MoodUSSNCT05451888
Assessing Effects of Mineral-rich Floatation Spa Treatment on Mood and Psychological Health Outcomes
A study testing Spa treatment in people with Mood, run by University of Reading at 1 site in United Kingdom.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Mood
- What is being tested?
- Spa treatment
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 55 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Jun 2022to 31 Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Any adult
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Mood
- Being tested
- Spa treatment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Spa treatmentBehavioural
A 40 minute period of lying in the spa treatment pool
| Study group | Role | What they receive |
|---|---|---|
| Celestial Floatation Pool | Experimental | Not described Receives: Behavioral: Spa treatment |
| Dead Sea Salt Pool | Experimental | Not described Receives: Behavioral: Spa treatment |
| Balneotherapy Control Pool | Active comparator | Not described Receives: Behavioral: Spa treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Positive Affect (chronic)
This will be a well-established measure of how positive an individual is feeling measured using the PANAS-X questionnaire
Measured: Change between baseline and 8 weeks
Negative Affect (chronic)
This will be a well-established measure of how negative an individual is feeling measured using the PANAS-X questionnaire
Measured: Change between Baseline and 8 weeks
Secondary outcomes (6)
Subjective mood
Assessed with the Immediate Mood Scaler
Measured: Change between baseline and 8 weeks
Subjective Stress
Assessed with the Perceived Stress Scale
Measured: Change between baseline and 8 weeks
Anxiety
Assessed with the GAD-7 and the Spielberger State Anxiety Inventory
Measured: Change between baseline and 8 weeks
Depression
PHQ-8
Measured: Change between baseline and 8 weeks
Sleep Quality
Pittsburgh Sleep Quality Index (PSQI)
Measured: Change between Baseline and 8 weeks
Subjective experience of the spa
captured using qualitative and quantitative questions on their enjoyment of the spa intervention and ease of use.
Measured: At 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2022
- Study start1 Jun 2022
- Primary completion31 Dec 2022
- Study completion31 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MoodStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 55 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Reading
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Daniel Lamport, University of Reading
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05451888
- Sponsor's protocol ID
- UReading Spa Study
- Acronym
- USS
- Status last verified
- May 2023
- First submitted
- 16 Jun 2022
- Last updated
- 26 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 26 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing Effects of Mineral-rich Floatation Spa Treatment on Mood and Psychological Health Outcomes
- ClinicalTrials.gov ID
- NCT05451888
- Acronym / sponsor ID
- USS / UReading Spa Study
- Conditions
- Mood
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 55 participants (actual)
- Lead sponsor
- University of ReadingUniversity, hospital or other
- Study start
- 1 Jun 2022 (actual)
- Primary completion
- 31 Dec 2022 (actual)
- Study completion
- 31 Dec 2022 (actual)
- First posted
- 11 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Celestial Floatation Pool | Experimental | Behavioral: Spa treatment |
| Dead Sea Salt Pool | Experimental | Behavioral: Spa treatment |
| Balneotherapy Control Pool | Active comparator | Behavioral: Spa treatment |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Any adult
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Spa treatmentA 40 minute period of lying in the spa treatment pool | Behavioural | Balneotherapy Control Pool, Celestial Floatation Pool, Dead Sea Salt Pool |
Primary outcome
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
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
6 secondary outcomes
Subjective mood
Time frame: Change between baseline and 8 weeks
Subjective Stress
Time frame: Change between baseline and 8 weeks
Anxiety
Time frame: Change between baseline and 8 weeks
Depression
Time frame: Change between baseline and 8 weeks
Sleep Quality
Time frame: Change between Baseline and 8 weeks
Subjective experience of the spa
Time frame: At 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 May 2023.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Spa treatment in people with Mood, run by University of Reading at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Positive Affect (chronic) (time frame: Change between baseline and 8 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 May 2023.