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NOT YET RECRUITING
NCT07077590
NA

Can Labor Pain be Reduced by Open Placebo Intervention? A Bayesian Account for Labor Pain

Sponsor: Roi Treister

View on ClinicalTrials.gov

Summary

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.

Key Details

Gender

FEMALE

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

120

Start Date

2025-07-15

Completion Date

2027-12-31

Last Updated

2025-07-22

Healthy Volunteers

No

Interventions

BEHAVIORAL

Open Label 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 a verbal suggustion. The placebo is 5 ml NaCl 0.9%.

Locations (1)

Hillel Yaffe Medical Center

Hadera, Israel