NCT05077891

Brief Summary

Measuring patient-oriented outcomes and satisfaction is important to guide meaningful changes in obstetric anesthesia care. Quality of Recovery (QoR) scores are patient rated measures, which provide a global measure of recovery after surgery. They go beyond the measure of physiological variables to include, physical, cognitive, emotive and functional outcomes. Satisfaction, in addition to QoR scores after anaesthesia is an important quality marker. Measuring satisfaction after the birth of a child is a complex and emotive subject. Understanding the factors that can influence maternal satisfaction may improve patient-centred care. Studies have shown that despite favorable clinical outcomes, many women undergoing caesarean deliveries continue to have poor experience with anaesthesia. These poor experiences go beyond inadequate pain control; many are due to poor communication with clinicians, lack of involvement in decision making, lack of provision of high quality education and information and a feeling of inadequate choice and control relating to decisions of the birth of their babies. In non-obstetric studies, satisfaction after anaesthesia has consistently been shown to be dependent on the information patient has received along with the quality of the communication and the quality of the anaesthetist-patient relationship.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
300

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Aug 2021

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

August 1, 2021

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

September 30, 2021

Completed
14 days until next milestone

First Posted

Study publicly available on registry

October 14, 2021

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 15, 2022

Completed
2.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 17, 2024

Completed
Last Updated

February 19, 2025

Status Verified

February 1, 2025

Enrollment Period

6 months

First QC Date

September 30, 2021

Last Update Submit

February 15, 2025

Conditions

Outcome Measures

Primary Outcomes (5)

  • Quality of Recovery Score (ObsQoR-11)

    Quality of recovery will be measured using the obstetric quality of recovery score (ObsQoR-11). This is a 11-item, multidimensional recovery scoring tool, which has been validated in this population

    5 Minutes

  • Maternal Satisfaction Scale for Cesarean Section (MSSCS)

    This 22 item questionnaire measures satisfaction with the anaesthetic, needle insertion, side effects and the theatre atmosphere. Items are rated on a 7-point likert scale from strongly disagree to strongly agree.

    5 Minutes

  • Satisfaction with Received Care

    First open ended question assessing: "What aspects of your care were you most satisfied with?"

    1 Minute

  • Dissatisfaction with Received Care

    Second open ended question assessing: "What aspects of your care were you most dissatisfied with?"

    1 Minute

  • Improvement of Satisfaction

    Third and last open ended question assessing: "Do you have any suggestions on what would improve your satisfaction?"

    1 Minute

Secondary Outcomes (25)

  • Obstetric History: Gravidity and Preterm

    1 Minute

  • Patient Age

    1 Minute

  • Gestational Age

    1 Minute

  • Patient Height

    1 Minute

  • Patient Weight

    1 Minute

  • +20 more secondary outcomes

Eligibility Criteria

Age19 Years+
Sexfemale
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All women above the age of 19 years old whom underwent a caesarean section will be eligible to participate. Women will be surveyed at 24 hours after their cesarean section. Data will be collected by means of validated paper questionnaires administered in person by a study investigator that is not part of clinical care.

You may qualify if:

  • Fluent English speaker
  • Older than 19 years of age
  • Received a cesarean delivery
  • Received a cesarean delivery 24-48 hours prior to time of recruitment

You may not qualify if:

  • Non-English speaker
  • Below the age of 19 years
  • Did not receive a cesarean delivery
  • Received a cesarean delivery more than 48hrs after time of recruitment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

BC Women's Hospital

Vancouver, British Columbia, V6H 3N1, Canada

Location

Related Publications (15)

  • 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
  • Bowyer A, Jakobsson J, Ljungqvist O, Royse C. A review of the scope and measurement of postoperative quality of recovery. Anaesthesia. 2014 Nov;69(11):1266-78. doi: 10.1111/anae.12730. Epub 2014 Jun 2.

    PMID: 24888412BACKGROUND
  • Heidegger T, Saal D, Nubling M. Patient satisfaction with anaesthesia - Part 1: satisfaction as part of outcome - and what satisfies patients. Anaesthesia. 2013 Nov;68(11):1165-72. doi: 10.1111/anae.12347. Epub 2013 Aug 8.

    PMID: 23926924BACKGROUND
  • Barnett SF, Alagar RK, Grocott MP, Giannaris S, Dick JR, Moonesinghe SR. Patient-satisfaction measures in anesthesia: qualitative systematic review. Anesthesiology. 2013 Aug;119(2):452-78. doi: 10.1097/ALN.0b013e3182976014.

    PMID: 23669268BACKGROUND
  • Camann W. Pain, Pain Relief, Satisfaction and Excellence in Obstetric Anesthesia: A Surprisingly Complex Relationship. Anesth Analg. 2017 Feb;124(2):383-385. doi: 10.1213/ANE.0000000000001676. No abstract available.

    PMID: 28098685BACKGROUND
  • Kingsley C, Patel S. Patient-reported outcome measures and patient-reported experience measures. BJA Education. 2017;17(4):137-44.

    BACKGROUND
  • Linda D. Results of the National Maternity Experience Survey 2020 2020 [Available from: https://yourexperience.ie/maternity/national-results/.

    BACKGROUND
  • Porter M, van Teijlingen E, Chi Ying Yip L, Bhattacharya S. Satisfaction with cesarean section: qualitative analysis of open-ended questions in a large postal survey. Birth. 2007 Jun;34(2):148-54. doi: 10.1111/j.1523-536X.2007.00161.x.

    PMID: 17542819BACKGROUND
  • Stewart MA. Effective physician-patient communication and health outcomes: a review. CMAJ. 1995 May 1;152(9):1423-33.

    PMID: 7728691BACKGROUND
  • Cook K, Loomis C. The Impact of Choice and Control on Women's Childbirth Experiences. J Perinat Educ. 2012 Summer;21(3):158-68. doi: 10.1891/1058-1243.21.3.158.

    PMID: 23730127BACKGROUND
  • Brooks H, Sullivan WJ. The importance of patient autonomy at birth. Int J Obstet Anesth. 2002 Jul;11(3):196-203. doi: 10.1054/ijoa.2002.0958.

    PMID: 15321548BACKGROUND
  • Morgan PJ, Halpern S, Lo J. The development of a maternal satisfaction scale for caesarean section. Int J Obstet Anesth. 1999 Jul;8(3):165-70. doi: 10.1016/s0959-289x(99)80132-0.

    PMID: 15321139BACKGROUND
  • Berning V, Laupheimer M, Nubling M, Heidegger T. Influence of quality of recovery on patient satisfaction with anaesthesia and surgery: a prospective observational cohort study. Anaesthesia. 2017 Sep;72(9):1088-1096. doi: 10.1111/anae.13906. Epub 2017 May 16.

    PMID: 28510285BACKGROUND
  • Myles PS, Reeves MD, Anderson H, Weeks AM. Measurement of quality of recovery in 5672 patients after anaesthesia and surgery. Anaesth Intensive Care. 2000 Jun;28(3):276-80. doi: 10.1177/0310057X0002800304.

    PMID: 10853209BACKGROUND
  • Ciechanowicz S, Howle R, Heppolette C, Nakhjavani B, Carvalho B, Sultan P. Evaluation of the Obstetric Quality-of-Recovery score (ObsQoR-11) following non-elective caesarean delivery. Int J Obstet Anesth. 2019 Aug;39:51-59. doi: 10.1016/j.ijoa.2019.01.010. Epub 2019 Feb 2.

    PMID: 30885691BACKGROUND

Study Officials

  • Anton Chau, MD MMSc

    University of British Columbia

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director of Research

Study Record Dates

First Submitted

September 30, 2021

First Posted

October 14, 2021

Study Start

August 1, 2021

Primary Completion

January 15, 2022

Study Completion

June 17, 2024

Last Updated

February 19, 2025

Record last verified: 2025-02

Data Sharing

IPD Sharing
Will not share

Locations