Clincosm LogoSign in Get a demo

PATIPS: Physical Activity Tracking in Paediatric Elective Tonsillectomy

Sponsor
University Children's Hospital Basel (Other)
Overall Status
Completed
CT.gov ID
NCT03174496
Collaborator
(none)
24
Enrollment
1
Location
12
Actual Duration (Months)
2
Patients Per Site Per Month

Study Details

Study Description

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 Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    24 participants
    Observational Model:
    Other
    Time Perspective:
    Prospective
    Official Title:
    Physical Activity Tracking in Paediatric Elective Tonsillectomy
    Actual Study Start Date :
    Jun 29, 2017
    Actual Primary Completion Date :
    May 25, 2018
    Actual Study Completion Date :
    Jun 30, 2018

    Arms and Interventions

    Arm Intervention/Treatment
    Children aged 4-7 years
    Children and adolescents aged 8-16 years

    Outcome Measures

    Primary Outcome Measures

    1. Feasibility of physical activity tracking in children [up to 6 weeks]

      Difference in proportions of patients having complete activity measurement data, comparing the electronic tracker with the conventional diary.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    4 Years to 16 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University Children's Hospital Basel Basel Basel-Stadt Switzerland 4056

    Sponsors and Collaborators

    • University Children's Hospital Basel

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Victoria Ziesenitz, MD, University Children's Hospital Basel
    ClinicalTrials.gov Identifier:
    NCT03174496
    Other Study ID Numbers:
    • UKBB 2017-012
    • BASEC 2017-00547
    First Posted:
    Jun 2, 2017
    Last Update Posted:
    Apr 22, 2019
    Last Verified:
    Apr 1, 2019
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No

    Study Results

    No Results Posted as of Apr 22, 2019