Quality of RecoveryNCT04729192
Translation and Validation of the Turkish Version of the ObsQoR-10 Questionnaire (ObsQoR-10T)
An observational study of Quality of Recovery and Delivery, run by Konya Meram State Hospital at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 48 years, women only
- Conditions the study is for
- Quality of Recovery, Delivery
- What is being tested?
- ObsQoR-10T Questionnaire
- How many people
- 100 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 5 Feb 2021to 12 Oct 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 48 years
- Women only
- No healthy volunteers
- Adult
Study population: All patients admitted for spontaneous obstetrical labor or scheduled cesarean section.
Who may be able to join
- 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
Who cannot join
- 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
Show all 10Show fewer
- Failed neuraxial analgesia: elective cesarean delivery
- General anesthesia
- Intrapartum cesarean
- Assisted/operative (i.e. vacuum, forceps) vaginal delivery
Trial locations and contacts
1 site in 1 country.
About this study
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
- Being tested
- ObsQoR-10T Questionnaire
- Keywords
- ObsQoR-10T Questionnaire
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ObsQoR-10T QuestionnaireOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | The patients will complete the ObsQoR-10T questionnaire on day 1 following delivery Receives: Other: ObsQoR-10T Questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: on day 1 following delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2021
- Study start5 Feb 2021
- Primary completion12 Oct 2021
- Study completion12 Oct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Quality of RecoveryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Konya Meram State Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Betul Kozanhan, Konya Meram State Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04729192
- Sponsor's protocol ID
- ObsQoR-10T
- Status last verified
- Oct 2021
- First submitted
- 24 Jan 2021
- Last updated
- 13 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Translation and Validation of the Turkish Version of the ObsQoR-10 Questionnaire (ObsQoR-10T)
- ClinicalTrials.gov ID
- NCT04729192
- Acronym / sponsor ID
- ObsQoR-10T
- Conditions
- Quality of Recovery, Delivery
- Keywords
- ObsQoR-10T Questionnaire
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Konya Meram State HospitalUniversity, hospital or other
- Study start
- 5 Feb 2021 (actual)
- Primary completion
- 12 Oct 2021 (actual)
- Study completion
- 12 Oct 2021 (actual)
- First posted
- 28 Jan 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention | – | Other: ObsQoR-10T QuestionnaireThe patients will complete the ObsQoR-10T questionnaire on day 1 following delivery |
Who may qualify
- Ages
- 18 to 48 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- All patients admitted for spontaneous obstetrical labor or scheduled cesarean section.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ObsQoR-10T QuestionnaireThe 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. | Other | Intervention |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Quality of Recovery and Delivery, run by Konya Meram State Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Validity of Obstetric Quality of Recovery-10 Turkish (ObsQoR-10T) questionnaire (time frame: on day 1 following delivery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Oct 2021.