Clinical trial NCT07000591: Massage Based on the Human Caring Model in Epilepsy
Official title: The Effect of Massage Based on the Human Caring Model on Self-Efficacy, Symptom Management, and Caregiver Burden in Patients With Epilepsy: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Epilepsy
Keywords: Epilepsy
Human Caring Model
Self-Efficacy
Symptom Management
Lead sponsor: Muş Alparslan University
Sponsor class: OTHER
Collaborators: name: Scientific Research Projects
First posted: 2025-06-03
Enrollment: 96
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: In this clinical trial, Jean Watson's Human Caring Model will be used. The model provides a holistic and humane approach to care, addressing patients' physical, emotional, and spiritual needs. Interventions based on Watson's "Caring" approach aim to promote patient relaxation, build a sense of security, and improve quality of life. Thus, the healing effect of nursing care during the treatment process will be supported.
Primary purpose: TREATMENT

Brief summary: This randomized controlled study will be conducted with 96 epilepsy patients and their caregivers at Atatürk University Research Hospital between November 2024 and February 2026. Participants will be randomly assigned to experimental and control groups. The experimental group will receive neck massage based on Jean Watson's Human Caring Model three times a week for eight weeks. Data will be collected using various scales to evaluate self-efficacy, symptom management, and caregiver burden before and after the intervention.

Detailed description: This study will be conducted between November 15, 2024, and February 15, 2026, at Atatürk University Research Hospital in Erzurum. The population will consist of patients diagnosed with Generalized Tonic-Clonic Seizures or Focal Epilepsy. The sample size will be determined using a priori power analysis, and a total of 96 participants, including 48 patients in each group, will be included in the study along with their caregivers. Participants will be randomly assigned to the experimental and control groups using a simple randomization method via random.org. Data collection tools will include the Patient and Caregiver Information Forms, Epilepsy Self-Efficacy Scale, Zarit Caregiver Burden Scale, Epilepsy Symptom Management Scale, and Neck Massage Follow-Up Form. Patients in the experimental group will receive neck massage based on the Human Caring Model three times a week for eight weeks, for a total of 24 sessions. Participants will be informed before each massage session, and the procedures will be conducted according to a standardized protocol. Pre- and post-massage assessments will be conducted to monitor changes in symptom management, self-efficacy levels, and caregiver burden. Jean Watson's Human Caring Model will be used as the theoretical framework throughout the entire process.

Eligibility criteria: Inclusion Criteria:

* Aged between 18 and 65 years,
* Diagnosed with Generalized Tonic-Clonic Seizures or Focal Epilepsy,
* Able to speak and understand Turkish,
* Conscious and alert,
* Able to communicate verbally,
* No history of neck trauma,
* No cervical disc herniation,
* No severe headaches or migraines,
* Not diagnosed with cancer,
* No neurological and/or psychiatric disorders affecting cognitive function,
* No acute (recently developed) health issues (e.g., heart attack, fainting),
* No uncontrolled high blood pressure,
* No use of analgesic medications in the past 24 hours,
* No contraindications to massage therapy (e.g., advanced COPD, asthma, heart or kidney failure, malignant conditions, febrile illnesses, or pregnancy),
* No skin issues (rash, redness, lesions, heat increase, swelling, edema, bone abnormalities, or localized infections) in the area where massage is to be applied.

Exclusion Criteria

* Declining to continue participation in the study,
* Experiencing pain during massage application,
* Changes in the pharmacological treatment regimen,
* Failing to attend massage sessions,
* Development of undesirable effects (e.g., bruising or discoloration) in the massage area, which leads to termination of sessions.

Primary outcomes:
measure: Epilepsy Self-Efficacy Scale
timeFrame: four months
measure: Zarit Burden Interview (ZBI)
timeFrame: four months
measure: Epilepsy Symptom Management Scale
timeFrame: four months
Secondary outcomes:
Other outcomes:
Locations:
city: Erzurum
country: Turkey
facility: Atatürk University
Study officials:
References: