NCT05552924

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 5, 2022

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

September 21, 2022

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 23, 2022

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 26, 2023

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 15, 2023

Completed
Last Updated

July 19, 2023

Status Verified

July 1, 2023

Enrollment Period

6 months

First QC Date

September 21, 2022

Last Update Submit

July 18, 2023

Conditions

Keywords

Self AcupressureFatigueSleep QualityEpilepsy Patients

Outcome Measures

Primary Outcomes (4)

  • 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.

    At the end of Sessions 1 (each Session 2 days a week)

  • 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.

    At the end of Sessions 16 (each Session 2 days a week)

  • 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"

    At the end of Sessions 1 (each Session 2 days a week)

  • 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"

    At the end of Sessions 16 (each Session 2 days a week)

Study Arms (2)

Self-Acupressure

EXPERIMENTAL

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

Other: Self-Acupressure

Control group

NO INTERVENTION

Routine maintenance will be applied.

Interventions

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.

Self-Acupressure

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Firat University

Elâzığ, Turkey (Türkiye)

Location

Related Publications (1)

  • 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.

    PMID: 18306446BACKGROUND

MeSH Terms

Conditions

EpilepsyFatigueSleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersMental Disorders

Study Officials

  • Gülcan Bahçecioğlu Turan, PhD

    Firat University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
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
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

September 21, 2022

First Posted

September 23, 2022

Study Start

September 5, 2022

Primary Completion

February 26, 2023

Study Completion

July 15, 2023

Last Updated

July 19, 2023

Record last verified: 2023-07

Data Sharing

IPD Sharing
Will not share

Locations