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 |
| Protocol serial number | N0184158213 |
| Sponsor | Peninsula Medical School (UK) |
| Funder | Supported by the DH-National Co-ordinating Centre for Research Capacity Development (NCC RCD); and by the Smoking Advice Service, Plymouth PCT (UK) |
- 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
Scientific
N32 ITTC Building
Tamar Science Park
Plymouth
OK6 8BX
United Kingdom
| Phone | +44 (0)1752 764448 |
|---|---|
| adrian.white@pms.ac.uk |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial with three arms. |
| Secondary study design | Randomised controlled trial |
| Scientific title | |
| Study objectives | Pilot 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) studied | Smoking cessation |
| Intervention | 1. Acupressure with two beads 2. Acupressure with one bead 3. No additional intervention All participants receive standard intervention with group therapy and NRT. |
| Intervention type | Drug |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Nicotine replacement therapy |
| Primary outcome measure(s) |
1. Counts (accrual, use of beads, adverse events) |
| Key secondary outcome measure(s) |
Not provided at time of registration |
| Completion date | 20/07/2005 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | All |
| Target sample size at registration | 24 |
| Key inclusion criteria | 1. 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 criteria | 1. 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 enrolment | 04/04/2005 |
| Date of final enrolment | 20/07/2005 |
Locations
Countries of recruitment
- United Kingdom
Study participating centre
N32 ITTC Building
Plymouth
OK6 8BX
United Kingdom
OK6 8BX
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not 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 |
