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Effects of Sympathy and Touch on Anxiety of Patients Undergoing Fiberoptic Bronchoscopy

Primary Purpose

Anxiety

Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
verbal expression for compassion
touch
Sponsored by
Seoul National University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Anxiety focused on measuring bronchoscopy, anxiety, touch, sympathy

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • adult patients undergoing diagnostic fiberoptic bronchoscopy
  • hospitalized patients

Exclusion Criteria:

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

Sites / Locations

  • Seoul National University Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

No Intervention

Arm Label

verbal expression for compassion

verbal expression and touch

control

Arm Description

verbal expression for compassion

verbal expression and touch

control

Outcomes

Primary Outcome Measures

change of visual analogue scale (VAS) for anxiety

Secondary Outcome Measures

Satisfaction of patients after fiberoptic bronchoscopy

Full Information

First Posted
November 20, 2013
Last Updated
April 18, 2016
Sponsor
Seoul National University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02000245
Brief Title
Effects of Sympathy and Touch on Anxiety of Patients Undergoing Fiberoptic Bronchoscopy
Official Title
Effects of Sympathy and Touch on Anxiety of Patients Undergoing Fiberoptic Bronchoscopy
Study Type
Interventional

2. Study Status

Record Verification Date
April 2016
Overall Recruitment Status
Completed
Study Start Date
October 2013 (undefined)
Primary Completion Date
December 2014 (Actual)
Study Completion Date
December 2014 (Actual)

3. Sponsor/Collaborators

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

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anxiety
Keywords
bronchoscopy, anxiety, touch, sympathy

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
267 (Actual)

8. Arms, Groups, and Interventions

Arm Title
verbal expression for compassion
Arm Type
Active Comparator
Arm Description
verbal expression for compassion
Arm Title
verbal expression and touch
Arm Type
Active Comparator
Arm Description
verbal expression and touch
Arm Title
control
Arm Type
No Intervention
Arm Description
control
Intervention Type
Behavioral
Intervention Name(s)
verbal expression for compassion
Intervention Description
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)
Intervention Type
Behavioral
Intervention Name(s)
touch
Intervention Description
The doctor going to perform bronchoscopy puts a hand on the patient's shoulder
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
Satisfaction of patients after fiberoptic bronchoscopy
Time Frame
within 6 hours after bronchoscopy

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: adult patients undergoing diagnostic fiberoptic bronchoscopy hospitalized patients Exclusion Criteria: patients who have undergone fiberoptic bronchoscopy not hospitalized patients cognitive impairment refusal to enroll
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jae-Joon Yim
Organizational Affiliation
Department of Internal Medicine, Seoul National University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Seoul National University Hospital
City
Seoul
ZIP/Postal Code
110-744
Country
Korea, Republic of

12. IPD Sharing Statement

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Effects of Sympathy and Touch on Anxiety of Patients Undergoing Fiberoptic Bronchoscopy

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