Patient Comfort During Dermatologic Procedures

Not Applicable

Completed

• Conditions: Anxiety; Pain
• Interventions: Procedure: Stress Ball; Procedure: Hand-holding

• Registration Number: NCT02816996
• Lead Sponsor: Northwestern University

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-06-27
• Study First Submitted QC: 2016-06-27
• Study First Posted: 2016-06-29
• Study Start: 2017-01-24
• Primary Completion: 2017-04-26
• Study Completion: 2017-04-26
• Status Verified: 2021-12
• Last Update Submitted: 2021-12-02
• Last Update Posted: 2021-12-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 135

Inclusion Criteria

• Age 18 and older
• Undergoing a dermatologic procedure
• Willing and able to understand and provide informed consent and communicate with the investigator

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Stress Ball	Stress Ball	Subjects will be randomized to be in the handholding, stress ball, or control study arms. The randomization will be 1:1:1.
Hand-holding	Hand-holding	Subjects will be randomized to be in the handholding, stress ball, or control study arms. The randomization will be 1:1:1.

Primary Outcome Measures

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

Trial Locations

Locations (1)

Northwestern Memorial Hospital; 🇺🇸 Chicago, Illinois, United States