Clincosm LogoSign in Get a demo

Evaluation and Management of Parturients' Pain Intensity

Sponsor
Harvard Medical School (HMS and HSDM) (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT04662450
Collaborator
(none)
90
Enrollment
3
Arms
27
Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: ABM affective pain stimuli
  • Behavioral: ABM sensory pain stimuli
  • Behavioral: Placebo
 N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
90 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Participant)
Primary Purpose:
Health Services Research
Official Title:
Evaluation and Management of Parturients' Pain Intensity
Anticipated Study Start Date :
Sep 1, 2023
Anticipated Primary Completion Date :
Sep 1, 2025
Anticipated Study Completion Date :
Dec 1, 2025

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Effects of Attentional Bias Modification (ABM) on labor pain [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 45 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Harvard Medical School (HMS and HSDM)

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Jie Zhou, Assistant Professor, Harvard Medical School (HMS and HSDM)
ClinicalTrials.gov Identifier:
NCT04662450
Other Study ID Numbers:
  • 2017P001416
First Posted:
Dec 10, 2020
Last Update Posted:
Nov 24, 2021
Last Verified:
Nov 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Labor Pain
Pain

Study Results

No Results Posted as of Nov 24, 2021