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The Effect of Yoga on Sleep and Quality of Life in Epilepsy Patients (Yoga)

Primary Purpose

Epilepsy

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Yoga practice
Sponsored by
Zülfünaz ÖZER
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Epilepsy focused on measuring yoga, Sleep, Quality life

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Having been diagnosed with epilepsy for at least six months,
  • Does not have any disease that causes insomnia and does not use sleeping pills
  • Have not participated in a similar regular exercise program in the last 6 months,
  • Seizures are under control,
  • Do not have a physical illness or cognitive deficiency and a psychiatric disease that prevents understanding of the education given

Exclusion Criteria:

  • Epilepsy patients who do not agree to participate in the study

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    Yoga practice

    Control group

    Arm Description

    The yoga practice will be held 2 days a week for 6 weeks, a total of 12 sessions. Each session is set as one hour

    Routine maintenance will be applied

    Outcomes

    Primary Outcome Measures

    Quality of Life Scale in Epilepsy
    Quality of life
    Quality of Life Scale in Epilepsy
    Quality of life

    Secondary Outcome Measures

    Pittsburgh Sleep Quality Index
    Sleep
    Pittsburgh Sleep Quality Index
    Sleep

    Full Information

    First Posted
    March 30, 2021
    Last Updated
    June 14, 2021
    Sponsor
    Zülfünaz ÖZER
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04828876
    Brief Title
    The Effect of Yoga on Sleep and Quality of Life in Epilepsy Patients
    Acronym
    Yoga
    Official Title
    The Effect of Yoga on Sleep and Quality of Life in Epilepsy Patients
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2021
    Overall Recruitment Status
    Unknown status
    Study Start Date
    June 30, 2021 (Anticipated)
    Primary Completion Date
    July 30, 2021 (Anticipated)
    Study Completion Date
    August 30, 2021 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor-Investigator
    Name of the Sponsor
    Zülfünaz ÖZER

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    Determining the sleep quality and quality of life of epilepsy patients and offering solutions can be effective in their success both in their professional and social lives. Therefore, in this study, it was aimed to evaluate the effectiveness of yoga therapy on sleep quality and quality of life in epilepsy patients.
    Detailed Description
    Yoga is an ancient Hindu practice with documented therapeutic effect in western countries and means perfect control of the body, emotions and mind. It consists of breathing exercises, asanas (posture), relaxation and meditation exercises. Through breathing exercises, various postures, and meditation in yoga, the connection between mind and body is established and a balanced health is assisted.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Epilepsy
    Keywords
    yoga, Sleep, Quality life

    7. Study Design

    Primary Purpose
    Supportive Care
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    This study is an experimental study with pre-test and post-test control groups.
    Masking
    Participant
    Masking Description
    Yoga and control group
    Allocation
    Randomized
    Enrollment
    60 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Yoga practice
    Arm Type
    Experimental
    Arm Description
    The yoga practice will be held 2 days a week for 6 weeks, a total of 12 sessions. Each session is set as one hour
    Arm Title
    Control group
    Arm Type
    No Intervention
    Arm Description
    Routine maintenance will be applied
    Intervention Type
    Behavioral
    Intervention Name(s)
    Yoga practice
    Intervention Description
    Yoga basically consists of breathing techniques, asanas (postures) and relaxation phases. Practiced Yoga Stages; 10 min. standing breathing exercise, 10 min. breathing exercise with seated asana, 10 min. lying down breathing exercise with asana, 20 min. sitting breathing exercise, 10 min. The session will be completed in 60 minutes, including deep relaxation stages by lying down. At the end of each session, patients' feedback about yoga practice will be received.
    Primary Outcome Measure Information:
    Title
    Quality of Life Scale in Epilepsy
    Description
    Quality of life
    Time Frame
    1. week
    Title
    Quality of Life Scale in Epilepsy
    Description
    Quality of life
    Time Frame
    6. week
    Secondary Outcome Measure Information:
    Title
    Pittsburgh Sleep Quality Index
    Description
    Sleep
    Time Frame
    1. week
    Title
    Pittsburgh Sleep Quality Index
    Description
    Sleep
    Time Frame
    6. week

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    55 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Having been diagnosed with epilepsy for at least six months, Does not have any disease that causes insomnia and does not use sleeping pills Have not participated in a similar regular exercise program in the last 6 months, Seizures are under control, Do not have a physical illness or cognitive deficiency and a psychiatric disease that prevents understanding of the education given Exclusion Criteria: Epilepsy patients who do not agree to participate in the study
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Zülfünaz ÖZER, Phd
    Phone
    +905379537007
    Email
    zulfinazozer@gmail.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Zülfünaz ÖZER, PhD
    Organizational Affiliation
    Istanbul Sabahattin Zaim University
    Official's Role
    Study Chair

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    33545575
    Citation
    Ozer Z, Bahcecioglu Turan G, Aksoy M. The effects of yoga on dyspnea, sleep and fatigue in chronic respiratory diseases. Complement Ther Clin Pract. 2021 May;43:101306. doi: 10.1016/j.ctcp.2021.101306. Epub 2021 Jan 19.
    Results Reference
    background
    PubMed Identifier
    29343930
    Citation
    Amaravathi E, Ramarao NH, Raghuram N, Pradhan B. Yoga-Based Postoperative Cardiac Rehabilitation Program for Improving Quality of Life and Stress Levels: Fifth-Year Follow-up through a Randomized Controlled Trial. Int J Yoga. 2018 Jan-Apr;11(1):44-52. doi: 10.4103/ijoy.IJOY_57_16.
    Results Reference
    result

    Learn more about this trial

    The Effect of Yoga on Sleep and Quality of Life in Epilepsy Patients

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