Clinical trial NCT04935775: The Effect of Touch on Pain and Anxiety During the Bone Marrow Biopsy Procedure
Official title: The Effect of Touch on Pain and Anxiety During the Bone Marrow Biopsy Procedure
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain, Acute
Anxiety
Lead sponsor: Dartmouth-Hitchcock Medical Center
Sponsor class: OTHER
First posted: 2021-06-23
Enrollment: 46
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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: 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.

Eligibility criteria: Inclusion Criteria:

1. 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.
2. Subjects must be able to read and write in English to provide informed consent and fill out the questionnaires.

Exclusion Criteria:

1. Patients who do not wish to have their feet and lower legs touched during the procedure
2. Open sores on their feet or lower legs.

Primary outcomes:
measure: Evaluate patient-reported pain levels
timeFrame: During the study procedure
measure: Evaluate patient-reported anxiety levels
timeFrame: During the study procedure
measure: Identify correlation between demographics and interventional response
timeFrame: During the study procedure
Secondary outcomes:
Other outcomes:
Locations:
city: Lebanon
country: United States
facility: Dartmouth Hitchcock Medical Center, Dartmouth Cancer Center
state: New Hampshire
Study officials:
affiliation: Dartmouth-Hitchcock Medical Center
name: Anna Schaal, MSN, APRN
role: PRINCIPAL_INVESTIGATOR
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