Multimedia Information and Pre-operative Anxiety (MIPA)
This study is not yet open for participant recruitment.
Verified June 2012 by Imperial College London
Sponsor:
Imperial College London
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
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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 May 21, 2013