- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05552924
Self Acupressure on Fatigue and Sleep Quality in Epilepsy Patients
July 18, 2023 updated by: gülcan bahcecioğlu, Ataturk University
The Effect of Self Acupressure on Fatigue and Sleep Quality in Epilepsy Patients
The aim of this study is to examine the effect of Self-acupressure application on fatigue and sleep quality in epilepsy patients.
Study Overview
Detailed Description
Acupressure is a therapy method performed with an instrument or hand, fingertip, palm, elbow, knee, thumb relaxation and wrist bands on various points representing the waist organs in our body in order to ensure the continuation and balance of the energy in our body.
Study Type
Interventional
Enrollment (Actual)
60
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Elazıg, Turkey
- Firat University
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 75 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- Being over 18 years old
- Volunteering to participate in the research
- Having the ability to use technological tools
- Not having a verbal communication disability (hearing and speaking)
- Not having a diagnosed psychiatric disorder
- Having a scale score of >5 on the Piper Fatigue Scale
- A score of >5 on the Pittsburgh Sleep Quality Scale
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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No Intervention: Control group
Routine maintenance will be applied.
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Experimental: Self-Acupressure
Each application to the acupressure points (H17, L14, ST36, SP6) will be done in 2 minutes and right and left)
|
Acupressure is a therapy method performed with an instrument or hand, fingertip, palm, elbow, knee, thumb relaxation and wrist bands on various points representing the waist organs in order to ensure the continuation and balance of the energy in our body.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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The Piper Fatigue Scale
Time Frame: At the end of Sessions 1 (each Session 2 days a week)
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It is a 22-item scale that measures four subscales: behavior (6 items), affect (5 items), sensory (5 items), and cognition/mood (6 items).
Each item has 11 response categories on a 0-10 metric with verbal descriptors anchoring the endpoints.
Each subscale is scored individually and then aggregated together for an overall score, with higher scores reflecting more fatigue.
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At the end of Sessions 1 (each Session 2 days a week)
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The Piper Fatigue Scale
Time Frame: At the end of Sessions 16 (each Session 2 days a week)
|
It is a 22-item scale that measures four subscales: behavior (6 items), affect (5 items), sensory (5 items), and cognition/mood (6 items).
Each item has 11 response categories on a 0-10 metric with verbal descriptors anchoring the endpoints.
Each subscale is scored individually and then aggregated together for an overall score, with higher scores reflecting more fatigue.
|
At the end of Sessions 16 (each Session 2 days a week)
|
|
Pittsburgh Sleep Quality Index (PSQI)
Time Frame: At the end of Sessions 1 (each Session 2 days a week)
|
The PSQI is a valid and consistent survey comprising of 19 questions to assess quality and amount of sleep and the existence of a sleep disorder and its level in the previous month.
The scale was adapted into the Turkish language by Agargün et al. (1996).
The scale consists of seven components that assess patients subjective sleep quality, sleep delay, use of sleeping medication and disfunction in daily activities.
Each item scores in the range 0-3 points and the total score of the seven components gives the total PSQI score.
The total score has a value between 0-21 and a high total score demonstrates a poor quality of sleep.
A total PSQI score which is ≤5 indicates "good sleep", and a score which is >5 indicates "poor sleep"
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At the end of Sessions 1 (each Session 2 days a week)
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Pittsburgh Sleep Quality Index (PSQI)
Time Frame: At the end of Sessions 16 (each Session 2 days a week)
|
The PSQI is a valid and consistent survey comprising of 19 questions to assess quality and amount of sleep and the existence of a sleep disorder and its level in the previous month.
The scale was adapted into the Turkish language by Agargün et al. (1996).
The scale consists of seven components that assess patients subjective sleep quality, sleep delay, use of sleeping medication and disfunction in daily activities.
Each item scores in the range 0-3 points and the total score of the seven components gives the total PSQI score.
The total score has a value between 0-21 and a high total score demonstrates a poor quality of sleep.
A total PSQI score which is ≤5 indicates "good sleep", and a score which is >5 indicates "poor sleep"
|
At the end of Sessions 16 (each Session 2 days a week)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Gülcan Bahçecioğlu Turan, PhD, Firat University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
September 5, 2022
Primary Completion (Actual)
February 26, 2023
Study Completion (Actual)
July 15, 2023
Study Registration Dates
First Submitted
September 21, 2022
First Submitted That Met QC Criteria
September 21, 2022
First Posted (Actual)
September 23, 2022
Study Record Updates
Last Update Posted (Actual)
July 19, 2023
Last Update Submitted That Met QC Criteria
July 18, 2023
Last Verified
July 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2022/ 04 - 34
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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