Patient Comfort During Dermatologic Procedures

December 2, 2021 updated by: Murad Alam, Northwestern University

Managing Patient Comfort During Dermatologic Procedures: A Randomized Controlled Trial

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

135

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

  • United States
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Northwestern Memorial 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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 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
Experimental: Hand-holding
Subjects will be randomized to be in the handholding, stress ball, or control study arms. The randomization will be 1:1:1.
Procedure: Hand-holding
Subject will have their hand held.
Experimental: Stress Ball
Subjects will be randomized to be in the handholding, stress ball, or control study arms. The randomization will be 1:1:1.
Procedure: Stress Ball
Subject will be given a stress ball to hold.
No Intervention: Nothing
Subjects will be randomized to be in the handholding, stress ball, or control study arms. The randomization will be 1:1:1.

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

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

Sponsor

Northwestern University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 (Actual)

January 24, 2017

Primary Completion (Actual)

April 26, 2017

Study Completion (Actual)

April 26, 2017

Study Registration Dates

First Submitted

June 27, 2016

First Submitted That Met QC Criteria

June 27, 2016

First Posted (Estimate)

June 29, 2016

Study Record Updates

Last Update Posted (Actual)

December 6, 2021

Last Update Submitted That Met QC Criteria

December 2, 2021

Last Verified

December 1, 2021

More Information

Terms related to this study

Other Study ID Numbers

  • STU00203158

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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