Effect of Aquatic Physiotherapy for People With Stress

  • STATUS
    Recruiting
  • End date
    Dec 30, 2022
  • participants needed
    36
  • sponsor
    vandfys
Updated on 11 March 2022

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

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/div erse/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.

Details
Condition Stress
Treatment Physiotherapeutic hydrotherapy treatment
Clinical Study IdentifierNCT05223855
Sponsorvandfys
Last Modified on11 March 2022

Eligibility

Yes No Not Sure

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
Clear my responses

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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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