Nature Sights and Sounds to Reduce Pain in Cancer Patients Undergoing Bone Marrow Aspiration and Biopsy
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Cancer |
Device: Biophilic Nature Scene and Sound |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Nature Sights and Sounds to Reduce Pain in Cancer Patients Undergoing Bone Marrow Aspiration and Biopsy |
- Pain ratings: Hopkins Pain Rating Instrument
- Affective Distress: Profile of Moods States
| Estimated Enrollment: | 120 |
| Study Start Date: | August 2004 |
| Estimated Study Completion Date: | June 2005 |
Show Detailed Description
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Diagnosis of cancer
- Age>18
- Outpatient in the Weinberg Cancer Pavilion
- Capable of providing informed consent
- Undergoing bone marrow aspirate/biopsy
- Lack of any exclusion criteria
Exclusion Criteria:
- 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
Contacts and Locations| United States, Maryland | |
| Johns Hopkins Hospital | |
| Baltimore, Maryland, United States, 21205 | |
| Principal Investigator: | Noah Lechtzin, MD, MHS | Johns Hopkins University |
More Information
No publications provided by Johns Hopkins University
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| ClinicalTrials.gov Identifier: | NCT00315796 History of Changes |
| Other Study ID Numbers: | J0387, NCCAM: AT00437 |
| Study First Received: | April 17, 2006 |
| Last Updated: | April 17, 2006 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Johns Hopkins University:
|
Mind-Body Intervention Distraction Biophilic Cancer pain |
Bedscapes procedures bone marrow aspirate bone marrow biopsy |
ClinicalTrials.gov processed this record on June 18, 2013