Patient Anxiety During Radiological Examination

NCT ID: NCT02496533

Last Updated: 2017-01-30

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

217 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-02-28

Study Completion Date

2015-01-31

Brief Summary

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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.

Detailed Description

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Conditions

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Anxiety

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Participants

Study Groups

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No Massage

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Hand Massage

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.

Group Type EXPERIMENTAL

Hand Massage

Intervention Type 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.

Interventions

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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.

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Midwestern Regional Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Jessica Kapustin

RN Survivorship

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jessica Kapustin, RN-C

Role: PRINCIPAL_INVESTIGATOR

Midwestern Regional Medical Center

Other Identifiers

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MRMC14-14

Identifier Type: -

Identifier Source: org_study_id

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