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Physical Activity Tracking in Paediatric Elective Tonsillectomy (PATIPS)

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ClinicalTrials.gov Identifier: NCT03174496
Recruitment Status : Recruiting
First Posted : June 2, 2017
Last Update Posted : June 14, 2017
Sponsor:
Information provided by (Responsible Party):
Victoria Ziesenitz, University Children's Hospital Basel

Brief 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.

Condition or disease
Tonsillectomy

Study Type : Observational
Estimated Enrollment : 24 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: Physical Activity Tracking in Paediatric Elective Tonsillectomy
Actual Study Start Date : June 7, 2017
Estimated Primary Completion Date : May 31, 2018
Estimated Study Completion Date : August 31, 2018

Resource links provided by the National Library of Medicine


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



Primary Outcome Measures :
  1. Feasibility of physical activity tracking in children [ Time Frame: up to 6 weeks ]
    Difference in proportions of patients having complete activity measurement data, comparing the electronic tracker with the conventional diary.



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Ages Eligible for Study:   4 Years to 16 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Children undergoing elective tonsillectomy or tonsillotomy
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03174496


Contacts
Contact: Sarah Koechlin, PharmD +41-61-704- ext 2851 sarah.koechlin@ukbb.ch
Contact: Philip Lambrechtse, BSc +41-61-704- ext 2856 philip.lambrechtse@ukbb.ch

Locations
Switzerland
University Children's Hospital Basel Recruiting
Basel, Basel-Stadt, Switzerland, 4056
Contact: Sarah Koechlin, PharmD    +41-61-704- ext 2851    sarah.koechlin@ukbb.ch   
Principal Investigator: Victoria Ziesenitz, MD         
Sub-Investigator: Johannes van den Anker, MD, PhD         
Sub-Investigator: Julia Bielicki, MD         
Sub-Investigator: Philip Lambrechtse, BSc         
Sponsors and Collaborators
University Children's Hospital Basel
Investigators
Principal Investigator: Victoria Ziesenitz, MD University Children's Hospital Basel

Responsible Party: Victoria Ziesenitz, MD, University Children's Hospital Basel
ClinicalTrials.gov Identifier: NCT03174496     History of Changes
Other Study ID Numbers: UKBB 2017-012
BASEC 2017-00547 ( Other Identifier: Swissethics )
First Posted: June 2, 2017    Key Record Dates
Last Update Posted: June 14, 2017
Last Verified: June 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No