Condition category
Mental and Behavioural Disorders
Date applied
29/09/2006
Date assigned
29/09/2006
Last edited
29/08/2013
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Steve Moores

ORCID ID

Contact details

West Bournemouth CMHT
Hahnemann House
Hahnemann Road
West Cliff
Bournemouth
BH2 5JW
United Kingdom
+44 (0)1202 584440

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

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

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

Publication citations

Additional files

Editorial Notes