Patient Comfort During Dermatologic Procedures

NCT ID: NCT02816996

Last Updated: 2021-12-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

135 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-01-24

Study Completion Date

2017-04-26

Brief Summary

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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

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Conditions

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Pain Anxiety

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Hand-holding

Subjects will be randomized to be in the handholding, stress ball, or control study arms. The randomization will be 1:1:1.

Group Type EXPERIMENTAL

Hand-holding

Intervention Type PROCEDURE

Subject will have their hand held.

Stress Ball

Subjects will be randomized to be in the handholding, stress ball, or control study arms. The randomization will be 1:1:1.

Group Type EXPERIMENTAL

Stress Ball

Intervention Type PROCEDURE

Subject will be given a stress ball to hold.

Nothing

Subjects will be randomized to be in the handholding, stress ball, or control study arms. The randomization will be 1:1:1.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Hand-holding

Subject will have their hand held.

Intervention Type PROCEDURE

Stress Ball

Subject will be given a stress ball to hold.

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Northwestern University

OTHER

Sponsor Role lead

Responsible Party

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Murad Alam

Professor in Dermatology, Otolaryngology-Head and Neck Surgery, and Surgery

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Murad Alam, MD

Role: PRINCIPAL_INVESTIGATOR

Northwestern University

Locations

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Northwestern Memorial Hospital

Chicago, Illinois, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 30027283 (View on PubMed)

Other Identifiers

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STU00203158

Identifier Type: -

Identifier Source: org_study_id