NCT04863651

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
65

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2020

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 13, 2020

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

April 26, 2021

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 28, 2021

Completed
3 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2021

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2021

Completed
Last Updated

April 28, 2021

Status Verified

April 1, 2021

Enrollment Period

1.3 years

First QC Date

April 26, 2021

Last Update Submit

April 27, 2021

Conditions

Keywords

CesareanCesarean SectionAttachment StyleRevised Adult Attachment StylePost Cesarean PainPost Cesarean Recovery

Outcome Measures

Primary Outcomes (1)

  • Pain Score

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

    24 hours

Secondary Outcomes (6)

  • ObsQoR10 Score

    24 hours

  • Total Opioid Consumption first 24h

    24 hours

  • First Occurrence of Nausea

    24 hours

  • First Occurrence of Vomiting

    24 hours

  • First Occurrence of Pruritis

    24 hours

  • +1 more secondary outcomes

Study Arms (2)

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)

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Victoria Hospital

London, Ontario, N6A 5W9, Canada

RECRUITING

Related Publications (6)

  • 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: 30579408BACKGROUND
  • 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: 30086610BACKGROUND
  • 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: 28885733BACKGROUND
  • 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: 25337857BACKGROUND
  • 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: 25641282BACKGROUND
  • 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.

    PMID: 30356426BACKGROUND

Study Officials

  • Ilana Sebbag, MD

    Western University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 26, 2021

First Posted

April 28, 2021

Study Start

January 13, 2020

Primary Completion

May 1, 2021

Study Completion

September 1, 2021

Last Updated

April 28, 2021

Record last verified: 2021-04

Data Sharing

IPD Sharing
Will not share

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.

Locations