Ignite Creation Date:
2025-12-24 @ 5:05 PM
Ignite Modification Date:
2026-01-17 @ 2:14 PM
Study NCT ID:
NCT04662450
Status:
WITHDRAWN
Last Update Posted:
2024-05-13
First Post:
2018-07-31
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation and Management of Parturients' Pain Intensity
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D048949', 'term': 'Labor Pain'}], 'ancestors': [{'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'Difficulty in recruiting patients.', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2024-09', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-05', 'completionDateStruct': {'date': '2026-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-05-09', 'studyFirstSubmitDate': '2018-07-31', 'studyFirstSubmitQcDate': '2020-12-09', 'lastUpdatePostDateStruct': {'date': '2024-05-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-12-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Effects of Attentional Bias Modification (ABM) on labor pain', 'timeFrame': '4 weeks (starting from 36-week gestation)', '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.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Labor Pain']}, 'referencesModule': {'references': [{'pmid': '27327608', 'type': 'BACKGROUND', '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.'}, {'pmid': '23731349', 'type': 'RESULT', '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.'}, {'pmid': '24447855', 'type': 'RESULT', '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.'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': "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."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'genderBased': True, 'genderDescription': 'Parturients', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Parturients who are at 36 weeks gestation (at time of starting the study)\n\nExclusion Criteria:\n\n1. Any patient who refuses\n2. Patients with impaired decision-making capacity\n3. Patients who are blind or extremely visually impaired\n4. Patients who cannot understand or read English'}, 'identificationModule': {'nctId': 'NCT04662450', 'briefTitle': "Evaluation and Management of Parturients' Pain Intensity", 'organization': {'class': 'OTHER', 'fullName': 'Harvard Medical School (HMS and HSDM)'}, 'officialTitle': "Evaluation and Management of Parturients' Pain Intensity", 'orgStudyIdInfo': {'id': '2017P001416'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Affective pain stimuli group', 'description': 'affective/neutral word pairs', 'interventionNames': ['Behavioral: ABM affective pain stimuli']}, {'type': 'EXPERIMENTAL', 'label': 'Sensory pain stimuli group', 'description': 'sensory/neutral word pairs', 'interventionNames': ['Behavioral: ABM sensory pain stimuli']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Control group', 'description': 'affective/neutral and sensory/neutral word pairs', 'interventionNames': ['Behavioral: Placebo']}], 'interventions': [{'name': 'ABM affective pain stimuli', 'type': 'BEHAVIORAL', 'description': 'Patients undergo ABM training to shift attention away from affective pain stimuli', 'armGroupLabels': ['Affective pain stimuli group']}, {'name': 'ABM sensory pain stimuli', 'type': 'BEHAVIORAL', 'description': 'Patients undergo ABM training to shift attention away from sensory pain stimuli', 'armGroupLabels': ['Sensory pain stimuli group']}, {'name': 'Placebo', 'type': 'BEHAVIORAL', 'description': 'Patients undergo ABM training to receive affective/neutral and sensory/neutral word pairs', 'armGroupLabels': ['Control group']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Jie Zhou, MD, MS, MBA', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Harvard Medical School (HMS and HSDM)'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Harvard Medical School (HMS and HSDM)', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Jie Zhou', 'investigatorAffiliation': 'Harvard Medical School (HMS and HSDM)'}}}}