Study Stopped
Difficulty in recruiting patients.
Evaluation and Management of Parturients' Pain Intensity
1 other identifier
interventional
N/A
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started Sep 2024
Typical duration for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 31, 2018
CompletedFirst Posted
Study publicly available on registry
December 10, 2020
CompletedStudy Start
First participant enrolled
September 1, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 1, 2026
May 13, 2024
May 1, 2024
2 years
July 31, 2018
May 9, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
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.
4 weeks (starting from 36-week gestation)
Study Arms (3)
Affective pain stimuli group
EXPERIMENTALaffective/neutral word pairs
Sensory pain stimuli group
EXPERIMENTALsensory/neutral word pairs
Control group
PLACEBO COMPARATORaffective/neutral and sensory/neutral word pairs
Interventions
Patients undergo ABM training to shift attention away from affective pain stimuli
Patients undergo ABM training to shift attention away from sensory pain stimuli
Patients undergo ABM training to receive affective/neutral and sensory/neutral word pairs
Eligibility Criteria
You may qualify if:
- Parturients who are at 36 weeks gestation (at time of starting the study)
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (3)
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.
PMID: 27327608BACKGROUNDSchoth 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.
PMID: 23731349RESULTDuschek 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.
PMID: 24447855RESULT
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jie Zhou, MD, MS, MBA
Harvard Medical School (HMS and HSDM)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor
Study Record Dates
First Submitted
July 31, 2018
First Posted
December 10, 2020
Study Start
September 1, 2024
Primary Completion (Estimated)
September 1, 2026
Study Completion (Estimated)
December 1, 2026
Last Updated
May 13, 2024
Record last verified: 2024-05
Data Sharing
- IPD Sharing
- Will not share