Patient Comfort During Dermatologic Procedures
Managing Patient Comfort During Dermatologic Procedures: A Randomized Controlled Trial
1 other identifier
interventional
135
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable pain
Started Jan 2017
Shorter than P25 for not_applicable pain
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 27, 2016
CompletedFirst Posted
Study publicly available on registry
June 29, 2016
CompletedStudy Start
First participant enrolled
January 24, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 26, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
April 26, 2017
CompletedDecember 6, 2021
December 1, 2021
3 months
June 27, 2016
December 2, 2021
Conditions
Outcome Measures
Primary Outcomes (2)
Anxiety
Subjects will complete the 6-item State-Trait Anxiety Inventory (STAI)
immediately after dermatologic procedure
Pain
Subjects will complete a visual analog scale for pain ranging from "no pain at all" to "worst possible pain."
immediately after dermatologic procedure
Study Arms (3)
Hand-holding
EXPERIMENTALSubjects will be randomized to be in the handholding, stress ball, or control study arms. The randomization will be 1:1:1.
Stress Ball
EXPERIMENTALSubjects will be randomized to be in the handholding, stress ball, or control study arms. The randomization will be 1:1:1.
Nothing
NO INTERVENTIONSubjects will be randomized to be in the handholding, stress ball, or control study arms. The randomization will be 1:1:1.
Interventions
Eligibility Criteria
You may qualify if:
- Age 18 and older
- Undergoing a dermatologic procedure
- Willing and able to understand and provide informed consent and communicate with the investigator
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Northwestern Memorial Hospital
Chicago, Illinois, 60611, United States
Related Publications (1)
Yanes AF, Weil A, Furlan KC, Poon E, Alam M. Effect of Stress Ball Use or Hand-holding on Anxiety During Skin Cancer Excision: A Randomized Clinical Trial. JAMA Dermatol. 2018 Sep 1;154(9):1045-1049. doi: 10.1001/jamadermatol.2018.1783.
PMID: 30027283DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Murad Alam, MD
Northwestern University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor in Dermatology, Otolaryngology-Head and Neck Surgery, and Surgery
Study Record Dates
First Submitted
June 27, 2016
First Posted
June 29, 2016
Study Start
January 24, 2017
Primary Completion
April 26, 2017
Study Completion
April 26, 2017
Last Updated
December 6, 2021
Record last verified: 2021-12