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NCT00315796 · ClinicalTrials.gov registry record · Phase 3
Nature Sights and Sounds to Reduce Pain in Cancer Patients Undergoing Bone Marrow Aspiration and Biopsy
A Phase 3 study, sponsored by Johns Hopkins University.
- Completed
- Registry status
- Phase 3
- Development phase
- 120
- Enrollment target
NCT00315796: Completed Phase 3 study, sponsored by Johns Hopkins University.
NCT00315796 is a Phase 3 study that has completed, run by Johns Hopkins University. The registered enrollment target is 120 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00315796, a Phase 3 study, has completed, sponsored by Johns Hopkins University.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 120 participants
- Enrollment target
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 thre
Interventions
- DEVICE Biophilic Nature Scene and Sound
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 120 participants |
| Start Date | 2004-08 |
| Est. Completion | 2005-06 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00315796
The ClinicalTrials.gov registry entry for NCT00315796 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 120 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Johns Hopkins University, which has 1,448 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Biophilic Nature Scene and Sound is the first listed.
NCT00315796 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00315796 about?
NCT00315796 is a clinical study titled "Nature Sights and Sounds to Reduce Pain in Cancer Patients Undergoing Bone Marrow Aspiration and Biopsy". 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 contr...
What is the current status of trial NCT00315796?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 120 participants. The study started on 2004-08. Estimated completion is 2005-06.
What interventions are being tested in trial NCT00315796?
The interventions under investigation include: Biophilic Nature Scene and Sound (DEVICE).
Who is sponsoring clinical trial NCT00315796?
This trial is sponsored by Johns Hopkins University, which has 1,448 total clinical trials registered on ClinicalTrials.gov.
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