'Effect of Aquatic Physiotherapy for People With Stress; a Randomized Controlled Trial (RCT)'
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 28
- Locations
- 2
- Primary Endpoint
- Level of stress
Study Overview
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:
- 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:
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Investigator, Outcomes Assessor)
Masking Description
The participant is presented a numbered, opaque, sealed envelope. The outcomes assessor will be presented with data masked from group participations.
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
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.
Secondary Outcomes
- Sleep disorder(8 weeks)
Investigators
Lone Nedergaard
Physiotherapist
vandfys