Translation and Validation of the Turkish Version of the ObsQoR-11 Questionnaire (ObsQoR-11T)

February 19, 2023 updated by: Umut Kara, Saglik Bilimleri Universitesi Gulhane Tip Fakultesi

Translation and Validation of the Turkish Version of the Obstetric QoR-11 Questionnaire for the Evaluation of Recovery After Caesarean Section: the ObsQoR-11T Questionnaire

Ciechanowicz et al. developed and validated a postpartum recovery score for women with a caesarean section: the ObsQoR-11. The psychometric validation of the ObsQoR-11 confirms its reliability, its response to change, its acceptability and its feasibility. The use of this score allows the investigators to quantify the quality of the patient's recovery between 0 and 110, by allocating a score from 0 to 10 for each item. ObsQoR-11 has not yet been validated for use in Turkish. Therefore the investigators aimed to psychometrically evaluate the Turkish translated version of the ObsQoR-11 in a Turkish cohort of women.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Recovery after caesarean section is a complex process, depending on the characteristics of the patient and the anaesthesia. Scales for measuring the quality of post-operative recovery have been developed. Ciechanowicz et al. developed and validated a postpartum recovery score for women with a caesarean section: the ObsQoR-11. This multidimensional scale is a questionnaire of 11 items evaluating: moderate pain, severe pain, nausea and vomiting, feeling of discomfort, shivering, feeling of comfort, ability to mobilize, ability to carry the newborn, ability to feed, ability to groom alone, and finally feeling of self-control. The investigators aimed to validate the translated version of the Turkish ObsQoR-11 scale.

Study Type

Observational

Enrollment (Actual)

200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
    • Ankara
      • Etlik, Ankara, Turkey, 06010
        • SBÜ Gülhane Education and Training Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

All patients admitted for cesarean section

Description

Inclusion Criteria:

  • ≥ 18 years old)
  • Turkish-speaking
  • Admitted for cesarean section
  • Able to answer the questionnaire, alone or with the help of a third party
  • Agreeing to participate in the study

Exclusion Criteria:

  • Psychiatric or neurological pathology

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Validity of ObsQoR-11T questionnaire
Time Frame: At 24 hours after caesarean section
Evaluate the validity of the Turkish version of the ObsQoR-11 to assess postoperative recovery
At 24 hours after caesarean section

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Saglik Bilimleri Universitesi Gulhane Tip Fakultesi

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 20, 2021

Primary Completion (Actual)

July 20, 2021

Study Completion (Actual)

September 30, 2021

Study Registration Dates

First Submitted

February 1, 2021

First Submitted That Met QC Criteria

February 4, 2021

First Posted (Actual)

February 8, 2021

Study Record Updates

Last Update Posted (Estimate)

February 21, 2023

Last Update Submitted That Met QC Criteria

February 19, 2023

Last Verified

February 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 2020-506

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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