NCT01621828

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable anxiety

Timeline
Completed

Started Jul 2012

Shorter than P25 for not_applicable anxiety

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 14, 2012

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 18, 2012

Completed
13 days until next milestone

Study Start

First participant enrolled

July 1, 2012

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2012

Completed
Last Updated

August 22, 2023

Status Verified

August 1, 2023

Enrollment Period

1 month

First QC Date

June 14, 2012

Last Update Submit

August 21, 2023

Conditions

Keywords

pre-operative anxietymultimedia informationoperating theatre

Outcome Measures

Primary Outcomes (1)

  • 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.

    two months

Study Arms (2)

video

OTHER

video showing a patient's pathway into the operating room.

Other: video

leaflet

OTHER

a written leaflet, about the operating room experience and environment.

Other: leaflet

Interventions

videoOTHER

a video, showing the patient pathway to and from the Operating Theatre, about the operating room experience and environment.

Also known as: operating room video
video
leafletOTHER

a written leaflet, about the operating room experience and environment.

Also known as: operating room leaflet
leaflet

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Imperial College Healthcare NHS Trust Charing Cross Hospital

London, w6 8RF, United Kingdom

Location

MeSH Terms

Conditions

Anxiety Disorders

Interventions

Videotape Recording

Condition Hierarchy (Ancestors)

Mental Disorders

Intervention Hierarchy (Ancestors)

Tape RecordingAudiovisual AidsEducational TechnologyTechnologyTechnology, Industry, and AgricultureTelevision

Study Officials

  • Valeria Silvestre

    Imperial College London

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 14, 2012

First Posted

June 18, 2012

Study Start

July 1, 2012

Primary Completion

August 1, 2012

Study Completion

August 1, 2012

Last Updated

August 22, 2023

Record last verified: 2023-08

Locations