Patient Comfort During Dermatologic Procedures

Northwestern University

Status: Completed

Conditions: Anxiety; Pain

Treatments: Procedure: Stress Ball; Procedure: Hand-holding

Study type: Interventional

Funder types: Other

Identifiers

NCT02816996

STU00203158

Details and patient eligibility

About

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

Enrollment: 135 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

135 participants in 3 patient groups

Hand-holding

Experimental group

Description:

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

Treatment:

Procedure: Hand-holding

Stress Ball

Experimental group

Description:

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

Treatment:

Procedure: Stress Ball

Nothing

No Intervention group

Description:

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