Traumatic Brain InjuriesTidal-TBINCT07507357
Tidal Model Nursing for TBI Caregivers
A study testing Tidal Model Based Nursing in people with Traumatic Brain Injuries and Caregivers, run by Gaziler Physical Medicine and Rehabilitation Education and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
Brain injury is a broad concept that may develop as a result of head trauma or surgical interventions, vascular injuries (such as subarachnoid hemorrhage or stroke), metabolic or toxic causes, cerebral anoxia, inflammation, or infection. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Traumatic Brain Injuries, Caregivers, Psychological Distress
- What is being tested?
- Tidal Model Based Nursing
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Aug 2025to 10 Mar 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Providing care for an individual diagnosed with Traumatic Brain Injury (TBI). Being between the ages of 18 and 65. Having provided care for the patient for at least 3 months. Volunteering and providing informed consent to participate in the study. Being proficient in speaking and understanding Turkish. Having no cognitive or physical impairments that would hinder effective communication.
Who cannot join
- Being under the age of 18 or over the age of 65. Having provided care for less than 3 months. Being illiterate or unable to read and write. Providing care for an individual with a diagnosis other than Traumatic Brain Injury (TBI).
- Unwillingness to participate in the study or refusal to provide informed consent.
- Failure to fully complete the required study forms and measurement scales.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Gaziler Physical Medicine and Rehabilitation Training and Research Hospital
Ankara, ÇANKAYA
About this study
Official title: Effectiveness of a Tidal Model-Based Nursing Approach for Caregivers of Individuals With Traumatic Brain Injury
Brain injury is a broad concept that may develop as a result of head trauma or surgical interventions, vascular injuries (such as subarachnoid hemorrhage or stroke), metabolic or toxic causes, cerebral anoxia, inflammation, or infection. A meta-analysis conducted between 1990 and 2016 reported an annual incidence of 43.6 million cases of brain injury worldwide. According to data published by the Turkish Statistical Institute in the same year, 24.3% of deaths in Türkiye were attributed to cerebrovascular events. Although advances in emergency medical services and palliative care have increased survival rates, a substantial proportion of survivors experience significant physical, cognitive, emotional, behavioral, and social disabilities. Consequently, these individuals often require supervision, support, and care from caregivers for the remainder of their lives. Caregivers in this population are typically family members who receive no financial compensation and are primarily responsible for providing social, mental, and physical care.
Studies examining caregivers have identified numerous physical, psychological, emotional, social, and economic challenges associated with caregiving. Research indicates that prolonged caregiving is associated with increased levels of anxiety, depression, deterioration in physical health, social isolation, burnout, and related conditions.
Read more
Mental health nurses, who play a critical role as healthcare professionals, adopt a holistic approach by evaluating individuals together with their families and caregivers throughout the care process. In this context, they implement various interventions that support treatment and rehabilitation. It is essential that these interventions also encompass caregivers and are grounded in evidence-based and collaborative practices.
According to Pektekin (2013), within the framework of the Tidal Model developed by psychiatric nursing theorists Phil Barker and Poppy Buchanan-Barker, emphasis is placed on individuals' lived experiences and the meanings they attribute to these experiences. This perspective, with its strong focus on individuality, is considered to facilitate a comprehensive evaluation of the person in all dimensions.
In light of this information, the aim of this study is to examine the effect of a Tidal Model-based nursing approach on the levels of anxiety, depression, and burnout among caregivers of individuals diagnosed with traumatic brain injury.
Read the detailed description
Aim of the Study (Primary and Secondary Objectives): Brain injury is a broad condition that may result from head trauma or surgical interventions, vascular injuries (such as subarachnoid hemorrhage or stroke), metabolic or toxic causes, cerebral anoxia, inflammation, or infection (Turner-Stokes, 2015). Meta-analyses conducted between 1990 and 2016 have estimated an annual incidence of 43.6 million new cases of brain injury worldwide (GBD, 2016).
Among the causes of traumatic brain injury (TBI), motor vehicle accidents rank first, accounting for approximately 50% of cases (Thurman et al., 1999), followed by falls, which constitute 20-30% of cases (Karpuz, 2019). The risk of TBI is highest among individuals aged 15-24 years, decreases in middle adulthood, and rises again after the age of 70 (Thurman et al., 1999). According to the Turkish Statistical Institute (2019), 24.3% of deaths in Türkiye are attributed to cerebrovascular diseases.
Head injuries are life-threatening conditions that can lead to long-term disability and require prolonged treatment and care, ranking fourth among the leading causes of death. Although advances in emergency care and palliative services have increased survival rates, many survivors experience significant physical, cognitive, emotional, behavioral, and social disabilities. As a result, these individuals often require continuous supervision, support, and care for the remainder of their lives.
Caregivers of individuals with TBI are typically unpaid individuals-most often family members-who are primarily responsible for providing physical, psychological, and social care (Çetinkaya \& Dönmez, 2023). Caregiving is defined as all activities performed attentively and respectfully to help individuals meet their basic needs, maintain and develop their abilities, and live with minimal suffering while sustaining a functional life (Engster, 2005).
Research has demonstrated that caregivers experience numerous physical, psychological, emotional, social, and economic challenges (Karahan \& İslam, 2013). Long-term caregiving has been associated with increased anxiety, depression, deterioration in physical health, social isolation, and burnout (Sarı, 2007; Dökmen, 2012).
Within healthcare systems, nurses play a crucial role as frontline professionals who maintain continuous contact with patients and caregivers. Structuring care within theoretical frameworks and models is essential for ensuring a systematic and holistic approach (Dökmen, 2012). Mental health nurses, in particular, implement evidence-based, collaborative, recovery-oriented, and holistic interventions that support both patients and caregivers throughout treatment and rehabilitation processes (Barker, 2001a).
The importance of focusing on individuals' strengths in improving mental health has been emphasized (Xie, 2013). Similarly, the Tidal Model developed by Phil Barker and Poppy Buchanan-Barker highlights individuals' lived experiences and the meanings they attribute to these experiences (Pektekin, 2013; Barker \& Buchanan-Barker, 2005). This model's emphasis on individuality enables comprehensive evaluation of individuals in all dimensions.
Within the context of this study, the challenges experienced by caregivers of individuals with TBI can be conceptualized through the Tidal Model: the chaos and instability they experience correspond to the "tides," their interpretation of caregiving reflects the inevitability of change, and the coping strategies they develop resemble "building a boat." Based on the model's philosophy of helping individuals facing life difficulties, it is considered appropriate for use with this population.
Accordingly, the primary aim of this doctoral study is to examine the effect of a Tidal Model-based nursing intervention on the levels of anxiety, depression, and burnout among caregivers of individuals with traumatic brain injury.
Expected Benefits and Risks: This study is expected to contribute to a comprehensive evaluation of caregivers by emphasizing their lived experiences and individuality, as proposed by the Tidal Model. The use of a randomized, pretest-posttest controlled experimental design combined with mixed methods (document analysis and discourse analysis) will enable a robust, evidence-based evaluation of the intervention's effectiveness.
The study is also anticipated to improve caregivers' coping skills related to psychological challenges and provide healthcare professionals with a novel perspective on caregiver support. Strengthening caregivers' mental well-being may also positively influence patient outcomes. Furthermore, the study is expected to contribute to the academic field by supporting the use of the Tidal Model in rehabilitation nursing and holistic care practices.
No risks are anticipated in this study. Type, Scope, and Design of the Study: This study will employ a randomized, pretest-posttest controlled experimental design alongside mixed methods, including document analysis and discourse analysis.
The sample will consist of individuals who meet the inclusion criteria and voluntarily agree to participate. Sample size was determined using G*Power analysis. Based on reference values from Yıldırım et al. (2024) (Beck Anxiety Scale scores: 25.67±7.98 and 16.22±6.78), with an effect size of 1.27, power of 80%, and alpha level of 0.05, the required sample size was calculated as 18 participants (9 experimental, 9 control).
Participants (Sample Characteristics and Selection Criteria):
The study sample will consist of male and female caregivers aged 18-65 years who provide care for individuals with TBI receiving treatment at the Acute Rehabilitation Clinic of Ankara Gaziler Physical Therapy and Rehabilitation Training and Research Hospital.
Inclusion, Exclusion, and Withdrawal Criteria
Inclusion criteria:
Providing care for an individual diagnosed with TBI Aged between 18 and 65 years Providing care for at least 3 months Ability to understand and speak Turkish No communication impairments Voluntary participation
Exclusion criteria:
Under 18 or over 65 years of age Providing care for less than 3 months Illiteracy Caring for individuals without TBI diagnosis willingness to participate Incomplete completion of study forms
Withdrawal criteria:
Voluntary withdrawal from the study Incomplete data collection forms Outcome Measures and Data Collection Tools
Participants will complete:
Informed Consent Form Sociodemographic Data Form Beck Anxiety Inventory (BAI) Beck Depression Inventory (BDI) Maslach Burnout Inventory (MBI) Pretests will be conducted during the first session, and posttests will be conducted during the final session.
Intervention Procedure
The intervention group will receive eight face-to-face sessions based on the Tidal Model (twice weekly, 45 minutes each, for four weeks). The sessions will include:
Orientation Acute care phase Developmental care phase Transitional care phase Semi-structured interviews will be conducted following the intervention. The control group will receive no intervention but will complete pretest and posttest assessments at equivalent time intervals.
Statistical Analysis:
Data will be analyzed using SPSS 24.0. Normality will be assessed using Kolmogorov-Smirnov and Shapiro-Wilk tests.
Parametric tests: Independent samples t-test, paired samples t-test Non-parametric tests: Mann-Whitney U test, Wilcoxon signed-rank test Correlation: Spearman correlation analysis Reliability: Cronbach's alpha Qualitative data will be analyzed using MAXQDA. The level of statistical significance will be set at p < 0.05.
- Conditions
- Traumatic Brain Injuries, Caregivers, Psychological Distress
- Being tested
- Tidal Model Based Nursing
- Keywords
- traumatic brain injuries, nursing, tidal model, Caregivers, nursing care
- Medical subject headings
- Brain Injuries, Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tidal Model Based NursingBehavioural
A nursing intervention structured around the 10 commitments of the Tidal Model, focusing on the caregiver's personal story, empowerment, and psychosocial support.
| Study group | Role | What they receive |
|---|---|---|
| Experimental Group: Tidal Model Approach | Experimental | Caregivers in this group will receive a nursing intervention based on the 10 commitments of the Tidal Model to support their psychosocial well-being. Receives: Behavioral: Tidal Model Based Nursing |
| Control Group: Standard Care | No intervention | Caregivers in this group will receive routine standard nursing care and follow-up without any specific model-based intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Maslach Burnout Inventory (MBI) Scores
The Maslach Burnout Inventory (MBI) will be used to assess the level of burnout among caregivers. The scale consists of 22 items categorized into three subscales: Emotional Exhaustion, Depersonalization, and Personal Accomplishment. Each item is rated on a 7-point Likert scale (0-6). For Emotional Exhaustion and Depersonalization, higher scores indicate a higher level of burnout. For Personal Accomplishment, lower scores indicate a higher level of burnout.
Measured: Baseline (Pre-intervention) and 4 weeks after the intervention (Post-intervention).
Secondary outcomes (2)
Change in Beck Anxiety Inventory (BAI) Scores
Measured using the Beck Anxiety Inventory (BAI). The scale consists of 21 items. Total scores range from 0 to 63, where higher scores indicate more severe anxiety symptoms.
Measured: Baseline (Pre-intervention) and 4 weeks after the intervention (Post-intervention).
Change in Beck Depression Inventory (BDI) Scores
Measured using the Beck Depression Inventory (BDI). The scale consists of 21 items. Total scores range from 0 to 63, where higher scores indicate greater severity of depression.
Measured: Baseline (Pre-intervention) and 8 weeks after the intervention (Post-intervention).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2026
- Study start1 Aug 2025
- Primary completion10 Mar 2026
- Study completion10 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (17)Papers the sponsor has linked to this study.
- Other trials for Traumatic Brain InjuriesStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be divided into two groups using \[Randomization Method\]. The experimental group will receive nursing interventions based on the 10 commitments of the Tidal Model, while the control group will continue with routine care/follow-up
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gaziler Physical Medicine and Rehabilitation Education and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yasin Demir, Gaziler Physical Medicine and Rehabilitation Education and Research Hospital
- Investigators
- BİRGÜL ÖZKAN, PhD, Study director, Department of Nursing, Faculty of Health Sciences, Ankara Yildirim Beyazit University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07507357
- Sponsor's protocol ID
- 17.04.2025-04/1229
- Acronym
- Tidal-TBI
- Status last verified
- Mar 2026
- First submitted
- 27 Mar 2026
- Last updated
- 2 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Turkish Statistical Institute. (2019, Mayıs). Mortality statistics. http://www.tuik.gov.tr/PreHaberBultenleri.do?id=21526
Yıldırım ve ark. Çözüm Odaklı Kısa Süreli Grupla Psikolojik Danışmanın Parçalanmış Aileye Sahip Ergenlerin Kaygı ve Umutsuzluk Düzeyleri Üzerindeki Etkisi. Humanistic Perspective 6.2 (2024).
Ergin, C. (1992). Doktor ve hemşirelerde tükenmişlik ve Maslach Tükenmişlik Ölçeği' nin uyarlanması. VII. Ulusal Psikoloji Kongresi Bilimsel Çalışmaları, Ankara; Türk Psikologlar Derneği Yayınları.
Maslach, C., & Jackson, S. E. (1986). Maslach Burnout Inventorymanual. Consulting Psychologists Press.
Hisli N. Beck depresyon envanterinin üniversite öğrencileri için geçerliliği, güvenilirliği. Psikoloji Dergisi. 1989;7(23): 8-13.
BECK AT, WARD CH, MENDELSON M, MOCK J, ERBAUGH J. An inventory for measuring depression. Arch Gen Psychiatry. 1961 Jun;4:561-71. doi: 10.1001/archpsyc.1961.01710120031004. No abstract available.
PubMed 13688369Barker, P., & Buchanan-Barker, P. (2005). The Tidal Model: A guide for mental health professionals. Routledge.
Barker P. The Tidal Model: developing an empowering, person-centred approach to recovery within psychiatric and mental health nursing. J Psychiatr Ment Health Nurs. 2001 Jun;8(3):233-40. doi: 10.1046/j.1365-2850.2001.00391.x.
PubMed 11882132Dökmen, Z. Y. (2012). Yakınlarına bakım verenlerin ruh sağlıkları ile sosyal destek algıları arasındaki ilişkiler. Ankara Üniversitesi Sosyal Bilimler Enstitüsü Dergisi, 3(1), 3-38.
Sarı, H. Y. (2007). Zihinsel engelli çocuğu olan ailelerde aile yüklenmesi. C.Ü. Hemşirelik Yüksekokulu Dergisi, 11(2), 1-7.
Karahan, A. Y., & İslam, S. (2013). Fiziksel engelli çocuk ve yaşlı hastalara bakım verme yükü üzerine bir karşılaştırma çalışması. Clinical and Experimental Health Sciences, 3(5).
Engster D. Rethinking Care Theory: The practice of caring and the obligation to care. Hypatia 2005; 20 (3): 50-74.
Çetinkaya, N., & Dönmez, E. (2023). İnmeli hastalara bakım verenlerde bakım yükü, anksiyete ve depresyon düzeyinin incelenmesi. Sağlık Akademisyenleri Dergisi, 10(1), 49-59.
Karpuz, S. (2019). Travmatik beyin hasarı rehabilitasyonu. Aegean Journal of Medical Sciences, 3(3), 161-167.
Thurman DJ, Alverson C, Dunn KA, Guerrero J, Sniezek JE. Traumatic brain injury in the United States: A public health perspective. J Head Trauma Rehabil. 1999 Dec;14(6):602-15. doi: 10.1097/00001199-199912000-00009.
PubMed 10671706
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of a Tidal Model-Based Nursing Approach for Caregivers of Individuals With Traumatic Brain Injury
- ClinicalTrials.gov ID
- NCT07507357
- Acronym / sponsor ID
- Tidal-TBI / 17.04.2025-04/1229
- Conditions
- Traumatic Brain Injuries, Caregivers, Psychological Distress
- Keywords
- traumatic brain injuries, nursing, tidal model, Caregivers, nursing care
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Gaziler Physical Medicine and Rehabilitation Education and Research HospitalUniversity, hospital or other
- Study start
- 1 Aug 2025 (actual)
- Primary completion
- 10 Mar 2026 (actual)
- Study completion
- 10 Mar 2026 (actual)
- First posted
- 2 Apr 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.
Brain injury is a broad concept that may develop as a result of head trauma or surgical interventions, vascular injuries (such as subarachnoid hemorrhage or stroke), metabolic or toxic causes, cerebral anoxia, inflammation, or infection. A meta-analysis conducted between 1990 and 2016 reported an annual incidence of 43.6 million cases of brain injury worldwide. According to data published by the Turkish Statistical Institute in the same year, 24.3% of deaths in Türkiye were attributed to cerebrovascular events. Although advances in emergency medical services and palliative care have increased survival rates, a substantial proportion of survivors experience significant physical, cognitive, emotional, behavioral, and social disabilities. Consequently, these individuals often require supervision, support, and care from caregivers for the remainder of their lives. Caregivers in this population are typically family members who receive no financial compensation and are primarily responsible for providing social, mental, and physical care.
Studies examining caregivers have identified numerous physical, psychological, emotional, social, and economic challenges associated with caregiving. Research indicates that prolonged caregiving is associated with increased levels of anxiety, depression, deterioration in physical health, social isolation, burnout, and related conditions.
Mental health nurses, who play a critical role as healthcare professionals, adopt a holistic approach by evaluating individuals together with their families and caregivers throughout the care process. In this context, they implement various interventions that support treatment and rehabilitation. It is essential that these interventions also encompass caregivers and are grounded in evidence-based and collaborative practices.
According to Pektekin (2013), within the framework of the Tidal Model developed by psychiatric nursing theorists Phil Barker and Poppy Buchanan-Barker, emphasis is placed on individuals' lived experiences and the meanings they attribute to these experiences. This perspective, with its strong focus on individuality, is considered to facilitate a comprehensive evaluation of the person in all dimensions.
In light of this information, the aim of this study is to examine the effect of a Tidal Model-based nursing approach on the levels of anxiety, depression, and burnout among caregivers of individuals diagnosed with traumatic brain injury.
Detailed description
Aim of the Study (Primary and Secondary Objectives): Brain injury is a broad condition that may result from head trauma or surgical interventions, vascular injuries (such as subarachnoid hemorrhage or stroke), metabolic or toxic causes, cerebral anoxia, inflammation, or infection (Turner-Stokes, 2015). Meta-analyses conducted between 1990 and 2016 have estimated an annual incidence of 43.6 million new cases of brain injury worldwide (GBD, 2016).
Among the causes of traumatic brain injury (TBI), motor vehicle accidents rank first, accounting for approximately 50% of cases (Thurman et al., 1999), followed by falls, which constitute 20-30% of cases (Karpuz, 2019). The risk of TBI is highest among individuals aged 15-24 years, decreases in middle adulthood, and rises again after the age of 70 (Thurman et al., 1999). According to the Turkish Statistical Institute (2019), 24.3% of deaths in Türkiye are attributed to cerebrovascular diseases.
Head injuries are life-threatening conditions that can lead to long-term disability and require prolonged treatment and care, ranking fourth among the leading causes of death. Although advances in emergency care and palliative services have increased survival rates, many survivors experience significant physical, cognitive, emotional, behavioral, and social disabilities. As a result, these individuals often require continuous supervision, support, and care for the remainder of their lives.
Caregivers of individuals with TBI are typically unpaid individuals-most often family members-who are primarily responsible for providing physical, psychological, and social care (Çetinkaya \& Dönmez, 2023). Caregiving is defined as all activities performed attentively and respectfully to help individuals meet their basic needs, maintain and develop their abilities, and live with minimal suffering while sustaining a functional life (Engster, 2005).
Research has demonstrated that caregivers experience numerous physical, psychological, emotional, social, and economic challenges (Karahan \& İslam, 2013). Long-term caregiving has been associated with increased anxiety, depression, deterioration in physical health, social isolation, and burnout (Sarı, 2007; Dökmen, 2012).
Within healthcare systems, nurses play a crucial role as frontline professionals who maintain continuous contact with patients and caregivers. Structuring care within theoretical frameworks and models is essential for ensuring a systematic and holistic approach (Dökmen, 2012). Mental health nurses, in particular, implement evidence-based, collaborative, recovery-oriented, and holistic interventions that support both patients and caregivers throughout treatment and rehabilitation processes (Barker, 2001a).
The importance of focusing on individuals' strengths in improving mental health has been emphasized (Xie, 2013). Similarly, the Tidal Model developed by Phil Barker and Poppy Buchanan-Barker highlights individuals' lived experiences and the meanings they attribute to these experiences (Pektekin, 2013; Barker \& Buchanan-Barker, 2005). This model's emphasis on individuality enables comprehensive evaluation of individuals in all dimensions.
Within the context of this study, the challenges experienced by caregivers of individuals with TBI can be conceptualized through the Tidal Model: the chaos and instability they experience correspond to the "tides," their interpretation of caregiving reflects the inevitability of change, and the coping strategies they develop resemble "building a boat." Based on the model's philosophy of helping individuals facing life difficulties, it is considered appropriate for use with this population.
Accordingly, the primary aim of this doctoral study is to examine the effect of a Tidal Model-based nursing intervention on the levels of anxiety, depression, and burnout among caregivers of individuals with traumatic brain injury.
Expected Benefits and Risks: This study is expected to contribute to a comprehensive evaluation of caregivers by emphasizing their lived experiences and individuality, as proposed by the Tidal Model. The use of a randomized, pretest-posttest controlled experimental design combined with mixed methods (document analysis and discourse analysis) will enable a robust, evidence-based evaluation of the intervention's effectiveness.
The study is also anticipated to improve caregivers' coping skills related to psychological challenges and provide healthcare professionals with a novel perspective on caregiver support. Strengthening caregivers' mental well-being may also positively influence patient outcomes. Furthermore, the study is expected to contribute to the academic field by supporting the use of the Tidal Model in rehabilitation nursing and holistic care practices.
No risks are anticipated in this study. Type, Scope, and Design of the Study: This study will employ a randomized, pretest-posttest controlled experimental design alongside mixed methods, including document analysis and discourse analysis.
The sample will consist of individuals who meet the inclusion criteria and voluntarily agree to participate. Sample size was determined using G*Power analysis. Based on reference values from Yıldırım et al. (2024) (Beck Anxiety Scale scores: 25.67±7.98 and 16.22±6.78), with an effect size of 1.27, power of 80%, and alpha level of 0.05, the required sample size was calculated as 18 participants (9 experimental, 9 control).
Participants (Sample Characteristics and Selection Criteria):
The study sample will consist of male and female caregivers aged 18-65 years who provide care for individuals with TBI receiving treatment at the Acute Rehabilitation Clinic of Ankara Gaziler Physical Therapy and Rehabilitation Training and Research Hospital.
Inclusion, Exclusion, and Withdrawal Criteria
Inclusion criteria:
Providing care for an individual diagnosed with TBI Aged between 18 and 65 years Providing care for at least 3 months Ability to understand and speak Turkish No communication impairments Voluntary participation
Exclusion criteria:
Under 18 or over 65 years of age Providing care for less than 3 months Illiteracy Caring for individuals without TBI diagnosis willingness to participate Incomplete completion of study forms
Withdrawal criteria:
Voluntary withdrawal from the study Incomplete data collection forms Outcome Measures and Data Collection Tools
Participants will complete:
Informed Consent Form Sociodemographic Data Form Beck Anxiety Inventory (BAI) Beck Depression Inventory (BDI) Maslach Burnout Inventory (MBI) Pretests will be conducted during the first session, and posttests will be conducted during the final session.
Intervention Procedure
The intervention group will receive eight face-to-face sessions based on the Tidal Model (twice weekly, 45 minutes each, for four weeks). The sessions will include:
Orientation Acute care phase Developmental care phase Transitional care phase Semi-structured interviews will be conducted following the intervention. The control group will receive no intervention but will complete pretest and posttest assessments at equivalent time intervals.
Statistical Analysis:
Data will be analyzed using SPSS 24.0. Normality will be assessed using Kolmogorov-Smirnov and Shapiro-Wilk tests.
Parametric tests: Independent samples t-test, paired samples t-test Non-parametric tests: Mann-Whitney U test, Wilcoxon signed-rank test Correlation: Spearman correlation analysis Reliability: Cronbach's alpha Qualitative data will be analyzed using MAXQDA. The level of statistical significance will be set at p < 0.05.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Participants will be divided into two groups using [Randomization Method]. The experimental group will receive nursing interventions based on the 10 commitments of the Tidal Model, while the control group will continue with routine care/follow-up
| Arm | Type | Receives |
|---|---|---|
| Experimental Group: Tidal Model Approach | Experimental | Behavioral: Tidal Model Based NursingCaregivers in this group will receive a nursing intervention based on the 10 commitments of the Tidal Model to support their psychosocial well-being. |
| Control Group: Standard Care | No intervention | –Caregivers in this group will receive routine standard nursing care and follow-up without any specific model-based intervention. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Providing care for an individual diagnosed with Traumatic Brain Injury (TBI). Being between the ages of 18 and 65. Having provided care for the patient for at least 3 months. Volunteering and providing informed consent to participate in the study. Being proficient in speaking and understanding Turkish. Having no cognitive or physical impairments that would hinder effective communication.
Key exclusion criteria (3 listed)
- Being under the age of 18 or over the age of 65. Having provided care for less than 3 months. Being illiterate or unable to read and write. Providing care for an individual with a diagnosis other than Traumatic Brain Injury (TBI).
- Unwillingness to participate in the study or refusal to provide informed consent.
- Failure to fully complete the required study forms and measurement scales.
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 |
|---|---|---|
| Tidal Model Based NursingA nursing intervention structured around the 10 commitments of the Tidal Model, focusing on the caregiver's personal story, empowerment, and psychosocial support. | Behavioural | Experimental Group: Tidal Model Approach |
Primary outcome
Change in Maslach Burnout Inventory (MBI) Scores
Time frame: Baseline (Pre-intervention) and 4 weeks after the intervention (Post-intervention).
The Maslach Burnout Inventory (MBI) will be used to assess the level of burnout among caregivers. The scale consists of 22 items categorized into three subscales: Emotional Exhaustion, Depersonalization, and Personal Accomplishment. Each item is rated on a 7-point Likert scale (0-6). For Emotional Exhaustion and Depersonalization, higher scores indicate a higher level of burnout. For Personal Accomplishment, lower scores indicate a higher level of burnout.
2 secondary outcomes
Change in Beck Anxiety Inventory (BAI) Scores
Time frame: Baseline (Pre-intervention) and 4 weeks after the intervention (Post-intervention).
Change in Beck Depression Inventory (BDI) Scores
Time frame: Baseline (Pre-intervention) and 8 weeks after the intervention (Post-intervention).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Apr 2026.
- BackgroundTurkish Statistical Institute. (2019, Mayıs). Mortality statistics. http://www.tuik.gov.tr/PreHaberBultenleri.do?id=21526
- BackgroundYıldırım ve ark. Çözüm Odaklı Kısa Süreli Grupla Psikolojik Danışmanın Parçalanmış Aileye Sahip Ergenlerin Kaygı ve Umutsuzluk Düzeyleri Üzerindeki Etkisi. Humanistic Perspective 6.2 (2024).
- BackgroundErgin, C. (1992). Doktor ve hemşirelerde tükenmişlik ve Maslach Tükenmişlik Ölçeği' nin uyarlanması. VII. Ulusal Psikoloji Kongresi Bilimsel Çalışmaları, Ankara; Türk Psikologlar Derneği Yayınları.
- BackgroundMaslach, C., & Jackson, S. E. (1986). Maslach Burnout Inventorymanual. Consulting Psychologists Press.
- BackgroundHisli N. Beck depresyon envanterinin üniversite öğrencileri için geçerliliği, güvenilirliği. Psikoloji Dergisi. 1989;7(23): 8-13.
- Background: PubMed 13688369BECK AT, WARD CH, MENDELSON M, MOCK J, ERBAUGH J. An inventory for measuring depression. Arch Gen Psychiatry. 1961 Jun;4:561-71. doi: 10.1001/archpsyc.1961.01710120031004. No abstract available.
- BackgroundBarker, P., & Buchanan-Barker, P. (2005). The Tidal Model: A guide for mental health professionals. Routledge.
- Background: PubMed 11882132Barker P. The Tidal Model: developing an empowering, person-centred approach to recovery within psychiatric and mental health nursing. J Psychiatr Ment Health Nurs. 2001 Jun;8(3):233-40. doi: 10.1046/j.1365-2850.2001.00391.x.
- BackgroundDökmen, Z. Y. (2012). Yakınlarına bakım verenlerin ruh sağlıkları ile sosyal destek algıları arasındaki ilişkiler. Ankara Üniversitesi Sosyal Bilimler Enstitüsü Dergisi, 3(1), 3-38.
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- BackgroundKarahan, A. Y., & İslam, S. (2013). Fiziksel engelli çocuk ve yaşlı hastalara bakım verme yükü üzerine bir karşılaştırma çalışması. Clinical and Experimental Health Sciences, 3(5).
- BackgroundEngster D. Rethinking Care Theory: The practice of caring and the obligation to care. Hypatia 2005; 20 (3): 50-74.
- 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. This study is not recruiting at the moment.
BİRGÜL ÖZKAN, PhD study director
Department of Nursing, Faculty of Health Sciences, Ankara Yildirim Beyazit University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tidal Model Based Nursing in people with Traumatic Brain Injuries and Caregivers, run by Gaziler Physical Medicine and Rehabilitation Education and Research Hospital 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 1 inclusion and 3 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: finished, as of the sponsor's last update on 2 Apr 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 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Change in Maslach Burnout Inventory (MBI) Scores (time frame: Baseline (Pre-intervention) and 4 weeks after the intervention (Post-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 NCT07507357, which also lists 17 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 2 Apr 2026.