Reflexology on Seizure Frequency, Fatigue, Stress and Sleep Quality in Epilepsy Patients

NCT06120101 | Unknown

• 1 other identifier: NihanTurkoglu
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

Epilepsy is among the diseases that cause loss of neurological abilities regardless of any trauma. Reflexology is one of the complementary therapies based on activating the body's self-healing power through special hand techniques applied to the feet. It is known that there are positive changes in seizure frequency, fatigue, stress and sleep quality in epilepsy patients after reflexology. This study will be conducted to determine the effect of reflexology on seizure frequency, fatigue, stress and sleep quality in epilepsy patients.

Conditions

Reflexology; Epilepsy; Fatigue; Stress

Outcome Measures

Primary Outcomes (3)

• Chalder Fatigue Scale (CFA)

  Individuals' fatigue level was evaluated with the CSI developed by Trudie Chalder in 1993. CWS is an 11-item scale that evaluates the fatigue felt by individuals during the last month through self-report. CEX consists of physical fatigue and mental fatigue subscales. A four-point Likert scale is used in the evaluation.

  two week

• Perceived Stress Scale (PSS)

  It was developed by Cohen, Kamarck \& Mermelste in 1983, and its Cronbach Alpha value was found to be 0.86 in the reliability study. In this study, the scale adapted to Turkish by Bilge, Öğce, Genç and Oran (2007) was used, and the Cronbach Alpha value was found to be 0.81 in the reliability study. Three items of the scale prepared in a 5-point Likert type (0 never, 4 very often) are reverse-worded (items 4, 5, 6), and five items are literal (items 1, 2, 3, 7, 8). ). A total score of 0-32 is taken from the scale. It has two subscales: perceived stress (items 1, 2, 3, 7, 8) and perceived coping (items 4, 5, and 6). The scale is evaluated on both total score and subscale scores. A high total score means a high perceived stress level. High scores from the subscales are a negative situation.

  Two week

• Pittsburg Sleep Quality scale (PSQI)

  The scale developed by Buysse et al., Turkish reliability and validity study by Ağargün et al. (Ağargün MY, Kara H, 1996). Made by. The scale, which examines the individual's sleep quality in the last month, consists of 24 items. Each question is evaluated with a number from 0 to 3. The highest score that can be obtained from the scale is 21. An increase in the score obtained from the scale indicates that sleep quality is poor.

  Two week

Study Arms (2)

Experimental

EXPERIMENTAL

Reflexology will be applied in a total of 3 sessions and the final test will be applied to the patients by phone 24 hours after the last reflexology application. At the end of the study, 3 reflexology sessions and 2 test measurements will be performed on the experimental group. Each reflexology session takes approximately 30-40 minutes. Sessions will be performed in a private room within the neurology clinic, on ergonomic and repositionable beds. Each session started with the right foot and will continue with the left foot. Primary relaxation techniques will be applied to both feet, followed by reflexology techniques to all system organs.

Behavioral: Reflexology Massage

Control

NO INTERVENTION

No application will be applied to the control group.

Interventions

Reflexology Massage BEHAVIORAL

The researcher washed his hands with an antibacterial soap before cleaning the patient's feet. The feet were cleaned according to the patient's preference; To wash feet with water or use disposable wet cloth. The patients were placed in a supine position on the bed in the room and their joint points were supported. The researcher stood at the end of the patient's bed during treatment. Unscented sesame oil at room temperature was used to provide lubrication during reflexology. The application started with the patient's right foot. The foot was first relaxed by applying effleurage, shaking, rotation and stretching methods. During the application, the researcher used the fingers of the other hand while supporting the patient's foot with one hand, and the thumb and caterpillar technique was mostly used. In other applications, the index finger and other fingers were used. The training ended by applying solar plexus pressure to both feet.

Experimental

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Knowing the diagnosis of the disease
• Having not received reflexology therapy before
• Being literate in Turkish
• Conscious Open,
• Able to communicate verbally,
• Being 18 years or older

You may not qualify if:

• Pain starts while doing massage,
• Having an infection,
• High fever,
• Having clot problems in the leg veins,
• Having an acute (newly developing) disease (heart attack, fainting, etc.),
• Wounds in the application area,
• Patients in the first 3 months of pregnancy.
• Paraplegia or thrombosis
• Leg varicose veins or foot disease (open wound or fracture on the foot)
• Diagnosis of psychiatric disorder or dementia

Sponsors & Collaborators

• Ataturk University: lead

Study Sites (1)

Nihan Türkoğlu

Erzurum, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Epilepsy; Fatigue

Interventions

Musculoskeletal Manipulations

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics; Physical Therapy Modalities; Rehabilitation

Study Officials

• Nihan Türkoğlu

  Ataturk University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Nihan Türkoğlu

CONTACT

+905315740889; nturkoglu@atauni.edu.tr

Esin Kavuran

CONTACT

05374302319; esinkavuran@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assist Prof.

Study Record Dates

• First Submitted: November 1, 2023
• First Posted: November 7, 2023
• Study Start: August 15, 2023
• Primary Completion: November 15, 2023
• Study Completion: December 15, 2023
• Last Updated: November 9, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)