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Supportive CareNCT06767826

The Effect of Care Based on the Salutogenesis Model

A study testing Salutogenesis Models in people with Supportive Care, run by TC Erciyes University at 1 site in Turkey (Türkiye).

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

On the basis of the Salutogenesis Model, this study is based on the development of individuals' internal and external resources for game addictions and strengthening their sense of integrity. Read more about this study

Who is it for?
Ages 15 to 18 yearsHealthy volunteers can take part
Conditions the study is for
Supportive Care
What is being tested?
Salutogenesis Models
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
1 siteTurkey (Türkiye)
Study dates
1 Apr 2024to 1 Jul 2025
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 18 years
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult

Who may be able to join

  • Having education at high school level,
  • Volunteer to participate in the study,
  • Having received at least 13 to 35 points from the digital game addiction scale using the polythetic method,
  • Having no history of psychiatric illness in his/her CV,
  • Does not have aphasia or any other problem that may prevent communication, students will be included in the research.

Who cannot join

  • Previously participated in a care program based on the salutogenesis model,
  • Students with a digital game addiction scale score below 13 points will not be included in the study.

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site
  • Eda Albayrak Günday

    Kayseri

Other trials in Turkey (Türkiye)

About this study

Official title: The Effect of Care Based on the Salutogenesis Model on Coping With Stress and the Sense of Integrity in Preventing Digital Game Addiction in Adolescents

On the basis of the Salutogenesis Model, this study is based on the development of individuals' internal and external resources for game addictions and strengthening their sense of integrity. It has been determined that digital game addiction and problematic internet use in adolescents form the basis of seven problems. These problems have been identified as mental health, vision, pain, sleep and rest patterns, nutrition, social contact and physical activity. Encouraging behavioral changes regarding internet use and teaching adolescents how to deal with these problems becomes a necessity in today's technology. In the literature, counseling has been provided for families and adolescents to prevent digital game addiction in adolescents. Care based on the salutogenesis model has never been studied in the world, but in Turkey, Uzdil et al. used the model in patient care by adapting it to care. Additionally, studies have suggested designing school-based intervention programs to prevent and reduce digital game addiction. In this context, the aim of the study is to improve coping with stress and eliminate digital game addiction by strengthening the sense of integrity of Care Based on the Salutogenesis Model in Preventing Digital Game Addiction in Adolescents.

Read the detailed description

The internet, which is the most indispensable technology of today, appeals to the needs of all age groups, as well as highlighting individuality, being easily accessible almost always, giving a feeling of superiority and achievement, and being able to be played without being tied to a physical location. With its features, it constantly attracts the attention of adolescents and causes them to actively use the internet. Problems associated with high levels of gaming and internet use are increasingly recognized as a potential public health burden across the developed world. Digital game addiction is considered a mental health problem by the World Health Organization (2018) and the American Psychiatric Association, and the fact that adolescence is full of excitement, anxiety and stressors for adolescents makes them an important risk group in digital game addiction. It is seen in international studies that this risk among adolescent individuals is up to 17%. In the study conducted by Ay on 865 adolescents in our country, this rate was found to be 28.8%, which is a remarkable finding. Other studies support these rates and reveal that digital game addiction is high in adolescents. In addition, in a study conducted in our country during the pandemic period, when digital game playing times before the pandemic and during the pandemic were compared; It was determined that this period increased significantly during the pandemic process.

Since adolescence constitutes the bond between childhood and adulthood, the individual in this period where some changes occur in cognitive, physical, psychological and social terms brought about by the transition period; They face many stressors such as family relationships, friendship relationships, characteristics of the developmental period, society's expectations, and anxiety about passing the university exam. Adolescents; It has been reported that in order to cope with these stressors or escape from stress, there may be behavior of escaping from the real world and turning to the virtual world, and it may evolve into addiction as a result of increased gaming behavior due to a sustaining stress factor such as a negative parental attitude. Looking at international and national research, it is seen that adolescents with high stress levels have high levels of digital game addiction.

One of the models based on stress management is the Salutogenesis Model. Antonovsky introduced the sense of cohesion as a salutogenic concept to explain how and why people can cope with stress better. The model argues that the individual's ability to successfully manage many stressors is achieved through the development of a sense of integrity. Sense of integrity; It explains the individual's ability to cope with tension, use internal and external resources to solve his problems in a healthy way, and the individual's general stance towards problems. A low sense of integrity indicates that the person cannot cope with stressful situations and does not use appropriate coping strategies. In this context, it is noteworthy that there are no studies examining the sense of integrity of adolescents who are in a stressful developmental period and aiming to increase the sense of integrity.

The concept of a sense of wholeness as a result of the developmental process during adolescence indicates that the concept is viewed primarily as a result of individual life experiences, learning processes, and environmental influences, rather than as a primary source and determinant of positive health. As they grow and convey positive coping experiences, adolescents develop a general sense of intelligibility and manageability of demands and a sense of meaningfulness about life as it is and overcoming challenges. From this perspective, adolescence is seen as vital life stages that are crucial for the development of a sense of personal harmony and individual health biography.

On the basis of the Salutogenesis Model, this study is based on the development of individuals' internal and external resources for game addictions and strengthening their sense of integrity. It has been determined that digital game addiction and problematic internet use in adolescents form the basis of seven problems. These problems have been identified as mental health, vision, pain, sleep and rest patterns, nutrition, social contact and physical activity. Encouraging behavioral changes regarding internet use and teaching adolescents how to deal with these problems becomes a necessity in today's technology. In the literature, counseling has been provided for families and adolescents to prevent digital game addiction in adolescents. Care based on the salutogenesis model has never been studied in the world, but in Turkey, Uzdil et al. used the model in patient care by adapting it to care. Additionally, studies have suggested designing school-based intervention programs to prevent and reduce digital game addiction. In this context, the aim of the study is to improve coping with stress and eliminate digital game addiction by strengthening the sense of integrity of Care Based on the Salutogenesis Model in Preventing Digital Game Addiction in Adolescents.

Conditions
Supportive Care
Being tested
Salutogenesis Models

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Salutogenesis ModelsBehavioural

    On the basis of the Salutogenesis Model, this study is based on the development of individuals' internal and external resources for game addictions and strengthening their sense of integrity. It has been determined that digital game addiction and problematic internet use in adolescents form the basis of seven problems. These problems have been identified as mental health, vision, pain, sleep and rest patterns, nutrition, social contact and physical activity. Encouraging behavioral changes regarding internet use and teaching adolescents how to deal with these problems becomes a necessity in today's technology. In the literature, counseling has been provided for families and adolescents to prevent digital game addiction in adolescents.

Study groups in NCT06767826
Study groupRoleWhat they receive
ExperimentExperimentalFor the pre-test data, the Introductory Information Form, DOBÖ-7, EBÇÖ and BDİ were applied to the intervention group. After the pre-test, 45-60 minute sessions will be held once a week through home visits to the adolescents in the intervention group and an 8-week individual care program specific to each individual will be applied. In this program, the sense of integrity, digital game addiction and what addiction brings to life will be addressed in the first two weeks, the needs and requirements of the adolescents will be determined and care will be provided to the adolescents in line with the salutogenesis model and the care guide adapted to digital game addiction.
Receives: Behavioral: Salutogenesis Models
ControlNo interventionThe adolescents in the control group will be introduced in the guidance room at school, explanations will be made and pre-test data will be taken. For the pre-test data, the Introductory Information Form, DOBÖ-7, EBÇÖ and BÖ will be applied to the control group. No intervention will be made to the adolescents in the control group throughout the process, their education at school will continue. If the adolescents have questions about the data forms, they will be answered. After the pre-test application, DOBÖ-7, EBÇÖ and BÖ will be applied to the adolescents again in the 3rd and 6th months. The 3rd month follow-up and 6th month follow-up measurements of the adolescents will be completed in the guidance room at school. The "handbook for preventing digital game addiction in adolescents" will be given to the control group at school after the 6th month follow-up measurement.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. stress coping skills in adolescents

    The highest score that can be obtained in active and avoidant coping styles is 12 points and in negative coping style is 9 points, while the lowest score is 0 in all subscales. The higher the score of a coping strategy, the more actively it is used.

    Measured: 3 months after the pre-test application to the intervention group (in the 1st month after the maintenance program), 6-month follow-up purposes. The adolescents' 3rd month follow-up and 6th month

Secondary outcomes (1)
  1. a sense of integrity in adolescents

    Understandability (Items 2, 6, 8, 9, 11), manageability (Items 3, 5, 10, 13), and meaningfulness (Items 1, 4, 7, 12). Items 1, 2, 3, 7, and 10 of these items should be reversed. The scale items are Likert-type, scored from 1 to 7. The scale allows for a total score as well as using subscale scores. The total BDI score varies between 13 and 91. High scores obtained from the scale indicate that the person has a high sense of coherence.

    Measured: 3 months after the pre-test application to the intervention group (in the 1st month after the maintenance program), 6-month follow-up purposes. The adolescents' 3rd month follow-up and 6th month

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Jan 2025
  2. Study start1 Apr 2024
  3. Primary completion1 Mar 2025 (estimated)
  4. Study completion1 Jul 2025 (estimated)

Resources

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
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
30 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06767826
Sponsor's protocol ID
ErciyesUnı1
Status last verified
Jan 2025
First submitted
18 Jul 2024
Last updated
10 Jan 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Salutogenesis Models in people with Supportive Care, run by TC Erciyes University at 1 site in Turkey (Türkiye).

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 5 inclusion and 2 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: under way, not looking for participants, as of the sponsor's last update on 10 Jan 2025. 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 Turkey (Türkiye). 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?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

stress coping skills in adolescents (time frame: 3 months after the pre-test application to the intervention group (in the 1st month after the maintenance program), 6-month follow-up purposes. The adolescents' 3rd month follow-up and 6th month). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
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 10 Jan 2025.

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