AnxietyPhase 2NCT02496533

Patient Anxiety During Radiological Examination

A Phase 2 study testing Hand Massage in people with Anxiety, run by Midwestern Regional Medical Center.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

This clinical trial design evaluates whether hand massage reduces anxiety levels in cancer patients as they undergo radiological examination to evaluate tumor response. Anxiety levels will be investigated before massage, after massage, and following the completion of the radiological exam. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Anxiety
What is being tested?: Hand Massage
Type of treatment: Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 217 participants
Where: No sites listed yet
Study dates: Feb 2014to Jan 2015
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

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
No healthy volunteers
Adult, Older adult

Who may be able to join

Signed informed consent
Age ≥ 18 years
Scheduled to undergo radiologic imaging evaluation of a tumor

Who cannot join

Known hand injury within 30 days prior to study participation
Known pregnancy
Mental disability as determined by the treating physician
Actively receiving radiation therapy
Actively receiving chemotherapy

About this study

Official title: The Prevalence of Anxiety in Patients Undergoing Radiologic Exam

Conditions: Anxiety
Being tested: Hand Massage
Medical subject headings: Anxiety Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Hand MassageProcedure or surgery
The hand massage procedure comprises 4 minutes of manipulation of the subject's hands (2 minutes per hand) by a skilled massage therapist or appropriately trained staff.

Study groups in NCT02496533
Study group	Role	What they receive
No Massage	No intervention	Subjects in this arm will complete rate their anxiety by visual analog scale (VAS). Blood pressure, pulse and respiration will be recorded before and after imaging. The anxiety VAS will be repeated after the imaging procedure. Subjects in this arm will not receive the hand massage prior to the imaging procedure.
Hand Massage	Experimental	Subjects in this arm will complete rate their anxiety by visual analog scale (VAS). Blood pressure, pulse and respiration will be recorded before massage, after massage but before imaging, and after imaging.The subjects will receive hand massage prior to the imaging procedure. The anxiety VAS will be repeated after the imaging procedure. Receives: Procedure: Hand Massage

What is being measured

The primary outcome is the main question the study is designed to answer.

Change in Anxiety as Measured by Visual Analog Scale
Subjects self-reported their perceived anxiety by marking a visual analog scale (VAS). The VAS covers the range 0 to 10. Higher values indicate greater anxiety (worse outcome). Analysis based on difference reported anxiety score between Baseline and after imaging.
Measured: Baseline and After Imaging

Secondary outcomes (3)

Change in Blood Pressure in mmHg
A trained clinician will measure and record the subject's blood pressure using standard practices.
Measured: Baseline and After Imaging
Change in Respiration Rate in Breaths Per Minute
A trained clinician will measure and record the subject's respiration rate using standard practices.
Measured: Baseline and After Imaging
Change in Pulse Rate
A trained clinician will measure and record the subject's radial pulse rate using standard practices.
Measured: Baseline and After Imaging

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Feb 2014Jan 2015

First posted14 Jul 2015 (estimated)
Study startFeb 2014
Primary completionJan 2015
Study completionJan 2015

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for AnxietyStudies of the same condition, open and under way.
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 2
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Participant
Enrolment: 217 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02496533
Sponsor's protocol ID: MRMC14-14
Status last verified: Dec 2016
First submitted: 8 Jul 2015
Last updated: 30 Jan 2017
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

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All Anxiety trials

Study at a glance

From the registry record, last updated by the sponsor on 30 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: The Prevalence of Anxiety in Patients Undergoing Radiologic Exam
ClinicalTrials.gov ID: NCT02496533
Acronym / sponsor ID: MRMC14-14
Conditions: Anxiety
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 217 participants (actual)
Lead sponsor: Midwestern Regional Medical CenterUniversity, hospital or other
Study start: Feb 2014
Primary completion: Jan 2015 (actual)
Study completion: Jan 2015 (actual)
First posted: 14 Jul 2015 (estimated)
Results: Posted 29 Nov 2016

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (participant)
Number of arms: 2

Arm	Type	Receives
No Massage	No intervention	–Subjects in this arm will complete rate their anxiety by visual analog scale (VAS). Blood pressure, pulse and respiration will be recorded before and after imaging. The anxiety VAS will be repeated after the imaging procedure. Subjects in this arm will not receive the hand massage prior to the imaging procedure.
Hand Massage	Experimental	Procedure: Hand MassageSubjects in this arm will complete rate their anxiety by visual analog scale (VAS). Blood pressure, pulse and respiration will be recorded before massage, after massage but before imaging, and after imaging.The subjects will receive hand massage prior to the imaging procedure. The anxiety VAS will be repeated after the imaging procedure.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

Signed informed consent
Age ≥ 18 years
Scheduled to undergo radiologic imaging evaluation of a tumor

Key exclusion criteria (5 listed)

Known hand injury within 30 days prior to study participation
Known pregnancy
Mental disability as determined by the treating physician
Actively receiving radiation therapy
Actively receiving chemotherapy

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 MassageThe hand massage procedure comprises 4 minutes of manipulation of the subject's hands (2 minutes per hand) by a skilled massage therapist or appropriately trained staff.	Procedure or surgery	Hand Massage

Primary outcome

Change in Anxiety as Measured by Visual Analog Scale
Time frame: Baseline and After Imaging
Subjects self-reported their perceived anxiety by marking a visual analog scale (VAS). The VAS covers the range 0 to 10. Higher values indicate greater anxiety (worse outcome). Analysis based on difference reported anxiety score between Baseline and after imaging.

3 secondary outcomes

Change in Blood Pressure in mmHg
Time frame: Baseline and After Imaging
Change in Respiration Rate in Breaths Per Minute
Time frame: Baseline and After Imaging
Change in Pulse Rate
Time frame: Baseline and After Imaging

Results and safety

Results posted to the registry on 29 Nov 2016, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Hand Massage	105	102
No Massage	112	106

Primary outcome: Change in Anxiety as Measured by Visual Analog Scale

Time frame: Baseline and After Imaging. Mean (Standard Deviation). Unit: units on a scale

Measure	Hand Massage n = 102	No Massage n = 106
Baseline	3.4 (3.5)	2.1 (2.6)
After Imaging	1.6 (2.4)	1.9 (2.5)

Hand Massage vs No Massage: Mean Difference (Net): 1.8, p <0.001, ANOVA

Population analysed: All patients completing the study per protocol were included in the analysis.

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: 30 days. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Hand Massage	0 of 105 (0%)	0 of 105 (0%)	Not reported
No Massage	0 of 112 (0%)	0 of 112 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2017.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Anxiety

Not yet recruiting
Building Resilience Through Anxiety Virtual Education in PICU Survivors
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Not yet recruiting
Mandala Coloring in Late Pregnancy
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Recruiting
Modulating Escape Using Focused Ultrasound
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Not yet recruitingObservational study
Ecological Momentary Assessment of State-Dependent Decision-Making and Metacognition Across a Psychopathology Continuum
Depression, Anxiety
Recruiting
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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.

Jessica Kapustin, RN-C principal investigator

Midwestern Regional Medical Center

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Hand Massage in people with Anxiety, run by Midwestern Regional Medical Center.

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 5 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 30 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.

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.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 29 Nov 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Change in Anxiety as Measured by Visual Analog Scale (time frame: Baseline and After Imaging). 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 NCT02496533.

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 30 Jan 2017.