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Evaluation and Management of Parturients' Pain Intensity

Primary Purpose

Labor Pain

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
ABM affective pain stimuli
ABM sensory pain stimuli
Placebo
Sponsored by
Harvard Medical School (HMS and HSDM)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Labor Pain

Eligibility Criteria

18 Years - 45 Years (Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Experimental

    Experimental

    Placebo Comparator

    Arm Label

    Affective pain stimuli group

    Sensory pain stimuli group

    Control group

    Arm Description

    affective/neutral word pairs

    sensory/neutral word pairs

    affective/neutral and sensory/neutral word pairs

    Outcomes

    Primary Outcome Measures

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

    Secondary Outcome Measures

    Full Information

    First Posted
    July 31, 2018
    Last Updated
    February 25, 2023
    Sponsor
    Harvard Medical School (HMS and HSDM)
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04662450
    Brief Title
    Evaluation and Management of Parturients' Pain Intensity
    Official Title
    Evaluation and Management of Parturients' Pain Intensity
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    September 2024 (Anticipated)
    Primary Completion Date
    September 2026 (Anticipated)
    Study Completion Date
    December 2026 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Harvard Medical School (HMS and HSDM)

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. 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.
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Labor Pain

    7. Study Design

    Primary Purpose
    Health Services Research
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Participant
    Allocation
    Randomized
    Enrollment
    90 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Affective pain stimuli group
    Arm Type
    Experimental
    Arm Description
    affective/neutral word pairs
    Arm Title
    Sensory pain stimuli group
    Arm Type
    Experimental
    Arm Description
    sensory/neutral word pairs
    Arm Title
    Control group
    Arm Type
    Placebo Comparator
    Arm Description
    affective/neutral and sensory/neutral word pairs
    Intervention Type
    Behavioral
    Intervention Name(s)
    ABM affective pain stimuli
    Intervention Description
    Patients undergo ABM training to shift attention away from affective pain stimuli
    Intervention Type
    Behavioral
    Intervention Name(s)
    ABM sensory pain stimuli
    Intervention Description
    Patients undergo ABM training to shift attention away from sensory pain stimuli
    Intervention Type
    Behavioral
    Intervention Name(s)
    Placebo
    Intervention Description
    Patients undergo ABM training to receive affective/neutral and sensory/neutral word pairs
    Primary Outcome Measure Information:
    Title
    Effects of Attentional Bias Modification (ABM) on labor pain
    Description
    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.
    Time Frame
    4 weeks (starting from 36-week gestation)

    10. Eligibility

    Sex
    Female
    Gender Based
    Yes
    Gender Eligibility Description
    Parturients
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    45 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Parturients who are at 36 weeks gestation (at time of starting the study) Exclusion Criteria: Any patient who refuses Patients with impaired decision-making capacity Patients who are blind or extremely visually impaired Patients who cannot understand or read English
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Jie Zhou, MD, MS, MBA
    Phone
    617-732-8220
    Email
    jzhou@mgh.harvard.edu
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Jie Zhou, MD, MS, MBA
    Organizational Affiliation
    Harvard Medical School (HMS and HSDM)
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    27327608
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    23731349
    Citation
    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.
    Results Reference
    result
    PubMed Identifier
    24447855
    Citation
    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.
    Results Reference
    result

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    Evaluation and Management of Parturients' Pain Intensity

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