Colorectal CancerNCT02873455
Effects of Video Information on Preoperative Anxiety in Patients With Colorectal Cancer
A study testing Short video clip including the circumstance of operation theater, and surgeon's interview in people with Colorectal Cancer and Video Information, run by Seoul National University Hospital.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 75 years
- Conditions the study is for
- Colorectal Cancer, Video Information
- What is being tested?
- Short video clip including the circumstance of operation theater, and surgeon's interview
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- No sites listed yet
- Study dates
- Aug 2016to Dec 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age: 20-75
- Elective surgery
Who cannot join
- History of previous any surgery
- emergency surgery
- dementia
- psychological disease
About this study
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.
- Conditions
- Colorectal Cancer, Video Information
- Being tested
- Short video clip including the circumstance of operation theater, and surgeon's interview
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Short video clip including the circumstance of operation theater, and surgeon's interviewOther
| Study group | Role | What they receive |
|---|---|---|
| watching video | Experimental | Short video clip including the circumstance of operation theater, and surgeon's interview Receives: Other: Short video clip including the circumstance of operation theater, and surgeon's interview |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of APAIS ((Amsterdam preoperative anxiety and information scale) from baseline APAIS to watching video.
Measured: baseline and 1 minute after watching video.
Secondary outcomes (2)
Change of HADS (Hospital Anxiety and Depression Scale) from baseline HADS to watching video.
Measured: baseline and 1 minute after watching video.
Postoperative hospital stay
Measured: through study completion and an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2016 (estimated)
- Study startAug 2016
- Primary completionMay 2017 (estimated)
- Study completionDec 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 32 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Heung-Kwon Oh, Seoul National University Bundang Hospital
- Investigators
- Heung-Kwon Oh, MS, Principal investigator, Seoul National University Bundang Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02873455
- Sponsor's protocol ID
- B-1608-359-302
- Status last verified
- Apr 2017
- First submitted
- 9 Aug 2016
- Last updated
- 26 Apr 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 26 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Video Information on Preoperative Anxiety in Patients With Colorectal Cancer
- ClinicalTrials.gov ID
- NCT02873455
- Acronym / sponsor ID
- B-1608-359-302
- Conditions
- Colorectal Cancer, Video Information
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 32 participants (estimated)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- Aug 2016
- Primary completion
- May 2017 (estimated)
- Study completion
- Dec 2017 (estimated)
- First posted
- 19 Aug 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| watching video | Experimental | Other: Short video clip including the circumstance of operation theater, and surgeon's interviewShort video clip including the circumstance of operation theater, and surgeon's interview |
Who may qualify
- Ages
- 20 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age: 20-75
- Elective surgery
Key exclusion criteria (4 listed)
- History of previous any surgery
- emergency surgery
- dementia
- psychological disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Short video clip including the circumstance of operation theater, and surgeon's interview | Other | watching video |
Primary outcome
Change of APAIS ((Amsterdam preoperative anxiety and information scale) from baseline APAIS to watching video.
Time frame: baseline and 1 minute after watching video.
2 secondary outcomes
Change of HADS (Hospital Anxiety and Depression Scale) from baseline HADS to watching video.
Time frame: baseline and 1 minute after watching video.
Postoperative hospital stay
Time frame: through study completion and an average of 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Apr 2017.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Heung-Kwon Oh, MS principal investigator
Seoul National University Bundang Hospital
Questions about this trial
What is this clinical trial studying?
A study testing Short video clip including the circumstance of operation theater, and surgeon's interview in people with Colorectal Cancer and Video Information, run by Seoul National University Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of APAIS ((Amsterdam preoperative anxiety and information scale) from baseline APAIS to watching video. (time frame: baseline and 1 minute after watching video.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Apr 2017.