Translation and Validation of the French Version of the ObsQoR-10 Questionnaire

Quality of Recovery Clinical Trial

— ObsQoR-10F  

Official title:

Translation and Validation of the French Version of the ObsQoR-10 Questionnaire for the Evaluation of Recovery After Childbirth: the ObsQoR-10F Questionnaire

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04489602
• Other study ID #: ObsQoR-10F
• Status: Recruiting
• Start date: February 1, 2021
• Est. completion date: August 2021

Study information

• Verified date: February 2021
• Source: University Hospital, Angers
• Contact: Maxime Léger, MD
• Phone: 2 41 35 36 35
• Email: maxime.leger[@]chu-angers.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Until recently, there was no validated scoring tool to assess recovery after childbirth. Ciechanowicz et al. developed and validated a postpartum recovery score for women with a caesarean section (scheduled or unscheduled): the ObsQoR-11. The psychometric validation of the ObsQoR-11 confirms its reliability, its response to change, its acceptability and its feasibility (average filling time of 2 minutes, and the possibility to print the questionnaire on one page). The use of this score allows the investigators to quantify the quality of the patient's recovery between 0 and 110 (0 being a really poor recovery, and 110 a total recovery), by allocating a score from 0 to 10 for each item.

Since then, the initial version of ObsQoR-11 has evolved into a smaller version, ObsQoR-10, for which the pain items have been merged. Similarly, by assigning a score from 0 to 10 for each item, the ObsQoR-10 score allows to quantify the quality of the patient's recovery between 0 and 100 (0 being a very poor recovery, and 100 being full recovery).

There are currently no translations of this score into another language, but the investigators can easily assume that they will be done in the near future. French remains the fifth most spoken language in the world. The investigators therefore feel it is necessary to validate the translated version of the ObsQoR-10 score.

Description:

Recovery after childbirth (by caesarean section or vaginal delivery) is a complex process, depending on the characteristics of the patient, the anaesthesia, and the need for surgery or an instrumental device. This event is a source of stress, anxiety and pain, and can also lead to postpartum complications. Studies evaluating interventions during childbirth traditionally focus on mortality and morbidity which, although important, do not describe the patient's experience or the quality of her recovery.

Scores for measuring the quality of post-operative recovery have been developed. These scoring tools accurately measure post-operative recovery by looking at some dimensions of the patient's experience. However, they have been developed and validated in non-obstetrical patients. They therefore contain aspects of recovery that are not relevant to delivery and postpartum. Furthermore, they do not include key elements, such as the ability to care for the newborn.

Until recently, there was no validated scoring tool to assess recovery after childbirth. Ciechanowicz et al. developed and validated a postpartum recovery score for women with a caesarean section (scheduled or unscheduled): the ObsQoR-11. This multidimensional score is a questionnaire of 11 items evaluating: moderate pain, severe pain, nausea and vomiting, feeling of discomfort, shivering, feeling of comfort, ability to mobilize, ability to carry the newborn, ability to feed, ability to groom alone, and finally feeling of self-control. The psychometric validation of the ObsQoR-11 confirms its reliability, its response to change, its acceptability and its feasibility (average filling time of 2 minutes, and the possibility to print the questionnaire on one page). The use of this score allows to quantify the quality of the patient's recovery between 0 and 110 (0 being a really poor recovery, and 110 a total recovery), by allocating a score from 0 to 10 for each item.

This tool has the advantage of efficiently evaluating the concept of immediate postpartum recovery, with an acceptable feasibility for both the patient and the caregivers. Since then, the initial version of ObsQoR-11 has evolved into a smaller version, ObsQoR-10, for which the pain items have been merged. Similarly, by assigning a score from 0 to 10 for each item, the ObsQoR-10 score allows to quantify the quality of the patient's recovery between 0 and 100 (0 being a very poor recovery, and 100 being full recovery).

There are currently no translations of this score into another language, but the investigators can easily assume that they will be done in the near future. French remains the fifth most spoken language in the world. The investigators therefore feel it is necessary to validate the translated version of the ObsQoR-10 score.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: August 2021
• Est. primary completion date: June 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• = 18 years old);

• French-speaking;

• Admitted for spontaneous obstetrical labor, induction of obstetrical labor, or scheduled cesarean section;

• Able to answer the questionnaire, alone or with the help of a third party;

• Agreeing to participate in the study

Exclusion Criteria:

• Psychiatric or neurological pathology compromising cooperation in the questionnaire validation protocol,

• Psychological history (medical termination of pregnancy, foetal death in utero).

Related Conditions & MeSH terms

• Childbirth
• Delivery
• Labor Complication
• Obstetric Labor Complications
• Patient Reported Outcome Measures
• Quality of Recovery

Intervention

Other:
• ObsQoR-10F Questionnaire
The ObsQoR-10F questionnaire consists of 10 items assessing different aspects of postpartum recovery: physical comfort and pain, physical independence and emotional status. It takes two minutes to complete all the items. If the patient is not able to read the questionnaire herself, a third person can ask the questions orally to the patient. If the patient has returned home with her child, she can be contacted by phone to complete the questionnaire. Each item is scored from 0 to 10 and the total score is the sum of the score for each item, which is a score from 0 to 110.

Locations

Country	Name	City	State
France	University Hospital of Angers	Angers

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Angers

Country where clinical trial is conducted

France, 

References & Publications (2)

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

Sultan P, Kormendy F, Nishimura S, Carvalho B, Guo N, Papageorgiou C. Comparison of spontaneous versus operative vaginal delivery using Obstetric Quality of Recovery-10 (ObsQoR-10): An observational cohort study. J Clin Anesth. 2020 Aug;63:109781. doi: 10.1016/j.jclinane.2020.109781. Epub 2020 Mar 20. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Validity of ObsQoR-10F questionnaire (Vaginal delivery)	Assess the validity of the questionnaire specifically in the subpopulation of patients with a vaginal delivery (with or without instrumental extraction) at 24 and 48 hours	2 days
Other	Minimal important difference	Estimate minimal important difference from the ObsQoR-10F questionnaire	2 days
Primary	Validity of ObsQoR-10F questionnaire	Evaluate the validity of the French version of the ObsQoR-10 to assess immediate postpartum recovery (at 24 and 48 hours after vaginal delivery or Caesarean section).	2 days
Secondary	Validity of ObsQoR-10F questionnaire (Caesarean section)	Ensure the validity of the questionnaire in the sub-population of Caesarean delivery population (scheduled and unscheduled) at 24 and 48 hours	2 days