Change i Perceived Stress in School-age Students When Add... | NCT05567913

Studies
Change i Perceived Stress in School-age Students When Adding Physiotherapists to a School's Health Team.

NCT05567913

Sponsor

Vastra Gotaland Region

Status

Completed

Last Update Posted

Apr 1, 2025Actual

Enrollment

80Actual

Phase

Not provided

Conditions

Stress-related Problem

Interventions

Not provided

Countries

Sweden

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2025

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 12, 2022Actual

Primary Completion Date

Oct 30, 2024Actual

Completion Date

Oct 30, 2024Actual

First Submitted Date

Oct 3, 2022

First Submission Date that Met QC Criteria

Oct 3, 2022

First Posted Date

Oct 5, 2022Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 31, 2025

Last Update Posted Date

Apr 1, 2025Actual

Name	Class
Dals-Ed Municipality	UNKNOWN

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

Brief Summary

School stress and performance requirements have been shown to contribute to mental illness among children and young people.

Student health teams have an important role regarding mental health of children and young people. Swedish student health teams include various health and pedagogical professionals, but physiotherapists are uncommon, despite the good effects school-related physical activity interventions have had on reducing anxiety and improving well-being in children and young people.

Haga School, Dals-Ed has now employed physiotherapists as part of the student health team to support students in learning to define, reduce and manage stress.

The purpose of the research project is to investigate changes in perceived stress level and stress-related symptoms, as well as study results and absence from school during two years for students in grades 4 to 9 at Haga School. A questionnaire will be sent out on four occasions over two years. Group level statistics on study results and school absence will be compared with years previous to the introduction of the school physiotherapist. The research contributes to increased knowledge about effects of having a physiotherapist as part of a student health team in Sweden.

Detailed Description

School stress and performance requirements have been shown to contribute to mental illness among children and young people.

Haga School, Dals-Ed has now employed physiotherapists as part of the student health team to support students in learning to define, reduce and manage stress.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

80Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change in perceived stress	Measured with single question on questionnaire with 4 possible levels to choose from, ranging from "not at all" to "very much".	Change between inclusion and 8 month, 12 and 20 month follow-ups.
Reasons for stress	Single question about stressors chosen from a list of 7 stressors or no stressors	Change between inclusion and 8 month, 12 and 20 month follow-ups.
School stress factors School stress factors School stress factors	Single question about factors that contribute to perceived stress in school, chosen from a list of 16 stressors.	Change between inclusion and 8 month, 12 and 20 month follow-ups.

Secondary Outcomes

Measure	Description	Time Frame
Stress-related symptoms	Measured with number of stress-related symptoms chosen from a list of 7 symptoms or no symptoms.	Change between inclusion and 8 month, 12 and 20 month follow-ups
Prevalence of specific stress-related symptoms

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Registered students in grades 4-9 at Haga School in Dals-Ed, Sweden

Exclusion Criteria:

None

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

9 Years

Maximum Age

16 Years

Standard Ages

Child

Study Population

All registered students in grade 4-9 at Haga school Dals-Ed, Sweden 2022-2025.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Anna Bergenheim, PhD	Region Västra Götaland, University of Gothenburg	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Haga School		Ed		66830	Sweden

IPD Sharing Statement Module

Plan to Share IPD

Description

There is no plan to share individual participant data with other researchers than the participating research group.

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D000092862	Psychological Well-Being

Ancestor Terms

ID	Term
D010549	Personal Satisfaction
D001519	Behavior

Browse Leaves

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Browse Branches

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