Attachment Predicts Post Cesarean Pain

Sponsor
Western University, Canada (Other)
Overall Status
Recruiting
CT.gov ID
NCT04863651
Collaborator
(none)
65
1
19.6
3.3

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    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).

    AAS 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.

    Literature 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

    While 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.

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    65 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Do Patient's Adult Attachment Style Correlate With Pain Post Cesarean Delivery?
    Actual Study Start Date :
    Jan 13, 2020
    Anticipated Primary Completion Date :
    May 1, 2021
    Anticipated Study Completion Date :
    Sep 1, 2021

    Arms and Interventions

    Arm Intervention/Treatment
    Securely Attached Parturients

    Parturients who have a secure attachment style according to the Revised Adult Attachment Scale (Collins, 1996)

    Insecurely Attached Parturients

    Parturients who have an insecure attachment style according to the Revised Adult Attachment Scale (Collins, 1996)

    Outcome Measures

    Primary Outcome Measures

    1. Pain Score [24 hours]

      Pain score from 0-10, measured at 24 hours post-operative

    Secondary Outcome Measures

    1. ObsQoR10 Score [24 hours]

      Total score on the ObsQoR10 tool, a quality of recovery tool post cesarean section. Collected at 24 hours post-operative.

    2. Total Opioid Consumption first 24h [24 hours]

      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.

    3. First Occurrence of Nausea [24 hours]

      The first time the patient reports feeling nauseous within the first 24 hours post-operative.

    4. First Occurrence of Vomiting [24 hours]

      The first time the patient reports feeling vomiting within the first 24 hours post-operative.

    5. First Occurrence of Pruritis [24 hours]

      The first time the patient reports feeling vomiting within the first 24 hours post-operative.

    6. First Occurence of Sedation [24 hours]

      The first time the patient reports feeling sedated within the first 24 hours post-operative.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:
    1. English Speaking ii. Elective Cesarean Sections iii. ASA 3 or lower iv. Singleton Pregnancy v. Between 37-40 weeks gestation
    Exclusion Criteria:
    1. Patient Refusal ii. History of chronic pain condition, currently on medication iii. Diagnosed General Anxiety Disorder iv. Diagnosed substance use disorder

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Victoria Hospital London Ontario Canada N6A 5W9

    Sponsors and Collaborators

    • Western University, Canada

    Investigators

    • Principal Investigator: Ilana Sebbag, MD, Western University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Western University, Canada
    ClinicalTrials.gov Identifier:
    NCT04863651
    Other Study ID Numbers:
    • WREM114262
    First Posted:
    Apr 28, 2021
    Last Update Posted:
    Apr 28, 2021
    Last Verified:
    Apr 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Western University, Canada

    Study Results

    No Results Posted as of Apr 28, 2021