Massage Based on the Human Caring Model in Epilepsy

Muş Alparslan University

Status: Completed

Conditions: Epilepsy

Treatments: Other: Experimental Group

Study type: Interventional

Funder types: Other

Identifiers

NCT07000591

MAUN-SBF-CO-01

Details and patient eligibility

About

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.

Full 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.

Enrollment: 96 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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96 participants in 2 patient groups

Control Group

No Intervention group

Description:

After the initial data is collected, no interventions other than routine nursing care will be applied to the patients and their caregivers. Not intervening in the control group will be necessary to accurately evaluate whether the research hypothesis is significant. This approach will ensure that only the effects of the intervention are isolated, allowing for a proper analysis of the differences between groups based on the research hypothesis. For this group, the researchers will administer the "Patient Introduction Form," the "Epilepsy Self-Efficacy Scale," and the "Epilepsy Symptom Management Scale" to the patients, and the "Caregiver Introduction Form" and the "Zarit Burden Interview" to the caregivers, as data collection tools, eight weeks after the initial assessment to collect the final test data.

Experimental group

Experimental group

Description:

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.

Treatment:

Other: Experimental Group