Translation and Validation Into French of a Maternal Satisfaction Scale Following a Cesarean Section (MSSCS)

Official title

Translation and Validation Into French of a Maternal Satisfaction Scale Following a Cesarean Section

Overview

Cesarean section is currently the most commonly performed surgical procedure worldwide, accounting for more than one-fifth of all deliveries in France. The experience of childbirth, particularly when it involves a cesarean section, is a significant life event with physical, psychological, and relational consequences. Many factors influence women's perceptions of this experience, including whether the procedure was planned or unexpected, the quality of analgesia, communication with healthcare providers, and the degree of involvement in decision-making. Conversely, a negative experience may impair the mother infant bond or delay postpartum recovery. The quality of anesthetic management is a major determinant of maternal satisfaction. Maternal satisfaction is widely recognized as an important indicator of healthcare quality. Its assessment requires a multidimensional approach. Although several tools exist in French to measure satisfaction during pregnancy or childbirth in general, none are specifically designed to evaluate the experience of cesarean section, with its particular features-especially those related to anesthesia. Scales such as Questionnaire for the Evaluation of the Childbirth Experience (QEVA) or Women's Views of Birth Labour Satisfaction Questionnaire (WOMBLSQ4) do not sufficiently address the specific characteristics of this procedure. The Maternal Satisfaction Scale for Caesarean Section (MSSCS), originally developed in English, is currently the only validated instrument specifically designed to assess women's satisfaction following a cesarean section. It covers the anesthetic, technical, psychological, and environmental dimensions of the procedure. To date, this scale has neither been translated nor validated in French. The availability of a validated French version of the MSSCS would improve the assessment of maternal experience in French-speaking settings and help identify concrete areas for improvement in anesthetic and obstetric care related to cesarean section.

Detailed description

This prospective, single-center, non-interventional study focuses on a specific population of women undergoing cesarean section and is conducted in two phases, including a questionnaire validation process.

The first phase involves the translation and cultural adaptation of the Maternal Satisfaction Scale for Caesarean Section (MSSCS) in accordance with the International Society for Pharmacoeconomics and Outcomes Research (ISPOR) guidelines. This phase includes several steps: forward translation by two independent translators (one physician and one non-physician), reconciliation of the translated versions, back-translation, harmonization by an expert committee, pilot testing with 10 patients, and finalization of the scale.

The second phase consists of administering the translated questionnaire to a sample of women who have delivered by cesarean section at the Hôpital Couple Enfant of Grenoble Alpes University Hospital during their maternity stay. Two additional satisfaction assessment tools (QEVA) and a global Visual Analog Scale will also be administered. Eligible patients will be informed both orally and in writing shortly after their cesarean section. If they agree to participate, they will complete the questionnaires on postoperative day 1 whenever possible, or at another time during their hospitalization, without any modification to their standard care. This phase will allow field testing of the final French version of the scale and enable its psychometric validation.

Interventions

• Other Post-Cesarean Maternal Satisfaction Scale Questionnaire
  consists of beta-testing the MSSCS on 10 cesarean patients to assess item clarity and comprehension, followed by analysis, minor revisions, and finalization of the translated scale in accordance with ISPOR guidelines. A final report will document all translation and cultural adaptation decisions. This phase 2 involves administering the finalized French version of the MSSCS, along with QEVA and a global visual analog scale, to eligible women after cesarean section during their maternity stay to e
• Other Post-Cesarean Maternal Satisfaction Scale Questionnaire
  This phase consists of beta-testing the MSSCS on 10 cesarean patients to assess item clarity and comprehension, followed by analysis, minor revisions, and finalization of the translated scale in accordance with ISPOR guidelines. A final report will document all translation and cultural adaptation decisions. Phase 2 involves administering the finalized French version of the MSSCS, along with QEVA and a global visual analog scale, to eligible women after cesarean section during their maternity sta

Primary outcome measures

• Translate and validate the "Maternal Satisfaction Scale for Caesarean Section" (MSSCS) questionnaire into French [Time frame: from day 1 to day 3]

Secondary outcome measures (1)

• Compare MSSCS scores based on factors that may influence the cesarean section experience : to demonstrate to study the determinants (known from the literature or hypothesized by the authors) of post-cesarean satisfaction at the Couple Enfant Hospital [Time frame: from day 1 to day 3]

Eligibility criteria

Inclusion criteria

• Patient on Day 1, Day 2, or Day 3 following a cesarean section performed under regional anesthesia at the Couple Enfant Hospital of the CHUGA
• Patient of legal age at the time of the cesarean section

Exclusion criteria

• Patients who underwent a cesarean section under general anesthesia
• Patients who underwent a cesarean section under deep sedation (this criterion will be verified by asking: "Do you remember your cesarean section?")
• Patients who were placed on mechanical ventilation and/or under sedation in the intensive care unit following their cesarean section
• Patient opposed to the use of her data for research purposes
• Non-French-speaking patient
• Patient who cannot read or write
• Patient with cognitive or psychiatric disorders preventing her from understanding the questionnaire
• Patient under legal guardianship or conservatorship, or deprived of liberty
• Patient not enrolled in the social security system

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model

Cohort

Study locations

Center list to be confirmed — check the primary protocol.

Publications

• Schober P, Boer C, Schwarte LA. Correlation Coefficients: Appropriate Use and Interpretation. Anesth Analg. 2018 May;126(5):1763-1768. doi: 10.1213/ANE.0000000000002864. PMID 29481436
• Nunnally JC, Bernstein IH. Psychometric theory. 3rd ed. New York: McGraw-Hill; 1994.
• Tsang S, Royse CF, Terkawi AS. Guidelines for developing, translating, and validating a questionnaire in perioperative and pain medicine. Saudi J Anaesth. 2017 May;11(Suppl 1):S80-S89. doi: 10.4103/sja.SJA_203_17. PMID 28616007
• Lucas DN, Yentis SM, Kinsella SM, Holdcroft A, May AE, Wee M, Robinson PN. Urgency of caesarean section: a new classification. J R Soc Med. 2000 Jul;93(7):346-50. doi: 10.1177/014107680009300703. PMID 10928020
• Betran AP, Vindevoghel N, Souza JP, Gulmezoglu AM, Torloni MR. A systematic review of the Robson classification for caesarean section: what works, doesn't work and how to improve it. PLoS One. 2014 Jun 3;9(6):e97769. doi: 10.1371/journal.pone.0097769. eCollection 2014. PMID 24892928
• 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 15321139
• Sword W, Heaman M, Peterson WE, Salvador A, Akhtar-Danesh N, Bradford-Janke A. Psychometric Testing of the French Language Quality of Prenatal Care Questionnaire. J Nurs Meas. 2015;23(3):436-51. doi: 10.1891/1061-3749.23.3.436. PMID 26673769
• Floris L, Mermillod B, Chastonay P. [Translation and validation in French of a multidimensional scale to evaluate the degree of satisfaction during childbirth]. Rev Epidemiol Sante Publique. 2010 Feb;58(1):13-22. doi: 10.1016/j.respe.2009.09.005. Epub 2010 Jan 25. French. PMID 20097497

Identifiers

NCT: NCT07555353 · 38RC25.0398

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗