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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05401396
Other study ID # 052022
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date May 28, 2022
Est. completion date June 4, 2022

Study information

Verified date October 2023
Source Herlev Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 27
Est. completion date June 4, 2022
Est. primary completion date June 4, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - =18 years - Healthy volunteers - Otherwise, no restriction since each participant acts as their own control Exclusion Criteria: - Smoking one hour prior to swimming - Participants who cannot swim

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Swimming immediately after eating
After having the last bite of lunch, the participants will swim in the pool with a specific distance.

Locations

Country Name City State
Denmark Center for Perioperative Optimisation, Department of Surgery, Herlev og Gentofte Hospital, University of Copenhagen Herlev

Sponsors (1)

Lead Sponsor Collaborator
Herlev Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type Measure Description Time frame Safety issue
Primary Occurrence of mortality Any adverse events leading to death During swimming
Secondary Swimming time Measured by seconds During swimming
Secondary 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. During the actual swimming and immediately after swimming is completed
Secondary Mood changes Measured by the Profile of mood states. A five-point scale indicating the level of affection. Minimum: 1. To Maximum: 5. Baseline and immediately after swimming
Secondary Number of patients with any adverse events Any adverse events other than already mentioned outcomes During and immediately after swimming is completed
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