Assessing Effects of Mineral-rich Floatation Spa Treatment on Mood and Psychological Health Outcomes (USS)

May 25, 2023 updated by: Daniel Lamport, University of Reading
This is a randomised parallel groups trial in healthy human adults exploring whether 8 weeks of treatment in various different spa pools is associated with benefits for mood and other psychological outcomes. Outcome measures will be taken at the beginning and the end of the 8 week period. In addition, outcome measures will be taken after the first spa session to assess acute effects.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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;

  1. 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.
  2. 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.
  3. 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.
  4. 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

Interventional

Enrollment (Actual)

55

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

    • Berkshire
      • Reading, Berkshire, United Kingdom, RG66AL
        • School of Psychology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2022

Primary Completion (Actual)

December 31, 2022

Study Completion (Actual)

December 31, 2022

Study Registration Dates

First Submitted

June 16, 2022

First Submitted That Met QC Criteria

July 6, 2022

First Posted (Actual)

July 11, 2022

Study Record Updates

Last Update Posted (Actual)

May 26, 2023

Last Update Submitted That Met QC Criteria

May 25, 2023

Last Verified

May 1, 2023

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)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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