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CompletedNCT04744311ObsQoR-11TUpdated Feb 21, 2023

Translation and Validation of the Turkish Version of the ObsQoR-11 Questionnaire

An observational study in Patient Reported Outcome Measures, Quality of Recovery and Cesarean Section, sponsored by Saglik Bilimleri Universitesi Gulhane Tip Fakultesi. Completed at 1 site in Turkey. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-02-21.

Sponsored by Saglik Bilimleri Universitesi Gulhane Tip Fakultesi · Observational

Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
200
Ages
18 Years and older
Sex
Female
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Study summary

Ciechanowicz et al. developed and validated a postpartum recovery score for women with a caesarean section: the ObsQoR-11. The psychometric validation of the ObsQoR-11 confirms its reliability, its response to change, its acceptability and its feasibility. The use of this score allows the investigators to quantify the quality of the patient's recovery between 0 and 110, by allocating a score from 0 to 10 for each item. ObsQoR-11 has not yet been validated for use in Turkish. Therefore the investigators aimed to psychometrically evaluate the Turkish translated version of the ObsQoR-11 in a Turkish cohort of women.

Read the detailed description

Recovery after caesarean section is a complex process, depending on the characteristics of the patient and the anaesthesia. Scales for measuring the quality of post-operative recovery have been developed. Ciechanowicz et al. developed and validated a postpartum recovery score for women with a caesarean section: the ObsQoR-11. This multidimensional scale 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 investigators aimed to validate the translated version of the Turkish ObsQoR-11 scale.

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Conditions studied

  • Patient Reported Outcome Measures
  • Quality of Recovery
  • Cesarean Section
  • General Anesthesia

Keywords

  • Questionnaire Obstetric Quality-of-recovery 11 (ObsQoR-11T)
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In context

Lead sponsor

Saglik Bilimleri Universitesi Gulhane Tip Fakultesi is the lead sponsor of 65 studies on the registry; 7 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
Female
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

All patients admitted for cesarean section

Inclusion criteria

  • ≥ 18 years old)
  • Turkish-speaking
  • Admitted for cesarean section
  • Able to answer the questionnaire, alone or with the help of a third party
  • Agreeing to participate in the study

Exclusion criteria

Exclusion Criteria:

  • Psychiatric or neurological pathology
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Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
200 participants (actual)
Patient registry
No

Interventions

  • OtherObsQoR-11T Questionnaire

    The ObsQoR-11T questionnaire consists of 11 items assessing different aspects of postpartum recovery: physical comfort and pain, physical independence and emotional status. If the patient is not able to read the questionnaire herself, a third person can ask the questions orally to the patient. 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.

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What researchers measure

Primary outcomes

  1. Validity of ObsQoR-11T questionnaire

    Evaluate the validity of the Turkish version of the ObsQoR-11 to assess postoperative recovery

    Time frame: At 24 hours after caesarean section

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Study locations

1 site
  • SBÜ Gülhane Education and Training Hospital
    Etlik, Ankara 06010, Turkey
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References and documents

Publications

  • 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. PubMed 30579408 ↗
  • 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. PubMed 30885691 ↗

Individual participant data

Plan to share: No

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 21, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04744311
Lead sponsor
Saglik Bilimleri Universitesi Gulhane Tip Fakultesi
Responsible party
Umut Kara (Consultant, Saglik Bilimleri Universitesi Gulhane Tip Fakultesi) — Principal investigator
First posted
Feb 8, 2021
Start date
Jan 20, 2021
Primary completion
Jul 20, 2021
Completion
Sep 30, 2021
Last update
Feb 21, 2023

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2023. You cannot join it, but the record below documents what was studied.

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