Back to resultsMultimedia Information and Pre-operative Anxiety (MIPA)
Primary Purpose
Anxiety
Status
Terminated
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
video
leaflet
Sponsored by
About this trial
This is an interventional supportive care trial for Anxiety focused on measuring pre-operative anxiety, multimedia information, operating theatre
Eligibility 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).
Sites / Locations
- Imperial College Healthcare NHS Trust Charing Cross Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
video
leaflet
Arm Description
video showing a patient's pathway into the operating room.
a written leaflet, about the operating room experience and environment.
Outcomes
Primary Outcome Measures
pre-operative anxiety
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.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01621828
Brief Title
Multimedia Information and Pre-operative Anxiety
Acronym
MIPA
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 Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Terminated
Study Start Date
July 2012 (undefined)
Primary Completion Date
August 2012 (Actual)
Study Completion Date
August 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Imperial College London
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anxiety
Keywords
pre-operative anxiety, multimedia information, operating theatre
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
50 (Actual)
8. Arms, Groups, and Interventions
Arm Title
video
Arm Type
Other
Arm Description
video showing a patient's pathway into the operating room.
Arm Title
leaflet
Arm Type
Other
Arm Description
a written leaflet, about the operating room experience and environment.
Intervention Type
Other
Intervention Name(s)
video
Other Intervention Name(s)
operating room video
Intervention Description
a video, showing the patient pathway to and from the Operating Theatre, about the operating room experience and environment.
Intervention Type
Other
Intervention Name(s)
leaflet
Other Intervention Name(s)
operating room leaflet
Intervention Description
a written leaflet, about the operating room experience and environment.
Primary Outcome Measure Information:
Title
pre-operative anxiety
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.
Time Frame
two months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility 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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Valeria Silvestre
Organizational Affiliation
Imperial College London
Official's Role
Principal Investigator
Facility Information:
Facility Name
Imperial College Healthcare NHS Trust Charing Cross Hospital
City
London
ZIP/Postal Code
w6 8RF
Country
United Kingdom
12. IPD Sharing Statement
Learn more about this trial
Multimedia Information and Pre-operative Anxiety
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