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Healing therapy in a gastroenterology outpatients

A randomised controlled trial of healing therapy in a gastroenterology outpatient setting

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN13039379
Enrollment
200
Registered
2010-07-16
Start date
2010-07-19
Completion date
Unknown
Last updated
2016-10-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Irritable bowel syndrome (IBS), inflammatory bowel disease (IBD), ulcerative colitis and Crohn's disease Digestive System Irritable bowel syndrome

Interventions

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
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.

Sponsors

Heart of England NHS Foundation Trust (UK)
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
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)

Countries

United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026