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

April 18, 2016 updated by: Jae-Joon Yim, Seoul National University Hospital
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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

267

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
      • Seoul, Korea, Republic of, 110-744
        • Seoul National University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: control
Active Comparator: verbal expression for compassion
Behavioral: verbal expression for compassion
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)
Active Comparator: verbal expression and touch
Behavioral: verbal expression for compassion
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)
Behavioral: touch
The doctor going to perform bronchoscopy puts a hand on the patient's shoulder

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
baseline (arrival at the test room), and follow-up (at least 10 min after baseline, right before undergoing bronchoscopy

Secondary Outcome Measures

Outcome Measure
Time Frame
Satisfaction of patients after fiberoptic bronchoscopy
Time Frame: within 6 hours after bronchoscopy
within 6 hours after bronchoscopy

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Seoul National University Hospital

Investigators

  • Principal Investigator: Jae-Joon Yim, Department of Internal Medicine, Seoul National University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2013

Primary Completion (Actual)

December 1, 2014

Study Completion (Actual)

December 1, 2014

Study Registration Dates

First Submitted

November 20, 2013

First Submitted That Met QC Criteria

November 26, 2013

First Posted (Estimate)

December 4, 2013

Study Record Updates

Last Update Posted (Estimate)

April 20, 2016

Last Update Submitted That Met QC Criteria

April 18, 2016

Last Verified

April 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STAF
  • 1307-042-504 (Other Identifier: Seoul National University Hospital)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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