Translation and Validation of the Turkish Version of the ObsQoR-10 Questionnaire (ObsQoR-10T)

Quality of Recovery Clinical Trial

Official title:

Translation and Validation of the Turkish Version of the ObsQoR-10 Questionnaire (ObsQoR-10T)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04729192
• Other study ID #: ObsQoR-10T
• Status: Completed
• Start date: February 5, 2021
• Est. completion date: October 12, 2021

Study information

• Verified date: October 2021
• Source: Konya Meram State Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The quality of recovery scoring tools for the obstetric patient population is limited. In 2019, Ciechanowicz et al. developed and validated a postpartum recovery score; the ObsQoR-11; used following elective and non-elective cesarean delivery. The ObsQoR-11 was modified to the ObsQoR-10 by Sultan et al. and used spontaneous and operative vaginal delivery based on patient feedback. There is currently only a Hebrew version of this recovery score. ObsQoR has not yet been validated for use in Turkish, which is one of the most spoken languages in the World. Therefore the investigators aimed to psychometrically evaluate (assess validity, reliability, and clinical feasibility) the Turkish translated version of the ObsQoR-10 PROM in a Turkish cohort of women.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: October 12, 2021
• Est. primary completion date: October 12, 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 48 Years

Eligibility

Inclusion Criteria:

• Turkish-speaking women (in Turkey) greater than 18 years of age who are also able to read and understand written Turkish
• Spontaneous vaginal delivery with or without neuraxial anesthesia for labor analgesia (including repair of vaginal tears and manual removal of the placenta) or elective cesarean delivery
• Women who have singleton births
• Primiparous (first baby) -=38 weeks gestational age

Exclusion Criteria:

• Psychiatric or neurological pathology compromising cooperation in the questionnaire validation protocol,
• Age < 18 years
• Women whose infants have died
• Mother or baby requiring ICU after delivery.
• Patient refusal to participate
• Inability to read or understand written Turkish
• Failed neuraxial analgesia: elective cesarean delivery
• General anesthesia
• Intrapartum cesarean
• Assisted/operative (i.e. vacuum, forceps) vaginal delivery

Related Conditions & MeSH terms

• Delivery
• Quality of Recovery

Intervention

Other:
• ObsQoR-10T Questionnaire
The ObsQoR-10T questionnaire consists of 10 items assessing physical comfort and pain, physical independence, and emotional status. 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	Betul Kozanhan	Konya

Sponsors (1)

Lead Sponsor	Collaborator
Konya Meram State Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Validity of Obstetric Quality of Recovery-10 Turkish (ObsQoR-10T) questionnaire	Evaluate the validity of the Turkish version of the ObsQoR-10 to assess immediate postpartum recovery following vaginal delivery or Caesarean section.The ObsQoR-10 based on patient feedback regarding the 0-10 scoring for "negative symptoms" such as pain, nausea and vomiting and dizziness (found in questions 1-4 of ObsQoR- 10) and "positive" symptoms such as comfort and feeling in control (found in questions 5-10 of ObsQoR-10). Overall higher recovery scores indicate better recovery.	on day 1 following delivery