Nature Sights and Sounds to Reduce Pain in Cancer Patients Undergoing Bone Marrow Aspiration and Biopsy

NCT00315796 | Completed Phase 3

• 2 other identifiers: J0387NCCAM: AT00437
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

Pain is a common and difficult problem for patients with cancer. It has been reported that over 80% of cancer patients suffer from pain. Much of this pain is iatrogenic and related to procedures. Dr. Grossman recently demonstrated that most patients undergoing bone marrow biopsy have poor pain control during the procedure. Treatment of pain is almost entirely with analgesic medications, principally opioids. These medications have numerous undesirable effects such as sedation, confusion, hypotension and constipation that limit their efficacy and utility. Drs. Diette, Lechtzin, Rubin and colleagues recently demonstrated that use of nature sights and sounds (NSS), a simple, safe, and inexpensive intervention, decreases pain during fiberoptic bronchoscopy, a procedure commonly performed to diagnose cancer and to detect pulmonary complications of cancer therapy. Patients were randomly assigned to either standard care with intravenous narcotics and benzodiazepines or standard care coupled with view of a nature scene and use of nature sounds before, during, and after bronchoscopy. The group assigned to the NSS reported significantly better pain control than the control group. While these findings are novel and exciting, they raised several new questions that suggest logical extensions of this work. It is not known whether this intervention can be applied to patients in other settings, nor is it known whether comparison to standard care is an appropriate control group. Further, the mechanism of action of NSS needs to be determined. NSS may simply be a form of distraction therapy but it may have other properties. The theory of biophilia proposes there are specific elements in nature imagery that exert beneficial health effects. Because NSS appears to be a promising and safe intervention for the treatment of pain, these investigators plan to perform a controlled clinical trial in cancer patients undergoing invasive procedures. Patients will be randomly assigned to one of three arms, standard care, NSS, and a non-nature based distraction technique. We will study the efficacy of NSS for the management of procedure-related pain in oncology patients. The findings will provide necessary background information to develop more definitive studies of NSS that should be competitive for external funding. This exciting study will help develop a harmless, inexpensive method to treat pain in cancer patients, that may complement or replace analgesic medications.

Conditions

Cancer

Keywords

Mind-Body Intervention; Distraction; Biophilic; Cancer; pain; Bedscapes; procedures; bone marrow aspirate; bone marrow biopsy

Outcome Measures

Primary Outcomes (1)

• Pain ratings: Hopkins Pain Rating Instrument

Secondary Outcomes (1)

• Affective Distress: Profile of Moods States

Interventions

Biophilic Nature Scene and Sound DEVICE

Eligibility Criteria

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

You may qualify if:

• Diagnosis of cancer
• Age\>18
• Outpatient in the Weinberg Cancer Pavilion
• Capable of providing informed consent
• Undergoing bone marrow aspirate/biopsy

You may not qualify if:

• Visual impairment precluding use of nature scenes or city skyline photo
• Hearing impairment precluding use of compact discs or nature sounds
• Altered mental status (mental status score \<25)
• Infection requiring contact isolation
• Language barrier that would limit ability to answer English language questionnaires
• Karnofsky performance score below 60
• Patients receiving conscious sedation

Sponsors & Collaborators

• Johns Hopkins University: lead
• National Center for Complementary and Integrative Health (NCCIH): collaborator

Study Sites (1)

Johns Hopkins Hospital

Baltimore, Maryland, 21205, United States

Location

Related Publications (1)

• Lechtzin N, Busse AM, Smith MT, Grossman S, Nesbit S, Diette GB. A randomized trial of nature scenery and sounds versus urban scenery and sounds to reduce pain in adults undergoing bone marrow aspirate and biopsy. J Altern Complement Med. 2010 Sep;16(9):965-72. doi: 10.1089/acm.2009.0531.

  PMID: 20799901 DERIVED

MeSH Terms

Conditions

Neoplasms; Pain

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Noah Lechtzin, MD, MHS

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: April 17, 2006
• First Posted: April 19, 2006
• Study Start: August 1, 2004
• Study Completion: June 1, 2005
• Last Updated: April 1, 2015

Record last verified: 2005-01

Locations

US (1)