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Effects of Video Information on Preoperative Anxiety in Patients With Colorectal Cancer

Primary Purpose

Colorectal Cancer, Video Information

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Short video clip including the circumstance of operation theater, and surgeon's interview
Sponsored by
Seoul National University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Colorectal Cancer

Eligibility Criteria

20 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Age: 20-75
  • Elective surgery

Exclusion Criteria:

  • History of previous any surgery
  • emergency surgery
  • dementia
  • psychological disease

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    watching video

    Arm Description

    Short video clip including the circumstance of operation theater, and surgeon's interview

    Outcomes

    Primary Outcome Measures

    Change of APAIS ((Amsterdam preoperative anxiety and information scale) from baseline APAIS to watching video.

    Secondary Outcome Measures

    Change of HADS (Hospital Anxiety and Depression Scale) from baseline HADS to watching video.
    Postoperative hospital stay

    Full Information

    First Posted
    August 9, 2016
    Last Updated
    April 24, 2017
    Sponsor
    Seoul National University Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02873455
    Brief Title
    Effects of Video Information on Preoperative Anxiety in Patients With Colorectal Cancer
    Official Title
    Effects of Video Information on Preoperative Anxiety in Patients With Colorectal Cancer
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2017
    Overall Recruitment Status
    Unknown status
    Study Start Date
    August 2016 (undefined)
    Primary Completion Date
    May 2017 (Anticipated)
    Study Completion Date
    December 2017 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Seoul National University Hospital

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    Patient's anxiety prior to surgery has been linked to more harmful outcome after surgery. The investigators aim to evaluate the effect of video information on preoperative anxiety level in patients with colorectal cancer.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Colorectal Cancer, Video Information

    7. Study Design

    Primary Purpose
    Supportive Care
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    32 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    watching video
    Arm Type
    Experimental
    Arm Description
    Short video clip including the circumstance of operation theater, and surgeon's interview
    Intervention Type
    Other
    Intervention Name(s)
    Short video clip including the circumstance of operation theater, and surgeon's interview
    Primary Outcome Measure Information:
    Title
    Change of APAIS ((Amsterdam preoperative anxiety and information scale) from baseline APAIS to watching video.
    Time Frame
    baseline and 1 minute after watching video.
    Secondary Outcome Measure Information:
    Title
    Change of HADS (Hospital Anxiety and Depression Scale) from baseline HADS to watching video.
    Time Frame
    baseline and 1 minute after watching video.
    Title
    Postoperative hospital stay
    Time Frame
    through study completion and an average of 1 year

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    20 Years
    Maximum Age & Unit of Time
    75 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Age: 20-75 Elective surgery Exclusion Criteria: History of previous any surgery emergency surgery dementia psychological disease
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Heung-Kwon Oh, MS
    Organizational Affiliation
    Seoul National University Bundang Hospital
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided

    Learn more about this trial

    Effects of Video Information on Preoperative Anxiety in Patients With Colorectal Cancer

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