NCT04828876

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2021

Shorter than P25 for not_applicable

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 30, 2021

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 2, 2021

Completed
3 months until next milestone

Study Start

First participant enrolled

June 30, 2021

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 30, 2021

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 30, 2021

Completed
Last Updated

June 15, 2021

Status Verified

June 1, 2021

Enrollment Period

1 month

First QC Date

March 30, 2021

Last Update Submit

June 14, 2021

Conditions

Keywords

yogaSleepQuality life

Outcome Measures

Primary Outcomes (2)

  • Quality of Life Scale in Epilepsy

    Quality of life

    1. week

  • Quality of Life Scale in Epilepsy

    Quality of life

    6. week

Secondary Outcomes (2)

  • Pittsburgh Sleep Quality Index

    1. week

  • Pittsburgh Sleep Quality Index

    6. week

Study Arms (2)

Yoga practice

EXPERIMENTAL

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

Behavioral: Yoga practice

Control group

NO INTERVENTION

Routine maintenance will be applied

Interventions

Yoga practiceBEHAVIORAL

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.

Yoga practice

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (2)

  • 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.

    PMID: 33545575BACKGROUND
  • 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.

MeSH Terms

Conditions

Epilepsy

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System Diseases

Study Officials

  • Zülfünaz ÖZER, PhD

    Istanbul Sabahattin Zaim University

    STUDY CHAIR

Central Study Contacts

Zülfünaz ÖZER, Phd

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
Yoga and control group
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: This study is an experimental study with pre-test and post-test control groups.
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
PhD., Assistant Prof

Study Record Dates

First Submitted

March 30, 2021

First Posted

April 2, 2021

Study Start

June 30, 2021

Primary Completion

July 30, 2021

Study Completion

August 30, 2021

Last Updated

June 15, 2021

Record last verified: 2021-06

Data Sharing

IPD Sharing
Will not share