Physical Activity Tracking in Paediatric Elective Tonsillectomy

Tonsillectomy Clinical Trial

— PATIPS  

Official title:

Physical Activity Tracking in Paediatric Elective Tonsillectomy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03174496
• Other study ID #: UKBB 2017-012
• Secondary ID: BASEC 2017-00547
• Status: Completed
• Start date: June 29, 2017
• Est. completion date: June 30, 2018

Study information

• Verified date: April 2019
• Source: University Children's Hospital Basel
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: June 30, 2018
• Est. primary completion date: May 25, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 4 Years to 16 Years

Eligibility

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.

Related Conditions & MeSH terms

• Tonsillectomy

Locations

Country	Name	City	State
Switzerland	University Children's Hospital Basel	Basel	Basel-Stadt

Sponsors (1)

Lead Sponsor	Collaborator
University Children's Hospital Basel

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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