Clinical trial NCT04744311: Translation and Validation of the Turkish Version of the ObsQoR-11 Questionnaire
Official title: Translation and Validation of the Turkish Version of the Obstetric QoR-11 Questionnaire for the Evaluation of Recovery After Caesarean Section: the ObsQoR-11T Questionnaire
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Patient Reported Outcome Measures
Quality of Recovery
Cesarean Section
General Anesthesia
Keywords: Questionnaire Obstetric Quality-of-recovery 11 (ObsQoR-11T)
Lead sponsor: Saglik Bilimleri Universitesi Gulhane Tip Fakultesi
Sponsor class: OTHER
First posted: 2021-02-08
Enrollment: 200
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients admitted for cesarean section

Brief 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.

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.

Eligibility criteria: 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:

* Psychiatric or neurological pathology

Primary outcomes:
measure: Validity of ObsQoR-11T questionnaire
timeFrame: At 24 hours after caesarean section
Secondary outcomes:
Other outcomes:
Locations:
city: Etlik
country: Turkey
facility: SBÜ Gülhane Education and Training Hospital
state: Ankara
Study officials:
References:
citation: 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.
citation: 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.