Patient Comfort During Dermatologic Procedures

• Sponsor: Northwestern University (Other)
• Overall Status: Completed
• CT.gov ID: NCT02816996
• Collaborator: (none)
• Enrollment: 135
• Location: 1
• Arms: 3
• Actual Duration (Months): 3
• Patients Per Site Per Month: 44.7

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Pain; Anxiety	Procedure: Hand-holding; Procedure: Stress Ball	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 135 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Supportive Care
• Official Title: Managing Patient Comfort During Dermatologic Procedures: A Randomized Controlled Trial
• Actual Study Start Date: Jan 24, 2017
• Actual Primary Completion Date: Apr 26, 2017
• Actual Study Completion Date: Apr 26, 2017

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

1. Anxiety [immediately after dermatologic procedure]

   Subjects will complete the 6-item State-Trait Anxiety Inventory (STAI)

2. Pain [immediately after dermatologic procedure]

   Subjects will complete a visual analog scale for pain ranging from "no pain at all" to "worst possible pain."

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Northwestern Memorial Hospital	Chicago	Illinois	United States	60611

Sponsors and Collaborators

• Northwestern University

Investigators

• Principal Investigator: Murad Alam, MD, Northwestern University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Murad Alam, Professor in Dermatology, Otolaryngology-Head and Neck Surgery, and Surgery, Northwestern University
• ClinicalTrials.gov Identifier: NCT02816996
• Other Study ID Numbers: STU00203158
• First Posted: Jun 29, 2016
• Last Update Posted: Dec 6, 2021
• Last Verified: Dec 1, 2021

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Study Results

No Results Posted as of Dec 6, 2021