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Social Habits and Insights in Shisha Use in Germany

Organizational Data

DRKS-ID:
DRKS00033530
Recruitment Status:
Recruiting planned
Date of registration in DRKS:
2024-01-31
Last update in DRKS:
2024-01-31
Registration type:
Prospective

Acronym/abbreviation of the study

SHISHA

URL of the study

No Entry

Brief summary in lay language

In Germany, many people are familiar with a waterpipe (also known as shisha). There are also special bars for adults where you can smoke waterpipes. More and more people have already tried a waterpipe or use it regularly. However, we know very little about what is special about waterpipe smoking and why people smoke waterpipes even though it is not good for their health. In addition, we know very little about whether the population is interested in taking part in such a study. We want to use an online survey to find out why people smoke waterpipes. We have designed a questionnaire for this purpose. The questionnaire covers various topics. We also want to find out whether this is an interesting questionnaire and how we can improve the questionnaire. We would also like to find out whether the participants would like to complete such a questionnaire on various topics relating to waterpipe smoking several times a year (three times) and what reasons there are for not continuing to take part.

Brief summary in scientific language

In recent years, waterpipe consumption has developed into an alternative form of tobacco consumption in Germany. However, the reasons for this development have hardly been scientifically investigated. The basic idea of the planned SHISHA study is therefore to create a basis for a panel survey, aiming to continuously gather current data on waterpipe consumption across various age groups: : Adolescents (14-17 years), young adults (18-25 years), older adults (26-40 years). The primary aim of this study is to gain insights into (1) different recruitment strategies in a very diverse sample (adolescents, young adults, adults, people with a migration background, etc.) and (2) the applicability of the developed survey tool within the target group. Additionally, the study aims to gain insight into findings regarding (3) dependency and health-related restrictions on consumption in the context of an initial sample of around 60 consuming panel participants and to explore whether (4) the implementation of a planned nationwide panel with around 1,000 participants appears possible on the basis of the experience gained or where adjustments may be needed. With the help of the SHISHA study, the basis for a planned Germany-wide panel survey will be developed. In addition to the technical development / programming of the survey tool, participants will also be recruited as part of this pilot project and relevant data on their consumption will be collected from the respondents at three measurement points. As part of the study, key aspects of the panel survey will be explored and important findings will be gained for the development of follow-up research projects.

Health condition or problem studied

ICD10:
F17 - Mental and behavioural disorders due to use of tobacco
Healthy volunteers:
Yes

Interventions, Observational Groups

Arm 1:
This study employs a longitudinal survey design, in which data is collected every two month over a period of three survey points using an online questionnaire. Approximately 60 study participants will be recruited (current waterpipe users aged between 14 and 40). In addition to the scheduled questionnaires, qualitatives interviews will be conducted with participants who initially committed to the follow-up surveys but subsequently withdrew, as well as those who successfully completed the entire study.

Endpoints

Primary outcome:
The primary aim of the study is to find out the reasons, motives and attractions behind the use of waterpipes; what influence the social background has on consumption; the influence of social background on consumption; how smoking careers develop and whether a switch between products (from waterpipe to cigarette) can be observed over time; what influence influencers and the social environment have on young people with regard to their consumption; how the target groups are advertised in the media; what negative health effects consumption has on users; whether manifest diseases have already occurred or are suspected by users when consuming waterpipes; whether demand can be regulated by price (tax measures).
Secondary outcome:
The secondary aim of the study is to gain insights into recruitment strategies and the applicability of the survey tool in order to create the basis for a larger Germany-wide panel study.

Study Design

Purpose:
Other
Retrospective/prospective:
Prospective
Study type:
Non-interventional
Longitudinal/cross-sectional:
Longitudinal study
Study type non-interventional:
Epidemiological study

Recruitment

Recruitment Status:
Recruiting planned
Reason if recruiting stopped or withdrawn:
No Entry

Recruitment Locations

Recruitment countries:
  • Germany
Number of study centers:
Monocenter study
Recruitment location(s):
  • University medical center Institute of General Practice, Addiction Research and Clinical Epidemiology Unit, Medical Faculty of the Heinrich-Heine-University Düsseldorf

Recruitment period and number of participants

Planned study start date:
2024-08-01
Actual study start date:
No Entry
Planned study completion date:
No Entry
Actual Study Completion Date:
No Entry
Target Sample Size:
60
Final Sample Size:
No Entry

Inclusion Criteria

Sex:
All
Minimum Age:
14 Years
Maximum Age:
no maximum age
Additional Inclusion Criteria:
Written consent for study participation

Exclusion Criteria

Language barriers, moderate to severe cognitive impairment, no internet access

Addresses

Primary Sponsor

Medical Faculty of the Heinrich-Heine-University Düsseldorf
Moorenstr. 5
40225 Düsseldorf
Germany
Telephone:
No Entry
Fax:
No Entry
Contact per E-Mail
URL:
No Entry
Investigator Sponsored/Initiated Trial (IST/IIT):
Yes

Contact for Scientific Queries

Institute of General Practice, Addiction Research and Clinical Epidemiology Unit, Medical Faculty of the Heinrich-Heine-University
Dr. Stephanie Klosterhalfen
Postfach 101007
40225 Düsseldorf
Germany
Telephone:
0049 (0)211 / 81 04045
Fax:
No Entry
Contact per E-Mail
URL:
No Entry

Contact for Public Queries

Institute of General Practice, Addiction Research and Clinical Epidemiology Unit, Medical Faculty of the Heinrich-Heine-University
Dr. Stephanie Klosterhalfen
Postfach 101007
40225 Düsseldorf
Germany
Telephone:
0049 (0)211 / 81 04045
Fax:
No Entry
Contact per E-Mail
URL:
No Entry

Principal Investigator

Institute of General Practice, Addiction Research and Clinical Epidemiology Unit, Medical Faculty of the Heinrich-Heine-University
Dr. Stephanie Klosterhalfen
Postfach 101007
40225 Düsseldorf
Germany
Telephone:
0049 (0)211 / 81 04045
Fax:
No Entry
Contact per E-Mail
URL:
No Entry

Sources of Monetary or Material Support

Institutional budget, no external funding (budget of sponsor/PI)

Research Commission Medical Faculty of the Heinrich-Heine-University Duesseldorf
40225 Düsseldorf
Germany
Telephone:
No Entry
Fax:
No Entry
Contact per E-Mail
URL:
No Entry

Ethics Committee

Address Ethics Committee

Ethikkommission an der Medizinischen Fakultät der Heinrich-Heine-Universität Düsseldorf
Moorenstr. 5
40225 Düsseldorf
Germany
Telephone:
+49-211-8119591
Fax:
No Entry
Contact per E-Mail
URL:
http://www.medizin.hhu.de/die-fakultaet/gremien-und-beauftragte-der-medizinischen-fakultaet/kommissionen/ethikkommission

Vote of leading Ethics Committee

Date of ethics committee application:
2023-03-14
Ethics committee number:
2023-2396
Vote of the Ethics Committee:
Approved
Date of the vote:
2023-09-11

Further identification numbers

Other primary registry ID:
No Entry
EudraCT Number:
No Entry
UTN (Universal Trial Number):
No Entry
EUDAMED Number:
No Entry

IPD - Individual Participant Data

Do you plan to make participant-related data (IPD) available to other researchers in an anonymized form?:
No
IPD Sharing Plan:
No Entry

Study protocol and other study documents

Study protocols:
No Entry
Study abstract:
No Entry
Other study documents:
No Entry
Background literature:
No Entry
Related DRKS studies:
No Entry

Publication of study results

Planned publication:
No Entry
Publikationen/Studienergebnisse:
No Entry
Date of first publication of study results:
No Entry
DRKS entry published for the first time with results:
No Entry

Basic reporting

Basic Reporting / Results tables:
No Entry
Brief summary of results:
No Entry