Validation of the Setswana Translated Quality of Recovery Questionnaire in Orthopaedic Patients at a Tertiary Hospital in South Africa

NCT07194369 | Not Yet Recruiting

• 1 other identifier: SMUREC/M/276/2025:PG
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

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).

Conditions

Quality of Recovery (QoR-15); Quality of Recovery From Anaesthesia

Keywords

Setswana translated QoR-15; Quality of Recovery in patients undergoing orthopaedic surgery

Outcome Measures

Primary Outcomes (1)

• 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).

  Pre-operative baseline and 24 hours postoperatively.

Secondary Outcomes (5)

• Construct validity of the Setswana-translated QoR-15 score

  Pre-operative (baseline) and 24 hours postoperatively

• Internal consistency of the Setswana translated QoR-15 score

  Pre-operative (baseline) and 24 hours postoperatively

• Test-retest variability of the Setswana-translated QoR-15 score

  60 minutes after first postoperative questionnaire

• Acceptability and feasibility of the Setswana-translated QoR-15 score

  During recruitment and postoperative assessment

• Responsiveness of the Setswana-translated QoR-15 score

  Pre-operative (baseline) and 24 hours postoperatively.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• Adult patients over 18 years of age
• Scheduled elective orthopaedic surgery at Dr George Mukhari Academic Hospital

You may not qualify if:

• 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.
• Postoperative confusion or delirium.
• Patients with a history of recent drug or alcohol abuse which may render responses unreliable.
• Incomplete QoR-15 questionnaires.

Sponsors & Collaborators

• Sefako Makgatho Health Sciences University: lead

Study Sites (1)

Dr George Mukhari Academic Hospital

Pretoria, Gauteng, 0204, South Africa

Location

Study Officials

• Charle Dr Steyl

  Sefako Makgatho Health Sciences University

  STUDY DIRECTOR

Central Study Contacts

Unathi Dr Mzinyathi

CONTACT

0711436058; 201308763@swave.smu.ac.za

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: DR

Study Record Dates

• First Submitted: September 1, 2025
• First Posted: September 26, 2025
• Study Start: October 15, 2025
• Primary Completion: December 15, 2025
• Study Completion: December 30, 2025
• Last Updated: September 26, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

ZA (1)