Prospective randomised controlled trial to assess the effect of colonoscopy patient information leaflets on patient knowledge and anxiety

ISRCTN ISRCTN51183614
DOI https://doi.org/10.1186/ISRCTN51183614
Protocol serial number N0263107686
Sponsor Department of Health (UK)
Funder University College London Hospitals NHS Trust (UK)
Submission date
12/09/2003
Registration date
12/09/2003
Last edited
07/06/2017
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Surgery
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

Miss C J Vaizey
Scientific

Department of Surgery
Charles Bell House
67-73 Riding House Street
London
W1P 7LD
United Kingdom

Phone +44 (0)20 7636 8333
Email carolynne.vaizey@nwlh.nhs.uk

Study information

Primary study designInterventional
Study designRandomised controlled trial
Secondary study designRandomised controlled trial
Study type Participant information sheet
Scientific titleProspective randomised controlled trial to assess the effect of colonoscopy patient information leaflets on patient knowledge and anxiety
Study objectivesDo patient information leaflets for colonoscopy improve patient knowledge and anxiety scores?
Ethics approval(s)Not provided at time of registration
Health condition(s) or problem(s) studiedSurgery: Colonoscopy
Intervention1. Standard pre-colonoscopy consultation
2. Standard consultation plus an information leaflet
Intervention typeProcedure/Surgery
Primary outcome measure(s)

1. Patient knowledge scores
2. Patient anxiety scores (STAI)
3. Patient satisfaction scores

Key secondary outcome measure(s)

Not provided at time of registration

Completion date01/06/2007

Eligibility

Participant type(s)Patient
Age groupNot Specified
SexNot Specified
Target sample size at registration80
Key inclusion criteriaNot provided at time of registration
Key exclusion criteriaNot provided at time of registration
Date of first enrolment01/06/2001
Date of final enrolment01/06/2007

Locations

Countries of recruitment

  • United Kingdom
  • England

Study participating centre

Department of Surgery
London
W1P 7LD
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot 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

MW 07/06/2017: No publications found, study status unverified