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?
Ethics approval
The Black Country Research Ethics Committee, 11/06/2010, ref: 10/H1202/36
Study design
Pragmatic single-centre randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Quality of life
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Irritable bowel syndrome (IBS), inflammatory bowel disease (IBD), ulcerative colitis and Crohn's disease
Intervention
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.
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measures
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.
Secondary outcome measures
Current secondary outcome measures as of 20/09/2012:
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) and modified version of the Harvey-Bradshaw Index.
Previous secondary outcome measures until 20/09/2012:
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)
Overall trial start date
19/07/2010
Overall trial end date
01/07/2012
Reason abandoned
Eligibility
Participant inclusion criteria
Current inclusion criteria as of 20/09/2012:
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 or Crohn's disease
Previous inclusion criteria until 20/09/2012:
2. Attending clinic with a clinician diagnosis of IBS (confirmed by ROME II criteria) or with a clinician diagnosis of ulcerative colitis
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
200
Participant exclusion criteria
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
Recruitment start date
19/07/2010
Recruitment end date
01/07/2012
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Good Hope Hospital
Birmingham
B75 7RR
United Kingdom
Sponsor information
Organisation
Heart of England NHS Foundation Trust (UK)
Sponsor details
c/o June DelaRue
Research & Development Directorate
Birmingham Heartlands Hospital
Bordesley Green
Birmingham
B9 5SS
United Kingdom
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
Big Lottery Fund (UK) (ref: C811A1336)
Alternative name(s)
Funding Body Type
private sector organisation
Funding Body Subtype
other non-profit
Location
United Kingdom
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