Condition category
Digestive System
Date applied
05/07/2010
Date assigned
16/07/2010
Last edited
11/04/2016
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Sukhdev Singh

ORCID ID

Contact details

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

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

http://www.heartofengland.nhs.uk/

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

Publication citations

Additional files

Editorial Notes

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