Self MedicationMedConCienciaNCT07389538
Promoting Safe Medication Practices in the Classroom
A study testing Educational intervention in people with Self Medication, run by Universidad de Granada at 1 site in Spain.
Trial summary
Self-medication has traditionally been defined as the consumption of medicines, herbs, and home remedies on one's own initiative or on the advice of another person, without consulting a doctor. Read more about this study
- Who is it for?
- Ages 15 to 24 years
- Conditions the study is for
- Self Medication
- What is being tested?
- Educational intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 202 participants
- Where
- 1 siteSpain
- Study dates
- 17 Mar 2025to Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 to 24 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Inclusion criteria will include being a student at secondary education institutions, vocational training programs, or undergraduate degree programs in the province of Granada, and being between 15 and 24 years of age.
Who cannot join
- Exclusion criteria will include: lack of informed consent from the participant or their legal guardians in the case of minors, and the presence of barriers that prevent proper understanding of the questionnaires and activities to be carried out (e.g., language barriers, intellectual disability, etc.).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Spain1 site, 1 recruiting
- Recruiting
University of Granada
Granada, Granada, 18016
About this study
Official title: Promoting Safe Medication Practices in the Classroom: Medicación Con-Ciencia
Self-medication has traditionally been defined as the consumption of medicines, herbs, and home remedies on one's own initiative or on the advice of another person, without consulting a doctor. In Spain, the consumption of non-prescription drugs is quite widespread among young people, since more than half of them have used medications without a medical prescription in the last year.
This high prevalence of self-medication among Spanish youth seems to be driven by various factors that encourage this practice. These include the increase in over-the-counter medications, delays in obtaining appointments at health centers, the influence of common family self-care practices, and the population's greater knowledge of and interest in health-related issues.
Read more
Inappropriate use of medications constitutes a public health problem and can cause significant risks to users' health, such as adverse reactions, drug resistance, and complications in diagnosing diseases, since it can lead to the masking of symptoms, as well as an increase in morbidity.
However, not all self-medication practices are harmful. Responsible self-medication refers to the use of over-the-counter medications (without a prescription) to treat common and mild symptoms (e.g., fever, mild pain, colds) for a reasonable period of time (two to three days, after which a doctor should be consulted if no improvement occurs). The benefits of responsible self-medication include convenience for the patient, reinforcement of personal autonomy through self-care, reduction of healthcare professionals' workload, and decreased costs to the healthcare system. In this regard, responsible self-medication not only provides individual and collective benefits but also promotes the development of personal autonomy, a key factor influencing young people's tendency to self-medicate. Attitudes toward autonomous medication use in young people are influenced by individual variables such as emotional regulation, family habits, peer influence, quality of life, and the use of other substances.
Given that these factors-greater access to medications, delays in healthcare access, family self-care practices, and individual psychosocial characteristics-appear to drive self-medication behaviors among youth, it is hypothesized that an educational intervention developed with the support of artificial intelligence, and focused on the responsible and safe use of medications, will improve young people's knowledge and attitudes toward self-medication. By targeting both knowledge and attitudes, the intervention aims to strengthen responsible practices while fostering autonomy and informed decision-making in medication use.
Read the detailed description
The present study is grounded in the premise that widespread lack of knowledge regarding the appropriate use of medications represents a relevant educational and public health problem that should be addressed from early stages of life. Accordingly, the primary objective of this study is to improve health literacy related to responsible self-medication among young people.
To achieve this objective, a longitudinal quasi-experimental clinical trial with a non-randomized control group was designed. The study will include young individuals aged 15 to 24 years recruited from secondary schools, vocational training programs, and undergraduate degree programs in the province of Granada. Data will be collected at two predefined time points: a baseline assessment conducted prior to the intervention (pre-intervention) and a follow-up assessment performed 6 to 9 months after the intervention (post-intervention).
At both assessment points, participants will independently complete a structured questionnaire collecting information on sociodemographic characteristics, self-medication practices, knowledge and attitudes toward self-medication, as well as physical and psychosocial factors. The outcome measures will be primarily assessed using validated instruments, including the Kidscreen-27 (Screening for Health-Related Quality of Life in Children and Adolescents, 27-item version) and the QAR-LS questionnaires (Risk Self-Medication Questionnaire focused on Health Literacy), ensuring the reliability and validity of the data collected.
Participants will be allocated to one of two study groups: an intervention group and a control group with a smaller sample size. Due to the non-randomized nature of the study, allocation to the control group will be determined by participants' absence during the implementation of the educational intervention. Participants in the control group will not receive the intervention but will complete the post-intervention assessment, allowing for between-group comparisons.
The intervention will consist of a structured educational program focused on the appropriate use of medications and the prevention of errors associated with self-medication. The program will be delivered face-to-face in participating educational institutions during regular school hours and within classroom settings, with an estimated duration of approximately two hours. The intervention will integrate theoretical and practical components organized into four workshops.
To enhance intervention fidelity and ensure suitability for the target population, artificial intelligence-based tools will be employed to adapt educational materials to participants' age and to language accessible to the general population. In addition, graphic and audiovisual resources, together with gamification strategies, will be incorporated to promote engagement and facilitate learning. As a complementary component, a gamified virtual escape room will be developed to encourage safe medication-use practices and to prevent risk behaviors among young people, thereby extending the potential reach of the intervention to young populations nationwide.
- Conditions
- Self Medication
- Being tested
- Educational intervention
- Keywords
- Health Literacy, Adolescent, Quality of Life, Self Medication, Artificial Intelligence, Education
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Educational interventionBehavioural
The intervention will consist of a structured educational program focused on the appropriate use of medications and the prevention of errors associated with self-medication.
| Study group | Role | What they receive |
|---|---|---|
| Control Group | No intervention | The control group consisted of participants who were absent during the intervention but completed the post-intervention questionnaire. |
| Educational intervention | Experimental | Group receiving the structured educational program focused on the appropriate use of medications and the prevention of errors associated with self-medication. Receives: Behavioral: Educational intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Risk Self-Medication Questionnaire focused on Health Literacy (QAR-LS)
The Risk Self-Medication Questionnaire focused on Health Literacy (QAR-LS) provides scores ranging from 35 to 175 points, where higher scores indicate a greater risk related to inadequate or unsafe self-medication practices.
Measured: Data will be collected at baseline and again 6-9 months after the intervention.
Secondary outcomes (2)
Health-related quality of life (Kidscreen-27)
The KIDSCREEN-27 (Screening for Health-Related Quality of Life in Children and Adolescents, 27-item version) consists of 27 items covering five dimensions: physical well-being, psychological well-being, autonomy and parent relations, social support and peers, and school environment. When summed, total raw scores may range from 27 to 135, although interpretation is typically based on dimension scores or standardized T-scores. Higher scores reflect better health-related quality of life.
Measured: Data will be collected at baseline and again 6-9 months after the intervention.
Problem-focused coping styles (COPE-28)
The COPE-28 (Coping Orientation to Problems Experienced, 28-item version) consists of 28 items rated on a 4-point Likert scale. When summed, total scores range from 28 to 112, although interpretation is typically based on its subscales. Higher scores indicate greater use of the coping strategies assessed.
The instrument includes 14 two-item subscales measuring specific coping responses, such as active coping, planning, seeking emotional or instrumental support, positive reframing, acceptance, humor, religion, self-distraction, denial, venting, substance use, behavioral disengagement, and self-blame. These can be grouped into broader domains (e.g., problem-focused, emotion-focused, dysfunctional coping).
Measured: Data will be collected at baseline and again 6-9 months after the intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2026
- Study start17 Mar 2025
- Primary completionNov 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Self MedicationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Longitudinal quasi-experimental clinical trial with a non-randomized control group in young people aged 15 to 24 years, designed to assess self-medication practices.
- Masking
- None (open label)
- Enrolment
- 202 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidad de Granada
- Sponsor type
- University, hospital or other
- Collaborators
- Ministerio de Ciencia e Innovación, Spain
- Responsible party
- Principal investigator, María Correa-Rodríguez, Universidad de Granada
- Investigators
- María Correa-Rodríguez, PhD, Principal investigator, Universidad de Granada
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07389538
- Sponsor's protocol ID
- 4384/CEIH/2024
- Acronym
- MedConCiencia
- Status last verified
- Jan 2026
- First submitted
- 28 Jan 2026
- Last updated
- 11 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ramírez Puerta, D., Larrubia Muñoz, O., Escortell Mayor, E., & Martínez Martínez, R. (2006). La automedicación responsable, la publicidad farmacéutica y su marco en la Atención Primaria. SEMERGEN, Soc. Esp. Med. Rural Gen. (Ed. impr.), 117-124.
Morán, C., Landero, R., & González, M. T. (2010). COPE-28: un análisis psicométrico de la versión en español del Brief COPE. Universitas Psychologica, 9(2), 543-552.
Kidscreen Group (2004). Estudio europeo de salud y bienestar de niños/as y adolescentes. Cuestionario para chicos y chicas de 8 a 18 años. https://www.kidscreen.org/english/questionnaires/kidscreen-27/
Barreto MAF, Negreiros FDDS, Cestari VRF, Sampaio HAC, Moreira TMM. Evidence of validity of the Risk Self-Medication Questionnaire focused on Health Literacy. Rev Bras Enferm. 2024 Jul 29;77(3):e20230386. doi: 10.1590/0034-7167-2023-0386. eCollection 2024.
PubMed 39082543Baracaldo-Santamaria D, Trujillo-Moreno MJ, Perez-Acosta AM, Feliciano-Alfonso JE, Calderon-Ospina CA, Soler F. Definition of self-medication: a scoping review. Ther Adv Drug Saf. 2022 Oct 5;13:20420986221127501. doi: 10.1177/20420986221127501. eCollection 2022.
PubMed 36211626
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Promoting Safe Medication Practices in the Classroom: Medicación Con-Ciencia
- ClinicalTrials.gov ID
- NCT07389538
- Acronym / sponsor ID
- MedConCiencia / 4384/CEIH/2024
- Conditions
- Self Medication
- Keywords
- Health Literacy, Adolescent, Quality of Life, Self Medication, Artificial Intelligence, Education
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 202 participants (estimated)
- Lead sponsor
- Universidad de GranadaUniversity, hospital or other
- Collaborators
- Ministerio de Ciencia e Innovación, Spain
- Study start
- 17 Mar 2025 (actual)
- Primary completion
- Nov 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 5 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Self-medication has traditionally been defined as the consumption of medicines, herbs, and home remedies on one's own initiative or on the advice of another person, without consulting a doctor. In Spain, the consumption of non-prescription drugs is quite widespread among young people, since more than half of them have used medications without a medical prescription in the last year.
This high prevalence of self-medication among Spanish youth seems to be driven by various factors that encourage this practice. These include the increase in over-the-counter medications, delays in obtaining appointments at health centers, the influence of common family self-care practices, and the population's greater knowledge of and interest in health-related issues.
Inappropriate use of medications constitutes a public health problem and can cause significant risks to users' health, such as adverse reactions, drug resistance, and complications in diagnosing diseases, since it can lead to the masking of symptoms, as well as an increase in morbidity.
However, not all self-medication practices are harmful. Responsible self-medication refers to the use of over-the-counter medications (without a prescription) to treat common and mild symptoms (e.g., fever, mild pain, colds) for a reasonable period of time (two to three days, after which a doctor should be consulted if no improvement occurs). The benefits of responsible self-medication include convenience for the patient, reinforcement of personal autonomy through self-care, reduction of healthcare professionals' workload, and decreased costs to the healthcare system. In this regard, responsible self-medication not only provides individual and collective benefits but also promotes the development of personal autonomy, a key factor influencing young people's tendency to self-medicate. Attitudes toward autonomous medication use in young people are influenced by individual variables such as emotional regulation, family habits, peer influence, quality of life, and the use of other substances.
Given that these factors-greater access to medications, delays in healthcare access, family self-care practices, and individual psychosocial characteristics-appear to drive self-medication behaviors among youth, it is hypothesized that an educational intervention developed with the support of artificial intelligence, and focused on the responsible and safe use of medications, will improve young people's knowledge and attitudes toward self-medication. By targeting both knowledge and attitudes, the intervention aims to strengthen responsible practices while fostering autonomy and informed decision-making in medication use.
Detailed description
The present study is grounded in the premise that widespread lack of knowledge regarding the appropriate use of medications represents a relevant educational and public health problem that should be addressed from early stages of life. Accordingly, the primary objective of this study is to improve health literacy related to responsible self-medication among young people.
To achieve this objective, a longitudinal quasi-experimental clinical trial with a non-randomized control group was designed. The study will include young individuals aged 15 to 24 years recruited from secondary schools, vocational training programs, and undergraduate degree programs in the province of Granada. Data will be collected at two predefined time points: a baseline assessment conducted prior to the intervention (pre-intervention) and a follow-up assessment performed 6 to 9 months after the intervention (post-intervention).
At both assessment points, participants will independently complete a structured questionnaire collecting information on sociodemographic characteristics, self-medication practices, knowledge and attitudes toward self-medication, as well as physical and psychosocial factors. The outcome measures will be primarily assessed using validated instruments, including the Kidscreen-27 (Screening for Health-Related Quality of Life in Children and Adolescents, 27-item version) and the QAR-LS questionnaires (Risk Self-Medication Questionnaire focused on Health Literacy), ensuring the reliability and validity of the data collected.
Participants will be allocated to one of two study groups: an intervention group and a control group with a smaller sample size. Due to the non-randomized nature of the study, allocation to the control group will be determined by participants' absence during the implementation of the educational intervention. Participants in the control group will not receive the intervention but will complete the post-intervention assessment, allowing for between-group comparisons.
The intervention will consist of a structured educational program focused on the appropriate use of medications and the prevention of errors associated with self-medication. The program will be delivered face-to-face in participating educational institutions during regular school hours and within classroom settings, with an estimated duration of approximately two hours. The intervention will integrate theoretical and practical components organized into four workshops.
To enhance intervention fidelity and ensure suitability for the target population, artificial intelligence-based tools will be employed to adapt educational materials to participants' age and to language accessible to the general population. In addition, graphic and audiovisual resources, together with gamification strategies, will be incorporated to promote engagement and facilitate learning. As a complementary component, a gamified virtual escape room will be developed to encourage safe medication-use practices and to prevent risk behaviors among young people, thereby extending the potential reach of the intervention to young populations nationwide.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Longitudinal quasi-experimental clinical trial with a non-randomized control group in young people aged 15 to 24 years, designed to assess self-medication practices.
| Arm | Type | Receives |
|---|---|---|
| Control Group | No intervention | –The control group consisted of participants who were absent during the intervention but completed the post-intervention questionnaire. |
| Educational intervention | Experimental | Behavioral: Educational interventionGroup receiving the structured educational program focused on the appropriate use of medications and the prevention of errors associated with self-medication. |
Who may qualify
- Ages
- 15 to 24 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- Inclusion criteria will include being a student at secondary education institutions, vocational training programs, or undergraduate degree programs in the province of Granada, and being between 15 and 24 years of age.
Key exclusion criteria (1 listed)
- Exclusion criteria will include: lack of informed consent from the participant or their legal guardians in the case of minors, and the presence of barriers that prevent proper understanding of the questionnaires and activities to be carried out (e.g., language barriers, intellectual disability, etc.).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Educational interventionThe intervention will consist of a structured educational program focused on the appropriate use of medications and the prevention of errors associated with self-medication. | Behavioural | Educational intervention |
Primary outcome
Risk Self-Medication Questionnaire focused on Health Literacy (QAR-LS)
Time frame: Data will be collected at baseline and again 6-9 months after the intervention.
The Risk Self-Medication Questionnaire focused on Health Literacy (QAR-LS) provides scores ranging from 35 to 175 points, where higher scores indicate a greater risk related to inadequate or unsafe self-medication practices.
2 secondary outcomes
Health-related quality of life (Kidscreen-27)
Time frame: Data will be collected at baseline and again 6-9 months after the intervention.
Problem-focused coping styles (COPE-28)
Time frame: Data will be collected at baseline and again 6-9 months after the intervention.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Feb 2026.
- BackgroundRamírez Puerta, D., Larrubia Muñoz, O., Escortell Mayor, E., & Martínez Martínez, R. (2006). La automedicación responsable, la publicidad farmacéutica y su marco en la Atención Primaria. SEMERGEN, Soc. Esp. Med. Rural Gen. (Ed. impr.), 117-124.
- BackgroundMorán, C., Landero, R., & González, M. T. (2010). COPE-28: un análisis psicométrico de la versión en español del Brief COPE. Universitas Psychologica, 9(2), 543-552.
- BackgroundKidscreen Group (2004). Estudio europeo de salud y bienestar de niños/as y adolescentes. Cuestionario para chicos y chicas de 8 a 18 años. https://www.kidscreen.org/english/questionnaires/kidscreen-27/
- Background: PubMed 39082543Barreto MAF, Negreiros FDDS, Cestari VRF, Sampaio HAC, Moreira TMM. Evidence of validity of the Risk Self-Medication Questionnaire focused on Health Literacy. Rev Bras Enferm. 2024 Jul 29;77(3):e20230386. doi: 10.1590/0034-7167-2023-0386. eCollection 2024.
- Background: PubMed 36211626Baracaldo-Santamaria D, Trujillo-Moreno MJ, Perez-Acosta AM, Feliciano-Alfonso JE, Calderon-Ospina CA, Soler F. Definition of self-medication: a scoping review. Ther Adv Drug Saf. 2022 Oct 5;13:20420986221127501. doi: 10.1177/20420986221127501. eCollection 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
María Correa-Rodríguez, PhD principal investigator
Universidad de Granada
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Educational intervention in people with Self Medication, run by Universidad de Granada at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 11 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact María Correa-Rodríguez, PhD (+34958243494, macoro@ugr.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Risk Self-Medication Questionnaire focused on Health Literacy (QAR-LS) (time frame: Data will be collected at baseline and again 6-9 months after the intervention.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07389538, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Feb 2026.