Cesarean Section Complications Clinical Trial
Official title:
Do Patient's Adult Attachment Style Correlate With Pain Post Cesarean Delivery?
NCT number | NCT04863651 |
Other study ID # | WREM114262 |
Secondary ID | |
Status | Recruiting |
Phase | |
First received | |
Last updated | |
Start date | January 13, 2020 |
Est. completion date | September 2021 |
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.
Status | Recruiting |
Enrollment | 65 |
Est. completion date | September 2021 |
Est. primary completion date | May 2021 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Canada | Victoria Hospital | London | Ontario |
Lead Sponsor | Collaborator |
---|---|
Western University, Canada |
Canada,
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. Epub 2014 Oct 22. — View 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. — View 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. Epub 2014 Dec 30. — View 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. — View Citation
Peñacoba 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. — View 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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Pain Score | Pain score from 0-10, measured at 24 hours post-operative | 24 hours | |
Secondary | ObsQoR10 Score | Total score on the ObsQoR10 tool, a quality of recovery tool post cesarean section. Collected at 24 hours post-operative. | 24 hours | |
Secondary | Total Opioid Consumption first 24h | 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 | |
Secondary | First Occurrence of Nausea | The first time the patient reports feeling nauseous within the first 24 hours post-operative. | 24 hours | |
Secondary | First Occurrence of Vomiting | The first time the patient reports feeling vomiting within the first 24 hours post-operative. | 24 hours | |
Secondary | First Occurrence of Pruritis | The first time the patient reports feeling vomiting within the first 24 hours post-operative. | 24 hours | |
Secondary | First Occurence of Sedation | The first time the patient reports feeling sedated within the first 24 hours post-operative. | 24 hours |
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