Stress-related ProblemNCT05567913
Change i Perceived Stress in School-age Students When Adding Physiotherapists to a School's Health Team.
An observational study of Stress-related Problem, run by Vastra Gotaland Region at 1 site in Sweden.
Trial 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. Read more about this study
- Who is it for?
- Ages 9 to 16 years
- Conditions the study is for
- Stress-related Problem
- How many people
- 80 participants
- Where
- 1 siteSweden
- Study dates
- 12 Oct 2022to 30 Oct 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 9 to 16 years
- All sexes
- No healthy volunteers
- Child
Study population: All registered students in grade 4-9 at Haga school Dals-Ed, Sweden 2022-2025.
Who may be able to join
- Registered students in grades 4-9 at Haga School in Dals-Ed, Sweden
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Change in Perceived Stress Level and Stress-related Symptoms in Elementary School Students During Active Stress Prevention Work With the Addition of a Physiotherapist to the School's Student Health Team.
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.
Read more
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.
Read the detailed description
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.
- Conditions
- Stress-related Problem
- Keywords
- School health services, Physical therapy modalities, Mental health, Child, Adolescent
- Medical subject headings
- Psychological Well-Being
What is being measured
The primary outcome is the main question the study is designed to answer.
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".
Measured: 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
Measured: 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.
Measured: Change between inclusion and 8 month, 12 and 20 month follow-ups.
Secondary outcomes (14)
Stress-related symptoms
Measured with number of stress-related symptoms chosen from a list of 7 symptoms or no symptoms.
Measured: Change between inclusion and 8 month, 12 and 20 month follow-ups
Prevalence of specific stress-related symptoms
Number of students who report each specific symptom from a list of 7 symptoms or no symptoms.
Measured: Change between inclusion and 8 month, 12 and 20 month follow-ups
Stress-alleviating factors
Single question regarding handling of stress symptoms, chosen from list of 9 suggestions or open-ended answer.
Measured: Change between inclusion and 8 month, 12 and 20 month follow-ups
Headache prevalence
Single question regarding prevalence of headache during the last month with 5 possible levels, ranging from "never" to "always".
Measured: Change between inclusion and 8 month, 12 and 20 month follow-ups.
Stomach-ache prevalence
Single question regarding prevalence of stomach-ache during the last month with 5 possible levels, ranging from "never" to "always".
Measured: Change between inclusion and 8 month, 12 and 20 month follow-ups.
Prevalence of irritability
Single question regarding irritation or bad mood during the last month with 5 possible levels ranging from "never" to "always".
Measured: Change between inclusion and 8 month, 12 and 20 month follow-ups.
Prevalence of depressive feelings
Single question regarding feeling sad or depressed feelings during the last month with 5 possible levels ranging from "never" to "always".
Measured: Change between inclusion and 8 month, 12 and 20 month follow-ups.
Sleeping habits
Single question about sleep quality with 5 possible answers ranging from "very bad" to "very good".
Measured: Change between inclusion and 8 month, 12 and 20 month follow-ups.
Well-being at school
Single question regarding well-being at school with 5 possible levels, ranging from "very bad" to "very good".
Measured: Change between inclusion and 8 month, 12 and 20 month follow-ups.
Physical activity
Single question about amount of physical activity during the last 7 days, with 8 possible levels, ranging from "less than 1 hour" to "more than 10 hours"
Measured: Change between inclusion and 8 month, 12 and 20 month follow-ups.
Transportation to school
Single question about commuting to school with four possible answers, walking, bicycling, bus, car/moped.
Measured: Change between inclusion and 8 month, 12 and 20 month follow-ups.
School absence
Group level school absence retrieved from school statistics. Measured in number of days. days.
Measured: Change between school-year 2021-2022 and 2023-2024.
Study results
Group level study results for each grade. Measured in grades E-A.
Measured: Change between school-year 2021-2022 and 2023-2024.
Eligibility upper-level secondary school
Group level eligibility for upper-level secondary school programs for students in Grade 9. Measured in number of students eligible for upper-level secondary school.
Measured: Change between school-year 2021-2022 and 2023-2024.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2022
- Study start12 Oct 2022
- Primary completion30 Oct 2024
- Study completion30 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stress-related ProblemStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vastra Gotaland Region
- Sponsor type
- Other government
- Collaborators
- Dals-Ed Municipality
- Responsible party
- Principal investigator, Anna Bergenheim, Vastra Gotaland Region
- Investigators
- Anna Bergenheim, PhD, Principal investigator, Region Västra Götaland, University of Gothenburg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05567913
- Sponsor's protocol ID
- VGFOUFBD976982
- Status last verified
- Mar 2025
- First submitted
- 3 Oct 2022
- Last updated
- 1 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is no plan to share individual participant data with other researchers than the participating research group.
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Change in Perceived Stress Level and Stress-related Symptoms in Elementary School Students During Active Stress Prevention Work With the Addition of a Physiotherapist to the School's Student Health Team.
- ClinicalTrials.gov ID
- NCT05567913
- Acronym / sponsor ID
- VGFOUFBD976982
- Conditions
- Stress-related Problem
- Keywords
- School health services, Physical therapy modalities, Mental health, Child, Adolescent
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Vastra Gotaland RegionOther government
- Collaborators
- Dals-Ed Municipality
- Study start
- 12 Oct 2022 (actual)
- Primary completion
- 30 Oct 2024 (actual)
- Study completion
- 30 Oct 2024 (actual)
- First posted
- 5 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 9 to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- All registered students in grade 4-9 at Haga school Dals-Ed, Sweden 2022-2025.
Key inclusion criteria (1 listed)
- Registered students in grades 4-9 at Haga School in Dals-Ed, Sweden
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Change in perceived stress
Time frame: Change between inclusion and 8 month, 12 and 20 month follow-ups.
Measured with single question on questionnaire with 4 possible levels to choose from, ranging from "not at all" to "very much".
Reasons for stress
Time frame: Change between inclusion and 8 month, 12 and 20 month follow-ups.
Single question about stressors chosen from a list of 7 stressors or no stressors
School stress factors School stress factors School stress factors
Time frame: Change between inclusion and 8 month, 12 and 20 month follow-ups.
Single question about factors that contribute to perceived stress in school, chosen from a list of 16 stressors.
14 secondary outcomes
Stress-related symptoms
Time frame: Change between inclusion and 8 month, 12 and 20 month follow-ups
Prevalence of specific stress-related symptoms
Time frame: Change between inclusion and 8 month, 12 and 20 month follow-ups
Stress-alleviating factors
Time frame: Change between inclusion and 8 month, 12 and 20 month follow-ups
Headache prevalence
Time frame: Change between inclusion and 8 month, 12 and 20 month follow-ups.
Stomach-ache prevalence
Time frame: Change between inclusion and 8 month, 12 and 20 month follow-ups.
Prevalence of irritability
Time frame: Change between inclusion and 8 month, 12 and 20 month follow-ups.
Prevalence of depressive feelings
Time frame: Change between inclusion and 8 month, 12 and 20 month follow-ups.
Sleeping habits
Time frame: Change between inclusion and 8 month, 12 and 20 month follow-ups.
Well-being at school
Time frame: Change between inclusion and 8 month, 12 and 20 month follow-ups.
Physical activity
Time frame: Change between inclusion and 8 month, 12 and 20 month follow-ups.
Transportation to school
Time frame: Change between inclusion and 8 month, 12 and 20 month follow-ups.
School absence
Time frame: Change between school-year 2021-2022 and 2023-2024.
Study results
Time frame: Change between school-year 2021-2022 and 2023-2024.
Eligibility upper-level secondary school
Time frame: Change between school-year 2021-2022 and 2023-2024.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2025.
- Individual participant dataSharing planned: No. There is no plan to share individual participant data with other researchers than the participating research group.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anna Bergenheim, PhD principal investigator
Region Västra Götaland, University of Gothenburg
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Stress-related Problem, run by Vastra Gotaland Region at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in perceived stress (time frame: Change between inclusion and 8 month, 12 and 20 month follow-ups.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Apr 2025.