The Effect of Touch on Pain and Anxiety During the Bone Marrow Biopsy Procedure

Study Overview
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Brief Summary
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This study is analyzing the benefit of untrained touch provided during a bone marrow biopsy procedure as compared to performing the procedure without providing it.

Detailed Description
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Two protocol-identified licensed nursing aides (LNA) will provide an unstructured simple touch intervention that requires no special training other than being oriented to rub patient's feet during the procedure. Data will be collected through patient-reported outcomes to determine if untrained touch has therapeutic results in managing a patient's pain and anxiety during a bone marrow biopsy procedure.

Official Title
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The Effect of Touch on Pain and Anxiety During the Bone Marrow Biopsy Procedure

Conditions
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Pain, Acute, Anxiety

Intervention / Treatment
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* Other: Untrained Touch


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients from Norris Cotton Cancer Center who have been scheduled for a bone marrow biopsy at the Outpatient Surgical Center at Dartmouth-Hitchcock Medical Center. Subjects must be able to read and write in English to provide informed consent and fill out the questionnaires. Exclusion Criteria: Patients who do not wish to have their feet and lower legs touched during the procedure Open sores on their feet or lower legs.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Untrained Touch Provided<br> | Other: Untrained Touch<br>* Subject's feet, ankles, and lower legs are touched and rubbed during a bone marrow biopsy procedure.<br>|
| No Intervention: Standard of Care<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluate patient-reported pain levels | Patients be asked to describe what their pain level was before, at its worst point during the procedure and after the bone marrow biopsy. The Visual Analog Scale (VAS) will be used on a 0 to 10 scale, 0 being no pain at all and 10 being the worst pain imaginable. | During the study procedure | 
| Evaluate patient-reported anxiety levels | The six -item short form Spiellberger State-Trait Anxiety Inventory (STAI), a self-reported questionnaire, will be administered on pencil and paper. Possible ranges of scores on the 6-item questionnaires vary from 6 to 24, with separate scores for both the state and trait anxiety sections. Answers to each question range from 1 to 4, 1 being no anxiety at all to 4 being very high anxiety (Julian, 2014). Patients will complete the short-form STAI before and after the procedure. | During the study procedure | 
| Identify correlation between demographics and interventional response | Secondary endpoints will include identifying any correlation between demographic data collected and response to the intervention. The patient experience will be evaluated by using a visual analog scale at the completion of the procedure via paper and pencil that the subjects will complete independently. These open ended questions will be used to inform larger study questions in the future. Abstracted and deidentified summaries of responses will be prepared by the study PI. | During the study procedure |