PainNCT02816996
Patient Comfort During Dermatologic Procedures
A study testing Hand-holding and Stress Ball in people with Pain and Anxiety, run by Northwestern University at 1 site in United States.
Trial summary
The goal of this study is to find the effect of holding a patient's hand on anxiety and pain during dermatologic procedures. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- What is being tested?
- Hand-holding and Stress Ball
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 135 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Jan 2017to 26 Apr 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age 18 and older
- Undergoing a dermatologic procedure
- Willing and able to understand and provide informed consent and communicate with the investigator
Who cannot join
- 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 locations and contacts
1 site in 1 country.
United States1 site
Northwestern Memorial Hospital
Chicago, Illinois, 60611
About this study
Official title: Managing Patient Comfort During Dermatologic Procedures: A Randomized Controlled Trial
The goal of this study is to find the effect of holding a patient's hand on anxiety and pain during dermatologic procedures.
- Being tested
- Hand-holding, Stress Ball
- Medical subject headings
- Pain, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hand-holdingProcedure or surgery
Subject will have their hand held.
Stress BallProcedure or surgery
Subject will be given a stress ball to hold.
| Study group | Role | What they receive |
|---|---|---|
| Hand-holding | Experimental | Subjects will be randomized to be in the handholding, stress ball, or control study arms. The randomization will be 1:1:1. Receives: Procedure: Hand-holding |
| Stress Ball | Experimental | Subjects will be randomized to be in the handholding, stress ball, or control study arms. The randomization will be 1:1:1. Receives: Procedure: Stress Ball |
| Nothing | No intervention | Subjects will be randomized to be in the handholding, stress ball, or control study arms. The randomization will be 1:1:1. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Anxiety
Subjects will complete the 6-item State-Trait Anxiety Inventory (STAI)
Measured: immediately after dermatologic procedure
Pain
Subjects will complete a visual analog scale for pain ranging from "no pain at all" to "worst possible pain."
Measured: immediately after dermatologic procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2016 (estimated)
- Study start24 Jan 2017
- Primary completion26 Apr 2017
- Study completion26 Apr 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for PainStudies of the same condition, open and under way.
- More trials run by Northwestern UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 135 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northwestern University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Murad Alam, Northwestern University
- Investigators
- Murad Alam, MD, Principal investigator, Northwestern University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02816996
- Sponsor's protocol ID
- STU00203158
- Status last verified
- Dec 2021
- First submitted
- 27 Jun 2016
- Last updated
- 6 Dec 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 30027283
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Managing Patient Comfort During Dermatologic Procedures: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02816996
- Acronym / sponsor ID
- STU00203158
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 135 participants (actual)
- Lead sponsor
- Northwestern UniversityUniversity, hospital or other
- Study start
- 24 Jan 2017 (actual)
- Primary completion
- 26 Apr 2017 (actual)
- Study completion
- 26 Apr 2017 (actual)
- First posted
- 29 Jun 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this study is to find the effect of holding a patient's hand on anxiety and pain during dermatologic procedures.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Hand-holding | Experimental | Procedure: Hand-holdingSubjects will be randomized to be in the handholding, stress ball, or control study arms. The randomization will be 1:1:1. |
| Stress Ball | Experimental | Procedure: Stress BallSubjects will be randomized to be in the handholding, stress ball, or control study arms. The randomization will be 1:1:1. |
| Nothing | No intervention | –Subjects will be randomized to be in the handholding, stress ball, or control study arms. The randomization will be 1:1:1. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age 18 and older
- Undergoing a dermatologic procedure
- Willing and able to understand and provide informed consent and communicate with the investigator
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hand-holdingSubject will have their hand held. | Procedure or surgery | Hand-holding |
| Stress BallSubject will be given a stress ball to hold. | Procedure or surgery | Stress Ball |
Primary outcome
Anxiety
Time frame: immediately after dermatologic procedure
Subjects will complete the 6-item State-Trait Anxiety Inventory (STAI)
Pain
Time frame: immediately after dermatologic procedure
Subjects will complete a visual analog scale for pain ranging from "no pain at all" to "worst possible pain."
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Dec 2021.
- Derived from this study: PubMed 30027283Yanes 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Murad Alam, MD principal investigator
Northwestern University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hand-holding and Stress Ball in people with Pain and Anxiety, run by Northwestern University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Anxiety (time frame: immediately after dermatologic procedure). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02816996, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Dec 2021.