NCT02000245

Brief 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

Trial Health

87
On Track

Trial Health Score

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

Enrollment
267

participants targeted

Target at P75+ for not_applicable anxiety

Timeline
Completed

Started Oct 2013

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2013

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

November 20, 2013

Completed
14 days until next milestone

First Posted

Study publicly available on registry

December 4, 2013

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
Last Updated

April 20, 2016

Status Verified

April 1, 2016

Enrollment Period

1.2 years

First QC Date

November 20, 2013

Last Update Submit

April 18, 2016

Conditions

Anxiety

Keywords

bronchoscopyanxietytouchsympathy

Outcome Measures

Primary Outcomes (1)

  • change of visual analogue scale (VAS) for anxiety

    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

    within 6 hours after bronchoscopy

Study Arms (3)

verbal expression for compassion

ACTIVE COMPARATOR

verbal expression for compassion

Behavioral: verbal expression for compassion

verbal expression and touch

ACTIVE COMPARATOR

verbal expression and touch

Behavioral: verbal expression for compassionBehavioral: touch

control

NO INTERVENTION

control

Interventions

verbal expression for compassionBEHAVIORAL

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)

verbal expression and touchverbal expression for compassion
touchBEHAVIORAL

The doctor going to perform bronchoscopy puts a hand on the patient's shoulder

verbal expression and touch

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • adult patients undergoing diagnostic fiberoptic bronchoscopy
  • hospitalized patients

You may not qualify if:

  • patients who have undergone fiberoptic bronchoscopy
  • not hospitalized patients
  • cognitive impairment
  • refusal to enroll

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul National University Hospital

Seoul, Seoul, 110-744, South Korea

Location

MeSH Terms

Conditions

Anxiety Disorders

Interventions

Touch

Condition Hierarchy (Ancestors)

Mental Disorders

Intervention Hierarchy (Ancestors)

SensationNervous System Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Jae-Joon Yim

    Department of Internal Medicine, Seoul National University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

November 20, 2013

First Posted

December 4, 2013

Study Start

October 1, 2013

Primary Completion

December 1, 2014

Study Completion

December 1, 2014

Last Updated

April 20, 2016

Record last verified: 2016-04

Locations

KR(1)