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

Not Applicable

Completed

• Conditions: Anxiety; Pain, Acute
• Interventions: Other: Untrained Touch

• Registration Number: NCT04935775
• Lead Sponsor: Dartmouth-Hitchcock Medical Center

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.

Study Timeline

• Study First Submitted: 2021-06-02
• Study First Submitted QC: 2021-06-15
• Study First Posted: 2021-06-23
• Study Start: 2021-10-13
• Primary Completion: 2022-01-28
• Study Completion: 2022-04-20
• Status Verified: 2023-06
• Last Update Submitted: 2023-06-29
• Last Update Posted: 2023-07-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 46

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Untrained Touch Provided	Untrained Touch	-

Primary Outcome Measures

Name	Time	Method
Identify correlation between demographics and interventional response	During the study procedure	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.
Evaluate patient-reported anxiety levels	During the study procedure	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.
Evaluate patient-reported pain levels	During the study procedure	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.

Trial Locations

Locations (1)

Dartmouth Hitchcock Medical Center, Dartmouth Cancer Center; 🇺🇸 Lebanon, New Hampshire, United States