An interventional study of Untrained Touch in Pain, Acute and Anxiety, sponsored by Dartmouth-Hitchcock Medical Center. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-07-03.
Sponsored by Dartmouth-Hitchcock Medical Center · Not applicable, Interventional, and Supportive care
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.
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.
908 studies on the registry are indexed under Acute Pain; 154 are open to participants now.
This study's enrollment of 46 is below the median of 87 across 759 interventional studies indexed under Acute Pain.
Browse Acute Pain studies →Dartmouth-Hitchcock Medical Center is the lead sponsor of 486 studies on the registry; 69 are open to participants now.
Of its 31 completed or terminated interventional studies of FDA-regulated products, 21 (68%) have results posted.
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Exclusion Criteria:
Other: Untrained Touch
Subject's feet, ankles, and lower legs are touched and rubbed during a bone marrow biopsy procedure.
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.
Time frame: 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.
Time frame: 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.
Time frame: During the study procedure
Plan to share: No
Ran from Oct 2021 to primary completion in Jan 2022, 3 months.
Of 314 non-industry interventional studies with no phase under Acute Pain, half reached primary completion within 11 months of starting (the median), counting those still running; a quarter within 5 and three quarters within 22. This study's 3 months is below that.
Counting every sponsor, half of 318 studies reached it within 11 months; a quarter within 5 and three quarters within 22.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jun 2023. You cannot join it, but the record below documents what was studied.
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