NCT07000591

Massage Based on the Human Caring Model in Epilepsy

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 96 (actual)
• Sponsor: Muş Alparslan University · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

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.

Conditions

• Epilepsy

Interventions

Type	Name	Description
OTHER	Experimental Group	Patients will receive a neck massage based on Watson's Human Caring Model in addition to standard medical care. The massage will be performed three times a week for eight weeks, totaling 24 sessions. Sessions will last 30 minutes and follow evidence-based nursing interventions. Care will be individualized and delivered in a calming environment. Pre- and post-intervention assessments will include the Epilepsy Self-Efficacy Scale and the Epilepsy Symptom Management Scale for patients, and the Zarit Burden Interview for caregivers. Caregivers will also complete an introductory form. All data will be collected at baseline and after eight weeks. The massage's impact on both patient outcomes and caregiver burden will be evaluated.

Timeline

• Start date: 2025-06-15
• Primary completion: 2025-06-15
• Completion: 2025-09-15
• First posted: 2025-06-03
• Last updated: 2025-10-01

Locations

1 site across 1 country: Turkey (Türkiye)