Ignite Creation Date:
2025-12-24 @ 10:53 PM
Ignite Modification Date:
2025-12-25 @ 8:22 PM
Study NCT ID:
NCT07194369
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-09-26
First Post:
2025-09-01
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Validation of the Setswana Translated Quality of Recovery Questionnaire in Orthopaedic Patients at a Tertiary Hospital in South Africa
Sponsor:
Sefako Makgatho Health Sciences University
Organization:
Study Overview
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
Status:
NOT_YET_RECRUITING
Status Verified Date:
2025-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 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).
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.
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: