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

Completed

• Conditions: Delivery; Quality of Recovery
• Interventions: Other: ObsQoR-10T Questionnaire

• Registration Number: NCT04729192
• Lead Sponsor: Konya Meram State Hospital

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-01-24
• Study First Submitted QC: 2021-01-24
• Study First Posted: 2021-01-28
• Study Start: 2021-02-05
• Status Verified: 2021-10
• Primary Completion: 2021-10-12
• Study Completion: 2021-10-12
• Last Update Submitted: 2021-10-12
• Last Update Posted: 2021-10-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 100

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Intervention	ObsQoR-10T Questionnaire	The patients will complete the ObsQoR-10T questionnaire on day 1 following delivery

Primary Outcome Measures

Name	Time	Method
Validity of Obstetric Quality of Recovery-10 Turkish (ObsQoR-10T) questionnaire	on day 1 following delivery	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.

Trial Locations

Locations (1)

Betul Kozanhan; 🇹🇷 Konya, Turkey