StressNCT05223855
Effect of Aquatic Physiotherapy for People With Stress
A study testing Physiotherapeutic hydrotherapy treatment in people with Stress, run by vandfys at 1 site in Denmark.
Trial summary
Brief summary: Effect of aquatic physiotherapy for people with stress; a randomized controlled trial (RCT) The purpose of the project is to investigate the effect of aquatic physiotherapy treatment in 34-36 degrees warm water. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stress
- What is being tested?
- Physiotherapeutic hydrotherapy treatment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteDenmark
- Study dates
- 27 Jan 2022to 30 Jun 2023
- Phase
- Interventional
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Has been reported sick by GP within the last four weeks, and is now on sick leave with stress.
- Is 18 years or older.
- Is on sick leave from work or school
- Speaks, reads and understands Danish fluently.
- Has had symptoms of stress during the last month
- Is willing to fill out questionnaires before, during and after treatment/treatment period.
Show all 9Show fewer
- Has the possibility to participate
- Would like treatment in hot water
- Has given informed consent
Who cannot join
- Previously been on sick leave with stress.
- Long-term / unresolved cases with authorities or former partners / spouses.
- Is taking sleep medication.
- Known with bipolar disorder.
- Fear of water.
- Fear of getting ears under water
- Physical state that prevents movement in water
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 'Effect of Aquatic Physiotherapy for People With Stress; a Randomized Controlled Trial (RCT)'
Brief summary:
Effect of aquatic physiotherapy for people with stress; a randomized controlled trial (RCT)
Read more
The purpose of the project is to investigate the effect of aquatic physiotherapy treatment in 34-36 degrees warm water.
The study is a randomized controlled trial, and participants are recruited from GPs in Lyngby-Taarbæk as well as Gentofte Kommune.
The participants are randomized using numbered, opaque and sealed envelopes.
Method:
The intervention Aquatic physiotherapy 1: 1 treatment in 34-36 degrees centigrade warm water.
The participant is placed supine in the water, supported by the physiotherapist as well as aqua noodles. The physiotherapist supports and moves the participant in the water and adapts to the participant's reaction.
Intervention Group:
The intervention group is treated twice a week. Duration of each treatment is 30 minutes. Period of treatment is 8 weeks.
Control Group:
The control group receives usual care through their GP for 8 weeks. Then they are offered participation in a de-stress class in 34-36 degrees centigrade warm water, twice a week.
Duration of each treatment is 30 minutes. Period of treatment is 8 weeks.
EFFECT MEASURES:
- Primary effect measures: Change of stress level from baseline using validated questionnaire Cohen's Perceived Stress Scale (PSS).
- Secondary effect measures:
Change of sleep disorders from baseline using validated questionnaire Pittsburgh Sleep Quality Index (PSQI).
Measurements to be taken before and after 8-weeks intervention
Read the detailed description
Stress is a growing public health issue and the health professional offerings are varied and with modest evidence. Warm water has been used for centuries for the relaxing and positive effect on well-being. The evidence of this form of treatment for stress sufferers has not previously been studied.
The purpose of the project is to investigate the effect of physiotherapeutic 1:1 treatment in 34-36 degree centigrade warm water, twice a week for 30 minutes over an eight week period.
Hypothesis:
Stress sufferers will experience a reduction in stress levels.
Methodical approach:
Design: randomized controlled trial with intervention group receiving treatment in warm water and control group receiving usual care via general practitioner during the control period and then offered participation in a de-stress class.
Control group Standard treatment cf. https://www.sundhed.dk/sundhedsfaglig/laegehaandbogen/sundhedsoplysning/sundhedsoplysning/diverse/stress/
Recruitment The participants are recruited from general practitioners in Gentofte and Lyngby Tårbæk municipality, cf. inclusion and exclusion criteria.
Estimated sample sizes:
N = 26 N per group =13
Empiri:
- Primary effect measures: Change of stress level from baseline using validated questionnaire Cohen's Perceived Stress Scale (PSS).
- Secondary effect measures:
- Change of sleep disorders from baseline using validated questionnaire Pittsburgh Sleep Quality Index (PSQI).
- Change in self-perceived quality of life measured by questionnaire (EQ-5D) Measurements to be taken before and after 8-weeks intervention
- Explorative measures: a )change in self-perceived level of depression measured by questionnaire Major Depression Index (MDI), and b) change in self-perceived level of burnout measured by questionnaire Karolinska Exhaustion Disorder Scale (KEDS)
Ethical considerations:
Participation in warm water treatment is considered without side effects or risks.
Using exercise in warm water is part of general physiotherapeutic practice. The treatment is handled by experienced physiotherapists. The project complies with the Helsinki Declaration.
- Conditions
- Stress
- Being tested
- Physiotherapeutic hydrotherapy treatment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physiotherapeutic hydrotherapy treatmentOther
Physiotherapeutic hydrotherapy treatment The intervention consists of physiotherapeutic one-on-one treatment in a 34-36 degrees centigrade hot water, where the participants are placed supine in the water supported by the physiotherapist as well as buoyant aqua noodles. The physiotherapist supports and moves the participants in the water and adapts to the participant's reaction.
The combination of heat, water, movement and touch affects the musculoskeletal and neuromuscular systems and thus has a depth-relaxing effect (Schoedinger, 2010).
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Active comparator | The intervention group receives intervention for 8 weeks Receives: Other: Physiotherapeutic hydrotherapy treatment |
| control group | No intervention | The control group receives usual care for 8 weeks and is then offered participation in a de-stress class for 8 weeks. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Level of stress
Cohens 10-item Perceived Stress Scale. A self-reported questionnaire of 10 questions that measures to which extent the respondent experiences that life is unpredictable, uncontrollable and overwhelming. Each question yields a score ranging from 0 to 4, with 4 indicating the highest level. The scores are summed to yield a total score ranging from 0 to 40 Minimum value is 0 Maximum value is 40
The aim of the evaluation is therefore to assess whether the respondent experiences a reduction in the degree of stress.
Measured: 8 weeks
Secondary outcomes (1)
Sleep disorder
Pittsburgh Sleep Quality Index. A self-reported questionnaire that contains 19 sleep components. Each component yields a score ranging from 0 to 3, with 3 indicating the greatest dysfunction. The sleep component scores are summed to yield a total score ranging from 0 to 21 with the higher total score (referred to as global score) indicating worse sleep quality.
Minimum value is 0 Maximum value is 21
The aim of the evaluation is therefore to assess whether the respondent experiences an improvement in sleep quality.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2022
- Study start27 Jan 2022
- Primary completion30 Jun 2023
- Study completion30 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StressStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Intervention group receives intervention twice a week for 8 weeks. Control group receives usual care through GP for 8 weeks, and are then offered participation in de-stress class twice a week for 8 weeks.
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- vandfys
- Sponsor type
- University, hospital or other
- Collaborators
- Herlev and Gentofte Hospital
- Responsible party
- Principal investigator, Lone Nedergaard, vandfys
- Investigators
- Carsten Bogh Juul, phD, Principal investigator, Herlev & Gentofte Hospitalers Forskningsenhed
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05223855
- Sponsor's protocol ID
- 0221
- Status last verified
- Sep 2023
- First submitted
- 29 Dec 2021
- Last updated
- 5 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The individuel participant data will not be made available to other researchers.
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 'Effect of Aquatic Physiotherapy for People With Stress; a Randomized Controlled Trial (RCT)'
- ClinicalTrials.gov ID
- NCT05223855
- Acronym / sponsor ID
- 0221
- Conditions
- Stress
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- vandfysUniversity, hospital or other
- Collaborators
- Herlev and Gentofte Hospital
- Study start
- 27 Jan 2022 (actual)
- Primary completion
- 30 Jun 2023 (actual)
- Study completion
- 30 Jun 2023 (actual)
- First posted
- 4 Feb 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.
Brief summary:
Effect of aquatic physiotherapy for people with stress; a randomized controlled trial (RCT)
The purpose of the project is to investigate the effect of aquatic physiotherapy treatment in 34-36 degrees warm water.
The study is a randomized controlled trial, and participants are recruited from GPs in Lyngby-Taarbæk as well as Gentofte Kommune.
The participants are randomized using numbered, opaque and sealed envelopes.
Method:
The intervention Aquatic physiotherapy 1: 1 treatment in 34-36 degrees centigrade warm water.
The participant is placed supine in the water, supported by the physiotherapist as well as aqua noodles. The physiotherapist supports and moves the participant in the water and adapts to the participant's reaction.
Intervention Group:
The intervention group is treated twice a week. Duration of each treatment is 30 minutes. Period of treatment is 8 weeks.
Control Group:
The control group receives usual care through their GP for 8 weeks. Then they are offered participation in a de-stress class in 34-36 degrees centigrade warm water, twice a week.
Duration of each treatment is 30 minutes. Period of treatment is 8 weeks.
EFFECT MEASURES:
- Primary effect measures: Change of stress level from baseline using validated questionnaire Cohen's Perceived Stress Scale (PSS).
- Secondary effect measures:
Change of sleep disorders from baseline using validated questionnaire Pittsburgh Sleep Quality Index (PSQI).
Measurements to be taken before and after 8-weeks intervention
Detailed description
Stress is a growing public health issue and the health professional offerings are varied and with modest evidence. Warm water has been used for centuries for the relaxing and positive effect on well-being. The evidence of this form of treatment for stress sufferers has not previously been studied.
The purpose of the project is to investigate the effect of physiotherapeutic 1:1 treatment in 34-36 degree centigrade warm water, twice a week for 30 minutes over an eight week period.
Hypothesis:
Stress sufferers will experience a reduction in stress levels.
Methodical approach:
Design: randomized controlled trial with intervention group receiving treatment in warm water and control group receiving usual care via general practitioner during the control period and then offered participation in a de-stress class.
Control group Standard treatment cf. https://www.sundhed.dk/sundhedsfaglig/laegehaandbogen/sundhedsoplysning/sundhedsoplysning/diverse/stress/
Recruitment The participants are recruited from general practitioners in Gentofte and Lyngby Tårbæk municipality, cf. inclusion and exclusion criteria.
Estimated sample sizes:
N = 26 N per group =13
Empiri:
- Primary effect measures: Change of stress level from baseline using validated questionnaire Cohen's Perceived Stress Scale (PSS).
- Secondary effect measures:
- Change of sleep disorders from baseline using validated questionnaire Pittsburgh Sleep Quality Index (PSQI).
- Change in self-perceived quality of life measured by questionnaire (EQ-5D) Measurements to be taken before and after 8-weeks intervention
- Explorative measures: a )change in self-perceived level of depression measured by questionnaire Major Depression Index (MDI), and b) change in self-perceived level of burnout measured by questionnaire Karolinska Exhaustion Disorder Scale (KEDS)
Ethical considerations:
Participation in warm water treatment is considered without side effects or risks.
Using exercise in warm water is part of general physiotherapeutic practice. The treatment is handled by experienced physiotherapists. The project complies with the Helsinki Declaration.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Intervention group receives intervention twice a week for 8 weeks. Control group receives usual care through GP for 8 weeks, and are then offered participation in de-stress class twice a week for 8 weeks.
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Active comparator | Other: Physiotherapeutic hydrotherapy treatmentThe intervention group receives intervention for 8 weeks |
| control group | No intervention | –The control group receives usual care for 8 weeks and is then offered participation in a de-stress class for 8 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Has been reported sick by GP within the last four weeks, and is now on sick leave with stress.
- Is 18 years or older.
- Is on sick leave from work or school
- Speaks, reads and understands Danish fluently.
- Has had symptoms of stress during the last month
Key exclusion criteria (7 listed)
- Previously been on sick leave with stress.
- Long-term / unresolved cases with authorities or former partners / spouses.
- Is taking sleep medication.
- Known with bipolar disorder.
- Fear of water.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Physiotherapeutic hydrotherapy treatmentPhysiotherapeutic hydrotherapy treatment The intervention consists of physiotherapeutic one-on-one treatment in a 34-36 degrees centigrade hot water, where the participants are placed supine in the water supported by the physiotherapist as well as buoyant aqua noodles. The physiotherapist supports and moves the participants in the water and adapts to the participant's reaction. The combination of heat, water, movement and touch affects the musculoskeletal and neuromuscular systems and thus has a depth-relaxing effect (Schoedinger, 2010). | Other | Intervention group |
Primary outcome
Level of stress
Time frame: 8 weeks
Cohens 10-item Perceived Stress Scale. A self-reported questionnaire of 10 questions that measures to which extent the respondent experiences that life is unpredictable, uncontrollable and overwhelming. Each question yields a score ranging from 0 to 4, with 4 indicating the highest level. The scores are summed to yield a total score ranging from 0 to 40 Minimum value is 0 Maximum value is 40 The aim of the evaluation is therefore to assess whether the respondent experiences a reduction in the degree of stress.
1 secondary outcome
Sleep disorder
Time frame: 8 weeks
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 5 Dec 2025.
- Individual participant dataSharing planned: No. The individuel participant data will not be made available to other researchers.
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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.
Carsten Bogh Juul, phD principal investigator
Herlev & Gentofte Hospitalers Forskningsenhed
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Physiotherapeutic hydrotherapy treatment in people with Stress, run by vandfys at 1 site in Denmark.
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 9 inclusion and 7 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 5 Dec 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 Denmark. 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?
Level of stress (time frame: 8 weeks). 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 5 Dec 2025.