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OpenTrials
Completed

NCT Number: NCT02496533

Patient Anxiety During Radiological Examination

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. The Visual Analog Scale (VAS), a validated anxiety assessment tool, will be used to measure anxiety.

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Key information

Conditions

Anxiety Anxiety Disorders Mental Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Hand Massage

Procedure

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. Change in Blood Pressure in mmHg

    Time frame: Baseline and After Imaging

    A trained clinician will measure and record the subject's blood pressure using standard practices.

  2. Change in Respiration Rate in Breaths Per Minute

    Time frame: Baseline and After Imaging

    A trained clinician will measure and record the subject's respiration rate using standard practices.

  3. Change in Pulse Rate

    Time frame: Baseline and After Imaging

    A trained clinician will measure and record the subject's radial pulse rate using standard practices.

Sponsors and collaborators

Lead sponsor

Midwestern Regional Medical Center

Other

Registry information

Official study title

The Prevalence of Anxiety in Patients Undergoing Radiologic Exam

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Jul 14, 2015
Registry last updated
Jan 30, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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