The effectiveness of sustained acupressure in addition to group counselling and nicotine replacement therapy in a smoking cessation clinic: a pilot study

ISRCTN ISRCTN77598683
DOI https://doi.org/10.1186/ISRCTN77598683
Secondary identifying numbers N0184158213
Submission date
19/09/2006
Registration date
30/10/2006
Last edited
16/05/2007
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Mental and Behavioural Disorders
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Adrian White
Scientific

N32 ITTC Building
Tamar Science Park
Plymouth
OK6 8BX
United Kingdom

+44 (0)1752 764448
adrian.white@pms.ac.uk

Study information

Study designRandomised controlled trial with three arms.
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Other
Study typeTreatment
Scientific title
Study objectivesPilot study: to test accrual, compliance, adverse events, outcome measures.
Underlying hypotheses: that acupuncture reduces either nicotine withdrawal symptoms and/or use of Nicotine Replacement Therapy (NRT).
Ethics approval(s)Approval granted 8 March 2005 (reference: 04/Q2103/154).
Health condition(s) or problem(s) studiedSmoking cessation
Intervention1. Acupressure with two beads
2. Acupressure with one bead
3. No additional intervention

All participants receive standard intervention with group therapy and NRT.
Intervention typeDrug
Pharmaceutical study type(s)
PhaseNot Specified
Drug / device / biological / vaccine name(s)Nicotine replacement therapy
Primary outcome measure1. Counts (accrual, use of beads, adverse events)
2. Mood and Physical Symptoms Scale
3. NRT consumption
Secondary outcome measuresNot provided at time of registration
Overall study start date04/04/2005
Completion date20/07/2005

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
SexBoth
Target number of participants24
Key inclusion criteria1. Smoke more than ten cigarettes/day
2. Were aged 18 years or over
3. Intended to stop smoking on the quit date
4. Chose NRT rather than bupropion
5. Gave informed consent
Key exclusion criteria1. History of current otitis externa or other pathological condition of the ear
2. History of a poorly controlled relevant medical condition
3. Currently taking anti-depressant or anti-psychotic medication
4. History of allergy to adhesive dressing
5. Belief of pregnancy
6. Already participating in a research project
Date of first enrolment04/04/2005
Date of final enrolment20/07/2005

Locations

Countries of recruitment

  • United Kingdom

Study participating centre

N32 ITTC Building
Plymouth
OK6 8BX
United Kingdom

Sponsor information

Peninsula Medical School (UK)
Hospital/treatment centre

c/o Professor John Campbell
Smeall Building
St Luke's Campus
Exeter
EX1 2LU
England
United Kingdom

+44 (0) 1752 262740
john.campbell@pms.ac.uk
ROR logo https://ror.org/04dtfyh05

Funders

Funder type

Government

Supported by the DH-National Co-ordinating Centre for Research Capacity Development (NCC RCD); and by the Smoking Advice Service, Plymouth PCT (UK)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article Results: 14/03/2007 Yes No
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