- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT03401021
Factors Related to the Intention to Quit Among Male Smokers During Their Wives Pregnancy
Factors Associated With Quit Intention Among Male Smokers Whose Partner Got Pregnant: An Exploration Study
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
With a globally growing number of smokers, up to about half of men and one tenth of women are becoming smokers and relatively few stopping, especially in Mainland China.
It has been proved that tobacco is responsible for even more deaths and diseases. Smokers have two to three times mortality in middle age among otherwise similar persons who had never smoked. According to the literature review, smoking has been confirmed to be an important risk factor to coronary heart disease, chronic obstructive lung disease, cancer, stroke, peptic ulcer, peripheral vascular disease, and so on. In addition, tobacco can also increase the incidence rate of cancer in lung, oral cavity, naso-, oro- and hypopharynx, nasal cavity et.al, as well as myeloid leukemia, among smokers.
For the male smokers at their reproductive ages, who is preparing to have a baby with their partners, smoking may negatively influence their reproductive capacity. Sufficient studies found that the quantity and duration of smoking, especially the current smoking is positively associated with the risk of erectile dysfunction. Smoking may increase the risk of a higher risk of developing oligospermia, asthenozoospermia and teratozoospermia for man in the reproductive years, which may lead to the inefficiency of fertilization and even give birth to abnormal fetus. Besides, secondhand Smoking (SHS) exposure also have further and longer negative effects on their female partner and their baby born in the future. The non-smoking population is much more sensitive to the nicotine in the passive smoking than smokers. The SHS may increase the risk of respiratory infections, ear problem, immediate adverse effects on cardiovascular system, CHD, lung cancer and so on to adults. For the children, the passive smoking makes children have a higher chance to get severe asthma, slow lung growth. Hence, children and women live with smokers may have a higher risk of premature death and disease. Besides, newborns whose mothers were exposed to secondhand smoking showed significantly lower scores in the habituation cluster and motor system cluster [16], as well as the delay of neurobehavioral development regardless of socio-demographic, obstetric and pediatric factors. Conclusively, smoking has direct and indirect negative effect to male smokers in reproductive ages themselves and their family members.
Based on the official statistic figures in 2010, about one third of people in China were current smokers, and the number of young smokers is increasing [4]. While most current smokers (83.9%) report having no intention to quit smoking (WHO, 2011). On average, between 60% and 70% of Chinese men continue to smoke into middle age, which is different with the western countries. Hence, finding out a solution to decrease the married reproductive male smoking rate is extremely crucial.
Overall awareness of the health hazards of tobacco has improved in the last 15 years in China, but is still relatively poor. Even there were several patterns of propaganda and education applied in China, the efficiency is not very satisfactory. Hence, an effective education intervention that delivery the health hazards of tobacco to male smokers and secondhand smoking to their wives and baby born in the future should be developed and implemented for reproductive male smokers in China.
Cigarette can negatively influence the function of respiratory, urinary and other systems, as well as increase the risk of different types of cancer. Secondhand smoking is harmful to their family members. What's worse, the impact of the reproductive system will further damage their baby born in the future. As the overlooking of the impact of maternal smoking on the fetus, the smoking cessation research for the male smokers who plan to have a baby is absent. For Chinese people, the high prevalence and low quitting rate made this situation much worse. In addition, as the cancel of the one-child policy, lots of couples are planning to give birth to a baby in the future decades compared with the period the policy was valid. Considering the high prevalence of male smoking and upcoming high birth rate in China, more smokers, pregnant, and fetus are under the hazard of tobacco use.
Before applying interventions to help male smokers whose partner got pregnant to quit or reduce cigarette smoking, a study exploring their intention to quit smoking and relevant factors must be implemented.
Type d'étude
Inscription (Réel)
Contacts et emplacements
Lieux d'étude
-
-
-
Hong Kong, Hong Kong
- The University of Hong Kong
-
-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
Méthode d'échantillonnage
Population étudiée
La description
Inclusion Criteria:
- (1) All participants should be males
- (2) All participants should be aged 18 or above;
- (3) All participants should be married;
- (4) All participants should be smoking at least one cigarette per day averagely during the past 3 months;
- (5) All participants should be able to communicate in Mandarin (including reading Chinese)
Exclusion Criteria:
- Smokers who meet the above criteria but are currently involved in other smoking cessation programs or the pilot study and/or mentally or physically unfit for communication will be excluded.
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
Cohortes et interventions
Groupe / Cohorte |
Intervention / Traitement |
---|---|
Crrent Male smokers
Male smokers met the inclusion criteria below will be invited to fill in the questionnaires set, part of them will be invited to attend a semi-structured interview(optional).
|
Participants will be asked to respond to the demographic information sheet, Smoking characteristics sheet, the Fagerstrom Test of Nicotine Dependence, the Transtheoretical Model (TTM) variables, Smoking Self-efficacy Questionnaire (SEQ-12), Family Adaptation, Partnership, Growth, Affection, and Resolve (Family APGAR), and a smoking hazard questionnaire.
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
Quit intention of smoking
Délai: Baseline
|
The level of intention to quit of smoking among male smokers who planning to have a baby with their partners will be measured by b) The Transtheoretical Model (TTM) variables.
The Stage of TTM will be assessed by asking the intention of quitting smoking in the past 6 months with the 6-items, which are Precontemplation, Contemplation, Preparation, Action, Maintenance, and Termination
|
Baseline
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
Dépendance à la nicotine
Délai: Ligne de base
|
Le niveau de dépendance à la nicotine des participants sera mesuré par l'échelle Fagerstrom Test of Nicotine Dependence (FTND).
Le FTND est un instrument standard pour évaluer l'intensité de la dépendance physique à la nicotine. Le test a été conçu pour fournir une mesure ordinale de la dépendance à la nicotine liée au tabagisme.
Il contient six items qui évaluent la quantité de cigarettes consommées, la compulsion à consommer et la dépendance.
Lors de la notation du test de Fagerstrom pour la dépendance à la nicotine, les items oui/non sont notés de 0 à 1 et les items à choix multiples sont notés de 0 à 3. Les items sont additionnés pour donner un score total de 0 à 10.
Plus le score total de Fagerstrom est élevé, plus la dépendance physique du patient à la nicotine est intense.
|
Ligne de base
|
Self-efficacy level
Délai: Baseline
|
Self-efficacy of participants against tobacco will be assessed by using by the SEQ-12.
The SEQ-12 is categorized into two subscales, namely internal stimuli (6 items) and external stimuli (6 items), with total possible scores ranging from 6 to 30 for both internal stimuli and external stimuli.
Higher scores of the SEQ-12 on both subscales indicate greater self-efficacy to refrain from smoking.
|
Baseline
|
Self-awareness of the hazard of smoking
Délai: Baseline
|
The self-awareness of the hazard of smoking among the participants will be measured by a self-designed smoking hazard questionnaire list.
The smoking hazard questionnaire lists 14 hazard of smoking and SHS to the pregnant, fetus, health, income, social activity, and so on.
Participants responded to each items using a -10 to 10 rating scale ranging from -10 (most negative influence) to 10 (most positive influence).
|
Baseline
|
Family support level
Délai: Baseline
|
The family support for smoking cessation will be assessed by using the Family APGAR.
The Family APGAR is a 5-item measure of perceived family support [71].
Participants responded to each item using a 5-point rating scale ranging from 0 (never) to 4 (always).
The standard scoring for the FAPGAR interprets high scores (7-10) as indicating a satisfactory support from family and low scores (0-3) indicating severe dysfunctionality support from the family members.
|
Baseline
|
Collaborateurs et enquêteurs
Parrainer
Publications et liens utiles
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Autres numéros d'identification d'étude
- UW17-509
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Étudie un produit d'appareil réglementé par la FDA américaine
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .
Essais cliniques sur Questionnaires set
-
Sheba Medical CenterMedtronicComplété
-
Medical University of South CarolinaNational Institute on Deafness and Other Communication Disorders (NIDCD)Actif, ne recrute pasAccident vasculaire cérébral | Aphasie | Aphasie Non FluentÉtats-Unis
-
Masimo CorporationRecrutement
-
University of MinnesotaRecrutement
-
Virginia Commonwealth UniversityComplétéPerte de poids | Surpoids ou obésité | Changement de poids, CorpsÉtats-Unis
-
University of PittsburghCambia Health FoundationComplétéMaladie critiqueÉtats-Unis
-
University of MiamiNational Institute on Minority Health and Health Disparities (NIMHD)Complété
-
Masimo CorporationRésilié
-
Florida State UniversityComplétéDésordre anxieux généralisé | Trouble d'anxiété sociale | Trouble paniqueÉtats-Unis
-
Becton, Dickinson and CompanyRetiréDiabète sucré, type 1