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

Cesarean Section Clinical Trial

— ObsQoR-11T  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04744311
• Other study ID #: 2020-506
• Status: Completed
• Start date: January 20, 2021
• Est. completion date: September 30, 2021

Study information

• Verified date: February 2023
• Source: Saglik Bilimleri Universitesi Gulhane Tip Fakultesi
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: September 30, 2021
• Est. primary completion date: July 20, 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

Other:
• ObsQoR-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.

Locations

Country	Name	City	State
Turkey	SBÜ Gülhane Education and Training Hospital	Etlik	Ankara

Sponsors (1)

Lead Sponsor	Collaborator
Saglik Bilimleri Universitesi Gulhane Tip Fakultesi

Country where clinical trial is conducted

Turkey, 

References & Publications (2)

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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Validity of ObsQoR-11T questionnaire	Evaluate the validity of the Turkish version of the ObsQoR-11 to assess postoperative recovery	At 24 hours after caesarean section