Clinical trial NCT04863651: Attachment Predicts Post Cesarean Pain
Official title: Do Patient's Adult Attachment Style Correlate With Pain Post Cesarean Delivery?
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Cesarean Section Complications
Attachment Disorder
Post Operative Recovery
Keywords: Cesarean
Cesarean Section
Attachment Style
Revised Adult Attachment Style
Post Cesarean Pain
Post Cesarean Recovery
Lead sponsor: Western University, Canada
Sponsor class: OTHER
First posted: 2021-04-28
Enrollment: 65
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Pain Score
timeFrame: 24 hours
Secondary outcomes:
measure: ObsQoR10 Score
timeFrame: 24 hours
measure: Total Opioid Consumption first 24h
timeFrame: 24 hours
measure: First Occurrence of Nausea
timeFrame: 24 hours
measure: First Occurrence of Vomiting
timeFrame: 24 hours
measure: First Occurrence of Pruritis
timeFrame: 24 hours
measure: First Occurence of Sedation
timeFrame: 24 hours
Other outcomes:
Locations:
city: London
country: Canada
facility: Victoria Hospital
state: Ontario
Study officials:
affiliation: Western University
name: Ilana Sebbag, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
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.
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.
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.