Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

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

Study information

Verified date April 2021
Source Western University, Canada
Contact Ilana Sebbag, MD
Phone 519 685 8500
Email Ilana.Sebbag@lhsc.on.ca
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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.


Recruitment information / eligibility

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

Study Design


Locations

Country Name City State
Canada Victoria Hospital London Ontario

Sponsors (1)

Lead Sponsor Collaborator
Western University, Canada

Country where clinical trial is conducted

Canada, 

References & Publications (6)

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

Outcome

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
See also
  Status Clinical Trial Phase
Terminated NCT04377984 - Impact of a Strategy Combining Morphine Savings and Anesthesia Technique on the Quality of Post-operative Rehabilitation
Recruiting NCT03248817 - Phenylephrine Infusion in Cesarean Delivery Phase 4
Completed NCT05037383 - Motion and Viewing Analysis of Surgeons During Minimally Invasive Gynecological Interventions N/A
Completed NCT05933993 - Mothers Experience of Pain Following Elective Cesarean Section. A Qualitative Study.
Recruiting NCT05021315 - Vaginal Cleaning Using Povidone Iodine Before CS to Reduce Postoperative Wound Infection Phase 3
Terminated NCT03246919 - Ideal Time of Oxytocin Infusion During Cesarean Section Phase 4
Completed NCT06403215 - Effect of Chewing Gum and Drinking Fennel Tea N/A
Not yet recruiting NCT06446258 - Assessment of the Impact of Soft Tissue Mobilization on the Scar in Patients After Cesarean Section N/A
Recruiting NCT06247852 - Persistent Pain After Cesarean Delivery - A Danish Multicenter Cohort Study
Not yet recruiting NCT06017076 - Effect of Preoperative Oral Energy Drinks Compared to Warming Matress on Body Temperature During Combined Spinal-epidural Anesthesia for Elective Cesarean Delivery. N/A
Completed NCT05005871 - Comparison of Quadratus Lumborum Intramuscular and Transmuscular in Postoperative Pain N/A
Recruiting NCT04518176 - Bilateral Uterine Artery Ligation During the Cesarean Delivery of Twins N/A
Not yet recruiting NCT04505644 - Lidocaine Patch Versus Intravenous Lidocaine in Pain Relief After Cesarean Section N/A
Not yet recruiting NCT03985618 - The MODE Trial: Planned Caesarean Section Versus Induction of Labour for Women With Class III Obesity N/A
Completed NCT04046510 - Comparaison of 3 Protocols of Ocytocin Administration in C Section N/A
Completed NCT03302039 - Three Protocols for Phenylephrine Administration in Cesarean Delivery Phase 4
Completed NCT03318536 - Effect of Granisetron on Usage of Sympathomimetics During Caesarean Section
Recruiting NCT03682510 - B-Lynch Transverse Compression Suture Versus a Sandwich Technique (N&H Technique) for Complete Placenta Previa N/A
Recruiting NCT03651076 - Traxi Panniculus Retractor for Cesarean Delivery N/A
Not yet recruiting NCT06060327 - Comparing Tranexamic Acid Versus Ecbolics in Preventing Hemorrhage During and After Cesarean Section N/A