Physical Activity Tracking in Paediatric Elective Tonsillectomy

NCT ID: NCT03174496

Last Updated: 2019-04-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

24 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-06-29

Study Completion Date

2018-06-30

Brief Summary

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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.

Detailed Description

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Conditions

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Tonsillectomy

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Study Groups

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Children aged 4-7 years

No interventions assigned to this group

Children and adolescents aged 8-16 years

No interventions assigned to this group

Eligibility Criteria

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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.
Minimum Eligible Age

4 Years

Maximum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Children's Hospital Basel

OTHER

Sponsor Role lead

Responsible Party

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Victoria Ziesenitz

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Victoria Ziesenitz, MD

Role: PRINCIPAL_INVESTIGATOR

University Children's Hospital Basel

Locations

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University Children's Hospital Basel

Basel, Canton of Basel-City, Switzerland

Site Status

Countries

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Switzerland

References

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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.

Reference Type DERIVED
PMID: 33394138 (View on PubMed)

Other Identifiers

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BASEC 2017-00547

Identifier Type: OTHER

Identifier Source: secondary_id

UKBB 2017-012

Identifier Type: -

Identifier Source: org_study_id

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