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NCT02816996 Clinical Trial

Patient Comfort During Dermatologic Procedures

Pain Clinical Trial

Official title:
Managing Patient Comfort During Dermatologic Procedures: A Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02816996
Other study ID # STU00203158
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date January 24, 2017
Est. completion date April 26, 2017

Study information
Verified date December 2021
Source Northwestern University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The goal of this study is to find the effect of holding a patient's hand on anxiety and pain during dermatologic procedures.

Recruitment information / eligibility
Status Completed
Enrollment 135
Est. completion date April 26, 2017
Est. primary completion date April 26, 2017
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Age 18 and older - Undergoing a dermatologic procedure - Willing and able to understand and provide informed consent and communicate with the investigator Exclusion Criteria: - Subjects who have wound healing problems - Subjects who are unable to understand the protocol or to give informed consent - Subjects with self-reported mental illness or other psychological conditions, such as psychotic disorders, mood disorders, anxiety disorders, cognitive disorders, depression with psychotic features, dissociative disorders

Study Design

Related Conditions & MeSH terms

Intervention

Procedure:
• Hand-holding
Subject will have their hand held.
• Stress Ball
Subject will be given a stress ball to hold.

Locations
Country Name City State
United States Northwestern Memorial Hospital Chicago Illinois

Sponsors (1)
Lead Sponsor Collaborator
Northwestern University

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Anxiety Subjects will complete the 6-item State-Trait Anxiety Inventory (STAI) immediately after dermatologic procedure
Primary Pain Subjects will complete a visual analog scale for pain ranging from "no pain at all" to "worst possible pain." immediately after dermatologic procedure
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