EpilepsyNCT05261568
The Effect of Progressive Relaxation Exercises on Fatigue and Sleep Quality in İndividuals With Epilepsy
A study testing PROGRESSIVE RELAXATION EXERCISE in people with Epilepsy and Sleep, run by Ataturk University at 1 site in Turkey (Türkiye).
Trial summary
Aim: It was conducted to determine the effect of web-based animation supported progressive relaxation exercise on fatigue and sleep quality in individuals with epilepsy. Material and Methods: As a randomized controlled study with a pretest- posttest model, it was conducted with individuals with epilepsy who applied to… Read more about this study
- Who is it for?
- Ages 18 years and older
- What is being tested?
- PROGRESSIVE RELAXATION EXERCISE
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 10 Sep 2021to 22 Dec 2022
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- be over the age of 18
- Having been diagnosed with epilepsy for at least 6 months
- Individuals with an average score of 4.1 or higher on the fatigue severity scale
- Individuals with a Pittsburg Sleep Quality Index total score above 5
- Being able to use mobile phone (IOS-Android)
- Being able to speak Turkish
- Up to 6 months before the study, techniques such as meditation, hypnosis, yoga not benefited,
- Having a neurological, systemic and psychiatric disease other than epilepsy not to be.
Who cannot join
- Not using a mobile phone,
- Up to 6 months before the study, techniques such as meditation, hypnosis, yoga to have benefited,
- Having a neurological, systemic and psychiatric disease other than epilepsy be.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Giresun Training and Research Hospital
Giresun, 28100
About this study
Official title: The Effect of Progressive Relaxation Exercises on Fatigue and Sleep Quality in Individuals With Epilepsy
Aim: It was conducted to determine the effect of web-based animation supported progressive relaxation exercise on fatigue and sleep quality in individuals with epilepsy. Material and Methods: As a randomized controlled study with a pretest- posttest model, it was conducted with individuals with epilepsy who applied to Giresun University Faculty of Medicine Neurology Outpatient Clinic between February and December 2022.The sample of the study was determined as 60 epilepsy patients, 30 of which were in the control-30 experimental group, using power analysis. The data were collected by face-to-face interview technique using Personal Information Form, Pittsburg Sleep Quality Index, Fatigue Severity Scale.
- Being tested
- PROGRESSIVE RELAXATION EXERCISE
- Medical subject headings
- Epilepsy, Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PROGRESSIVE RELAXATION EXERCISEBehavioural
Progressive relaxation exercise will be done for 6 weeks by watching the animation video in the mobile application program.
| Study group | Role | What they receive |
|---|---|---|
| experimental group | Experimental | The first application is carried out by a researcher close to the polyclinic with care and demonstration.
The application will be suggested by hanging it from side to side in sitting position. They will be informed about the same application conditions in their own practice at home.
The program, which will last for 6 weeks, will continue from the home environment after a video surveillance observed by the beneficiary.
Periods of entry and exit times thanks to the mobile program. It will be done over the phone by the people who will come for 6 weeks. history book, lack of tools, etc. a website will be searched. Adhering to application products through study. A total of 42 sessions for 6 weeks, 7 days a week. About 30min. It is used to benefit from training to benefit from sustained progression. Apart from that, he can enjoy wearing it by dressing casually and casually. Receives: Behavioral: PROGRESSIVE RELAXATION EXERCISE |
| control gruop | No intervention | The control group did not receive any intervention other than their own treatment during the study. will not be applied. Progressive relaxation exercise application to the individuals included in the control group personal information form, Pittsburgh sleep quality index, fatigue severity scale will be applied as test-post-test. |
What is being measured
The primary outcome is the main question the study is designed to answer.
fatigue severity scale
finished
Measured: An average of 1 year
Secondary outcomes (1)
pittsburg sleep quality scale
finished
Measured: An average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2022
- Study start10 Sep 2021
- Primary completion22 Dec 2022
- Study completion22 Dec 2022
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.
- More trials run by Ataturk UniversityThe sponsor's other registered studies.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ataturk University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Neşe İŞCAN AYYILDIZ, Ataturk University
- Investigators
- Nuray DAYAPOĞLU, Principal investigator, Ataturk University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05261568
- Sponsor's protocol ID
- AtaturkUnıversıty Nusing
- Status last verified
- Feb 2023
- First submitted
- 14 Jan 2022
- Last updated
- 17 Feb 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Progressive Relaxation Exercises on Fatigue and Sleep Quality in Individuals With Epilepsy
- ClinicalTrials.gov ID
- NCT05261568
- Acronym / sponsor ID
- AtaturkUnıversıty Nusing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Ataturk UniversityUniversity, hospital or other
- Study start
- 10 Sep 2021 (actual)
- Primary completion
- 22 Dec 2022 (actual)
- Study completion
- 22 Dec 2022 (actual)
- First posted
- 2 Mar 2022 (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.
Aim: It was conducted to determine the effect of web-based animation supported progressive relaxation exercise on fatigue and sleep quality in individuals with epilepsy. Material and Methods: As a randomized controlled study with a pretest- posttest model, it was conducted with individuals with epilepsy who applied to Giresun University Faculty of Medicine Neurology Outpatient Clinic between February and December 2022.The sample of the study was determined as 60 epilepsy patients, 30 of which were in the control-30 experimental group, using power analysis. The data were collected by face-to-face interview technique using Personal Information Form, Pittsburg Sleep Quality Index, Fatigue Severity Scale.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| experimental group | Experimental | Behavioral: PROGRESSIVE RELAXATION EXERCISEThe first application is carried out by a researcher close to the polyclinic with care and demonstration. The application will be suggested by hanging it from side to side in sitting position. They will be informed about the same application conditions in their own practice at home. The program, which will last for 6 weeks, will continue from the home environment after a video surveillance observed by the beneficiary. Periods of entry and exit times thanks to the mobile program. It will be done over the phone by the people who will come for 6 weeks. history book, lack of tools, etc. a website will be searched. Adhering to application products through study. A total of 42 sessions for 6 weeks, 7 days a week. About 30min. It is used to benefit from training to benefit from sustained progression. Apart from that, he can enjoy wearing it by dressing casually and casually. |
| control gruop | No intervention | –The control group did not receive any intervention other than their own treatment during the study. will not be applied. Progressive relaxation exercise application to the individuals included in the control group personal information form, Pittsburgh sleep quality index, fatigue severity scale will be applied as test-post-test. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- be over the age of 18
- Having been diagnosed with epilepsy for at least 6 months
- Individuals with an average score of 4.1 or higher on the fatigue severity scale
- Individuals with a Pittsburg Sleep Quality Index total score above 5
- Being able to use mobile phone (IOS-Android)
Key exclusion criteria (3 listed)
- Not using a mobile phone,
- Up to 6 months before the study, techniques such as meditation, hypnosis, yoga to have benefited,
- Having a neurological, systemic and psychiatric disease other than epilepsy be.
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 |
|---|---|---|
| PROGRESSIVE RELAXATION EXERCISEProgressive relaxation exercise will be done for 6 weeks by watching the animation video in the mobile application program. | Behavioural | experimental group |
Primary outcome
fatigue severity scale
Time frame: An average of 1 year
finished
1 secondary outcome
pittsburg sleep quality scale
Time frame: An average of 1 year
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 17 Feb 2023.
- Individual participant dataSharing planned: No
Related trials for Epilepsy
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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.
Nuray DAYAPOĞLU principal investigator
Ataturk University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PROGRESSIVE RELAXATION EXERCISE in people with Epilepsy and Sleep, run by Ataturk 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 8 inclusion and 3 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 17 Feb 2023. 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?
fatigue severity scale (time frame: An average of 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 17 Feb 2023.