Condition category
Injury, Occupational Diseases, Poisoning
Date applied
10/08/2006
Date assigned
29/01/2007
Last edited
04/07/2011
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

http://www.miskin-group.org.uk/tmvs%20project.htm

Contact information

Type

Scientific

Primary contact

Dr Denise Kendrick

ORCID ID

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

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 measures

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

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

http://www.dh.gov.uk/Home/fs/en

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

Results - basic reporting

Publication summary

1. 2011 results in http://www.ncbi.nlm.nih.gov/pubmed/21670072

Publication citations

  1. 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.

Additional files

Editorial Notes