Plain English Summary
Not provided at time of registration
Trial website
Contact information
Type
Scientific
Primary contact
Dr Denise Kendrick
ORCID ID
http://orcid.org/0000-0003-3603-6542
Contact details
13th Floor
Tower Building
University of Nottingham
Nottingham
NG7 2RD
United Kingdom
+44 (0)115 8466903
denise.kendrick@nottingham.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
001/0009
Study information
Scientific title
Randomised controlled trial of thermostatic mixer valves in reducing bath hot tap water temperature in families with young children in social housing
Acronym
Study hypothesis
To assess the effectiveness of Thermostatic Mixer Valves (TMVs) in reducing bath water temperature in the homes of families with children under the age of five years living in rented social housing.
Ethics approval
Nottingham Research Ethics Committee 1 opinion given on 15th March 2005 (ref: 05/Q2403/37).
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Other
Trial type
Prevention
Patient information sheet
Condition
Childhood injury prevention: Bath tap water scald prevention
Intervention
The intervention will comprise:
1. Educational leaflet devised by the research team sent to participant prior to installation of TMV.
2. Installation of a TMV valve to the hot and cold water supply to the bath by a qualified plumber. The cost of the intervention will be borne by the social housing provider. The maximum temperature at which this will be set will be 44°C as agreed with the social housing provider.
3. Educational hanger on how to use TMV to be attached to the tap at installation.
The control group receives no intervention or information.
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measure
Proportion of families having bath tap hot water at or below 46°C at baseline, three and 12 months.
Secondary outcome measures
At 12 months only:
Intervention group:
1. Proportion of valves:
a. that fail or are replaced
b. are unofficially adjusted
2. Acceptability of valves, potentially unsafe practices and adverse events in event of valve failure.
In both groups:
1. Acceptability of bath hot tap water
2. Potentially unsafe practices and actual adverse events
Overall trial start date
01/03/2005
Overall trial end date
29/02/2008
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
Families living in rented social housing with at least one child under the age of five years.
Participant type
Patient
Age group
Child
Gender
Not Specified
Target number of participants
120
Participant exclusion criteria
1. Participation in on-going tap water scald prevention studies
2. Pipework unsuitable for fitting a TMV
Recruitment start date
01/03/2005
Recruitment end date
29/02/2008
Locations
Countries of recruitment
United Kingdom
Trial participating centre
13th Floor, Tower Building
Nottingham
NG7 2RD
United Kingdom
Sponsor information
Organisation
Department of Health (UK)
Sponsor details
Research and Development Directorate
Richmond House
Whitehall
London
SW1A 2NL
United Kingdom
+44 (0)20 7972 5635
punam.saini@dh.gsi.gov.uk
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
Department of Health (UK) (ref: 001/0009)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
1. 2008 protocol in: https://www.ncbi.nlm.nih.gov/pubmed/18348736
2. 2010 results in: http://dx.doi.org/10.1136/adc.2009.175059
3. 2011 results in: http://www.ncbi.nlm.nih.gov/pubmed/21670072
Publication citations
-
Results
Phillips CJ, Humphreys I, Kendrick D, Stewart J, Hayes M, Nish L, Stone D, Coupland C, Towner E, Preventing bath water scalds: a cost-effectiveness analysis of introducing bath thermostatic mixer valves in social housing., Inj. Prev., 2011, 17, 4, 238-243, doi: 10.1136/ip.2010.031393.