Does hydration have effects on competence in doctors?
| ISRCTN | ISRCTN79051745 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN79051745 |
| ClinicalTrials.gov (NCT) | Nil known |
| Clinical Trials Information System (CTIS) | Nil known |
| Protocol serial number | P2S1 |
| Sponsor | University of Reading |
| Funder | Investigator initiated and funded |
- Submission date
- 05/02/2021
- Registration date
- 10/02/2021
- Last edited
- 11/10/2022
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Other
Plain English summary of protocol
Background and study aims
Research has found that doctors in the United Kingdom were clinically dehydrated at the start (36%) and end (45%) of shifts. As little as 2% dehydration as a percentage of total body weight can cause impaired physical, psychomotor, cognitive, psychiatric and visuomotor performance, in addition to greater fatigue, and reduced alertness. The addition of PPE as standard workplace practice (beyond what was previously expected) is likely to have magnified the speed at which doctors dehydrate (due to elevated temperature), and due to the functional infection-control barriers of fluid intake. Given the fundamental importance of hydration for psychophysiological functioning, exploring doctor’s hydration levels and impact on measures of competence is a valuable area of research. Therefore, the aim of this research is to explore the association between hydration and competence in doctors.
Who can participate?
This study invites adults currently in employment as a doctor by the National Health Service in the United Kingdom. Due to their specific health needs, we can’t include people who are pregnant or breastfeeding. Nor can we include doctors with current renal, cardiac, pulmonary, hepatic, digestive, thyroid, neurological or haematological disease, in addition to anyone taking medications (either prescribed or over-the-counter) that influence weight, fluid, or electrolyte balance.
What does the study involve?
Those who are eligible and decide to participate will be emailed a participant ID code, and a link to an online survey platform including the consent form. Participants will receive a testing pack in the post including sample pots, urinalysis reagent strips and comprehensive self-testing and online reporting instructions. They will be asked to complete online surveys on three occasions that they may access in private via a home laptop or PC. The first can be completed at any time convenient for the participant, the second and third must be completed when they return home following a working shift. In addition to the surveys, participants will be asked to undertake self-assessed urinalysis using reagent Labstick’s. The self-administered urinalysis method is quick, non-invasive and participants will be able to dispose of the sample immediately following input of their results. They will be required to provide a fluid record based over the duration of their working shift. On completion of the study you they will be provided with a written debriefing and offered a telephone debriefing (on request).
What are the possible benefits and risks of participating?
The aim of this study is to capture professional experiences. Results from this study may be published to inform future research and support professional and public awareness of any identified needs. Publication of the results from this study may allow dissemination of valuable information that may prompt support and understanding for the needs of medical staff. This study invites participants to think reflectively about their personal and professional experiences, this may have positive and negative emotional responses. Participants urinalysis results are non-diagnostic but may indicate health needs (e.g. dehydration), they will be given details of the healthy-range scores and advised to seek medical guidance if they need further support to meet their health needs.
Where is the study run from?
University of Reading (UK)
When is the study starting and how long is it expected to run for?
November 2020 to March 2023
Who is funding the study?
Investigator initiated and funded
Who is the main contact?
Kirsty Hodgson, k.l.hodgson@pgr.reading.ac.uk
Dr Allán Laville, a.laville@reading.ac.uk
Associate Professor Daniel Lamport, daniel.lamport@reading.ac.uk
Contact information
Scientific
The University of Reading School of Psychology
Harry Pitt Building
Whiteknights
University of Reading
Reading
RG6 6AH
United Kingdom
 ORCID ID |
0000-0001-9678-9269 |
|---|---|
| Phone | +44 (0)118 3788523 |
| a.laville@reading.ac.uk |
Scientific
The University of Reading School of Psychology
Harry Pitt Building
Whiteknights
University of Reading
Reading
RG6 6AH
United Kingdom
| ORCID ID |
0000-0002-4592-0439 |
|---|---|
| Phone | +44 (0)118 3788523 |
| daniel.lamport@reading.ac.uk |
Public
The University of Reading School of Psychology
Harry Pitt Building
Whiteknights
University of Reading
Reading
RG6 6AH
United Kingdom
| ORCID ID |
0000-0002-9680-0445 |
|---|---|
| Phone | +44 (0)118 3788523 |
| k.l.hodgson@pgr.reading.ac.uk |
Study information
| Primary study design | Observational |
|---|---|
| Study design | Observational cohort study |
| Secondary study design | Cohort study |
| Study type | Participant information sheet |
| Scientific title | Exploration of the association between hydration status and competence in doctors |
| Study objectives | Through psychophysiological effects, this research hypothesises that there will be a positive association between hydration status and competency. |
| Ethics approval(s) | Approved 14/01/2021, The University of Reading School of Psychology Research Ethics Committee (Whiteknights, University of Reading, Reading, Berkshire, RG6 6AH, UK; +44 (0)118 3788523; pclsethics@reading.ac.uk), ref: 2020-193-AL |
| Health condition(s) or problem(s) studied | Measures of competence, hydration and psychophysiological status in doctors in the United Kingdom |
| Intervention | Those who are eligible and decide to participate will be emailed a participant ID code, and a link to an online survey platform including the consent form. Participants will receive a testing pack in the post including sample pots, urinalysis reagent strips and comprehensive self-testing and online reporting instructions. They will be asked to complete online surveys on three occasions that they may access in private via a home laptop or PC. The first can be completed at any time convenient for the participant, the second and third must be completed when they return home following a working shift. In addition to the surveys, participants will be asked to undertake self-assessed urinalysis using reagent Labstick’s. The self-administered urinalysis method is quick, non-invasive and participants will be able to dispose of the sample immediately following input of their results. They will be required to provide a fluid record based over the duration of their working shift. On completion of the study they will be provided with a written debriefing and offered a telephone debriefing (on request). Within 3-days following the baseline testing session, participants will also be asked to complete Day 1 of the working day assessment. B0 - T2 is designed to be completed within a 7-day period according to each doctor’s shift pattern. |
| Intervention type | Other |
| Primary outcome measure(s) |
1. Competence is measured using a Self-Assessment Questionnaire (M-SQ) following two working shifts (T1 - T2) |
| Key secondary outcome measure(s) |
Current secondary outcome measures as of 01/03/2021: |
| Completion date | 15/03/2023 |
Eligibility
| Participant type(s) | Health professional |
|---|---|
| Age group | Adult |
| Sex | All |
| Target sample size at registration | 30 |
| Total final enrolment | 61 |
| Key inclusion criteria | Healthy adult volunteers currently in employment as a doctor by the National Health Service in the United Kingdom, and have access to a private home laptop or PC to complete the online testing. |
| Key exclusion criteria | 1. Pregnant, or breastfeeding 2. Current renal, cardiac, pulmonary, hepatic, digestive, thyroid, neurological or haematological disease, in addition to anyone taking medications (either prescribed or over-the-counter) that influence weight, fluid, or electrolyte balance |
| Date of first enrolment | 15/02/2021 |
| Date of final enrolment | 01/09/2022 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
Whiteknights
University of Reading
Reading
RG6 6AH
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | Yes |
|---|---|
| IPD sharing plan summary | Available on request |
| IPD sharing plan | The datasets generated during and/or analysed during the current study are available from the corresponding author on reasonable request. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
| Protocol file | 01/03/2021 | No | No |
Additional files
- ISRCTN79051745_PROTOCOL_no_date.docx
- uploaded 01/03/2021
Editorial Notes
11/10/2022: The following changes were made to the trial record:
1. The overall end date was changed from 01/10/2022 to 15/03/2023.
2. The intention to publish date was changed from 01/12/2022 to 15/12/2023.
3. The plain English summary was updated to reflect these changes.
4. The total final enrolment was added.
11/07/2022: The recruitment end date has been changed from 01/07/2022 to 01/09/2022.
08/11/2021: The following changes were made to the trial record:
1. The recruitment end date was changed from 01/11/2021 to 01/07/2022.
2. The overall end date was changed from 01/01/2022 to 01/10/2022.
3. The intention to publish date was changed from 15/05/2022 to 01/12/2022.
4. The plain English summary was updated to reflect these changes.
14/04/2021: Internal review.
01/03/2021: The following changes were made to the trial record:
1. The protocol (not peer reviewed) Version n/a, no date, was uploaded to the study record. The protocol document was provided to the ISRCTN editorial team on 10/02/2021.
2. The secondary outcome measures were updated to correct an error made previously by the ISRCTN editorial team.
10/02/2021: Trial’s existence confirmed by University of Reading
