Patient Anxiety During Radiological Examination

Anxiety Clinical Trial

Official title:

The Prevalence of Anxiety in Patients Undergoing Radiologic Exam

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02496533
• Other study ID #: MRMC14-14
• Status: Completed
• Phase: Phase 2
• First received: July 8, 2015
• Last updated: July 9, 2015
• Start date: February 2014
• Est. completion date: January 2015

Study information

• Verified date: July 2015
• Source: Midwestern Regional Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

This clinical trial design evaluates whether hand message 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. The Visual Analog Scale (VAS), a validated anxiety assessment tool, will be used to measure anxiety.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 217
• Est. completion date: January 2015
• Est. primary completion date: January 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Signed informed consent

• Age = 18 years

• Scheduled to undergo radiologic imaging evaluation of a tumor

Exclusion Criteria:

• 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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Anxiety
• Anxiety Disorders

Intervention

Procedure:
• Hand Massage
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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Midwestern Regional Medical Center

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Anxiety as measured by Visual Analog Scale	Subjects will self-report their perceived anxiety by marking a visual analog scale.	30-60 minutes	No
Secondary	Blood pressure in mm/Hg	A trained clinician will measure and record the subject's blood pressure using standard practices.	30-60 minutes	No
Secondary	Respiration rate in breaths per minute	A trained clinician will measure and record the subject's respiration rate using standard practices.	30-60 minutes	No
Secondary	Pulse rate	A trained clinician will measure and record the subject's radial pulse rate using standard practices.	30-60 minutes	Yes