- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05451888
Assessing Effects of Mineral-rich Floatation Spa Treatment on Mood and Psychological Health Outcomes (USS)
Study Overview
Detailed Description
This experiment is investigating whether mineral-rich floatation spa treatments influence mood and psychological health outcomes. The study will be undertaken at Nirvana Spa in Wokingham over a duration of 8 weeks for each participant. Participants will be randomly allocated to one of three experimental groups. Each group will be assigned to a different mineral-rich spa treatment pool; either a Celestial Floatation pool, Dead Sea Salt Therapy pool, or a control pool which does not contain any minerals (Balneotherapy pool). Participants will undergo one 40-minute treatment, once a week for 8 weeks. The recommended duration for Dead Sea Salt and Celestial floatation pool sessions are 30-40 minutes, thus this study will reflect everyday consumer behaviour. A follow-up assessment of the outcome measures will take place 2 weeks after cessation of treatment to assess possible carry-over effects.
Specifically, there are four research aims of the study;
- To investigate the effects of regular weekly treatment in the Celestial Floatation Pool on mood outcomes including positive and negative affect, anxiety, depression, and stress.
- To investigate the effects of regular weekly treatment in the Dead Sea Salt Therapy pool on mood outcomes including positive and negative affect, anxiety, depression, and stress.
- To investigate the effects of a single 40-minute treatment in the Celestial Floatation Pool and the Dead Sea Salt Therapy pool on mood outcomes including positive and negative affect, anxiety and stress.
- Do any beneficial effects of spa treatment persist beyond cessation of treatment?
Outcome measures will be used to assess mood and psychological health outcomes both at the beginning (baseline) and at the end (8 weeks) of each treatment (see procedures). In addition, outcome measures will be taken immediately after the first spa treatment to assess acute effects. Specifically, the outcome measures are:
- Positive and Negative Affect using the PANAS-X. This will be a well-established measure of how positive and negative an individual is feeling (these are two separate outcome measures).
- Subjective mood with the Immediate Mood Scaler. This is a recently published novel 22-item measure developed to assess dynamic components of mood. Participants rate their current mood state on a continuum using 7-point Likert scales (eg, happy-sad, distracted-focused, sleepy-alert, fearful-fearless. For each item, an integer score between 1 and 7 is derived. The total score for this scale is the sum of the scores on all 22 items.
- Stress using the Perceived Stress Scale.
- Anxiety with the GAD-7 and the Spielberger State Anxiety Inventory.
- Depression with the PHQ-8
- Sleep quality with the Pittsburgh Sleep Quality Index (PSQI)
- Experience of spa use will be captured using qualitative and quantitative questions on their enjoyment of the spa intervention and ease of use.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Daniel J Lamport, PhD
- Phone Number: 01183785032
- Email: daniel.lamport@reading.ac.uk
Study Contact Backup
- Name: Katie L Barfoot, PhD
- Phone Number: 01183783347
- Email: katie.barfoot@reading.ac.uk
Study Locations
-
-
Berkshire
-
Reading, Berkshire, United Kingdom, RG66AL
- School of Psychology
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
Any adult
Exclusion Criteria:
Any diagnosed mental health conditions or physical conditions/injuries (including those still undergoing physiotherapy for a previous condition or injury), arthritis and previous regular use of spa treatments which is defined as use of spa facilities once a month or more over the previous 8 weeks. The rational for these exclusion criteria is that the spa is known to benefit injury and joint pain recovery. This is not a mechanism of interest for this study, therefore we want to exclude these participants.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Celestial Floatation Pool
|
A 40 minute period of lying in the spa treatment pool
|
Experimental: Dead Sea Salt Pool
|
A 40 minute period of lying in the spa treatment pool
|
Active Comparator: Balneotherapy Control Pool
|
A 40 minute period of lying in the spa treatment pool
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Positive Affect (chronic)
Time Frame: Change between baseline and 8 weeks
|
This will be a well-established measure of how positive an individual is feeling measured using the PANAS-X questionnaire
|
Change between baseline and 8 weeks
|
Negative Affect (chronic)
Time Frame: Change between Baseline and 8 weeks
|
This will be a well-established measure of how negative an individual is feeling measured using the PANAS-X questionnaire
|
Change between Baseline and 8 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Subjective mood
Time Frame: Change between baseline and 8 weeks
|
Assessed with the Immediate Mood Scaler
|
Change between baseline and 8 weeks
|
Subjective Stress
Time Frame: Change between baseline and 8 weeks
|
Assessed with the Perceived Stress Scale
|
Change between baseline and 8 weeks
|
Anxiety
Time Frame: Change between baseline and 8 weeks
|
Assessed with the GAD-7 and the Spielberger State Anxiety Inventory
|
Change between baseline and 8 weeks
|
Depression
Time Frame: Change between baseline and 8 weeks
|
PHQ-8
|
Change between baseline and 8 weeks
|
Sleep Quality
Time Frame: Change between Baseline and 8 weeks
|
Pittsburgh Sleep Quality Index (PSQI)
|
Change between Baseline and 8 weeks
|
Subjective experience of the spa
Time Frame: At 8 weeks
|
captured using qualitative and quantitative questions on their enjoyment of the spa intervention and ease of use.
|
At 8 weeks
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- UReading Spa Study
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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