Effect of Aquatic Physiotherapy for People With Stress

Stress Clinical Trial

Official title: 'Effect of Aquatic Physiotherapy for People With Stress; a Randomized Controlled Trial (RCT)'

Status Completed

Clinical 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.

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

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Stress

• NCT number: NCT05223855
• Study type: Interventional
• Source: vandfys
• Status: Completed
• Phase: N/A
• Start date: January 1, 2022
• Completion date: June 30, 2023