Clinical trial NCT05223855: Effect of Aquatic Physiotherapy for People With Stress
Official title: 'Effect of Aquatic Physiotherapy for People With Stress; a Randomized Controlled Trial (RCT)'
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stress
Lead sponsor: vandfys
Sponsor class: OTHER
Collaborators: name: Herlev and Gentofte Hospital
First posted: 2022-02-04
Enrollment: 28
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: TREATMENT

Brief 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.

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:

1. Primary effect measures:

   Change of stress level from baseline using validated questionnaire Cohen's Perceived Stress Scale (PSS).
2. 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:

1. Primary effect measures:

   Change of stress level from baseline using validated questionnaire Cohen's Perceived Stress Scale (PSS).
2. Secondary effect measures:

   1. Change of sleep disorders from baseline using validated questionnaire Pittsburgh Sleep Quality Index (PSQI).
   2. Change in self-perceived quality of life measured by questionnaire (EQ-5D)

   Measurements to be taken before and after 8-weeks intervention
3. 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.

Eligibility criteria: Inclusion criteria:

* 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.
* Has the possibility to participate
* Would like treatment in hot water
* Has given informed consent

Exclusion criteria:

* 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

Primary outcomes:
measure: Level of stress
timeFrame: 8 weeks
Secondary outcomes:
measure: Sleep disorder
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Lions Kollegiets varmtvandsbassin
Study officials:
affiliation: Herlev & Gentofte Hospitalers Forskningsenhed
name: Carsten Bogh Juul, phD
role: PRINCIPAL_INVESTIGATOR
References: