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
About this trial
This is an interventional health services research trial for Labor Pain
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
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
NCT ID
NCT04662450
First Posted
July 31, 2018
Last Updated
February 25, 2023
Sponsor
Harvard Medical School (HMS and HSDM)
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
Learn more about this trial
Evaluation and Management of Parturients' Pain Intensity
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