MedTrace Logo

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

NCT07077590 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2025-07-22

No results posted yet for this study

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.

Conditions

  • Labor Pain and to Reduce Pain

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%.

Sponsors & Collaborators

  • Hillel Yaffe Medical Center

    collaborator OTHER_GOV

  • Roi Treister

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-07-15
Primary Completion
2027-05-31
Completion
2027-12-31

Countries

  • Israel

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07077590 on ClinicalTrials.gov