EpilepsyMassage BasedNCT07000591

Massage Based on the Human Caring Model in Epilepsy

A study testing Experimental Group in people with Epilepsy, run by Muş Alparslan University at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 to 65 yearsHealthy volunteers can take part
Conditions the study is for: Epilepsy
What is being tested?: Experimental Group
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 96 participants
Where: 1 siteTurkey (Türkiye)
Study dates: 15 Jun 2025to 15 Sep 2025
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
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

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,

Show all 15Show fewer

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.

Who cannot join

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 locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site

Atatürk University
Erzurum, Erzurum, 25100

Other trials in Turkey (Türkiye)

About this study

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

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.

Read the 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
Being tested: Experimental Group
Keywords: Epilepsy, Human Caring Model, Self-Efficacy, Symptom Management
Medical subject headings: Epilepsy

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Experimental GroupOther
Also called Treatment
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.

Study groups in NCT07000591
Study group	Role	What they receive
Control Group	No intervention	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	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. Receives: Other: Experimental Group

What is being measured

The primary outcome is the main question the study is designed to answer.

Epilepsy Self-Efficacy Scale
The Epilepsy Self-Efficacy Scale was originally developed by DiIorio et al. in 1992 as a 25-item tool to assess individuals' belief in their ability to manage their epilepsy. In 2000, 8 additional items were included in the original scale. The Turkish validity and reliability study was conducted in 2019 by Öznur Adadıoğlu. Cronbach's alpha values were reported as 0.88 for the management factor, 0.84 for the general management factor, 0.82 for illness and medication management, 0.55 for seizure management, and 0.91 for the total scale. Based on factor analysis, 2 items were removed, and the final Turkish version included 31 items. Items are scored from "0 - I cannot do at all" to "10 - I am absolutely sure I can do," and total scores range from 0 to 310. When averaged, scores range from 0 to 10. Higher scores indicate greater self-efficacy.
Measured: four months
Zarit Burden Interview (ZBI)
The Zarit Burden Interview was developed in 1980 by Zarit, Reever, and Bach-Peterson to assess the level of stress experienced by caregivers. It consists of 22 items addressing social and emotional aspects of caregiving. Each item is scored on a 5-point Likert scale ranging from "never" to "nearly always." Total scores range from 0 to 88, with higher scores indicating greater caregiver burden. Reliability studies found internal consistency coefficients between 0.87 and 0.94. The Turkish validity and reliability study was conducted by İnci in 2006, with a Cronbach's alpha of 0.95.
Measured: four months
Epilepsy Symptom Management Scale
This scale was developed by the researchers based on relevant literature (Kurt \& Ünsar, 2009; Yeşilbalkan et al., 2008; Yıldırım et al., 2011; Tülek et al., 2016; Mollaoğlu et al., 2015; Önsöz \& Usta Yeşilbalkan, 2013; Atay Turan et al., 2007) for use in a doctoral dissertation. Initially, 40 items were drafted. Following expert review, two items were removed, one was split into two, and six were revised, resulting in a final version with 39 items. The scale provides a holistic, user-friendly tool for epilepsy patients to self-assess all symptoms in a single form. Patients indicate whether they experienced symptoms in the past week (Yes/No). If "Yes," they rate the impact on a 5-point Likert scale: 1 = Not at all disturbing to 5 = Extremely disturbing. Total scores range from 0 to 195, with higher scores indicating greater symptom burden. To assess content validity, 10 experts evaluated each item using Davis' method, which involves rating items as: 1 = Not appropriate, 2 = Needs major
Measured: four months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

15 Jun 202515 Sep 2025

First posted3 Jun 2025
Study start15 Jun 2025
Primary completion15 Jun 2025
Study completion15 Sep 2025

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for EpilepsyStudies 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: Treatment
Allocation: Randomised
Intervention model: Parallel groups
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.
Masking: None (open label)
Enrolment: 96 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07000591
Sponsor's protocol ID: MAUN-SBF-CO-01
Acronym: Massage Based
Status last verified: May 2025
First submitted: 24 May 2025
Last updated: 1 Oct 2025
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingObservational study
Evaluation and Treatment of Neurosurgical Disorders
Neurologic Disorders
RecruitingPhase 1
Investigation of Blood-Brain-Barrier Breakdown Using Manganese Magnetic Resonance Imaging in Drug-Resistant Epilepsy
Epilepsy
RecruitingPhase 3
A Study of EPX-100 (Clemizole Hydrochloride) in Participants With Dravet Syndrome
Dravet Syndrome
Active, not recruitingPhase 2
Stopping TSC Onset and Progression 2B: Sirolimus TSC Epilepsy Prevention Study
Tuberous Sclerosis Complex, Epilepsy
RecruitingPhase 4
Early Post-Traumatic Seizures Prevention Trial (E-PTS Trial)
Seizures, Traumatic Brain Injuries

All Epilepsy trials

Study at a glance

From the registry record, last updated by the sponsor on 1 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT07000591
Acronym / sponsor ID: Massage Based / MAUN-SBF-CO-01
Conditions: Epilepsy
Keywords: Epilepsy, Human Caring Model, Self-Efficacy, Symptom Management
Study type: Interventional
Recruitment status: Completed
Enrolment: 96 participants (actual)
Lead sponsor: Muş Alparslan UniversityUniversity, hospital or other
Collaborators: Scientific Research Projects
Study start: 15 Jun 2025 (actual)
Primary completion: 15 Jun 2025 (actual)
Study completion: 15 Sep 2025 (actual)
First posted: 3 Jun 2025 (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.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2
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.

Arm	Type	Receives
Control Group	No intervention	–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	Other: Experimental GroupPatients 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.

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (15 listed)

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,

Key exclusion criteria (5 listed)

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.

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
Experimental GroupAlso: TreatmentPatients 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.	Other	Experimental group

Primary outcome

Epilepsy Self-Efficacy Scale
Time frame: four months
The Epilepsy Self-Efficacy Scale was originally developed by DiIorio et al. in 1992 as a 25-item tool to assess individuals' belief in their ability to manage their epilepsy. In 2000, 8 additional items were included in the original scale. The Turkish validity and reliability study was conducted in 2019 by Öznur Adadıoğlu. Cronbach's alpha values were reported as 0.88 for the management factor, 0.84 for the general management factor, 0.82 for illness and medication management, 0.55 for seizure management, and 0.91 for the total scale. Based on factor analysis, 2 items were removed, and the final Turkish version included 31 items. Items are scored from "0 - I cannot do at all" to "10 - I am absolutely sure I can do," and total scores range from 0 to 310. When averaged, scores range from 0 to 10. Higher scores indicate greater self-efficacy.
Zarit Burden Interview (ZBI)
Time frame: four months
The Zarit Burden Interview was developed in 1980 by Zarit, Reever, and Bach-Peterson to assess the level of stress experienced by caregivers. It consists of 22 items addressing social and emotional aspects of caregiving. Each item is scored on a 5-point Likert scale ranging from "never" to "nearly always." Total scores range from 0 to 88, with higher scores indicating greater caregiver burden. Reliability studies found internal consistency coefficients between 0.87 and 0.94. The Turkish validity and reliability study was conducted by İnci in 2006, with a Cronbach's alpha of 0.95.
Epilepsy Symptom Management Scale
Time frame: four months
This scale was developed by the researchers based on relevant literature (Kurt \& Ünsar, 2009; Yeşilbalkan et al., 2008; Yıldırım et al., 2011; Tülek et al., 2016; Mollaoğlu et al., 2015; Önsöz \& Usta Yeşilbalkan, 2013; Atay Turan et al., 2007) for use in a doctoral dissertation. Initially, 40 items were drafted. Following expert review, two items were removed, one was split into two, and six were revised, resulting in a final version with 39 items. The scale provides a holistic, user-friendly tool for epilepsy patients to self-assess all symptoms in a single form. Patients indicate whether they experienced symptoms in the past week (Yes/No). If "Yes," they rate the impact on a 5-point Likert scale: 1 = Not at all disturbing to 5 = Extremely disturbing. Total scores range from 0 to 195, with higher scores indicating greater symptom burden. To assess content validity, 10 experts evaluated each item using Davis' method, which involves rating items as: 1 = Not appropriate, 2 = Needs major

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 1 Oct 2025.
Individual participant dataSharing planned: No

Related trials for Epilepsy

RecruitingObservational study
Evaluation and Treatment of Neurosurgical Disorders
Neurologic Disorders
RecruitingPhase 1
Investigation of Blood-Brain-Barrier Breakdown Using Manganese Magnetic Resonance Imaging in Drug-Resistant Epilepsy
Epilepsy
RecruitingPhase 3
A Study of EPX-100 (Clemizole Hydrochloride) in Participants With Dravet Syndrome
Dravet Syndrome
Active, not recruitingPhase 2
Stopping TSC Onset and Progression 2B: Sirolimus TSC Epilepsy Prevention Study
Tuberous Sclerosis Complex, Epilepsy
RecruitingPhase 4
Early Post-Traumatic Seizures Prevention Trial (E-PTS Trial)
Seizures, Traumatic Brain Injuries

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.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Experimental Group in people with Epilepsy, run by Muş Alparslan University 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 15 inclusion and 5 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 1 Oct 2025. 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?

Epilepsy Self-Efficacy Scale (time frame: four months). The study lists 3 primary outcomes in all. 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 NCT07000591.

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 1 Oct 2025; AzTrials last refreshed its copy on 30 Oct 2026.