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

Sponsor

Saglik Bilimleri Universitesi Gulhane Tip Fakultesi (Other)

Overall Status

Recruiting

CT.gov ID

NCT04744311

Collaborator

(none)

200

Enrollment

Location

8.3

Anticipated Duration (Months)

24.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Patient Reported Outcome Measures Quality of Recovery Cesarean Section General Anesthesia	Other: ObsQoR-11T Questionnaire

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 Design

Study Type:

Observational

Anticipated Enrollment :

200 participants

Observational Model:

Case-Only

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Jan 20, 2021

Anticipated Primary Completion Date :

Jul 20, 2021

Anticipated Study Completion Date :

Sep 30, 2021

Outcome Measures

Primary Outcome Measures

Validity of ObsQoR-11T questionnaire [At 24 hours after caesarean section]
Evaluate the validity of the Turkish version of the ObsQoR-11 to assess postoperative recovery

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	SBÜ Gülhane Education and Training Hospital	Etlik	Ankara	Turkey	06010

Sponsors and Collaborators

Saglik Bilimleri Universitesi Gulhane Tip Fakultesi

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:

Umut Kara, Consultant, Saglik Bilimleri Universitesi Gulhane Tip Fakultesi

ClinicalTrials.gov Identifier:

NCT04744311

Other Study ID Numbers:

2020-506

First Posted:

Feb 8, 2021

Last Update Posted:

Feb 8, 2021

Last Verified:

Feb 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Umut Kara, Consultant, Saglik Bilimleri Universitesi Gulhane Tip Fakultesi

Questionnaire Obstetric Quality-of-recovery 11 (ObsQoR-11T)

Study Results

No Results Posted as of Feb 8, 2021