- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04935775
The Effect of Touch on Pain and Anxiety During the Bone Marrow Biopsy Procedure (Dixon Project)
June 29, 2023 updated by: Anna D. Schaal, Dartmouth-Hitchcock Medical Center
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.
Study Overview
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 Type
Interventional
Enrollment (Actual)
46
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
New Hampshire
-
Lebanon, New Hampshire, United States, 03756
- Dartmouth Hitchcock Medical Center, Dartmouth Cancer Center
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- Patients who do not wish to have their feet and lower legs touched during the procedure
- Open sores on their feet or lower legs.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
No Intervention: Standard of Care
|
|
Experimental: Untrained Touch Provided
|
Subject's feet, ankles, and lower legs are touched and rubbed during a bone marrow biopsy procedure.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Evaluate patient-reported pain levels
Time Frame: 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.
|
During the study procedure
|
Evaluate patient-reported anxiety levels
Time Frame: 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.
|
During the study procedure
|
Identify correlation between demographics and interventional response
Time Frame: 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.
|
During the study procedure
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Anna Schaal, MSN, APRN, Dartmouth-Hitchcock Medical Center
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Thrane S, Cohen SM. Effect of Reiki therapy on pain and anxiety in adults: an in-depth literature review of randomized trials with effect size calculations. Pain Manag Nurs. 2014 Dec;15(4):897-908. doi: 10.1016/j.pmn.2013.07.008. Epub 2014 Feb 28.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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
- Kutner JS, Smith MC, Corbin L, Hemphill L, Benton K, Mellis BK, Beaty B, Felton S, Yamashita TE, Bryant LL, Fairclough DL. Massage therapy versus simple touch to improve pain and mood in patients with advanced cancer: a randomized trial. Ann Intern Med. 2008 Sep 16;149(6):369-79. doi: 10.7326/0003-4819-149-6-200809160-00003.
- Lutgendorf SK, Mullen-Houser E, Russell D, Degeest K, Jacobson G, Hart L, Bender D, Anderson B, Buekers TE, Goodheart MJ, Antoni MH, Sood AK, Lubaroff DM. Preservation of immune function in cervical cancer patients during chemoradiation using a novel integrative approach. Brain Behav Immun. 2010 Nov;24(8):1231-40. doi: 10.1016/j.bbi.2010.06.014. Epub 2010 Jun 30.
- Robison JG, Smith CL. Therapeutic Massage During Chemotherapy and/or Biotherapy Infusions: Patient Perceptions of Pain, Fatigue, Nausea, Anxiety, and Satisfaction. Clin J Oncol Nurs. 2016 Apr;20(2):E34-40. doi: 10.1188/16.CJON.E34-E40.
- Rosenbaum MS, Velde J. The Effects of Yoga, Massage, and Reiki on Patient Well-Being at a Cancer Resource Center. Clin J Oncol Nurs. 2016 Jun 1;20(3):E77-81. doi: 10.1188/16.CJON.E77-E81.
- Snow A, Dorfman D, Warbet R, Cammarata M, Eisenman S, Zilberfein F, Isola L, Navada S. A randomized trial of hypnosis for relief of pain and anxiety in adult cancer patients undergoing bone marrow procedures. J Psychosoc Oncol. 2012;30(3):281-93. doi: 10.1080/07347332.2012.664261.
- Jane SW, Wilkie DJ, Gallucci BB, Beaton RD. Systematic review of massage intervention for adult patients with cancer: a methodological perspective. Cancer Nurs. 2008 Nov-Dec;31(6):E24-35. doi: 10.1097/01.NCC.0000339242.51291.85.
- Tabatabaee A, Tafreshi MZ, Rassouli M, Aledavood SA, AlaviMajd H, Farahmand SK. EFFECT OF THERAPEUTIC TOUCH ON PAIN RELATED PARAMETERS IN PATIENTS WITH CANCER: A RANDOMIZED CLINICAL TRIAL. Mater Sociomed. 2016 Jun;28(3):220-3. doi: 10.5455/msm.2016.28.220-223. Epub 2016 Jun 1.
- Tucker DL, Rockett M, Hasan M, Poplar S, Rule SA. Does transcutaneous electrical nerve stimulation (TENS) alleviate the pain experienced during bone marrow sampling in addition to standard techniques? A randomised, double-blinded, controlled trial. J Clin Pathol. 2015 Jun;68(6):479-83. doi: 10.1136/jclinpath-2015-202908. Epub 2015 Mar 10.
- Ucuzal M, Kanan N. Foot massage: effectiveness on postoperative pain in breast surgery patients. Pain Manag Nurs. 2014 Jun;15(2):458-65. doi: 10.1016/j.pmn.2012.03.001. Epub 2012 Jun 20.
- Watmough S, Flynn M. A review of pain management interventions in bone marrow biopsy. J Clin Nurs. 2011 Mar;20(5-6):615-23. doi: 10.1111/j.1365-2702.2010.03485.x.
- Weze C, Leathard HL, Grange J, Tiplady P, Stevens G. Evaluation of healing by gentle touch in 35 clients with cancer. Eur J Oncol Nurs. 2004 Mar;8(1):40-9. doi: 10.1016/j.ejon.2003.10.004.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
October 13, 2021
Primary Completion (Actual)
January 28, 2022
Study Completion (Actual)
April 20, 2022
Study Registration Dates
First Submitted
June 2, 2021
First Submitted That Met QC Criteria
June 15, 2021
First Posted (Actual)
June 23, 2021
Study Record Updates
Last Update Posted (Actual)
July 3, 2023
Last Update Submitted That Met QC Criteria
June 29, 2023
Last Verified
June 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- D21039
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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