Multimedia Information and Pre-operative Anxiety (MIPA)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2012 by Imperial College London.
Recruitment status was  Not yet recruiting
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 September 22, 2014