Pediatric Health Empowerment: Improving Children´s Perioperative Experiences With Patient-Reported Measures

Status: Recruiting
Location: See all (4) locations...
Study Type: Observational
SUMMARY

Objectives: The study aims to enhance the assessment of children's outcomes and experiences in perioperative settings, ultimately improving pediatric perioperative healthcare. The objectives include: 1. Translation and Adaptation: a. Translate and adapt the PedSQoR for Danish children aged 4-12. b. Validate the Danish PedSQoR version. 2. Development of a PREM Instrument: a. Develop a comprehensive PREM for children's experiences during surgery and anesthesia. b. Pilot-test and adjust the PREM questionnaire with a group of children aged 4-12. Study

Methods: 1. PedSQoR Translation and Validation: A single-center prospective cohort study will adapt and test the PedSQoR for Danish children. The process involves translating the 21-item scale, validating it with a sample size of 150, and ensuring reliability through various statistical methods, including Cronbach's Alpha and test-retest reliability. Data will be collected from the Department of Anesthesiology and Intensive Care at Gødstrup Hospital. 2. PREM Instrument Development: This study will develop a PREM instrument using the Warwick Patient Experiences Framework (WaPEF), which encompasses seven dimensions of patient experience. The process will involve forming a panel of child experts, conducting focus groups, and translating insights into a pictorial questionnaire. The PREM will undergo pilot testing with 20 children to validate its effectiveness in capturing the dimensions of the WaPEF. Research Ethics: Given the vulnerability of children in research, this study will prioritize their safety and comfort, ensuring the study's benefits outweigh any potential risks. Informed consent will be obtained from both parents and children. The study will be registered with the Region Central Denmark's list of research projects and will not require approval from the Scientific Ethics Committee.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 4
Maximum Age: 12
Healthy Volunteers: f
View:

• Pediatric patients aged 4-12, American Society of Anesthesiologists physical status classification (ASA) I-III undergoing surgery.

Locations
Other Locations
Denmark
Aalborg University Hospital
NOT_YET_RECRUITING
Aalborg
Aarhus University Hospital
NOT_YET_RECRUITING
Aarhus
Copenhagen University Hospital
NOT_YET_RECRUITING
Copenhagen
Gødstrup Hospital
RECRUITING
Herning
Contact Information
Primary
Johanna Arnbjørn C Arnbjørn
johkoc@rm.dk
+4527141475
Backup
Anne Højager Nielsen, Ph.D.
anne.hoejager.nielsen@rm.dk
Time Frame
Start Date: 2026-01-01
Estimated Completion Date: 2030-12-31
Participants
Target number of participants: 250
Treatments
Children age 4-12, undergoing surgery and general anesthesia
Related Therapeutic Areas
Sponsors
Leads: Gødstrup Hospital
Collaborators: Aarhus University Hospital

This content was sourced from clinicaltrials.gov