Translation and Validation of the French Version of the ObsQoR-10 Questionnaire (ObsQoR-10F)

February 10, 2021 updated by: University Hospital, Angers

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Observational

Enrollment (Anticipated)

500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Angers, France, 49000
        • Recruiting
        • University Hospital of Angers
        • Contact:
          • Maxime Léger, Dr

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

All patients admitted for spontaneous obstetrical labor, induction of obstetrical labor, or scheduled cesarean section.

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Intervention
Each patient complete ObsQoR-10F questionnaire 3 times (before delivery, on Day 1, on Day 2)
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Validity of ObsQoR-10F questionnaire
Time Frame: 2 days
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Validity of ObsQoR-10F questionnaire (Caesarean section)
Time Frame: 2 days
Ensure the validity of the questionnaire in the sub-population of Caesarean delivery population (scheduled and unscheduled) at 24 and 48 hours
2 days

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Validity of ObsQoR-10F questionnaire (Vaginal delivery)
Time Frame: 2 days
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
Minimal important difference
Time Frame: 2 days
Estimate minimal important difference from the ObsQoR-10F questionnaire
2 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Angers

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

February 1, 2021

Primary Completion (ANTICIPATED)

June 1, 2021

Study Completion (ANTICIPATED)

August 1, 2021

Study Registration Dates

First Submitted

July 23, 2020

First Submitted That Met QC Criteria

July 23, 2020

First Posted (ACTUAL)

July 28, 2020

Study Record Updates

Last Update Posted (ACTUAL)

February 15, 2021

Last Update Submitted That Met QC Criteria

February 10, 2021

Last Verified

February 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ObsQoR-10F

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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