Tidal Model Nursing for TBI Caregivers

NCT07507357 | Completed DMC

• 1 other identifier: 17.04.2025-04/1229
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Traumatic Brain Injuries; Caregivers; Psychological Distress

Keywords

traumatic brain injuries; nursing; tidal model; Caregivers; nursing care

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline (Pre-intervention) and 4 weeks after the intervention (Post-intervention).

Secondary Outcomes (2)

• Change in Beck Anxiety Inventory (BAI) Scores

  Baseline (Pre-intervention) and 4 weeks after the intervention (Post-intervention).

• Change in Beck Depression Inventory (BDI) Scores

  Baseline (Pre-intervention) and 8 weeks after the intervention (Post-intervention).

Study Arms (2)

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.

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.

Interventions

Tidal Model Based Nursing BEHAVIORAL

A nursing intervention structured around the 10 commitments of the Tidal Model, focusing on the caregiver's personal story, empowerment, and psychosocial support.

Experimental Group: Tidal Model Approach

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Gaziler Physical Medicine and Rehabilitation Education and Research Hospital: lead

Study Sites (1)

Gaziler Physical Medicine and Rehabilitation Training and Research Hospital

Ankara, ÇANKAYA, Turkey (Türkiye)

Location

Related Publications (17)

• Turkish Statistical Institute. (2019, Mayıs). Mortality statistics. http://www.tuik.gov.tr/PreHaberBultenleri.do?id=21526

  BACKGROUND

• 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).

  BACKGROUND

• Ergin, C. (1992). Doktor ve hemşirelerde tükenmişlik ve Maslach Tükenmişlik Ölçeği' nin uyarlanması. VII. Ulusal Psikoloji Kongresi Bilimsel Çalışmaları, Ankara; Türk Psikologlar Derneği Yayınları.

  BACKGROUND

• Maslach, C., & Jackson, S. E. (1986). Maslach Burnout Inventorymanual. Consulting Psychologists Press.

  BACKGROUND

• Hisli N. Beck depresyon envanterinin üniversite öğrencileri için geçerliliği, güvenilirliği. Psikoloji Dergisi. 1989;7(23): 8-13.

  BACKGROUND

• Beck AT. An inventory for measuring depression. Arch Gen Psychiatry. 1961;4(6):561-71.

  BACKGROUND

• Barker, P., & Buchanan-Barker, P. (2005). The Tidal Model: A guide for mental health professionals. Routledge.

  BACKGROUND

• Barker, P. (2001a). The Tidal Model: developing an empowering, person-centred approach to recoverywithin psychiatric and mental health nursing. Journal of Psychiatric and Mental Health Nursing, 8(3), 233-240.

  BACKGROUND

• Dökmen, Z. Y. (2012). Yakınlarına bakım verenlerin ruh sağlıkları ile sosyal destek algıları arasındaki ilişkiler. Ankara Üniversitesi Sosyal Bilimler Enstitüsü Dergisi, 3(1), 3-38.

  BACKGROUND

• Sarı, H. Y. (2007). Zihinsel engelli çocuğu olan ailelerde aile yüklenmesi. C.Ü. Hemşirelik Yüksekokulu Dergisi, 11(2), 1-7.

  BACKGROUND

• 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).

  BACKGROUND

• Engster D. Rethinking Care Theory: The practice of caring and the obligation to care. Hypatia 2005; 20 (3): 50-74.

  BACKGROUND

• Çetinkaya, N., & Dönmez, E. (2023). İnmeli hastalara bakım verenlerde bakım yükü, anksiyete ve depresyon düzeyinin incelenmesi. Sağlık Akademisyenleri Dergisi, 10(1), 49-59.

  BACKGROUND

• Karpuz, S. (2019). Travmatik beyin hasarı rehabilitasyonu. Aegean Journal of Medical Sciences, 3(3), 161-167.

  BACKGROUND

• Thurman, D. J., Alverson, C., Dunn, K. A., Guerrero, J., & Sniezek, J. E. (1999). Traumatic brain injury in the United States: A public health perspective. Journal of Head Trauma Rehabilitation, 13(5), 1-8.

  BACKGROUND

• GBD 2016 Traumatic Brain Injury and Spinal Cord Injury Collaborators. (2019). Global, regional, and national burden of traumatic brain injury and spinal cord injury, 1990-2016: a systematic analysis for the Global Burden of Disease Study 2016. The Lancet Neurology, 18(1), 56-81.

  BACKGROUND

• Turner-Stokes, L., Pick, A., Nair, A., & diğerleri. (2015). Multi-disciplinary rehabilitation for acquired brain injury in adults of working age. Cochrane Database of Systematic Reviews, 2015(1), CD004170.

  BACKGROUND

MeSH Terms

Conditions

Brain Injuries, Traumatic

Condition Hierarchy (Ancestors)

Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries

Study Officials

• BİRGÜL ÖZKAN, PhD

  Department of Nursing, Faculty of Health Sciences, Ankara Yildirim Beyazit University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The statistical analysis will be performed by a researcher who is blinded to the group assignments to prevent bias.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD Student

Model Details: 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

Study Record Dates

• First Submitted: March 27, 2026
• First Posted: April 2, 2026
• Study Start: August 1, 2025
• Primary Completion: March 10, 2026
• Study Completion: March 10, 2026
• Last Updated: April 2, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)