Physical Activity Tracking in Paediatric Elective Tonsillectomy (PATIPS)

This pilot study will investigate the feasibility of physical activity tracking in patients aged 4-16 years before and after elective tonsillectomy as an innovative tool in paediatric research. The participating patients will receive a wearable physical activity tracker (CE-certified) that will continuously measure the patients' physical activity before and after an elective tonsillectomy, in addition to their parents' documentation of their child's activity in a conventional diary.

Study Overview

• Status: Completed
• Conditions: Tonsillectomy

• Study Type: Observational
• Enrollment (Actual): 24

Contacts and Locations

Study Locations

• Switzerland
  • Basel-Stadt
    • Basel, Basel-Stadt, Switzerland, 4056
      • University Children's Hospital Basel

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 4 years to 16 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Children undergoing elective tonsillectomy or tonsillotomy

Description

Inclusion Criteria:

• Age 4 to 16 years old, in 2 subgroups (4-7 years, 8-16 years)
• Inpatient surgery at University Children's Hospital Basel (UKBB), Switzerland
• Children undergoing an elective tonsillectomy or tonsillotomy. Children having additional ENT procedures, such as adenectomy, tympanostomy, etc. may be included as well.

Exclusion Criteria:

• Children with mental or physical impairment during daily-life activities.
• Children undergoing additional surgical procedures other than Ear, Nose & Throat (ENT) procedures impacting the recovery period.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Children aged 4-7 years
Children and adolescents aged 8-16 years

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Feasibility of physical activity tracking in children	Difference in proportions of patients having complete activity measurement data, comparing the electronic tracker with the conventional diary.	up to 6 weeks

Collaborators and Investigators

• Sponsor: University Children's Hospital Basel
• Investigators: Principal Investigator: Victoria Ziesenitz, MD, University Children's Hospital Basel

Publications and helpful links

General Publications

• Lambrechtse P, Ziesenitz VC, Atkinson A, Bos EJ, Welzel T, Gilgen Y, Gurtler N, Heuscher S, Cohen AF, van den Anker JN. Monitoring the recovery time of children after tonsillectomy using commercial activity trackers. Eur J Pediatr. 2021 Feb;180(2):527-533. doi: 10.1007/s00431-020-03900-4. Epub 2021 Jan 4.

Study record dates

Study Major Dates

• Study Start (Actual): June 29, 2017
• Primary Completion (Actual): May 25, 2018
• Study Completion (Actual): June 30, 2018

Study Registration Dates

• First Submitted: May 30, 2017
• First Submitted That Met QC Criteria: May 30, 2017
• First Posted (Actual): June 2, 2017

Study Record Updates

• Last Update Posted (Actual): April 22, 2019
• Last Update Submitted That Met QC Criteria: April 19, 2019
• Last Verified: April 1, 2019

More Information

Terms related to this study

• Other Study ID Numbers: UKBB 2017-012; BASEC 2017-00547 (Other Identifier: Swissethics)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No