Healing therapy in a gastroenterology outpatients
| ISRCTN | ISRCTN13039379 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN13039379 |
| Secondary identifying numbers | DSS01 |
- Submission date
- 05/07/2010
- Registration date
- 16/07/2010
- Last edited
- 11/04/2016
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Digestive System
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Sukhdev Singh
Scientific
Scientific
Gastroenterology
Good Hope Hospital
Rectory Road
Sutton Coldfield
Birmingham
B75 7RR
United Kingdom
Study information
| Study design | Pragmatic single-centre randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Quality of life |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | A randomised controlled trial of healing therapy in a gastroenterology outpatient setting |
| Study objectives | 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(s) | The Black Country Research Ethics Committee, 11/06/2010, ref: 10/H1202/36 |
| Health condition(s) or problem(s) studied | 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 |
| Primary outcome measure | 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 study start date | 19/07/2010 |
| Completion date | 01/07/2012 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 200 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 19/07/2010 |
| Date of final enrolment | 01/07/2012 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Good Hope Hospital
Birmingham
B75 7RR
United Kingdom
B75 7RR
United Kingdom
Sponsor information
Heart of England NHS Foundation Trust (UK)
Hospital/treatment centre
Hospital/treatment centre
c/o June DelaRue
Research & Development Directorate
Birmingham Heartlands Hospital
Bordesley Green
Birmingham
B9 5SS
England
United Kingdom
| Website | http://www.heartofengland.nhs.uk/ |
|---|
Funders
Funder type
Government
Big Lottery Fund (UK) (ref: C811A1336)
Private sector organisation / Other non-profit organizations
Private sector organisation / Other non-profit organizations
- Alternative name(s)
- BIG
- Location
- United Kingdom
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Editorial Notes
11/04/2016: No publications found, verifying study status with principal investigator
