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OpenTrials
Completed

NCT Number: NCT04729192

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

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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Key information

Age range

18 year–48 year

Sex eligibility

Female

Study type

Observational

Primary location

Betul Kozanhan

Konya, 42005, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ObsQoR-10T Questionnaire

Other

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.

Primary outcomes

  1. Validity of Obstetric Quality of Recovery-10 Turkish (ObsQoR-10T) questionnaire

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Konya Meram State Hospital

Other

Registry information

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Jan 28, 2021
Registry last updated
Oct 13, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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