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Multimedia Information and Pre-operative Anxiety (MIPA)

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ClinicalTrials.gov Identifier: NCT01621828
Recruitment Status : Unknown
Verified June 2012 by Imperial College London.
Recruitment status was:  Not yet recruiting
First Posted : June 18, 2012
Last Update Posted : June 18, 2012
Sponsor:
Information provided by (Responsible Party):
Imperial College London

Brief Summary:
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 or disease Intervention/treatment Phase
Anxiety Other: video Other: leaflet Not Applicable

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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
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
Study Start Date : July 2012
Estimated Primary Completion Date : August 2012
Estimated Study Completion Date : August 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety
U.S. FDA Resources

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. pre-operative anxiety [ Time Frame: two months ]
    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.



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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Imperial College London
ClinicalTrials.gov Identifier: NCT01621828     History of Changes
Other Study ID Numbers: CRO1879
First Posted: June 18, 2012    Key Record Dates
Last Update Posted: June 18, 2012
Last Verified: June 2012

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

Additional relevant MeSH terms:
Anxiety Disorders
Mental Disorders