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临床试验/NCT00315796
NCT00315796已完成3 期

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

Johns Hopkins University2 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2004年8月最近更新:
适应症

试验速览

阶段
3 期
状态
已完成
入组人数
120
试验地点
2
主要终点
Pain ratings: Hopkins Pain Rating Instrument

研究概览

简要总结

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.

详细描述

Study Design: This is a randomized, controlled trial assessing the impact of nature sights and sounds (NSS) on pain control in oncology outpatients undergoing bone marrow aspirate and biopsy (BMBx) in the Weinberg Cancer Center at Johns Hopkins. One hundred twenty patients will be assigned to one of three groups: 1) standard care, 2) NSS, 3) Music/Photo. The primary outcome will be pain scores during the procedures as measured by the Hopkins Pain Rating Instrument (HPRI). Patients in all groups will receive analgesic medications as dictated by the personnel performing the procedure and the physicians responsible for their clinical care. Patients in the NSS group will have Bedscapes nature scene murals placed at the bedside in a location that is visible throughout the procedure. They will also listen to a complementary audiotape during the procedure. The music/photo group will listen to city sounds during the procedure and view a poster of a city skyline.

Setting: The study will be conducted in the Weinberg Cancer Pavilion of the Kimmel Cancer Center at the Johns Hopkins Hospital.

Patient Selection: All patients 18 years and older with a diagnosis of cancer undergoing a BMBx in the Johns Hopkins Oncology Center will be screened for enrollment in the study.

Informed Consent: The study design and consent procedure will be explained to all prospective patients. If patients are interested in taking part in the study, written informed consent will be obtained. The study nurse will administer a mental status exam and assess eligibility. Consent and screening must occur within 5 days of the patient's procedure.

Randomization: Blocked randomization will be used with variable block sizes to ensure roughly equal numbers of patients in each study arm.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Diagnosis of cancer
  • Outpatient in the Weinberg Cancer Pavilion
  • Capable of providing informed consent
  • Undergoing bone marrow aspirate/biopsy
  • Lack of any exclusion criteria

排除标准

  • 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

结局指标

主要结局

Pain ratings: Hopkins Pain Rating Instrument

次要结局

  • Affective Distress: Profile of Moods States

研究者

申办方类型
Other

研究点 (2)

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