Music and/or Video Games for Pain Management During Induction of Labor
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 253
- 试验地点
- 2
- 主要终点
- Time until patient request for pain medication after Foley bulb placement.
研究概览
简要总结
Data are lacking regarding the use of music and video games for the management of pain in labor. Pregnant women that are scheduled for labor induction with Foley bulb after 37 weeks will be approached for participation in the study. Patients will be randomized to a music/video games group and a non-music/video games group. Those randomized to group with music/video games will be given an iPod for those purposes.The primary outcome will be the time for patients to request pain medications after Foley bulb placement. The two groups will be compared for differences in pain outcomes.
详细描述
For decades, investigators have been evaluating the efficacy of music for pain relief. Music for pain management has been studied in the field of palliative care, oncology, physical therapy, pediatrics, post-operative procedural pain and childbirth. A 2006 Cochrane review found that listening to music reduces pain intensity levels and opioid requirements, but the magnitude of the benefits is small and the clinical importance unclear. Previous studies in obstetrics vary, as some evaluate music for pain control at time of cesarean section and others during labor. A 2014 study investigated the effect of progressive muscle relaxation exercises and music on low back pain and quality of life in pregnancy. Some previous studies investigating music or white noise for pain control during labor revealed beneficial results. One prospective trial of 25 women found little practical value of audio-analgesia.
However, most studies evaluating music therapy for pain relief in labor were limited by sample size. Specifically, a 2011 Cochrane review investigating randomized controlled trials comparing relaxation methods as a method of pain management in labor found insufficient evidence for the role of music and audio-analgesia and the need for further research. Excluded from this review was a trial by Phumdoung et al. due to the inability to obtain additional methodological and statistical information from the authors. More recently, a randomized controlled trial (RCT) done in Turkey randomized 156 women into a music and control group. Mothers in the music group were found to have a significantly lower level of pain and anxiety in all stages of labor. Pain and anxiety were evaluated by a visual analog scale. While this evidence is the best to date, there is a lack of generalizability for other populations and the primary outcome was subjective. A 2012 systematic review of video games found improvement in psychological therapy, physical therapy, physical activity, clinical skills, health education, pain distraction, and disease self-management outcomes.
Labor induction is a common obstetrical procedure. Labor results in severe pain for many women and typically requires medical treatment for pain relief. Types of analgesia for pain control on labor include parenteral (Fentanyl, Nalbuphine, Meperidine) and regional (spinal, epidural, combined spinal epidural) analgesia. However, all types of analgesia pose risks to the mother and fetus. Administration of parenteral agents result in minimal-to-absent reduction in pain scores and high doses affect fetal heart rate tracing and later increase the number of infants requiring naloxone therapy. While regional analgesia provides superior pain relief, common complications include hypotension, fever, postdural puncture headache, transient fetal heart rate decelerations, pruritus, and inadequate pain relief. Due to these risks and other reasons, many women prefer to go through labor without medical therapies or with minimal medical therapy and desire complementary therapies to help manage their pain. Data are lacking regarding the use of music and video games for the management of pain in labor.
In view of the lack of good quality evidence from well designed RCTs, we propose a randomized controlled trial to determine the utility of music and video games for pain management during induction of labor. Pregnant women that are scheduled for labor induction with Foley bulb after 37 weeks will be approached for participation in the study. The study informed consent will be obtained. Patients will be randomized to a music/video games group (group 1) and a non-music/video games group (group 2). Those randomized to group with music/video games will be given an iPod for those purposes. The iPod will include free music applications such as Pandora as well as some of the most commonly downloaded games. Randomization will be performed using a computer generated random list of numbers assigning patients to the 2 groups of the study. Randomization will occur after the Foley bulb is placed. Study assignment and the list of random number assignments will be kept secure in opaque envelopes until the end of the study.
Prospective subjects presenting for induction of labor in labor and delivery, and willing to participate in the study will be evaluated for their eligibility. After the Foley bulb is placed, patients will be randomized. Those assigned to the music/video game group will be given an iPod to use during labor. These patients will have the choice of listening to music via earphones or a speaker which amplifies the sound. Patients assigned to the non-music/video game group will not be given an iPod and will be asked to avoid using their own personal devices (if applicable) as much as possible. Understanding that patients randomized to the non-music/video game may still elect to use their own electronic devices, time of use of electronics for music/video game purposes will be recorded in both groups with assistance from the patients and nursing staff.
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
- Female
- 接受健康志愿者
- 是
入选标准
- •Age > or = 18 years old
- •Pregnant women > or = 37 weeks gestation
- •Induction of labor using Foley bulb
- •Singleton gestation
- •Vertex fetal presentation
- •Intact membranes
排除标准
- •Any contraindication for vaginal delivery (malpresentation, placenta previa)
- •Previous cesarean section
- •Gestational age <37 weeks gestation
- •Receiving pain medication at time of Foley bulb placement
- •Chronic narcotic use (methadone, suboxone, oxycodone, etc.)
- •Visual or auditory impairment.
研究组 & 干预措施
Music/video games
iPod (Music/video games)
干预措施: iPod (Music/video games) (Other)
No intervention
No intervention
结局指标
主要结局
Time until patient request for pain medication after Foley bulb placement.
时间窗: From time of Foley bulb placement (randomization) until time of request for pain medicine or time of delivery, whichever came first, assessed up to 3 days.
Time from Foley bulb placement until patient requests pain medication.
次要结局
- Parenteral medication(From time of Foley bulb placement (randomization) until time of delivery, assessed up to 3 days.)
- Visual analog scale (VAS) pain score(Six hours from time of Foley bulb placement (randomization).)
