CClinicalTrials.gg
CompletedNCT04729192Updated Oct 13, 2021

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

An observational study in Quality of Recovery and Delivery, sponsored by Konya Meram State Hospital. Completed at 1 site in Turkey. Open to female participants aged 18 Years to 48 Years. Per ClinicalTrials.gov, last updated 2021-10-13.

Sponsored by Konya Meram State Hospital · Observational

Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
100
Ages
18 Years to 48 Years
Sex
Female
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Study 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.

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Conditions studied

  • Quality of Recovery
  • Delivery

Keywords

  • ObsQoR-10T Questionnaire
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In context

Lead sponsor

Konya Meram State Hospital is the lead sponsor of 45 studies on the registry; 1 is 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 to 48 Years
Sexes eligible
Female
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

All patients admitted for spontaneous obstetrical labor or scheduled cesarean section.

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

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
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Study design

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

Groups and cohorts

  • Intervention

    The patients will complete the ObsQoR-10T questionnaire on day 1 following delivery

    Other: ObsQoR-10T Questionnaire

Interventions

  • OtherObsQoR-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.

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What researchers measure

Primary outcomes

  1. 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.

    Time frame: on day 1 following delivery

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Study locations

1 site
  • Betul Kozanhan
    Konya, 42005, Turkey
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 13, 2021, 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
NCT04729192
Lead sponsor
Konya Meram State Hospital
Responsible party
Betul Kozanhan (Ass.Prof., Konya Meram State Hospital) — Principal investigator
First posted
Jan 28, 2021
Start date
Feb 5, 2021
Primary completion
Oct 12, 2021
Completion
Oct 12, 2021
Last update
Oct 13, 2021

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 Oct 2021. You cannot join it, but the record below documents what was studied.

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