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

NCT04935775 | Completed

• 1 other identifier: D21039
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

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.

Conditions

Pain, Acute; Anxiety

Outcome Measures

Primary Outcomes (3)

• 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.

  During the study procedure

• 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.

  During the study procedure

• 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.

  During the study procedure

Study Arms (2)

Untrained Touch Provided

EXPERIMENTAL

Other: Untrained Touch

Standard of Care

NO INTERVENTION

Interventions

Untrained Touch OTHER

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

Untrained Touch Provided

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Dartmouth-Hitchcock Medical Center: lead

Study Sites (1)

Dartmouth Hitchcock Medical Center, Dartmouth Cancer Center

Lebanon, New Hampshire, 03756, United States

Location

Related Publications (27)

• 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.

  PMID: 28181973 BACKGROUND

• 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

  BACKGROUND

• 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.

  PMID: 21306863 BACKGROUND

• 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.

  PMID: 21998438 BACKGROUND

• 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.

  PMID: 23018166 BACKGROUND

• 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.

  PMID: 21287348 BACKGROUND

• 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.

  PMID: 8477405 BACKGROUND

• 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.

  PMID: 25284739 BACKGROUND

• 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.

  PMID: 25253110 BACKGROUND

• 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

  BACKGROUND

• 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.

  PMID: 10851775 BACKGROUND

• 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.

  PMID: 21951738 BACKGROUND

• 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.

  PMID: 23224244 BACKGROUND

• 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.

  PMID: 18047576 BACKGROUND

• 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

  BACKGROUND

• 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.

  PMID: 18794556 BACKGROUND

• 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.

  PMID: 20600809 BACKGROUND

• 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.

  PMID: 26991721 BACKGROUND

• 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.

  PMID: 27206308 BACKGROUND

• 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.

  PMID: 22571244 BACKGROUND

• 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.

  PMID: 18987505 BACKGROUND

• 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.

  PMID: 27482166 BACKGROUND

• 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.

  PMID: 24582620 BACKGROUND

• 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.

  PMID: 25759407 BACKGROUND

• 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.

  PMID: 24882025 BACKGROUND

• 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.

  PMID: 21320190 BACKGROUND

• 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.

  PMID: 15003743 BACKGROUND

MeSH Terms

Conditions

Acute Pain; Anxiety Disorders

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders

Study Officials

• Anna Schaal, MSN, APRN

  Dartmouth-Hitchcock Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Hematology Nurse Practitioner

Study Record Dates

• First Submitted: June 2, 2021
• First Posted: June 23, 2021
• Study Start: October 13, 2021
• Primary Completion: January 28, 2022
• Study Completion: April 20, 2022
• Last Updated: July 3, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)