Attachment Predicts Post Cesarean Pain

April 27, 2021 updated by: Western University, Canada

Do Patient's Adult Attachment Style Correlate With Pain Post Cesarean Delivery?

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.

Study Overview

Status

Recruiting

Conditions

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 Type

Observational

Enrollment (Anticipated)

65

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Canada
    • Ontario
      • London, Ontario, Canada, N6A 5W9
        • Recruiting
        • Victoria Hospital
        • Contact:
        • Contact:
        • Sub-Investigator:
          • Yueyang Li, BSc
        • Sub-Investigator:
          • Jill Querney, MD
        • Sub-Investigator:
          • Yahui Symons, MD
        • Sub-Investigator:
          • Philip Jones, MD
        • Sub-Investigator:
          • Sonali Hastir, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

65 English speaking parturients undergoing elective cesarean section at Victoria Hospital's Obstetrical Care Unit will be approached prior to their scheduled operation.

Description

Inclusion Criteria:

i. English Speaking ii. Elective Cesarean Sections iii. ASA 3 or lower iv. Singleton Pregnancy v. Between 37-40 weeks gestation

Exclusion Criteria:

i. Patient Refusal ii. History of chronic pain condition, currently on medication iii. Diagnosed General Anxiety Disorder iv. Diagnosed substance use disorder

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain Score
Time Frame: 24 hours
Pain score from 0-10, measured at 24 hours post-operative
24 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
ObsQoR10 Score
Time Frame: 24 hours
Total score on the ObsQoR10 tool, a quality of recovery tool post cesarean section. Collected at 24 hours post-operative.
24 hours
Total Opioid Consumption first 24h
Time Frame: 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.
24 hours
First Occurrence of Nausea
Time Frame: 24 hours
The first time the patient reports feeling nauseous within the first 24 hours post-operative.
24 hours
First Occurrence of Vomiting
Time Frame: 24 hours
The first time the patient reports feeling vomiting within the first 24 hours post-operative.
24 hours
First Occurrence of Pruritis
Time Frame: 24 hours
The first time the patient reports feeling vomiting within the first 24 hours post-operative.
24 hours
First Occurence of Sedation
Time Frame: 24 hours
The first time the patient reports feeling sedated within the first 24 hours post-operative.
24 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Western University, Canada

Investigators

  • Principal Investigator: Ilana Sebbag, MD, Western University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 13, 2020

Primary Completion (Anticipated)

May 1, 2021

Study Completion (Anticipated)

September 1, 2021

Study Registration Dates

First Submitted

April 26, 2021

First Submitted That Met QC Criteria

April 27, 2021

First Posted (Actual)

April 28, 2021

Study Record Updates

Last Update Posted (Actual)

April 28, 2021

Last Update Submitted That Met QC Criteria

April 27, 2021

Last Verified

April 1, 2021

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • WREM114262

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan 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.

Data will not be shared with researchers whom are not included in this study.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Cesarean Section Complications

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in France

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe