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Smoking-related cardiopulmonary diseases account for a large number of hospital admissions. We investigated the efficacy of hypnotherapy as an aid to a counseling-based smoking cessation program in improving quit rates of hospitalized smoking patients at 12 and 26 weeks after hospital discharge. We compared outcomes with hospitalized patients who received more conventional therapy, namely nicotine replacement therapy, or patients who decided to quit on their own. We also compared smoking cessation rates at 12 and 26 weeks after hospitalization among patients admitted with a cardiac or a pulmonary diagnosis.
Hospitalized patients with a cardiopulmonary diagnosis who were contemplating quitting were recruited into 4 groups: Hypnotherapy, Nicotine replacement therapy (NRT), both hypnotherapy and NRT, and self-quit group. All patients received self-help brochures and in-hospital counseling. Intervention groups received more extensive counseling, free NRT supply for a month and/or a 90 minute hypnotherapy session within 2 weeks of discharge. They also had follow up telephone counseling at 1,2,4,8 and 12 weeks after discharge. 7 day prevalence of tobacco abstinence rates at 26 weeks after hospitalization were verified by self report and urinary Cotinine levels.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Hypnotherapy | Experimental | Patients admitted with a cardiopulmonary illness received a 90 minute free hypnotherapy session within 2 weeks of discharge, and a standardized tape for smoking cessation and relaxation for continued use after the session. They also received self-help brochures, and counseling during hospitalization and by telephone at 1,2,4,8 and 12 weeks after discharge. |
|
| Nicotine Replacement Therapy | Experimental | Patients recieved a free one month supply of Nicotine replacement therapy to include patches and Gum, lozenges or sprays. Patients also received self-help brochures, and counseling during hospitalization and by telephone at 1,2,4,8 and 12 weeks after hospitalization. |
|
| Hypnotherapy and Nicotine replacement | Experimental | The group received similar hypnotherapy session and tape, similar brochure and counseling protocol, as well as free nicotine replacement supplies for a month after discharge. |
|
| Self-Quit group | No Intervention | Patients were given brief counseling during hospitalization and will not be contacted until 26 weeks after hospitalization. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| hypnotherapy | Behavioral | One 90 minute session within 2 weeks of hospital discharge |
|
| Measure | Description | Time Frame |
|---|---|---|
| Abstinence From Smoking | Assessed by 7-day prevalence of verified tobacco abstinence at 26 weeks after hospitalization for a cardiopulmoanry illness. Verification was confirmed biochemically by urine Cotinine testing or by telephone and discussion with a household proxy. Patients lost to follow up were considered to be persistent smokers. | at 26 weeks after hospitalization |
| Measure | Description | Time Frame |
|---|---|---|
| Smoking Cessation | Abstinence from smoking at 12 weeks after hospitalization was measured by self reported 7-day prevalence and verified urinary Cotinine test. This included participants in groups receiving hypnotherapy, NRT or both. Self quit group was not approached until 26 weeks after discharge. Patients lost to follow up were considered smokers. | at 12 weeks after hospitalization |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Faysal Hasan, M.D. | North Shore Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| North Shore Medical Center | Salem | Massachusetts | 01970 | United States |
published in: Complementary Therapies in Medicine 2014: 22: 1-8.
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| ID | Title | Description |
|---|---|---|
| FG000 | Hypnotherapy | Patients admitted with a cardiopulmonary illness will receive a 90 minute free hypnotherapy session within 2 weeks of discharge, and a standardized tape for smoking cessation and relaxation for continued use after the session. They will also recieve self-help brochures, and counseling during hospitalization and by telephone at 1,2,4,8 and 12 weeks after discharge. hypnotherapy: One 90 minute session within 2 weeks of hospital discharge |
| FG001 | Nicotine Replacement Therapy | Patients will recieve a free one month supply of Nicotine replacement therapy to include patches and Gum, lozenges or sprays. Patients will receive self-help brochures, and counseling during hospitalization and by telephone at 1,2,4,8 and 12 weeks after hospitalization. Nicotine: free one month supply after hospital discharge |
| FG002 | Hypnotherapy and Nicotine Replacement | The group will recieve similar hypnotherapy session and tape, similar brochure and counseling protocol, as well as free nictotine replacement supplies for a month after discharge. hypnotherapy: One 90 minute session within 2 weeks of hospital discharge Nicotine: free one month supply after hospital discharge |
| FG003 | Self-Quit Group | patients will be given brief counseling during hospitalization and will not be contacted until 26 weeks after hospitalization. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
patients included in analysis were less than numbers recruited in groups because some patients were eliminated due to severity of illness including mortality and one developed psychosis, thus became eligible. All patients that were lost to follow up were considered to be smokers for analysis.
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| ID | Title | Description |
|---|---|---|
| BG000 | Hypnotherapy | Patients received a 90 minute free hypnotherapy session within 2 weeks of discharge, and a standardized tape for smoking cessation and relaxation for continued use . They also received counseling during hospitalization and by telephone at 1,2,4,8 and 12 weeks after discharge. |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Abstinence From Smoking | Assessed by 7-day prevalence of verified tobacco abstinence at 26 weeks after hospitalization for a cardiopulmoanry illness. Verification was confirmed biochemically by urine Cotinine testing or by telephone and discussion with a household proxy. Patients lost to follow up were considered to be persistent smokers. | Posted | Number | percentage of participants | at 26 weeks after hospitalization |
|
12 and 26 weeks after hospital discharge
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Hypnotherapy | patients receiving a free intensive session of hypnotherapy within 2 weeks of hospitalization |
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Comparing two vastly different modalities such as hypnosis and NRT represented a randomizing challenge, as participants and researchers could not be blinded to interventions.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Faysal M. Hasan | North Shore Medical Center | 978-741-1200 | 4901 | fhasan@partners.org |
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| ID | Term |
|---|---|
| D016540 | Smoking Cessation |
| ID | Term |
|---|---|
| D015438 | Health Behavior |
| D001519 | Behavior |
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| ID | Term |
|---|---|
| D006990 | Hypnosis |
| D009538 | Nicotine |
| D000095488 | Nicotine Replacement Therapy |
| ID | Term |
|---|---|
| D026441 | Mind-Body Therapies |
| D000529 | Complementary Therapies |
| D013812 | Therapeutics |
| D011613 | Psychotherapy |
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| Nicotine | Drug | free one month supply after hospital discharge |
|
|
| Smoking Abstinence Rate at 12 and 26 Weeks | Abstinence rates were calculated for patients hospitalized with a cardiac or a pulmonary diagnosis. | 12 weeks and 26 weeks after hospital discharge |
| Physician Decision |
|
| Death |
|
| Nicotine Replacement Therapy |
Patients received a free one month supply of Nicotine replacement therapy to include patches and Gum, lozenges or sprays, self-help brochures, and counseling during hospitalization and by telephone at 1,2,4,8 and 12 weeks after hospitalization. |
| BG002 | Hypnotherapy and Nicotine Replacement | patients recieved both a similar hypnotherapy session and tape, similar brochure and counseling protocol, as well as free nictotine replacement supplies for a month after discharge. |
| BG003 | Self-Quit Group | Patients were given brief counseling during hospitalization and were not contacted until 26 weeks after hospitalization. They received no telephone contact and or counseling after discharge. |
| BG004 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | White Race ( n, %) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Years of education | Mean | Standard Deviation | years |
|
| Number of cigarettes smoked | Mean | Standard Deviation | Cigarettes smoked /day |
|
| Total years of smoking | Mean | Standard Deviation | years |
|
| Living with a smoker | Count of Participants | Participants |
|
| Admitted with Cardiac Diagnosis | Count of Participants | Participants |
|
| Lost to Follow up (Considered non-quitters) | Count of Participants | Participants |
|
| OG001 |
| Nicotine Replacement Therapy |
Patients received a free one month supply of Nicotine replacement therapy to include patches and Gum, lozenges or sprays. Patients also received self-help brochures, and counseling during hospitalization and by telephone at 1,2,4,8 and 12 weeks after hospitalization. Nicotine: free one month supply after hospital discharge |
| OG002 | Hypnotherapy and Nicotine Replacement | The group received similar hypnotherapy session and tape, similar brochure and counseling protocol, as well as free nicotine replacement supplies for a month after discharge. hypnotherapy: One 90 minute session within 2 weeks of hospital discharge Nicotine: free one month supply after hospital discharge |
| OG003 | Self-Quit Group | patients were given brief counseling during hospitalization and will not be contacted until 26 weeks after hospitalization. |
|
|
|
| Secondary | Smoking Cessation | Abstinence from smoking at 12 weeks after hospitalization was measured by self reported 7-day prevalence and verified urinary Cotinine test. This included participants in groups receiving hypnotherapy, NRT or both. Self quit group was not approached until 26 weeks after discharge. Patients lost to follow up were considered smokers. | Posted | Count of Participants | Participants | at 12 weeks after hospitalization |
|
|
|
|
| Secondary | Smoking Abstinence Rate at 12 and 26 Weeks | Abstinence rates were calculated for patients hospitalized with a cardiac or a pulmonary diagnosis. | Abstinence comparing the 2 admitting diagnoses was similar within each arm, thus analysis for admitting diagnosis was done combining the 4 arms. | Posted | Number | percentage of smoking abstinence rate | 12 weeks and 26 weeks after hospital discharge |
|
|
|
|
| 0 |
| 41 |
| 0 |
| 41 |
| EG001 | Nicotine Replacement Therapy | Patients receiving a free months supply of nicotine | 0 | 39 | 0 | 39 |
| EG002 | Hypnotherapy and Nicotine Replacement | Patients receiving hypnotherapy and nicotine supply | 0 | 38 | 0 | 38 |
| EG003 | Self-Quit Group | patient who decided to quit on their own | 0 | 37 | 0 | 37 |
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| D004191 |
| Behavioral Disciplines and Activities |
| D012991 | Solanaceous Alkaloids |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D004358 | Drug Therapy |
| Risk Ratio (RR) |
| 2.3 |
| 2-Sided |
| 95 |
| 1.2 |
| 10 |
| Superiority or Other |
| Title | Measurements |
|---|---|
|
| % quit rate for pulmonary diagnosis at 26 weeks |
|
| 0.07 |
| Superiority or Other |