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Self Acupressure on Fatigue and Sleep Quality in Epilepsy Patients

Primary Purpose

Epilepsy

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Self-Acupressure
Sponsored by
Ataturk University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Epilepsy focused on measuring Self Acupressure, Fatigue, Sleep Quality, Epilepsy Patients

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Firat University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Self-Acupressure

Control group

Arm Description

Each application to the acupressure points (H17, L14, ST36, SP6) will be done in 2 minutes and right and left)

Routine maintenance will be applied.

Outcomes

Primary Outcome Measures

The Piper Fatigue Scale
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.
The Piper Fatigue Scale
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.
Pittsburgh Sleep Quality Index (PSQI)
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"
Pittsburgh Sleep Quality Index (PSQI)
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"

Secondary Outcome Measures

Full Information

First Posted
September 21, 2022
Last Updated
July 18, 2023
Sponsor
Ataturk University
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1. Study Identification

Unique Protocol Identification Number
NCT05552924
Brief Title
Self Acupressure on Fatigue and Sleep Quality in Epilepsy Patients
Official Title
The Effect of Self Acupressure on Fatigue and Sleep Quality in Epilepsy Patients
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Completed
Study Start Date
September 5, 2022 (Actual)
Primary Completion Date
February 26, 2023 (Actual)
Study Completion Date
July 15, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ataturk University

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
The aim of this study is to examine the effect of Self-acupressure application on fatigue and sleep quality in epilepsy patients.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Epilepsy
Keywords
Self Acupressure, Fatigue, Sleep Quality, Epilepsy Patients

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
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Self-Acupressure
Arm Type
Experimental
Arm Description
Each application to the acupressure points (H17, L14, ST36, SP6) will be done in 2 minutes and right and left)
Arm Title
Control group
Arm Type
No Intervention
Arm Description
Routine maintenance will be applied.
Intervention Type
Other
Intervention Name(s)
Self-Acupressure
Intervention 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 order to ensure the continuation and balance of the energy in our body.
Primary Outcome Measure Information:
Title
The Piper Fatigue Scale
Description
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.
Time Frame
At the end of Sessions 1 (each Session 2 days a week)
Title
The Piper Fatigue Scale
Description
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.
Time Frame
At the end of Sessions 16 (each Session 2 days a week)
Title
Pittsburgh Sleep Quality Index (PSQI)
Description
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"
Time Frame
At the end of Sessions 1 (each Session 2 days a week)
Title
Pittsburgh Sleep Quality Index (PSQI)
Description
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"
Time Frame
At the end of Sessions 16 (each Session 2 days a week)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gülcan Bahçecioğlu Turan, PhD
Organizational Affiliation
Firat University
Official's Role
Study Director
Facility Information:
Facility Name
Firat University
City
Elazıg
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
18306446
Citation
Wang T, Zhang Q, Xue X, Yeung A. A systematic review of acupuncture and moxibustion treatment for chronic fatigue syndrome in China. Am J Chin Med. 2008;36(1):1-24. doi: 10.1142/S0192415X08005540.
Results Reference
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Self Acupressure on Fatigue and Sleep Quality in Epilepsy Patients

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