Pediatric Anesthesia: The Childs Voice

NCT07289152 | Recruiting DMC

• 1 other identifier: 1-16-02-129-25
• Study Type: observational
• Target: 250
• Locations: 1 country
• Sites: 3

Brief Summary

In Denmark, around 25,000 children under 18 undergo general anesthesia annually. Hospital stays and anesthesia can induce significant anxiety and stress in children due to unfamiliar environments, procedures, and communication issues. This anxiety can be linked to postoperative complications such as emergence delirium and may negatively impact both the child and their family's well-being. Engaging patients actively in their healthcare, including pediatric cases, is essential for improving outcomes. Assessing perioperative patient and family outcomes, particularly through patient-reported outcome measures (PROM) and patient-reported experience measures (PREM), can significantly enhance the quality of care provided to children. While PROMs are widely used in adults, they are less common in pediatric settings. The Pediatric Scale for Quality of Recovery (PedSQoR), developed by Australian and American researchers, is one such tool designed to measure recovery in children. This study aims to translate andvalidate the PedSQoR for Danish children aged 4-12. Furthermore, no existing instruments comprehensively assess pediatric surgery patients' experiences under general anesthesia, particularly from the child's perspective without relying on parents as proxies. Empowering children to express their healthcare experiences gives healthcare workers an insight into what matters for children and gives children a more positive outlook on healthcare, benefiting lifelong engagement. Study Aims and 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. 1.Translation and Adaptation: a. Translate and adapt the PedSQoR for Danish children aged 4-12. b. Validate the Danish PedSQoR version.
2. 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.
3. 3.PedSQoR Translation and Validation:
4. 4.PREM Instrument Development:

Conditions

Pediatric Anesthesia; Pediatric Surgery; PROMs; PREMs

Keywords

PROM; Patient-reported outcom measues; Children; child; PREM; Patient-reported experience measures

Outcome Measures

Primary Outcomes (2)

• To validate the Danish version of the PedSQoR in children aged 4-12.

  From enrollment to the end of week 4 after surgery

• To pilot-test and adjust the questionnaire on a group of children aged 4-12 who have undergone surgery and anaesthesia

  Patient Reported Experience Measure (PREM)

  From enrollment to 4 weeks after surgery

Study Arms (1)

Children age 4-12, undergoing surgery and general anesthesia

Eligibility Criteria

• Age: 4 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Probability Sample

Study Population

Children undergoing surgery and general anesthesia aged 4-12 years.

You may qualify if:

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

You may not qualify if:

• Children with cognitive or sensory disorders
• children or parents who do not speak Danish,
• patients for whom there is no consent to participate.

Sponsors & Collaborators

• Gødstrup Hospital: lead
• Aarhus University Hospital: collaborator

Study Sites (3)

Aarhus University Hospital

Aarhus, Central Jutland, 8200, Denmark

RECRUITING

Copenhagen University Hospital

Copenhagen, Region Sjælland, 2100, Denmark

RECRUITING

Gødstrup Hospital

Herning, 7400, Denmark

RECRUITING

Central Study Contacts

Johanna Arnbjørn C Arnbjørn

CONTACT

+4527141475; johkoc@rm.dk

Anne Højager Nielsen, Ph.D.

CONTACT

anne.hoejager.nielsen@rm.dk

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 3, 2025
• First Posted: December 17, 2025
• Study Start: January 1, 2026
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2030
• Last Updated: April 23, 2026

Record last verified: 2025-05

Locations

DK (3)