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

NCT04729192 | Completed

• 1 other identifier: ObsQoR-10T
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Quality of Recovery; Delivery

Keywords

ObsQoR-10T Questionnaire

Outcome Measures

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.

  on day 1 following delivery

Study Arms (1)

Intervention

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

Other: ObsQoR-10T Questionnaire

Interventions

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.

Intervention

Eligibility Criteria

• Age: 18 Years - 48 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Konya Meram State Hospital: lead

Study Sites (1)

Betul Kozanhan

Konya, 42005, Turkey (Türkiye)

Location

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Ass.Prof.

Study Record Dates

• First Submitted: January 24, 2021
• First Posted: January 28, 2021
• Study Start: February 5, 2021
• Primary Completion: October 12, 2021
• Study Completion: October 12, 2021
• Last Updated: October 13, 2021

Record last verified: 2021-10

Locations

TU (1)