SadnessNCT05401396
Swimming Immediately After Having a Meal
A study testing Swimming immediately after eating in people with Sadness, run by Herlev Hospital at 1 site in Denmark.
Trial summary
Many believe that it is unsafe to swim immediately after having a meal and that it is preferable to wait at least 30 minutes. The fear is that swimming can cause stomach cramps and muscle cramps with discomfort and potentially drowning. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Sadness
- What is being tested?
- Swimming immediately after eating
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 1 siteDenmark
- Study dates
- 28 May 2022to 4 Jun 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
- ≥18 years
- Healthy volunteers
- Otherwise, no restriction since each participant acts as their own control
Who cannot join
- Smoking one hour prior to swimming
- Participants who cannot swim
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Center for Perioperative Optimisation, Department of Surgery, Herlev og Gentofte Hospital, University of Copenhagen
Herlev, 2730
About this study
Official title: Swimming Immediately After Having a Meal: a Randomized Controlled Study
Many believe that it is unsafe to swim immediately after having a meal and that it is preferable to wait at least 30 minutes. The fear is that swimming can cause stomach cramps and muscle cramps with discomfort and potentially drowning.
With this randomized controlled trial, the aim was to investigate whether there was any hold in this belief and what could potentially happen by swimming with the stomach full immediately after a meal.
Read the detailed description
All volunteers will be adults. Participants will receive both oral and written information about the trial prior to giving consent for participation.
Participants will act as their own control over two days. On the first day, participants will be randomized to either swim immediately after they have eaten their usual lunch or 30 minutes after the last bite. They will do the opposite on the second day. The randomization will be done by throwing a dice.
Prior to swimming, participants will fill out the following:
- Visual analogue scale (VAS) about their well-being
- Questionnaire about their mood state
After swimming, participants will fill out the following:
- Visual analogue scale (VAS) about their well-being
- Questionnaire about their mood state
- Adverse events
Prior to swimming and afterwards, the participants' blood pressure, pulse, and blood oxygen levels will be measured.
Sample size: Convenience sample.
Withdrawal and dropout criteria: All participants will be informed that they can withdraw their consent at any point during the trial without having to explain any reasons.
- Conditions
- Sadness
- Being tested
- Swimming immediately after eating
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Swimming immediately after eatingOther
After having the last bite of lunch, the participants will swim in the pool with a specific distance.
| Study group | Role | What they receive |
|---|---|---|
| Swimming immediately after eating | Experimental | Two arms but all participants are performing both the intervention and the comparison. Receives: Other: Swimming immediately after eating |
| Swimming 30 minutes after eating | No intervention | Two arms but all participants are performing both the intervention and the comparison. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Occurrence of mortality
Any adverse events leading to death
Measured: During swimming
Secondary outcomes (4)
Swimming time
Measured by seconds
Measured: During swimming
Discomfort
Self-reported assessment of discomfort on a visual analogue scale. Minimum: 0. To Maximum: 100mm. Ranging from no discomfort to the worse imaginable discomfort.
Measured: During the actual swimming and immediately after swimming is completed
Mood changes
Measured by the Profile of mood states. A five-point scale indicating the level of affection. Minimum: 1. To Maximum: 5.
Measured: Baseline and immediately after swimming
Number of patients with any adverse events
Any adverse events other than already mentioned outcomes
Measured: During and immediately after swimming is completed
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2022
- Study start28 May 2022
- Primary completion4 Jun 2022
- Study completion4 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SadnessStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Each participant will on the first day of the trial be randomized either to swim in a pool immediately after lunch or to wait 30 minutes before swimming. The participants will do the opposite on the second day of the trial. The randomization will be done by throwing a dice.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- Herlev Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sehriban Harmankaya, Herlev Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05401396
- Sponsor's protocol ID
- 052022
- Status last verified
- Oct 2023
- First submitted
- 25 May 2022
- Last updated
- 26 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Swimming Immediately After Having a Meal: a Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT05401396
- Acronym / sponsor ID
- 052022
- Conditions
- Sadness
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- Herlev HospitalUniversity, hospital or other
- Study start
- 28 May 2022 (actual)
- Primary completion
- 4 Jun 2022 (actual)
- Study completion
- 4 Jun 2022 (actual)
- First posted
- 2 Jun 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.
Many believe that it is unsafe to swim immediately after having a meal and that it is preferable to wait at least 30 minutes. The fear is that swimming can cause stomach cramps and muscle cramps with discomfort and potentially drowning.
With this randomized controlled trial, the aim was to investigate whether there was any hold in this belief and what could potentially happen by swimming with the stomach full immediately after a meal.
Detailed description
All volunteers will be adults. Participants will receive both oral and written information about the trial prior to giving consent for participation.
Participants will act as their own control over two days. On the first day, participants will be randomized to either swim immediately after they have eaten their usual lunch or 30 minutes after the last bite. They will do the opposite on the second day. The randomization will be done by throwing a dice.
Prior to swimming, participants will fill out the following:
- Visual analogue scale (VAS) about their well-being
- Questionnaire about their mood state
After swimming, participants will fill out the following:
- Visual analogue scale (VAS) about their well-being
- Questionnaire about their mood state
- Adverse events
Prior to swimming and afterwards, the participants' blood pressure, pulse, and blood oxygen levels will be measured.
Sample size: Convenience sample.
Withdrawal and dropout criteria: All participants will be informed that they can withdraw their consent at any point during the trial without having to explain any reasons.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Each participant will on the first day of the trial be randomized either to swim in a pool immediately after lunch or to wait 30 minutes before swimming. The participants will do the opposite on the second day of the trial. The randomization will be done by throwing a dice.
| Arm | Type | Receives |
|---|---|---|
| Swimming immediately after eating | Experimental | Other: Swimming immediately after eatingTwo arms but all participants are performing both the intervention and the comparison. |
| Swimming 30 minutes after eating | No intervention | –Two arms but all participants are performing both the intervention and the comparison. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- ≥18 years
- Healthy volunteers
- Otherwise, no restriction since each participant acts as their own control
Key exclusion criteria (2 listed)
- Smoking one hour prior to swimming
- Participants who cannot swim
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 |
|---|---|---|
| Swimming immediately after eatingAfter having the last bite of lunch, the participants will swim in the pool with a specific distance. | Other | Swimming immediately after eating |
Primary outcome
Occurrence of mortality
Time frame: During swimming
Any adverse events leading to death
4 secondary outcomes
Swimming time
Time frame: During swimming
Discomfort
Time frame: During the actual swimming and immediately after swimming is completed
Mood changes
Time frame: Baseline and immediately after swimming
Number of patients with any adverse events
Time frame: During and immediately after swimming is completed
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 Oct 2023.
- Individual participant dataSharing planned: No
Related trials for Sadness
Recruiting
Investigation of TVNS Administration on Postpartum Mental Health
Postpartum Depression (PPD), Postpartum Anxiety
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 Swimming immediately after eating in people with Sadness, run by Herlev Hospital at 1 site in Denmark.
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 3 inclusion and 2 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 Oct 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 Denmark. 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?
Occurrence of mortality (time frame: During swimming). 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 Oct 2023; AzTrials last refreshed its copy on 30 Oct 2026.