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

NCT ID: NCT04935775

Last Updated: 2023-07-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

46 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-10-13

Study Completion Date

2022-04-20

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.

Conditions

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Pain, Acute Anxiety

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Untrained Touch Provided

Group Type EXPERIMENTAL

Untrained Touch

Intervention Type OTHER

Subject's feet, ankles, and lower legs are touched and rubbed during a bone marrow biopsy procedure.

Standard of Care

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Untrained Touch

Subject's feet, ankles, and lower legs are touched and rubbed during a bone marrow biopsy procedure.

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Dartmouth-Hitchcock Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Anna D. Schaal

Hematology Nurse Practitioner

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Anna Schaal, MSN, APRN

Role: PRINCIPAL_INVESTIGATOR

Dartmouth-Hitchcock Medical Center

Locations

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Dartmouth Hitchcock Medical Center, Dartmouth Cancer Center

Lebanon, New Hampshire, United States

Site Status

Countries

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United States

References

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Other Identifiers

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D21039

Identifier Type: -

Identifier Source: org_study_id

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