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

NCT ID: NCT04729192

Last Updated: 2021-10-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-02-05

Study Completion Date

2021-10-12

Brief Summary

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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

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Conditions

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Quality of Recovery Delivery

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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Intervention

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

ObsQoR-10T Questionnaire

Intervention Type 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.

Interventions

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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.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

48 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Konya Meram State Hospital

OTHER

Sponsor Role lead

Responsible Party

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Betul Kozanhan

Ass.Prof.

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Betul Kozanhan

Konya, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Other Identifiers

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ObsQoR-10T

Identifier Type: -

Identifier Source: org_study_id