Evaluation and Management of Parturients' Pain Intensity

NCT ID: NCT04662450

Last Updated: 2024-05-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2024-09-30

Study Completion Date

2026-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The primary objective of this study is to examine the effects of Attentional Bias Modification (ABM) on the labor pain in parturients. One-third of the participants will undergo ABM training away from affective pain stimuli. One-third of the participants will undergo ABM training away from sensory pain stimuli. The rest of participants will be the control group.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

In recent years, significant attention has been paid to the attentional bias in patients with chronic pain. Studies found that Attentional Bias Modification (ABM) could reduce the pain intensity in participants with chronic pain. The investigator's goal is to evaluate the effects of ABM on labor pain and patient satisfaction with the labor and delivery experience.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Labor Pain

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

SINGLE

Participants

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Affective pain stimuli group

affective/neutral word pairs

Group Type EXPERIMENTAL

ABM affective pain stimuli

Intervention Type BEHAVIORAL

Patients undergo ABM training to shift attention away from affective pain stimuli

Sensory pain stimuli group

sensory/neutral word pairs

Group Type EXPERIMENTAL

ABM sensory pain stimuli

Intervention Type BEHAVIORAL

Patients undergo ABM training to shift attention away from sensory pain stimuli

Control group

affective/neutral and sensory/neutral word pairs

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type BEHAVIORAL

Patients undergo ABM training to receive affective/neutral and sensory/neutral word pairs

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

ABM affective pain stimuli

Patients undergo ABM training to shift attention away from affective pain stimuli

Intervention Type BEHAVIORAL

ABM sensory pain stimuli

Patients undergo ABM training to shift attention away from sensory pain stimuli

Intervention Type BEHAVIORAL

Placebo

Patients undergo ABM training to receive affective/neutral and sensory/neutral word pairs

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Parturients who are at 36 weeks gestation (at time of starting the study)

Exclusion Criteria

1. Any patient who refuses
2. Patients with impaired decision-making capacity
3. Patients who are blind or extremely visually impaired
4. Patients who cannot understand or read English
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Harvard Medical School (HMS and HSDM)

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Jie Zhou

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Jie Zhou, MD, MS, MBA

Role: PRINCIPAL_INVESTIGATOR

Harvard Medical School (HMS and HSDM)

References

Explore related publications, articles, or registry entries linked to this study.

Todd J, Sharpe L, Colagiuri B. Attentional bias modification and pain: The role of sensory and affective stimuli. Behav Res Ther. 2016 Aug;83:53-61. doi: 10.1016/j.brat.2016.06.002. Epub 2016 Jun 15.

Reference Type BACKGROUND
PMID: 27327608 (View on PubMed)

Schoth DE, Georgallis T, Liossi C. Attentional bias modification in people with chronic pain: a proof of concept study. Cogn Behav Ther. 2013;42(3):233-43. doi: 10.1080/16506073.2013.777105. Epub 2013 Jun 4.

Reference Type RESULT
PMID: 23731349 (View on PubMed)

Duschek S, Werner NS, Limbert N, Winkelmann A, Montoya P. Attentional bias toward negative information in patients with fibromyalgia syndrome. Pain Med. 2014 Apr;15(4):603-12. doi: 10.1111/pme.12360. Epub 2014 Jan 21.

Reference Type RESULT
PMID: 24447855 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2017P001416

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.