Healing therapy in a gastroenterology outpatients

ISRCTN	ISRCTN13039379
DOI	https://doi.org/10.1186/ISRCTN13039379
Protocol serial number	DSS01
Sponsor	Heart of England NHS Foundation Trust (UK)
Funder	Big Lottery Fund (UK) (ref: C811A1336)

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

Gastroenterology
Good Hope Hospital
Rectory Road
Sutton Coldfield
Birmingham
B75 7RR
United Kingdom

Study information

Primary study design	Interventional
Study design	Pragmatic single-centre randomised controlled trial
Secondary study design	Randomised controlled trial
Study type	Participant 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(s)	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.
Key secondary outcome measure(s)	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)
Completion date	01/07/2012

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	All
Target sample size at registration	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

United Kingdom
England

Study participating centre

Good Hope Hospital

Birmingham
B75 7RR
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes

Editorial Notes

11/04/2016: No publications found, verifying study status with principal investigator