xml: <clinical_study>
    <!-- This xml conforms to an XML Schema at:
      https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
    <required_header>
      <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
      <link_text>Link to the current ClinicalTrials.gov record.</link_text>
      <url>https://clinicaltrials.gov/ct2/show/NCT06038903</url>
    </required_header>
    <id_info>
      <org_study_id>EskisehirTU-SBF-CK-02</org_study_id>
      <nct_id>NCT06038903</nct_id>
    </id_info>
    <brief_title>The Turkish Version Of The Brief-Caffeine Expectancy Questionnaire</brief_title>
    <official_title>Evaluation of The Psychometric Properties of The Turkish Version of The Brief-Caffeine Expectancy Questionnaire (B-CaffeQ): An Adaptation Study in Recreationally Active Individuals</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Eskisehir Technical University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Eskisehir Technical University</source>
    <oversight_info>
      <has_dmc>No</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        Caffeine is a psycho-active substance that is widely consumed in the world. It is seen that&#xD;
        its widespread consumption is related to expectancies of consumption as well as cultural&#xD;
        factors. Recreationally active individuals may have various expectations from caffeine&#xD;
        consumption in line with their lifestyles and goals such as physical, social and/or other&#xD;
        aspects. It can be stated that caffeine consumption expectancies have an important role in&#xD;
        the process of evaluating consumption patterns. However, in the literature it seems to be&#xD;
        very limited information about expectancies related to caffeine consumption. In this&#xD;
        direction, the aim of the research was to test the compatibility of Brief-Caffeine Expectancy&#xD;
        Questionnaire (B-CaffeQ) to Turkish culture and language. In the study, data will be&#xD;
        collected from two separate participant groups and going to analysis. To reveal the structure&#xD;
        on the first group (n=250-300 approx.) data, Exploratory Factor Analysis (EFA), and to verify&#xD;
        the structure on the second group (n=313) data, Confirmatory Factor Analysis (CFA) will be&#xD;
        used. Reliability will be assessed by performing test-retest and internal consistency&#xD;
        analyzes on both the two data groups.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        INTRODUCTION&#xD;
  &#xD;
        Caffeine (1,3,7-trimethylxanthine) is most commonly found in coffee as the main&#xD;
        pharmacologically active ingredient. In general, brewed coffee has the highest content among&#xD;
        foodstuffs containing caffeine. Coffee (230-250ml), depending on the preparation method, the&#xD;
        type of beans, roasting, grinding type and brand, contains 35-250 mg of caffeine while tea&#xD;
        (150 ml) 24-50 mg, cola drinks (180 ml) 15-30 mg, cocoa (150 ml) 2-7 mg, chocolate (28 g)&#xD;
        1-36 mg, and the foods containing chocolate mostly contain less than 15 mg caffeine (Gray,&#xD;
        1998; Fredholm et al., 1999; Barone &amp; Roberts, 2012).&#xD;
  &#xD;
        Doses of up to 300-400mg per day in healthy adults (19 and over) are specified as safe upper&#xD;
        limit without any harmful effects. This amount corresponds to 4-5 cups of medium coffee.&#xD;
        However, it is stated that caffeine consumption equal to 6 cups of dark coffee generally does&#xD;
        not cause any side effects. It is stated that the daily limit for adolescents and children is&#xD;
        100 mg and this limit should not be exceeded. However, coffee is not the only source of&#xD;
        caffeine, and other sources caffeine consumed should also be taken into account (Gray, 1998;&#xD;
        Nawrot et al., 2003; Seifert et al., 2011; Temple et al., 2017).&#xD;
  &#xD;
        The average daily caffeine consumption in Turkey for adolescents and children aged 15 and&#xD;
        below is an average of 197 mg and 202 mg for 18 and older. The source of caffeine for&#xD;
        adolescents is mostly tea, carbonated soft drinks and instant coffee consumption&#xD;
        (Küçükkömürler &amp; Kurt, 2018). Average daily caffeine consumption in adult working individuals&#xD;
        is 247 mg, and this is due to the consumption of carbonated soft drinks, chocolate, instant&#xD;
        coffee, respectively (Khorshid &amp; Dilek, 2013). It is seen that 20% of university students who&#xD;
        consume caffeine have an average daily consumption of 250 mg and above, and this mostly due&#xD;
        to the consumption of tea, coffee, Turkish coffee, carbonated soft drinks and chocolate&#xD;
        (Aydın &amp; Eryılmaz, 2019). In USA, while the main source of caffeine is coffee for the age of&#xD;
        18 and above, it is caffeine-containing soft drinks for the age of 2-17 (Frary et al., 2005).&#xD;
  &#xD;
        There is evidence that some individuals' expectancies of caffeine's effects on physical&#xD;
        performance and mood may affect the magnitude of these effects. There are studies showing&#xD;
        that caffeine anticipation effect affects mood, attention, and vitality (Dawkins et al.,&#xD;
        2011). In the case of caffeine expectancy, placebo administration stimulates changes in the&#xD;
        dopaminergic system in the brain. The neurobiological mechanisms of caffeine and placebo&#xD;
        caffeine were similar in the brain, but somewhat more limited in placebo caffeine (Kaasinen&#xD;
        et al., 2004). It is stated that the expectancy of the individual may manage the placebo&#xD;
        effect and accordingly, the expected effect of caffeine or the drug consumed may change the&#xD;
        response to placebo (Fillmore &amp; Vogel-Sprott, 1992). Beyond the pharmacological effects of a&#xD;
        drug, an individual's expectancies of it may also contribute to the intensive experiences of&#xD;
        the drug in question (Heinz et al., 2009). The fact that individuals who are told they had&#xD;
        decaffeinated coffee but are given caffeine perform worse than those who do not consume&#xD;
        caffeine, support the view that the pharmacological effects of caffeine act synergistically&#xD;
        with anticipation (Elliman et al., 2010). In addition, it has been stated that the effects&#xD;
        caused by caffeine withdrawal may also be caused by the negative expectancies (nosebo) of an&#xD;
        individual (Juliano et al., 2019). These results provided evidence that the subjective and&#xD;
        behavioral effects of caffeine consumption may be positive or negative depending on the&#xD;
        individual's expectancies from caffeine. These expectancies may arise from the individual's&#xD;
        previous experiences with caffeine (Oei &amp; Hartley, 2005; Harrell &amp; Juliano, 2009). The&#xD;
        effects of caffeine depend on the individual's expectancies, so if the individual consumes a&#xD;
        beverage expecting that it has caffeine in it, these expectancies may be generalized as&#xD;
        placebo conditions (Smith, 2002). In placebo studies, it is stated that one of the factors&#xD;
        that cause an individual to respond to a treatment may be caused by the type of individual&#xD;
        who may respond to treatment via expectancies. In other words, this view is not specific to&#xD;
        the treatment of the practice applied, rather that the response may be shaped according to&#xD;
        the expectancies of the individual, that expectancies may cause a placebo (or nosebo) effect&#xD;
        (Geers &amp; Caplandies, 2020). When there is confidence in the drug effect of a drug in a&#xD;
        particular activity, an expectancy of a specific behavioral effect of that drug may also be&#xD;
        formed. Based on expectancies about the effects of caffeine, the behavioral response to this&#xD;
        drug derivative can be predicted (Fillmore, 1999). However, this expectancy theory is&#xD;
        insufficient to explain the fact that some individuals without expectancies not showing&#xD;
        stimulating effects when they consume caffeine for the first time (Oei &amp; Hartley, 2005).&#xD;
        There are other studies which do not observe expectancy affects in caffeine consumption,&#xD;
        suggesting placebo and expectancy effects are caused by introspection (Schneider et al.,&#xD;
        2006). The results showed that both pharmacological and expectancy factors affect the actual&#xD;
        and expectancy effects of caffeine in an individual's behaviour (Lotshaw et al., 1996).&#xD;
  &#xD;
        Some of the performance enhancing effects of caffeine appear to be linked to expectancies.&#xD;
        Since the bitter taste of caffeine may act as a signal that caffeine has been consumed, it&#xD;
        seems possible that some anticipatory effects of caffeine consumption may be driven by this&#xD;
        bitter taste (Pickering, 2019). It is said that consuming 300-400 mg caffeine a day,&#xD;
        equivalent of 3-4 cups of coffee daily, may have positive effects on the well-being of an&#xD;
        individual and may partially improve mental-physical disorders (Fatolahi et al., 2020).&#xD;
        Performance increases were also observed with individuals who consume coffee regularly when&#xD;
        they are given decaffeinated coffee. This suggests a caffeine related stimulus causes a&#xD;
        caffeine related effect. This result also indicates, other features of coffee such as its&#xD;
        smell and taste rather than caffeine itself, may also be effective in the development of&#xD;
        these expectancies. It has been observed when these individuals who consume coffee regularly&#xD;
        do not wish to consume caffeine yet want to benefit from its performance enhancement effects,&#xD;
        decaffeinated coffee also creates a good effect on performance enhancement (Fukuda &amp; Aoyama,&#xD;
        2017). In addition, the expectancy for the positive effects of caffeine consumption is an&#xD;
        indicator of how much and how often caffeine will be consumed (Lau-Barraco &amp; Linden, 2014).&#xD;
  &#xD;
        PURPOSE OF RESEARCH Since caffeine consumption is rather widespread in Turkey, it can be seen&#xD;
        that an instrument to be used in research on caffeine consumption expectancies such as&#xD;
        caffeine expectancy survey is needed. Accordingly, the purpose of this research is to adapt&#xD;
        and verify the Breif-Caffeine Expectancy Questionnaire (B-CaffeQ) which has been developed by&#xD;
        Kearns et al. (2018) and consists of seven dimensions: withdrawal / dependence, energy / work&#xD;
        enhancement, appetite suppression, social / mood enhancement, physical performance&#xD;
        enhancement, anxiety / negative physical effects, and sleep disturbance, to Turkish culture&#xD;
        and language.&#xD;
  &#xD;
        METHODOLOGY Research model&#xD;
  &#xD;
        This research model includes a methodological process in which the Brief-Caffeine Expectancy&#xD;
        Questionnaire is evaluated through the validity and reliability analysis of the Turkish&#xD;
        language and culture. This process includes some steps will be deemed necessary for the&#xD;
        adaptation of the questionnaire. These stages will be followed in the following order&#xD;
        (Hambleton &amp; Patsula, 1999; Seçer, 2015):&#xD;
  &#xD;
          -  Survey translation.&#xD;
  &#xD;
          -  Evaluating the items and making the necessary corrections.&#xD;
  &#xD;
          -  Testing the items.&#xD;
  &#xD;
          -  Creating the initial form of the questionnaire.&#xD;
  &#xD;
          -  Implementation of the survey.&#xD;
  &#xD;
          -  Conducting analyses.&#xD;
  &#xD;
          -  Finalizing the questionnaire.&#xD;
  &#xD;
          -  Examination of the measurement model.&#xD;
  &#xD;
          -  Reporting of the process.&#xD;
  &#xD;
        Research group The participants in this study are recreationally active individuals. Data&#xD;
        will be collected from two different groups for validity and reliability assessments. Data&#xD;
        will be obtained from the first group, in which the processes related to Exploratory Factor&#xD;
        Analysis (EFA) will be carried out, and the processes related to Confirmatory Factor Analysis&#xD;
        (CFA) will carry out with the data collected from the second group. Groups consist of&#xD;
        participants will select by the purposive sampling. For the purpose of this research,&#xD;
        individuals who consume products containing caffeine such as coffee, tea, and soft drinks&#xD;
        constitute the research group. Accordingly, data will collect from 250-300 (aprroximately)&#xD;
        participants for EFA process and from 30 participants for CFA process.&#xD;
  &#xD;
        Ethical clearance The study protocol was approved by the Scientific Research and Publishing&#xD;
        Ethics Committee of Eskisehir Technical University (Decree number:&#xD;
        E-87914409-050.03.04-8971).&#xD;
  &#xD;
        Data collection tool and technique During the data collection phase, a questionnaire form&#xD;
        consisting of three parts will use. In the first part, explanations about the research and&#xD;
        caffeine containing product information which the participant based their answers on&#xD;
        included. In the second part of the questionnaire, Brief-Caffeine Expectancy Questionnaire,&#xD;
        which is a simplified version of the caffeine expectancy questionnaire developed by Huntley&#xD;
        and Juliano (2012), will be included. This questionnaire, whish has been simplified by Kearns&#xD;
        et al. (2018) by carrying out validity and reliability studies, has a 7-factor structure,&#xD;
        consisting of 20 articles (Huntley &amp; Juliano, 2012; Kearns et al., 2018). The rating of this&#xD;
        questionnaire, which was created in six Likert type, was defined as &quot;1 = Strongly Disagree&quot;&#xD;
        to &quot;6= Strongly Agree&quot;. In the last part of the questionnaire, there will be questions from&#xD;
        which the demographic information of the participants such as age, gender, educational&#xD;
        status, etc. obtain.&#xD;
  &#xD;
        Aforementioned questionnaire form will be prepared on an online platform and the connection&#xD;
        link will be provided. This link will be conveyed to participants through posts shared on&#xD;
        these social media accounts.&#xD;
  &#xD;
        Language equivalence In the process of adapting B-CaffeQ to Turkish language and culture,&#xD;
        back translation method will be used in order to provide language equivalence (Brislin &amp;&#xD;
        Freimanis, 2001). Accordingly, both the English to Turkish and Turkish to English&#xD;
        translations will made independently by two different linguists who are adept in both&#xD;
        languages and cultures. Finally, the articles will translate back into English and compare&#xD;
        with their original forms.&#xD;
  &#xD;
        Data analysis EFA will use in order to determine what kind of a structure pattern the survey&#xD;
        constitutes in Turkish language and culture. CFA will use to test the accuracy of the&#xD;
        structure resulting from EFA. Reliability tests of the questionnaire will perform through&#xD;
        Cronbach Alpha coefficient and test-retest analysis.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">September 8, 2023</start_date>
    <completion_date type="Anticipated">October 15, 2023</completion_date>
    <primary_completion_date type="Anticipated">October 10, 2023</primary_completion_date>
    <study_type>Observational [Patient Registry]</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Cohort</observational_model>
      <time_perspective>Cross-Sectional</time_perspective>
    </study_design_info>
    <target_duration>30 Days</target_duration>
    <primary_outcome>
      <measure>the Breif-Caffeine Expectancy Questionnaire (B-CaffeQ)</measure>
      <time_frame>two weeks</time_frame>
      <description>Brief-Caffeine Expectancy Questionnaire, which is a simplified version of the caffeine expectancy questionnaire developed by Huntley and Juliano (2012), will be included. This questionnaire, whish has been simplified by Kearns et al. (2018) by carrying out validity and reliability studies, has a 7-factor structure, consisting of 20 articles (Huntley &amp; Juliano, 2012; Kearns et al., 2018). The rating of this questionnaire, which was created in six Likert type, was defined as &quot;1 = Strongly Disagree&quot; to &quot;6= Strongly Agree&quot;. In the last part of the questionnaire, there will be questions from which the demographic information of the participants such as age, gender, educational status, etc. obtaine.</description>
    </primary_outcome>
    <number_of_groups>2</number_of_groups>
    <enrollment type="Anticipated">300</enrollment>
    <condition>Caffeine</condition>
    <condition>Adaptation</condition>
    <condition>Expectations</condition>
    <condition>Language</condition>
    <arm_group>
      <arm_group_label>EFA group</arm_group_label>
      <description>This group for exploratory factor analysis (EFA)</description>
    </arm_group>
    <arm_group>
      <arm_group_label>CFA group</arm_group_label>
      <description>This group for confirmatory factor analysis (CFA)</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>caffeine consumption expectation</intervention_name>
      <description>The group to which the Short-form caffeine expectation questionnaire (B-CaffeQ) was applied, which evaluated the expectations from caffeine consumption.</description>
      <arm_group_label>CFA group</arm_group_label>
      <arm_group_label>EFA group</arm_group_label>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          Physically active, physiologically healthy and routinely caffeine consumer male and females&#xD;
          between 18-60 ages.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
          - Participants consisted of women and men aged between 18 and 60. The volunteers to be&#xD;
          included in the study are male and female individuals who have a history of any cardiac&#xD;
          diseas in the last two months at least for the CFA and EFA group and healthy individuals&#xD;
          without any injury and the selection will be made at randomly.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  As criteria for excluding the participants in the study; Those who have a risk of&#xD;
               heart disease, use of pacemaker, epilepsy, transient ischemic attack, stroke or&#xD;
               similar nervous disorders and any similar health problems,&#xD;
  &#xD;
            -  Those with psychiatric, cardiac, pulmonary diseases, pregnant women, those who use&#xD;
               drugs that affect the heart rate and blood pressure, those with systemic,&#xD;
               neuroplastic, inflammation disorders, those with structural back anomalies, and those&#xD;
               who have had lumbar disc herniation complications will not be included in the study.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>60 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>celil kaçoğlu, assoc. prof.</last_name>
      <role>Principal Investigator</role>
      <affiliation>Eskişehir Tecnical University</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>celil kaçoğlu, assoc. prof.</last_name>
      <phone>+905064017872</phone>
      <email>ckacoglu@anadolu.edu.tr</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Anıl Onur Mercanoğlu, phd</last_name>
      <phone>+905064017872</phone>
      <email>ckacoglu@anadolu.edu.tr</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Eskişehir Technical University</name>
        <address>
          <city>Eskişehir</city>
          <state>Tepebaşı</state>
          <zip>26555</zip>
          <country>Turkey</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Celil Kaçoğlu, assoc prof</last_name>
        <phone>+905064017872</phone>
        <email>ckacoglu@eskisehir.edu.tr</email>
      </contact>
    </location>
    <location_countries>
      <country>Turkey</country>
    </location_countries>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>September 8, 2023</study_first_submitted>
    <study_first_submitted_qc>September 8, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 15, 2023</study_first_posted>
    <last_update_submitted>September 8, 2023</last_update_submitted>
    <last_update_submitted_qc>September 8, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 15, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Eskisehir Technical University</investigator_affiliation>
      <investigator_full_name>Celil Kaçoğlu</investigator_full_name>
      <investigator_title>Associated profesor</investigator_title>
    </responsible_party>
    <keyword>expectation</keyword>
    <keyword>caffeine</keyword>
    <keyword>Brief-Caffeine Expectancy Questionnaire</keyword>
    <keyword>Language adaptation study</keyword>
    <intervention_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Caffeine</mesh_term>
    </intervention_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: download date: ClinicalTrials.gov processed this data on September 20, 2023
  link text: Link to the current ClinicalTrials.gov record.
  url: https://clinicaltrials.gov/ct2/show/NCT06038903
  org study id: EskisehirTU-SBF-CK-02
  nct id: NCT06038903
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  Caffeine is a psycho-active substance that is widely consumed in the world. It is seen that
        its widespread consumption is related to expectancies of consumption as well as cultural
        factors. Recreationally active individuals may have various expectations from caffeine
        consumption in line with their lifestyles and goals such as physical, social and/or other
        aspects. It can be stated that caffeine consumption expectancies have an important role in
        the process of evaluating consumption patterns. However, in the literature it seems to be
        very limited information about expectancies related to caffeine consumption. In this
        direction, the aim of the research was to test the compatibility of Brief-Caffeine Expectancy
        Questionnaire (B-CaffeQ) to Turkish culture and language. In the study, data will be
        collected from two separate participant groups and going to analysis. To reveal the structure
        on the first group (n=250-300 approx.) data, Exploratory Factor Analysis (EFA), and to verify
        the structure on the second group (n=313) data, Confirmatory Factor Analysis (CFA) will be
        used. Reliability will be assessed by performing test-retest and internal consistency
        analyzes on both the two data groups.
  INTRODUCTION
  
        Caffeine (1,3,7-trimethylxanthine) is most commonly found in coffee as the main
        pharmacologically active ingredient. In general, brewed coffee has the highest content among
        foodstuffs containing caffeine. Coffee (230-250ml), depending on the preparation method, the
        type of beans, roasting, grinding type and brand, contains 35-250 mg of caffeine while tea
        (150 ml) 24-50 mg, cola drinks (180 ml) 15-30 mg, cocoa (150 ml) 2-7 mg, chocolate (28 g)
        1-36 mg, and the foods containing chocolate mostly contain less than 15 mg caffeine (Gray,
        1998; Fredholm et al., 1999; Barone & Roberts, 2012).
  
        Doses of up to 300-400mg per day in healthy adults (19 and over) are specified as safe upper
        limit without any harmful effects. This amount corresponds to 4-5 cups of medium coffee.
        However, it is stated that caffeine consumption equal to 6 cups of dark coffee generally does
        not cause any side effects. It is stated that the daily limit for adolescents and children is
        100 mg and this limit should not be exceeded. However, coffee is not the only source of
        caffeine, and other sources caffeine consumed should also be taken into account (Gray, 1998;
        Nawrot et al., 2003; Seifert et al., 2011; Temple et al., 2017).
  
        The average daily caffeine consumption in Turkey for adolescents and children aged 15 and
        below is an average of 197 mg and 202 mg for 18 and older. The source of caffeine for
        adolescents is mostly tea, carbonated soft drinks and instant coffee consumption
        (Küçükkömürler & Kurt, 2018). Average daily caffeine consumption in adult working individuals
        is 247 mg, and this is due to the consumption of carbonated soft drinks, chocolate, instant
        coffee, respectively (Khorshid & Dilek, 2013). It is seen that 20% of university students who
        consume caffeine have an average daily consumption of 250 mg and above, and this mostly due
        to the consumption of tea, coffee, Turkish coffee, carbonated soft drinks and chocolate
        (Aydın & Eryılmaz, 2019). In USA, while the main source of caffeine is coffee for the age of
        18 and above, it is caffeine-containing soft drinks for the age of 2-17 (Frary et al., 2005).
  
        There is evidence that some individuals' expectancies of caffeine's effects on physical
        performance and mood may affect the magnitude of these effects. There are studies showing
        that caffeine anticipation effect affects mood, attention, and vitality (Dawkins et al.,
        2011). In the case of caffeine expectancy, placebo administration stimulates changes in the
        dopaminergic system in the brain. The neurobiological mechanisms of caffeine and placebo
        caffeine were similar in the brain, but somewhat more limited in placebo caffeine (Kaasinen
        et al., 2004). It is stated that the expectancy of the individual may manage the placebo
        effect and accordingly, the expected effect of caffeine or the drug consumed may change the
        response to placebo (Fillmore & Vogel-Sprott, 1992). Beyond the pharmacological effects of a
        drug, an individual's expectancies of it may also contribute to the intensive experiences of
        the drug in question (Heinz et al., 2009). The fact that individuals who are told they had
        decaffeinated coffee but are given caffeine perform worse than those who do not consume
        caffeine, support the view that the pharmacological effects of caffeine act synergistically
        with anticipation (Elliman et al., 2010). In addition, it has been stated that the effects
        caused by caffeine withdrawal may also be caused by the negative expectancies (nosebo) of an
        individual (Juliano et al., 2019). These results provided evidence that the subjective and
        behavioral effects of caffeine consumption may be positive or negative depending on the
        individual's expectancies from caffeine. These expectancies may arise from the individual's
        previous experiences with caffeine (Oei & Hartley, 2005; Harrell & Juliano, 2009). The
        effects of caffeine depend on the individual's expectancies, so if the individual consumes a
        beverage expecting that it has caffeine in it, these expectancies may be generalized as
        placebo conditions (Smith, 2002). In placebo studies, it is stated that one of the factors
        that cause an individual to respond to a treatment may be caused by the type of individual
        who may respond to treatment via expectancies. In other words, this view is not specific to
        the treatment of the practice applied, rather that the response may be shaped according to
        the expectancies of the individual, that expectancies may cause a placebo (or nosebo) effect
        (Geers & Caplandies, 2020). When there is confidence in the drug effect of a drug in a
        particular activity, an expectancy of a specific behavioral effect of that drug may also be
        formed. Based on expectancies about the effects of caffeine, the behavioral response to this
        drug derivative can be predicted (Fillmore, 1999). However, this expectancy theory is
        insufficient to explain the fact that some individuals without expectancies not showing
        stimulating effects when they consume caffeine for the first time (Oei & Hartley, 2005).
        There are other studies which do not observe expectancy affects in caffeine consumption,
        suggesting placebo and expectancy effects are caused by introspection (Schneider et al.,
        2006). The results showed that both pharmacological and expectancy factors affect the actual
        and expectancy effects of caffeine in an individual's behaviour (Lotshaw et al., 1996).
  
        Some of the performance enhancing effects of caffeine appear to be linked to expectancies.
        Since the bitter taste of caffeine may act as a signal that caffeine has been consumed, it
        seems possible that some anticipatory effects of caffeine consumption may be driven by this
        bitter taste (Pickering, 2019). It is said that consuming 300-400 mg caffeine a day,
        equivalent of 3-4 cups of coffee daily, may have positive effects on the well-being of an
        individual and may partially improve mental-physical disorders (Fatolahi et al., 2020).
        Performance increases were also observed with individuals who consume coffee regularly when
        they are given decaffeinated coffee. This suggests a caffeine related stimulus causes a
        caffeine related effect. This result also indicates, other features of coffee such as its
        smell and taste rather than caffeine itself, may also be effective in the development of
        these expectancies. It has been observed when these individuals who consume coffee regularly
        do not wish to consume caffeine yet want to benefit from its performance enhancement effects,
        decaffeinated coffee also creates a good effect on performance enhancement (Fukuda & Aoyama,
        2017). In addition, the expectancy for the positive effects of caffeine consumption is an
        indicator of how much and how often caffeine will be consumed (Lau-Barraco & Linden, 2014).
  
        PURPOSE OF RESEARCH Since caffeine consumption is rather widespread in Turkey, it can be seen
        that an instrument to be used in research on caffeine consumption expectancies such as
        caffeine expectancy survey is needed. Accordingly, the purpose of this research is to adapt
        and verify the Breif-Caffeine Expectancy Questionnaire (B-CaffeQ) which has been developed by
        Kearns et al. (2018) and consists of seven dimensions: withdrawal / dependence, energy / work
        enhancement, appetite suppression, social / mood enhancement, physical performance
        enhancement, anxiety / negative physical effects, and sleep disturbance, to Turkish culture
        and language.
  
        METHODOLOGY Research model
  
        This research model includes a methodological process in which the Brief-Caffeine Expectancy
        Questionnaire is evaluated through the validity and reliability analysis of the Turkish
        language and culture. This process includes some steps will be deemed necessary for the
        adaptation of the questionnaire. These stages will be followed in the following order
        (Hambleton & Patsula, 1999; Seçer, 2015):
  
          -  Survey translation.
  
          -  Evaluating the items and making the necessary corrections.
  
          -  Testing the items.
  
          -  Creating the initial form of the questionnaire.
  
          -  Implementation of the survey.
  
          -  Conducting analyses.
  
          -  Finalizing the questionnaire.
  
          -  Examination of the measurement model.
  
          -  Reporting of the process.
  
        Research group The participants in this study are recreationally active individuals. Data
        will be collected from two different groups for validity and reliability assessments. Data
        will be obtained from the first group, in which the processes related to Exploratory Factor
        Analysis (EFA) will be carried out, and the processes related to Confirmatory Factor Analysis
        (CFA) will carry out with the data collected from the second group. Groups consist of
        participants will select by the purposive sampling. For the purpose of this research,
        individuals who consume products containing caffeine such as coffee, tea, and soft drinks
        constitute the research group. Accordingly, data will collect from 250-300 (aprroximately)
        participants for EFA process and from 30 participants for CFA process.
  
        Ethical clearance The study protocol was approved by the Scientific Research and Publishing
        Ethics Committee of Eskisehir Technical University (Decree number:
        E-87914409-050.03.04-8971).
  
        Data collection tool and technique During the data collection phase, a questionnaire form
        consisting of three parts will use. In the first part, explanations about the research and
        caffeine containing product information which the participant based their answers on
        included. In the second part of the questionnaire, Brief-Caffeine Expectancy Questionnaire,
        which is a simplified version of the caffeine expectancy questionnaire developed by Huntley
        and Juliano (2012), will be included. This questionnaire, whish has been simplified by Kearns
        et al. (2018) by carrying out validity and reliability studies, has a 7-factor structure,
        consisting of 20 articles (Huntley & Juliano, 2012; Kearns et al., 2018). The rating of this
        questionnaire, which was created in six Likert type, was defined as "1 = Strongly Disagree"
        to "6= Strongly Agree". In the last part of the questionnaire, there will be questions from
        which the demographic information of the participants such as age, gender, educational
        status, etc. obtain.
  
        Aforementioned questionnaire form will be prepared on an online platform and the connection
        link will be provided. This link will be conveyed to participants through posts shared on
        these social media accounts.
  
        Language equivalence In the process of adapting B-CaffeQ to Turkish language and culture,
        back translation method will be used in order to provide language equivalence (Brislin &
        Freimanis, 2001). Accordingly, both the English to Turkish and Turkish to English
        translations will made independently by two different linguists who are adept in both
        languages and cultures. Finally, the articles will translate back into English and compare
        with their original forms.
  
        Data analysis EFA will use in order to determine what kind of a structure pattern the survey
        constitutes in Turkish language and culture. CFA will use to test the accuracy of the
        structure resulting from EFA. Reliability tests of the questionnaire will perform through
        Cronbach Alpha coefficient and test-retest analysis.
  observational model: Cohort
  time perspective: Cross-Sectional
  measure: the Breif-Caffeine Expectancy Questionnaire (B-CaffeQ)
  time frame: two weeks
  description: Brief-Caffeine Expectancy Questionnaire, which is a simplified version of the caffeine expectancy questionnaire developed by Huntley and Juliano (2012), will be included. This questionnaire, whish has been simplified by Kearns et al. (2018) by carrying out validity and reliability studies, has a 7-factor structure, consisting of 20 articles (Huntley & Juliano, 2012; Kearns et al., 2018). The rating of this questionnaire, which was created in six Likert type, was defined as "1 = Strongly Disagree" to "6= Strongly Agree". In the last part of the questionnaire, there will be questions from which the demographic information of the participants such as age, gender, educational status, etc. obtaine.
  arm group label: EFA group
  description: This group for exploratory factor analysis (EFA)
  arm group label: CFA group
  description: This group for confirmatory factor analysis (CFA)
  intervention type: Other
  intervention name: caffeine consumption expectation
  description: The group to which the Short-form caffeine expectation questionnaire (B-CaffeQ) was applied, which evaluated the expectations from caffeine consumption.
  arm group label: CFA group
  arm group label: EFA group
  study pop: 
  sampling method: Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 60 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: celil kaçoğlu, assoc. prof.
  role: Principal Investigator
  affiliation: Eskişehir Tecnical University
  last name: celil kaçoğlu, assoc. prof.
  phone: +905064017872
  email: ckacoglu@anadolu.edu.tr
  last name: Anıl Onur Mercanoğlu, phd
  phone: +905064017872
  email: ckacoglu@anadolu.edu.tr
  facility: 
  status: Recruiting
  contact: 
  country: Turkey
  responsible party type: Principal Investigator
  investigator affiliation: Eskisehir Technical University
  investigator full name: Celil Kaçoğlu
  investigator title: Associated profesor
  mesh term: Caffeine
  sharing ipd: No