Can Labor Pain be Reduced by Open Placebo Intervention? A Bayesian Account for Labor Pain
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Pain intensity on a 0-10 Numerical Pain Scale (NPS)
研究概览
简要总结
The human nervous system continuously processes a potentially overwhelming stream of signals from bodily senses, which induces uncertainty. To reduce this uncertainty, the brain transforms sensory input into a reliable perception of the world. According to the Bayesian hypothesis of perception, based on probabilistic estimation, conscious perception is shaped by both the current state of sensory information and by past experiences, associative learning, stored memories, and beliefs. This framework is particularly relevant for explaining the phenomenon of pain, including individual differences in pain perception and response.
The focus of the present work is pain during childbirth, representing a major acute pain event. Pain during childbirth is a complex and unique experience with both sensory and emotional components, embedded within a defined physiological process. A key concept of the Bayesian model related to pain perception is the placebo phenomenon, which offers a compelling explanation for the analgesic placebo response.
The overarching aim of this study is to evaluate whether the Bayesian model can account for changes in pain perception during labor following open placebo administration, as well as the involvement of expectations and personality traits.
The study will be conducted at Hillel-Yaffe Medical Center, with the participation of 120 pregnant women. The research will be divided into two stages. The first stage will occur during the prenatal period, while participants are in a pain-free state. During this stage, questionnaires will be completed to assess expectations and personality traits, and the Focused Analgesia Selection Test (FAST) will be administered to evaluate within-subject variability in pain intensity. The second stage will take place during labor and will involve an open placebo intervention, during which pain levels and analgesic consumption will be monitored.
详细描述
Aims and Hypotheses
Overall Aim:
To assess whether the Bayesian model can explain changes in pain perception during labor following open-placebo administration.
Specific Aims and Hypotheses:
Aim 1: To investigate whether open placebo reduces pain and analgesic consumption during labor.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Pregnant women with one fetus who are after 24th week onwards.
- •Without contraindications for analgesia at birth.
- •Without contraindications for vaginal birth.
排除标准
- •Women in obstetric emergencies, including intrauterine death, suspected placental separation, uterine rupture, placental opening
- •Elective cesarean section
- •Receiving psychiatric treatment.
研究组 & 干预措施
Usual care (control arm)
Any woman who arrive to the labor room is connected to fluids (Hartman's solution), as part of routine care. In the control arm, the information given will be:" These fluids are important to keep your fluids balance, and is given to any delivering woman".
Open placebo
Any woman who arrive to the labor room is connected to fluids (Hartman's solution), as part of routine care. The study intervention (open placebo) is based on injection of placebo into an infusion bag accompanied by the verbal explanation. The placebo is 5 ml NaCl 0.9%.
干预措施: Open Label Placebo (Behavioral)
结局指标
主要结局
Pain intensity on a 0-10 Numerical Pain Scale (NPS)
时间窗: Each 60 minutes through the labor process.
Pain assessment will be performed by using the unidimensional Numerical Pain Scale (NPS) by asking the patient to range the pain, subjectively, from her point of view, from none (0) to a worst imaginable pain (10). Pain intensity will be assessed once in 60 minutes for the duration of the labor. Since each labor duration is difrent, the primary outcome would be the levels of pain during the labor process. Those intensities over time will be compared bewteen the two study arms. In addition, in additional analyses, pain intensities will be compared for each labor phase, seperatly.
Within-subject variability of pain reports
时间窗: At baseline
The Focused Analgesia Selection Test (FAST) procedure will be used to assess the within-subject variability of pain reports. The FAST includes exposure to several thermal noxious stimuli, administrated repeatedly at different intensities, which will be delivered to the ventral surface of the non-dominant arm (Medoc® Thermal Sensory Analyzer II with a thermodin size of 30 \* 30 mm). Pain intensity ratings are obtained from the participant after each stimulus on a 0-100 numerical rating scale (NRS) ranging from 0 ("no pain") to 100 ("worst pain imaginable"). Stimuli will be triggered automatically every 20 seconds. Relationship between stimulus intensities and pain reports are calculated (R2 and ICC) to assess the magnitude of variability observed.
次要结局
- Assessment of expectations from the treatment(At baseline)
- Questionnaire for the prediction of the placebo response(At baseline)
- Fear of childbirth(At baseline)
- Suggestibility(At baseline)
- Anxiety(At baseline)
- Interoception(At baseline)
- Body Awareness(At baseline)
- Self-consciousness(At baseline)
研究者
Roi Treister
Prof. Roi Treister, PhD
University of Haifa