Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N0321166096
Study information
Scientific title
Acronym
Study hypothesis
Primary hypothesis: that aromatherapy massage will reduce anxiety in clients having serious mental disorders, as measured by standardised assessments over a six-week period. This will be tested in a randomised controlled trial against a control group who will remain untreated temporarily on a six-week waiting list.
Ethics approval
Not provided at time of registration
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Treatment
Patient information sheet
Condition
Mental and Behavioural Disorders: Anxiety
Intervention
1. Group receiving aromatherapy massage
2. Group temporarily not receiving aromatherapy massage
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measures
Trait and State anxiety assessment by self-completed, standardised inventories: Hospital Anxiety and Depression Scale (HADS), General Health Questionnaire (GHQ-30); State--Trait Anxiety Inventory (STAI-30).
Physiological measurement of blood pressure, pulse rate and breathing rate.
Secondary outcome measures
Not provided at time of registration
Overall trial start date
20/09/2004
Overall trial end date
24/11/2005
Reason abandoned
Eligibility
Participant inclusion criteria
Clients of community health teams in Bournemouth, Poole or Dorset who have a diagnosis of serious mental disorder of a non-psychotic nature (regarding affective disorders) and require specialist anxiety therapy for a concurrent/principal anxiety state. Clients will be referred by their care-coordinator under CPA (Care Plan Approach) on standard or enhanced care.
Participant type
Patient
Age group
Adult
Gender
Not Specified
Target number of participants
61
Participant exclusion criteria
People with psychotic disorders or drug/alcohol dependency problems.
Recruitment start date
20/09/2004
Recruitment end date
24/11/2005
Locations
Countries of recruitment
United Kingdom
Trial participating centre
West Bournemouth CMHT
Bournemouth
BH2 5JW
United Kingdom
Sponsor information
Organisation
Record Provided by the NHSTCT Register - 2006 Update - Department of Health
Sponsor details
The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
+44 (0)20 7307 2622
dhmail@doh.gsi.org.uk
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
Dorset Healthcare NHS Trust (UK)
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