AnxietyNCT02000245
Effects of Sympathy and Touch on Anxiety of Patients Undergoing Fiberoptic Bronchoscopy
A study testing verbal expression for compassion and touch in people with Anxiety, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
The purpose of this study is to evaluate the effect of verbal expression of sympathy and touch on anxiety of patients undergoing fiberoptic bronchoscopy Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Anxiety
- What is being tested?
- verbal expression for compassion and touch
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 267 participants
- Where
- 1 siteSouth Korea
- Study dates
- Oct 2013to Dec 2014
- 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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- adult patients undergoing diagnostic fiberoptic bronchoscopy
- hospitalized patients
Who cannot join
- patients who have undergone fiberoptic bronchoscopy
- not hospitalized patients
- cognitive impairment
- refusal to enroll
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Seoul National University Hospital
Seoul, Seoul, 110-744
About this study
The purpose of this study is to evaluate the effect of verbal expression of sympathy and touch on anxiety of patients undergoing fiberoptic bronchoscopy
- Conditions
- Anxiety
- Being tested
- verbal expression for compassion, touch
- Keywords
- bronchoscopy, anxiety, touch, sympathy
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
verbal expression for compassionBehavioural
The doctor going to perform bronchoscopy tells a short sentence to a patient. (Hello, I'm Dr.OO. During this test, I will keep an eye on you. Don't worry)
touchBehavioural
The doctor going to perform bronchoscopy puts a hand on the patient's shoulder
| Study group | Role | What they receive |
|---|---|---|
| verbal expression for compassion | Active comparator | verbal expression for compassion Receives: Behavioral: verbal expression for compassion |
| verbal expression and touch | Active comparator | verbal expression and touch Receives: Behavioral: verbal expression for compassion; Behavioral: touch |
| control | No intervention | control |
What is being measured
The primary outcome is the main question the study is designed to answer.
change of visual analogue scale (VAS) for anxiety
Measured: baseline (arrival at the test room), and follow-up (at least 10 min after baseline, right before undergoing bronchoscopy
Secondary outcomes (1)
Satisfaction of patients after fiberoptic bronchoscopy
Measured: within 6 hours after bronchoscopy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2013 (estimated)
- Study startOct 2013
- Primary completionDec 2014
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnxietyStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 267 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jae-Joon Yim, Seoul National University Hospital
- Investigators
- Jae-Joon Yim, Principal investigator, Department of Internal Medicine, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02000245
- Sponsor's protocol ID
- STAF
- Other IDs
- 1307-042-504
- Status last verified
- Apr 2016
- First submitted
- 20 Nov 2013
- Last updated
- 20 Apr 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Sympathy and Touch on Anxiety of Patients Undergoing Fiberoptic Bronchoscopy
- ClinicalTrials.gov ID
- NCT02000245
- Acronym / sponsor ID
- STAF
- Conditions
- Anxiety
- Keywords
- bronchoscopy, anxiety, touch, sympathy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 267 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- Oct 2013
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 4 Dec 2013 (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.
The purpose of this study is to evaluate the effect of verbal expression of sympathy and touch on anxiety of patients undergoing fiberoptic bronchoscopy
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| verbal expression for compassion | Active comparator | Behavioral: verbal expression for compassionverbal expression for compassion |
| verbal expression and touch | Active comparator | Behavioral: verbal expression for compassion, Behavioral: touchverbal expression and touch |
| control | No intervention | –control |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- adult patients undergoing diagnostic fiberoptic bronchoscopy
- hospitalized patients
Key exclusion criteria (4 listed)
- patients who have undergone fiberoptic bronchoscopy
- not hospitalized patients
- cognitive impairment
- refusal to enroll
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 |
|---|---|---|
| verbal expression for compassionThe doctor going to perform bronchoscopy tells a short sentence to a patient. (Hello, I'm Dr.OO. During this test, I will keep an eye on you. Don't worry) | Behavioural | verbal expression and touch, verbal expression for compassion |
| touchThe doctor going to perform bronchoscopy puts a hand on the patient's shoulder | Behavioural | verbal expression and touch |
Primary outcome
change of visual analogue scale (VAS) for anxiety
Time frame: baseline (arrival at the test room), and follow-up (at least 10 min after baseline, right before undergoing bronchoscopy
1 secondary outcome
Satisfaction of patients after fiberoptic bronchoscopy
Time frame: within 6 hours after bronchoscopy
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2016.
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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.
Jae-Joon Yim principal investigator
Department of Internal Medicine, Seoul National University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing verbal expression for compassion and touch in people with Anxiety, run by Seoul National University Hospital at 1 site in South Korea.
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: finished, as of the sponsor's last update on 20 Apr 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 visual analogue scale (VAS) for anxiety (time frame: baseline (arrival at the test room), and follow-up (at least 10 min after baseline, right before undergoing bronchoscopy). 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 20 Apr 2016.