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Pain, AcuteDixon ProjectNCT04935775

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

A study testing Untrained Touch in people with Pain, Acute and Anxiety, run by Dartmouth-Hitchcock Medical Center at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Pain, Acute, Anxiety
What is being tested?
Untrained Touch
Could I receive a placebo?
No, everyone receives an active treatment
How many people
46 participants
Where
1 siteUnited States
Study dates
13 Oct 2021to 20 Apr 2022
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Dartmouth Hitchcock Medical Center, Dartmouth Cancer Center

    Lebanon, New Hampshire, 03756

Other trials in United States

About this study

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.

Read the 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.

Conditions
Pain, Acute, Anxiety
Being tested
Untrained Touch
Medical subject headings
Acute Pain, Anxiety Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Untrained TouchOther

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

Study groups in NCT04935775
Study groupRoleWhat they receive
Untrained Touch ProvidedExperimentalNot described
Receives: Other: Untrained Touch
Standard of CareNo interventionNot described

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: During the study procedure

  2. 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.

    Measured: During the study procedure

  3. 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.

    Measured: During the study procedure

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Jun 2021
  2. Study start13 Oct 2021
  3. Primary completion28 Jan 2022
  4. Study completion20 Apr 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
46 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04935775
Sponsor's protocol ID
D21039
Acronym
Dixon Project
Status last verified
Jun 2023
First submitted
2 Jun 2021
Last updated
3 Jul 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Baldwin AL, Vitale A, Brownell E, Kryak E, Rand W. Effects of Reiki on Pain, Anxiety, and Blood Pressure in Patients Undergoing Knee Replacement: A Pilot Study. Holist Nurs Pract. 2017 Mar/Apr;31(2):80-89. doi: 10.1097/HNP.0000000000000195.

    PubMed 28181973

  • Abdelaziz, S. H., & Mohammed, H. E. (2014). Effect of foot massage on postoperative pain and vital signs in breast cancer patient. Journal of Nursing Education and Practice, 4(8). doi:10.5430/jnep.v4n8p115

  • Bao T, Ye X, Skinner J, Cao B, Fisher J, Nesbit S, Grossman SA. The analgesic effect of magnetic acupressure in cancer patients undergoing bone marrow aspiration and biopsy: a randomized, blinded, controlled trial. J Pain Symptom Manage. 2011 Jun;41(6):995-1002. doi: 10.1016/j.jpainsymman.2010.08.012. Epub 2011 Feb 9.

    PubMed 21306863

  • Birocco N, Guillame C, Storto S, Ritorto G, Catino C, Gir N, Balestra L, Tealdi G, Orecchia C, Vito GD, Giaretto L, Donadio M, Bertetto O, Schena M, Ciuffreda L. The effects of Reiki therapy on pain and anxiety in patients attending a day oncology and infusion services unit. Am J Hosp Palliat Care. 2012 Jun;29(4):290-4. doi: 10.1177/1049909111420859. Epub 2011 Oct 13.

    PubMed 21998438

  • Bourque AL, Sullivan ME, Winter MR. Reiki as a pain management adjunct in screening colonoscopy. Gastroenterol Nurs. 2012 Sep;35(5):308-12. doi: 10.1097/SGA.0b013e3182603436.

    PubMed 23018166

  • Brunetti GA, Tendas A, Meloni E, Mancini D, Maggiore P, Scaramucci L, Giovannini M, Niscola P, Cartoni C, Alimena G. Pain and anxiety associated with bone marrow aspiration and biopsy: a prospective study on 152 Italian patients with hematological malignancies. Ann Hematol. 2011 Oct;90(10):1233-5. doi: 10.1007/s00277-011-1166-7. Epub 2011 Feb 2. No abstract available.

    PubMed 21287348

  • Ferrell-Torry AT, Glick OJ. The use of therapeutic massage as a nursing intervention to modify anxiety and the perception of cancer pain. Cancer Nurs. 1993 Apr;16(2):93-101.

    PubMed 8477405

  • Gay CW, Robinson ME, George SZ, Perlstein WM, Bishop MD. Immediate changes after manual therapy in resting-state functional connectivity as measured by functional magnetic resonance imaging in participants with induced low back pain. J Manipulative Physiol Ther. 2014 Nov-Dec;37(9):614-27. doi: 10.1016/j.jmpt.2014.09.001. Epub 2014 Oct 3.

    PubMed 25284739

  • Gonella S, Garrino L, Dimonte V. Biofield therapies and cancer-related symptoms: a review. Clin J Oncol Nurs. 2014 Oct;18(5):568-76. doi: 10.1188/14.CJON.568-576.

    PubMed 25253110

  • Gorji, A., Taebei, M., Ranjbar, M., & Hatkehlouei, M. (2016). Effect of Distraction Technique and Hypnosis in Pain of Bone Marrow Aspiration in Children: A Systematic Review Study. International Journal of Pediatrics, 5(3). doi:10.22038/ijp.2016.20976.1754

  • Grealish L, Lomasney A, Whiteman B. Foot massage. A nursing intervention to modify the distressing symptoms of pain and nausea in patients hospitalized with cancer. Cancer Nurs. 2000 Jun;23(3):237-43. doi: 10.1097/00002820-200006000-00012.

    PubMed 10851775

  • Hart LK, Freel MI, Haylock PJ, Lutgendorf SK. The use of healing touch in integrative oncology. Clin J Oncol Nurs. 2011 Oct;15(5):519-25. doi: 10.1188/11.CJON.519-525.

    PubMed 21951738

  • Hjortholm N, Jaddini E, Halaburda K, Snarski E. Strategies of pain reduction during the bone marrow biopsy. Ann Hematol. 2013 Jan;92(2):145-9. doi: 10.1007/s00277-012-1641-9. Epub 2012 Dec 6.

    PubMed 23224244

  • Johnson H, Burke D, Plews C, Newell R, Parapia L. Improving the patient's experience of a bone marrow biopsy - an RCT. J Clin Nurs. 2008 Mar;17(6):717-25. doi: 10.1111/j.1365-2702.2007.01991.x. Epub 2007 Nov 30.

    PubMed 18047576

  • Kuball, J., Shuz, J., Gamm, H., & Weber, M. (n.d.). Bone marrow punctures and pain. Acute Pain, 6(1), 9-14. doi:10.1016/j.acpain.2004.02.003

Questions about this trial

What is this clinical trial studying?

A study testing Untrained Touch in people with Pain, Acute and Anxiety, run by Dartmouth-Hitchcock Medical Center at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 3 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Evaluate patient-reported pain levels (time frame: During the study procedure). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04935775, which also lists 27 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jul 2023.

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