Multimedia Information and Pre-operative Anxiety (MIPA)

This study is not yet open for participant recruitment.
Verified June 2012 by Imperial College London
Sponsor:
Information provided by (Responsible Party):
Imperial College London
ClinicalTrials.gov Identifier:
NCT01621828
First received: June 14, 2012
Last updated: June 15, 2012
Last verified: June 2012
  Purpose

The aim of this study is to investigate a possible reduction in pre-operative anxiety in patients undergoing major elective surgery, by providing multimedia information regarding the patient pathway to and from the Operating Theatre.


Condition Intervention
Anxiety
Other: video
Other: leaflet

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Supportive Care
Official Title: A Prospective Randomised Controlled Trial of the Impact of Multimedia Information to Reduce Pre-operative Anxiety in Patients Undergoing Major Elective Surgery

Resource links provided by NLM:


Further study details as provided by Imperial College London:

Primary Outcome Measures:
  • pre-operative anxiety [ Time Frame: two months ] [ Designated as safety issue: No ]
    To determine whether multimedia information reduces the level of pre-operative anxiety in patients undergoing major elective surgery. To evaluate the efficacy of a video, showing the patient pathway to and from the Operating Theatre, compared with standard information, a written leaflet, about the operating room experience and environment.


Estimated Enrollment: 50
Study Start Date: July 2012
Estimated Study Completion Date: August 2012
Estimated Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
video
video showing a patient's pathway into the operating room.
Other: video
a video, showing the patient pathway to and from the Operating Theatre, about the operating room experience and environment.
Other Name: operating room video
leaflet
a written leaflet, about the operating room experience and environment.
Other: leaflet
a written leaflet, about the operating room experience and environment.
Other Name: operating room leaflet

Detailed Description:

To determine whether multimedia information reduces the level of pre-operative anxiety in patients undergoing major elective surgery. To evaluate the efficacy of a video, showing the patient pathway to and from the Operating Theatre, compared with standard information, a written leaflet, about the operating room experience and environment.

  Eligibility

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Adult patients undergoing major elective surgery, never previously undergoing surgery as an adult (>18) and admitted to hospital at least one day before the scheduled surgery.

Exclusion Criteria:

  • Patients unable to give consent.
  • Patients not able to watch the video.
  • Patients admitted the same day of the planned surgery.
  • Patients not at the first experience of surgery as an adult (>18).
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01621828

Contacts
Contact: Valeria Silvestre valeria.silvestre10@imperial.ac.uk

Locations
United Kingdom
Imperial College Healthcare NHS Trust Charing Cross Hospital Not yet recruiting
London, United Kingdom, w6 8RF
Principal Investigator: Valeria Silvestre         
Sponsors and Collaborators
Imperial College London
Investigators
Principal Investigator: Valeria Silvestre Imperial College London
  More Information

No publications provided

Responsible Party: Imperial College London
ClinicalTrials.gov Identifier: NCT01621828     History of Changes
Other Study ID Numbers: CRO1879
Study First Received: June 14, 2012
Last Updated: June 15, 2012
Health Authority: United Kingdom: Research Ethics Committee
United Kingdom: National Health Service

Keywords provided by Imperial College London:
pre-operative anxiety
multimedia information
operating theatre

Additional relevant MeSH terms:
Anxiety Disorders
Mental Disorders

ClinicalTrials.gov processed this record on April 17, 2014