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

NCT00315796 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2015-04-01

No results posted yet for this study

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

Interventions

DEVICE

Biophilic Nature Scene and Sound

Sponsors & Collaborators

Principal Investigators

  • Noah Lechtzin, MD, MHS · Johns Hopkins University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2004-08-31
Completion
2005-06-30

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00315796 on ClinicalTrials.gov