Quality of Recovery (QoR-15)NCT07194369
Validation of the Setswana Translated Quality of Recovery Questionnaire in Orthopaedic Patients at a Tertiary Hospital in South Africa
An observational study of Quality of Recovery (QoR-15) and Quality of Recovery From Anaesthesia, run by Sefako Makgatho Health Sciences University at 1 site in South Africa.
Trial summary
This observational study aims to evaluate the validity, reliability and feasibility of the Setswana-translated version of the 15-item Quality of Recovery (QoR-15) questionnaire. The question it aims to answer is: Does the Setswana translation of the QoR-15 serve as a valid, reliable and user friendly tool for… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Quality of Recovery (QoR-15), Quality of Recovery From Anaesthesia
- How many people
- 150 participants
- Where
- 1 siteSouth Africa
- Study dates
- 15 Oct 2025to 30 Dec 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- Adult, Older adult
Study population: The study population will consist of adult patients (aged 18 years and older) who are fluent in Setswana and are scheduled for elective orthopaedic surgery at the hospital. The population is expected to be diverse in terms of gender, age, and socioeconomic background, reflecting the typical demographic of Setswana-speaking patients. These patients are expected to be conscious and alert in the postoperative period, able to provide informed consent, and cognitively capable of understanding and responding to a questionnaire. Participants with known cognitive impairments, severe postoperative complications that impair communication, or those unwilling to participate will be excluded.
Who may be able to join
- Adult patients over 18 years of age
- Scheduled elective orthopaedic surgery at Dr George Mukhari Academic Hospital
Who cannot join
- Patients who are not fluent in Setswana
- Patients booked for emergency surgery where a delay to surgery could be detrimental.
- Patients where the surgery is delayed beyond 10 days of the initial assessment and pre-operative QoR-15 measurement.
- Patients with a psychiatric disturbance that precludes complete co-operation.
- Patients with a severe debilitating medical or surgical condition that may limit objective assessment after surgery.
- Patients with any life threatening postoperative complication.
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- Postoperative confusion or delirium.
- Patients with a history of recent drug or alcohol abuse which may render responses unreliable.
- Incomplete QoR-15 questionnaires.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
South Africa1 site
Dr George Mukhari Academic Hospital
Pretoria, Gauteng, 0204
Kenneth Dr Matea, 0125293876/7 ext. 0125293876, Kenneth.Matea@gauteng.gov.za
Keitumetse Mongale, 0125293877 ext. 0125293877, keitumetse.mongale@gauteng.gov.za
About this study
Official title: Validation of the Setswana Translated Quality of Recovery Questionnaire in Orthopaedic Patients at a Tertiary Hospital in South Africa: a Cross-Sectional Observational Study
This observational study aims to evaluate the validity, reliability and feasibility of the Setswana-translated version of the 15-item Quality of Recovery (QoR-15) questionnaire. The question it aims to answer is:
Does the Setswana translation of the QoR-15 serve as a valid, reliable and user friendly tool for assessing postoperative recovery in Setswana speaking patients undergoing orthopaedic surgery at a tertiary hospital in Gauteng, South Africa?
The participants will be asked to complete the Setswana-translated QoR-15 questionnaire both preoperatively and postoperatively.
In addition, they will be asked to rate their overall postoperative recovery using a visual analog scale (VAS).
Read the detailed description
Patient reported outcome measures are increasingly recognised as important in preoperative research, yet their routine use in clinical practice remains limited in South Africa.
While quality of recovery measures have been widely applied in general and ambulatory surgery settings, there is a relative paucity of data specifically addressing orthopaedic populations.
Orthopaedic surgical procedures are associated with significant postoperative pain, functional limitations and extended rehabilitation periods, all of which can substantially impact the patient's overall recovery experience. Evaluating a short-term postoperative outcome like quality of recovery in this surgical cohort may help tailor postoperative care to patient needs, which may lead to better patient-clinician communication, better surgical outcomes and better patient satisfaction.
A lack of standardised and validated outcome measures in local languages and high rates of illiteracy may be impediments to implementing widespread use of patient reported outcome questionnaires in practice. Patients who are functionally literate may still not understand medical terms if not presented in their home language and proficiency in English varies widely across South Africa. South Africa has a diverse language heritage with 11 official languages and high rates of functional illiteracy. While many South Africans are able to communicate in English, only a small minority reports English as the primary language used most often outside the household. For black South Africans, the most common languages spoken outside of the home most commonly are IsiZulu, IsiXhosa and the Sotho-Tswana languages.
At present, validated translations of the QoR-15 questionnaire are only available in English and IsiZulu for South African use.
By adding another validated translation in a local language, it is hoped that it will be easier to measure quality of recovery in Setswana speaking populations to address health disparities.
A Setswana translation of the QoR-15 questionnaire exists from a previous study which may be of use in Ga-Rankuwa, which is home to a Setswana speaking population. This translated questionnaire is yet to be validated in this population. For patient reported outcome measures (PROMs) to be effective in non-English speaking populations, rigorous linguistic and cultural adaptation is necessary.
In this study, quality of recovery will be measured with the Setswana translation of the QoR-15 questionnaire as well as with a visual analog scale on which patients can rate their overall postoperative recovery.
- Keywords
- Setswana translated QoR-15, Quality of Recovery in patients undergoing orthopaedic surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
Convergent validity of the Setswana-translated QoR-15 score
To evaluate convergent validity by assessing the Spearman correlation between the Setswana-translated QoR-15 score and a general visual analog scale (VAS).
Unit of measure: Correlation co-efficient (r).
Measured: Pre-operative baseline and 24 hours postoperatively.
Secondary outcomes (5)
Construct validity of the Setswana-translated QoR-15 score
To evaluate construct validity by assessing associations between the QoR-15 score and patient factors (age, gender, duration \& severity of surgery).
Unit of Measure: Regression coefficients/association statistics
Measured: Pre-operative (baseline) and 24 hours postoperatively
Internal consistency of the Setswana translated QoR-15 score
To evaluate internal consistency using Cronbach's alpha based on the average correlation between the QoR-15 items.
Measured: Pre-operative (baseline) and 24 hours postoperatively
Test-retest variability of the Setswana-translated QoR-15 score
To evaluate test-retest variability in a subset of 25 patients who will be asked to complete a repeat assessment 60 minutes after their first postoperative questionnaire.
Unit of measure: intraclass correlation coefficient
Measured: 60 minutes after first postoperative questionnaire
Acceptability and feasibility of the Setswana-translated QoR-15 score
To evaluate acceptability and feasibility by calculating the recruitment rate, completion rate and time taken to complete the questionnaire
Measured: During recruitment and postoperative assessment
Responsiveness of the Setswana-translated QoR-15 score
To evaluate responsiveness by calculating Cohen's effect size of change in QoR-15 scores from pre-operative to postoperative assessment.
Measured: Pre-operative (baseline) and 24 hours postoperatively.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2025
- Study start15 Oct 2025 (estimated)
- Primary completion15 Dec 2025 (estimated)
- Study completion30 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Quality of Recovery (QoR-15)Studies 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
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sefako Makgatho Health Sciences University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Unathi Mzinyathi, Sefako Makgatho Health Sciences University
- Investigators
- Charle Dr Steyl, Study director, Sefako Makgatho Health Sciences University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07194369
- Sponsor's protocol ID
- SMUREC/M/276/2025:PG
- Status last verified
- Sep 2025
- First submitted
- 1 Sep 2025
- Last updated
- 26 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Regarding anonymity of patient information, the only documents to contain the patient's name will be the consent form and a sequentially numbered list that will be completed at recruitment that the PI will store to keep track of patients in the study. All data will be de-identified, no personal information (for example name and file number) will be recorded on any of the other study documents. Confidentiality will be ensured by the PI storing all paper documents in lever-arch files in a secure location that only the PI and research assistant has access to. The sequentially numbered list will be stored electronically in a password controlled online folder that only the PI has access to. Personal information will not be shared without express patient permission.
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of the Setswana Translated Quality of Recovery Questionnaire in Orthopaedic Patients at a Tertiary Hospital in South Africa: a Cross-Sectional Observational Study
- ClinicalTrials.gov ID
- NCT07194369
- Acronym / sponsor ID
- SMUREC/M/276/2025:PG
- Keywords
- Setswana translated QoR-15, Quality of Recovery in patients undergoing orthopaedic surgery
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Sefako Makgatho Health Sciences UniversityUniversity, hospital or other
- Study start
- 15 Oct 2025 (estimated)
- Primary completion
- 15 Dec 2025 (estimated)
- Study completion
- 30 Dec 2025 (estimated)
- First posted
- 26 Sep 2025 (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.
This observational study aims to evaluate the validity, reliability and feasibility of the Setswana-translated version of the 15-item Quality of Recovery (QoR-15) questionnaire. The question it aims to answer is:
Does the Setswana translation of the QoR-15 serve as a valid, reliable and user friendly tool for assessing postoperative recovery in Setswana speaking patients undergoing orthopaedic surgery at a tertiary hospital in Gauteng, South Africa?
The participants will be asked to complete the Setswana-translated QoR-15 questionnaire both preoperatively and postoperatively.
In addition, they will be asked to rate their overall postoperative recovery using a visual analog scale (VAS).
Detailed description
Patient reported outcome measures are increasingly recognised as important in preoperative research, yet their routine use in clinical practice remains limited in South Africa.
While quality of recovery measures have been widely applied in general and ambulatory surgery settings, there is a relative paucity of data specifically addressing orthopaedic populations.
Orthopaedic surgical procedures are associated with significant postoperative pain, functional limitations and extended rehabilitation periods, all of which can substantially impact the patient's overall recovery experience. Evaluating a short-term postoperative outcome like quality of recovery in this surgical cohort may help tailor postoperative care to patient needs, which may lead to better patient-clinician communication, better surgical outcomes and better patient satisfaction.
A lack of standardised and validated outcome measures in local languages and high rates of illiteracy may be impediments to implementing widespread use of patient reported outcome questionnaires in practice. Patients who are functionally literate may still not understand medical terms if not presented in their home language and proficiency in English varies widely across South Africa. South Africa has a diverse language heritage with 11 official languages and high rates of functional illiteracy. While many South Africans are able to communicate in English, only a small minority reports English as the primary language used most often outside the household. For black South Africans, the most common languages spoken outside of the home most commonly are IsiZulu, IsiXhosa and the Sotho-Tswana languages.
At present, validated translations of the QoR-15 questionnaire are only available in English and IsiZulu for South African use.
By adding another validated translation in a local language, it is hoped that it will be easier to measure quality of recovery in Setswana speaking populations to address health disparities.
A Setswana translation of the QoR-15 questionnaire exists from a previous study which may be of use in Ga-Rankuwa, which is home to a Setswana speaking population. This translated questionnaire is yet to be validated in this population. For patient reported outcome measures (PROMs) to be effective in non-English speaking populations, rigorous linguistic and cultural adaptation is necessary.
In this study, quality of recovery will be measured with the Setswana translation of the QoR-15 questionnaire as well as with a visual analog scale on which patients can rate their overall postoperative recovery.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- The study population will consist of adult patients (aged 18 years and older) who are fluent in Setswana and are scheduled for elective orthopaedic surgery at the hospital. The population is expected to be diverse in terms of gender, age, and socioeconomic background, reflecting the typical demographic of Setswana-speaking patients. These patients are expected to be conscious and alert in the postoperative period, able to provide informed consent, and cognitively capable of understanding and responding to a questionnaire. Participants with known cognitive impairments, severe postoperative complications that impair communication, or those unwilling to participate will be excluded.
Key inclusion criteria (2 listed)
- Adult patients over 18 years of age
- Scheduled elective orthopaedic surgery at Dr George Mukhari Academic Hospital
Key exclusion criteria (9 listed)
- Patients who are not fluent in Setswana
- Patients booked for emergency surgery where a delay to surgery could be detrimental.
- Patients where the surgery is delayed beyond 10 days of the initial assessment and pre-operative QoR-15 measurement.
- Patients with a psychiatric disturbance that precludes complete co-operation.
- Patients with a severe debilitating medical or surgical condition that may limit objective assessment after surgery.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Convergent validity of the Setswana-translated QoR-15 score
Time frame: Pre-operative baseline and 24 hours postoperatively.
To evaluate convergent validity by assessing the Spearman correlation between the Setswana-translated QoR-15 score and a general visual analog scale (VAS). Unit of measure: Correlation co-efficient (r).
5 secondary outcomes
Construct validity of the Setswana-translated QoR-15 score
Time frame: Pre-operative (baseline) and 24 hours postoperatively
Internal consistency of the Setswana translated QoR-15 score
Time frame: Pre-operative (baseline) and 24 hours postoperatively
Test-retest variability of the Setswana-translated QoR-15 score
Time frame: 60 minutes after first postoperative questionnaire
Acceptability and feasibility of the Setswana-translated QoR-15 score
Time frame: During recruitment and postoperative assessment
Responsiveness of the Setswana-translated QoR-15 score
Time frame: Pre-operative (baseline) and 24 hours postoperatively.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Sep 2025.
- Individual participant dataSharing planned: No. Regarding anonymity of patient information, the only documents to contain the patient's name will be the consent form and a sequentially numbered list that will be completed at recruitment that the PI will store to keep track of patients in the study. All data will be de-identified, no personal information (for example name and file number) will be recorded on any of the other study documents. Confidentiality will be ensured by the PI storing all paper documents in lever-arch files in a secure location that only the PI and research assistant has access to. The sequentially numbered list will be stored electronically in a password controlled online folder that only the PI has access to. Personal information will not be shared without express patient permission.
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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.
Charle Dr Steyl study director
Sefako Makgatho Health Sciences University
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 (QoR-15) and Quality of Recovery From Anaesthesia, run by Sefako Makgatho Health Sciences University at 1 site in South Africa.
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 2 inclusion and 9 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: opening soon, as of the sponsor's last update on 26 Sep 2025. 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 South Africa. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Unathi Dr Mzinyathi (0711436058, 201308763@swave.smu.ac.za), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Convergent validity of the Setswana-translated QoR-15 score (time frame: Pre-operative baseline and 24 hours postoperatively.). 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 26 Sep 2025.