Evaluation and Management of Parturients' Pain Intensity

May 9, 2024 updated by: Jie Zhou, Harvard Medical School (HMS and HSDM)
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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (Adult)

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Affective pain stimuli group
affective/neutral word pairs
Behavioral: ABM affective pain stimuli
Patients undergo ABM training to shift attention away from affective pain stimuli
Experimental: Sensory pain stimuli group
sensory/neutral word pairs
Behavioral: ABM sensory pain stimuli
Patients undergo ABM training to shift attention away from sensory pain stimuli
Placebo Comparator: Control group
affective/neutral and sensory/neutral word pairs
Behavioral: Placebo
Patients undergo ABM training to receive affective/neutral and sensory/neutral word pairs

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Effects of Attentional Bias Modification (ABM) on labor pain
Time Frame: 4 weeks (starting from 36-week gestation)
Change in pain threshold and labor pain as measured by Fear of Pain Questionnaire (FPQ), Brief Pain Inventory (BPI) and McGill Pain Questionnaire (MPQ) before and after the ABM training.
4 weeks (starting from 36-week gestation)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Harvard Medical School (HMS and HSDM)

Investigators

  • Principal Investigator: Jie Zhou, MD, MS, MBA, Harvard Medical School (HMS and HSDM)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

September 1, 2024

Primary Completion (Estimated)

September 1, 2026

Study Completion (Estimated)

December 1, 2026

Study Registration Dates

First Submitted

July 31, 2018

First Submitted That Met QC Criteria

December 9, 2020

First Posted (Actual)

December 10, 2020

Study Record Updates

Last Update Posted (Actual)

May 13, 2024

Last Update Submitted That Met QC Criteria

May 9, 2024

Last Verified

May 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2017P001416

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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