Ignite Creation Date:
2025-12-24 @ 11:44 PM
Ignite Modification Date:
2025-12-25 @ 9:37 PM
Study NCT ID:
NCT04863651
Status:
UNKNOWN
Last Update Posted:
2021-04-28
First Post:
2021-04-26
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Attachment Predicts Post Cesarean Pain
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 65}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-01-13', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-04', 'completionDateStruct': {'date': '2021-09', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-04-27', 'studyFirstSubmitDate': '2021-04-26', 'studyFirstSubmitQcDate': '2021-04-27', 'lastUpdatePostDateStruct': {'date': '2021-04-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-04-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-05', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pain Score', 'timeFrame': '24 hours', 'description': 'Pain score from 0-10, measured at 24 hours post-operative'}], 'secondaryOutcomes': [{'measure': 'ObsQoR10 Score', 'timeFrame': '24 hours', 'description': 'Total score on the ObsQoR10 tool, a quality of recovery tool post cesarean section. Collected at 24 hours post-operative.'}, {'measure': 'Total Opioid Consumption first 24h', 'timeFrame': '24 hours', 'description': 'Total consumption of opioids by the patient in the first 24 hours post-operative, including the time at which additional opioid analgesia was first requested by the patient.'}, {'measure': 'First Occurrence of Nausea', 'timeFrame': '24 hours', 'description': 'The first time the patient reports feeling nauseous within the first 24 hours post-operative.'}, {'measure': 'First Occurrence of Vomiting', 'timeFrame': '24 hours', 'description': 'The first time the patient reports feeling vomiting within the first 24 hours post-operative.'}, {'measure': 'First Occurrence of Pruritis', 'timeFrame': '24 hours', 'description': 'The first time the patient reports feeling vomiting within the first 24 hours post-operative.'}, {'measure': 'First Occurence of Sedation', 'timeFrame': '24 hours', 'description': 'The first time the patient reports feeling sedated within the first 24 hours post-operative.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Cesarean', 'Cesarean Section', 'Attachment Style', 'Revised Adult Attachment Style', 'Post Cesarean Pain', 'Post Cesarean Recovery'], 'conditions': ['Cesarean Section Complications', 'Attachment Disorder', 'Post Operative Recovery']}, 'referencesModule': {'references': [{'pmid': '30579408', 'type': 'BACKGROUND', 'citation': 'Ciechanowicz S, Setty T, Robson E, Sathasivam C, Chazapis M, Dick J, Carvalho B, Sultan P. Development and evaluation of an obstetric quality-of-recovery score (ObsQoR-11) after elective Caesarean delivery. Br J Anaesth. 2019 Jan;122(1):69-78. doi: 10.1016/j.bja.2018.06.011. Epub 2018 Jul 31.'}, {'pmid': '30086610', 'type': 'BACKGROUND', 'citation': 'Lee SS, Rim HD, Won SH, Woo J. Avoidant Insecure Attachment as a Predictive Factor for Psychological Distress in Patients with Early Breast Cancer: A Preliminary 1-Year Follow-Up Study. Psychiatry Investig. 2018 Aug;15(8):805-810. doi: 10.30773/pi.2018.06.07. Epub 2018 Aug 9.'}, {'pmid': '28885733', 'type': 'BACKGROUND', 'citation': 'Penacoba C, Perez-Calvo S, Blanco S, Sanroman L. Attachment styles, pain intensity and emotional variables in women with fibromyalgia. Scand J Caring Sci. 2018 Jun;32(2):535-544. doi: 10.1111/scs.12477. Epub 2017 Sep 8.'}, {'pmid': '25337857', 'type': 'BACKGROUND', 'citation': 'Andrews NE, Meredith PJ, Strong J, Donohue GF. Adult attachment and approaches to activity engagement in chronic pain. Pain Res Manag. 2014 Nov-Dec;19(6):317-27. doi: 10.1155/2014/838954. Epub 2014 Oct 22.'}, {'pmid': '25641282', 'type': 'BACKGROUND', 'citation': "Costa Martins JM, da Silva CF, Pereira M, Martins H, Oliveira C, Puga A, Coelho R, Tavares J. Women's attachment as a predictor of pain during labour and post-delivery: a prospective observational study. Acta Med Port. 2014 Nov-Dec;27(6):692-9. doi: 10.20344/amp.4960. Epub 2014 Dec 30."}, {'pmid': '30356426', 'type': 'BACKGROUND', 'citation': 'Suso-Ribera C, Sullivan MJL, Suso-Vergara S. Pain Intensity Is Not Always Associated with Poorer Health Status: Exploring the Moderating Role of Spouse Personality. Pain Res Manag. 2018 Sep 26;2018:7927656. doi: 10.1155/2018/7927656. eCollection 2018.'}]}, 'descriptionModule': {'briefSummary': "The Adult Attachment Style (AAS) is a questionnaire designed to measure how an adult generally feels in their close personal relationships. The questionnaire has two main axes of measurements - avoidance and anxiety, that gives rise to four different categories of attachment styles. Women's attachment styles have been shown to be correlated to pain during labour, but not after. No study has analyzed whether attachment styles are correlated to the pain after cesarean section. This study will assess correlation between the AAS score, and pain after elective cesarean section. Additionally, this study aims to clarify the correlation between attachment scale and overall quality of recovery after cesarean section as defined by a recently validated tool, the ObsQoR10.", 'detailedDescription': 'Overall recovery after cesarean section is difficult to measure and must consider several factors that may influence recovery. The ObsQoR10 is a recently validated tool that provides an overall picture of post cesarean recovery using pain, functional milestones, and emotional needs1. One of the factors that may influence recovery post operatively is a person\'s Adult Attachment Style (AAS).\n\nAAS refers to how a person "generally feels in close relationships in their lives" and is prevalent in literature in the context of chronic pain. AAS has been shown to be correlated to patients\' psychological stress2, self reported pain intensity and even the prevalence of chronic pain conditions like fibromyalgia3. In a cohort of patients with chronic pain, securely attached individuals were less likely to report disability due to pain, depressive symptoms and perceived negative spouse responses in comparison to securely attached individuals4. Another cohort showed that patients were characterized as fearful avoidant were more likely to catastrophize their pain and exhibit activity avoiding behaviours5.\n\nLiterature on AAS in the context of pain experienced by parturients is not as well characterized. Costas-Martins et al showed that insecurely attached women experience more pain during labour6. Costas-Martins et al include in their cohort a number of cesarean patients but do not consider them separately. To date there has not been a study investigating whether the AAS of parturients undergoing cesarean section is correlated to their perceived pain.2\n\nWhile pain is an important clinical outcome, overall recovery as measured by the ObsQoR10 may present a more complete clinical picture of the predictive power of a person\'s AAS. Our study aims to characterize whether parturients\' AAS is correlated with their overall recovery post cesarean section as well as pain.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': "65 English speaking parturients undergoing elective cesarean section at Victoria Hospital's Obstetrical Care Unit will be approached prior to their scheduled operation.", 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\ni. English Speaking ii. Elective Cesarean Sections iii. ASA 3 or lower iv. Singleton Pregnancy v. Between 37-40 weeks gestation\n\nExclusion Criteria:\n\ni. Patient Refusal ii. History of chronic pain condition, currently on medication iii. Diagnosed General Anxiety Disorder iv. Diagnosed substance use disorder'}, 'identificationModule': {'nctId': 'NCT04863651', 'briefTitle': 'Attachment Predicts Post Cesarean Pain', 'organization': {'class': 'OTHER', 'fullName': 'Western University, Canada'}, 'officialTitle': "Do Patient's Adult Attachment Style Correlate With Pain Post Cesarean Delivery?", 'orgStudyIdInfo': {'id': 'WREM114262'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Securely Attached Parturients', 'description': 'Parturients who have a secure attachment style according to the Revised Adult Attachment Scale (Collins, 1996)'}, {'label': 'Insecurely Attached Parturients', 'description': 'Parturients who have an insecure attachment style according to the Revised Adult Attachment Scale (Collins, 1996)'}]}, 'contactsLocationsModule': {'locations': [{'zip': 'N6A 5W9', 'city': 'London', 'state': 'Ontario', 'status': 'RECRUITING', 'country': 'Canada', 'contacts': [{'name': 'Ilana Sebbag, MD', 'role': 'CONTACT', 'email': 'Ilana.Sebbag@lhsc.on.ca', 'phone': '519 685 8500', 'phoneExt': '13545'}, {'name': 'Indu Singh, MD', 'role': 'CONTACT', 'email': 'indu.singh@lhsc.on.ca', 'phone': '519 646 6000', 'phoneExt': '6421913545'}, {'name': 'Yueyang Li, BSc', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Jill Querney, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Yahui Symons, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Philip Jones, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Sonali Hastir, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Victoria Hospital', 'geoPoint': {'lat': 42.98339, 'lon': -81.23304}}], 'centralContacts': [{'name': 'Ilana Sebbag, MD', 'role': 'CONTACT', 'email': 'Ilana.Sebbag@lhsc.on.ca', 'phone': '519 685 8500', 'phoneExt': '13545'}, {'name': 'Indu Singh, MD', 'role': 'CONTACT', 'email': 'Indu.Singh@lhsc.on.ca', 'phone': '519 646 6000', 'phoneExt': '64219'}], 'overallOfficials': [{'name': 'Ilana Sebbag, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Western University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Study data will only be linked to a research number which will be correlated with identifying information on a master list paper copy only accessible to the members of this study.\n\nData will not be shared with researchers whom are not included in this study.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Western University, Canada', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}