Music as an Auxiliary Analgesic and Anxiolytic During First Trimester Abortion
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 106
- 试验地点
- 1
- 主要终点
- Pain and anxiety experienced during first trimester abortion.
研究概览
简要总结
Most first trimester abortions are performed under local anesthesia using either manual or electric vacuum suction aspiration. The majority of women undergoing these procedures experience some amount of pain and anxiety. The investigators seek to understand if the provision of music during first trimester abortion will reduce pain and anxiety associated with this procedure. This study will involve the use of music during first trimester abortion as an additional method of pain and anxiety control. The investigators will recruit women seeking a first trimester suction aspiration procedure primarily for elective pregnancy termination or for other related indications such as an abnormal pregnancy, inevitable abortion, or retained products of conception. Participation will be voluntary and include informed consent. Recruited women will be divided into two groups: control group (no music) and intervention (music) group. All subjects will receive routine care and standard pain control measures, including local anesthesia, during their procedure. Those assigned to the intervention group will receive a portable digital music player (iPOD™ Nano) with headphones to listen to during their procedure. All subjects will complete preoperative and postoperative pain and anxiety questionnaires in addition to a patient satisfaction survey at the end of their visit. The provider will also assess and record the subject's pain experienced during the procedure. The investigators will also measure preoperative and postoperative vital signs on all participants. Subjects will be compensated for their time and study participation will not affect any care received at the clinic. Upon completion of their visit, there will be no additional followup for this study.
详细描述
Nearly 90% of abortions occur during the first trimester and a majority of these are performed by suction curettage in an outpatient setting using local anesthesia (Grimes, 2007; Lichtenberg, 2001). When only local anesthesia is used, 97% of women experience pain, and anxiety level is a positive predictor of pain during abortion (Bélanger, 1989). Although general anesthesia offers better agents for anxiety and pain management, this route is less commonly used because of prohibitive costs and potential complications (Grimes, 2007). Because many first trimester abortion providers utilize local anesthesia as primary pain management during the procedure, multiple agents and techniques have been investigated to supplement or enhance the effects of the local anesthetic. Investigated methods include time delay between paracervical block administration and cervical dilation, intrauterine lidocaine infusion, and various combinations of inhaled, oral, and intravenous analgesics and anxiolytics. Additionally, complementary and alternative regimens such as relaxation, distraction, hypnosis, and aromatherapy have also been evaluated as auxiliary analgesics and anxiolytics during first trimester abortion. Despite these attempts to improve the anxiety and pain associated with abortion under local anesthesia, the results and efficacy of these methods is variable and inconsistent.
Music therapy is classified as a cognitive-behavioral intervention that helps patients by providing them with a greater sense of self-control in assessing and managing pain (AHCPR, 1992). In 1992, recommendations by the Agency for Healthcare Research and Quality included music as one type of cognitive-behavioral intervention for pain management (AHCPR, 1992). The exact mechanism as to how music impacts pain sensory systems has not been fully elucidated, but it is thought to engage specific brain functions involved in memory, learning, and multiple motivational and emotional states (Nilsson, 2008). As the most influential theory on the nature of pain, the Gate Control Theory hypothesizes that cognitive-behavioral interventions work by closing the gate of nerve fibers that transmit ascending sensory information to the brain while concurrently modulating input from inhibitory systems and psychological factors, the sum of which leads to a reduction in the pain experience (Tse, 2005; Sendelbach, 2006). The Gate Control Theory posits that music acts as a distracter, diverting attention away from a noxious stimulus by redirecting a person's attention or by involving the individual in a distracting task (Tse, 2005).
The role of music as an auxiliary analgesic and anxiolytic has been evaluated in such outpatient procedures as colonoscopy, laceration repair, dental work, lithotripsy, nasal surgery, breast biopsy, and colposcopy (Chan, 2003). In addition to other nonpharmacologic approaches to pain management such as relaxation, distraction, and guided imagery, musical interventions have demonstrated favorable effects upon pain, anxiety, wound healing, and recovery among patients in the peri-operative setting (Laurion, 2003). Physiological parameters such as heart rate, blood pressure, and stress hormone levels improve under the influence of music (Leardi, 2007). A Cochrane Collaboration review on the use of music for pain relief found that music reduced pain intensity levels but recommended that music not be used for primary pain control (Cepeda, 2006). The authors also concluded that the impact of music on anxiety has not yet been determined and needs to be further investigated. Given music's demonstrated benefits as an auxiliary analgesic and anxiolytic in multiple operative settings, its role in the abortion setting deserves further examination. The objective of this study is to evaluate the role of music as an alternative agent for pain and anxiety management during first trimester abortion.
A systematic review of 42 randomized controlled trials evaluated the effects of music in multiple peri-operative settings and found that the intervention had positive effects in reducing patient pain and anxiety in approximately half of the reviewed studies (Nilsson, 2008). Many included trials were noted to be of "insufficient quality" and a meta-analysis could not be performed due to variation in the types of music used, the duration of listening time, and procedures investigated. Furthermore, some studies used non-validated questionnaires and had other methodological limitations. Nonetheless, the author concluded that peri-operative musical interventions are easy to implement and effective in reducing patient pain, anxiety, and stress (Nilsson, 2008).
A 2006 Cochrane Collaboration review examined the effect of music on acute and chronic pain in 51 randomized controlled trials. They calculated the mean difference in pain intensity levels, percentage of patients with at least 50% pain relief, and opioid requirements among 3663 subjects. The authors concluded that listening to music reduced pain intensity levels and opioid requirements but that the magnitude of these benefits is small with uncertain clinical significance (Cepeda, 2006). Although the pooled results indicated statistical significance in the reduction of post-operative pain intensity levels, the authors stated that the role of music in pain relief warrants further investigation as does its role as a potential anxiolytic. As musical interventions have not been shown to have adverse effects, it is worth pursuing this nonpharmacologic agent as a supplemental resource for patients undergoing medical procedures such as first trimester abortion.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Viable or non-viable intrauterine pregnancy less than or equal to 14 weeks gestational age (including women with an abnormal pregnancy, inevitable abortion, or retained products of conception)
- •Ability to read and speak English or Spanish
- •Willingness to participate in the randomized trial
排除标准
- •Hearing or visual impairment
- •Allergy to ibuprofen or lidocaine
结局指标
主要结局
Pain and anxiety experienced during first trimester abortion.
时间窗: 1 day. Outcome measured immediately after procedure without additional follow-up.
次要结局
- Heart rate and blood pressure changes.(Measured before and after procedure.)
- Overall patient satisfaction.(Assessed immediately after procedure.)
- Provider assessment of patient's pain.(Assessed immediately after procedure.)
研究者
Paula Castano
Assistant Clinical Professor
Columbia University
