Self Acupressure on Fatigue and Sleep Quality in Epilepsy Patients

Sponsor
Ataturk University (Other)
Overall Status
Recruiting
CT.gov ID
NCT05552924
Collaborator
(none)
52
1
2
8.8
5.9

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Self-Acupressure
N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
52 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
This study is an experimental study with pre-test and post-test control groupsThis study is an experimental study with pre-test and post-test control groups
Masking:
Single (Participant)
Primary Purpose:
Supportive Care
Official Title:
The Effect of Self Acupressure on Fatigue and Sleep Quality in Epilepsy Patients
Actual Study Start Date :
Sep 5, 2022
Anticipated Primary Completion Date :
Feb 26, 2023
Anticipated Study Completion Date :
May 30, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: Self-Acupressure

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

Other: Self-Acupressure
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.

No Intervention: Control group

Routine maintenance will be applied.

Outcome Measures

Primary Outcome Measures

  1. The Piper Fatigue Scale [At the end of Sessions 1 (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.

  2. The Piper Fatigue Scale [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.

  3. Pittsburgh Sleep Quality Index (PSQI) [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"

  4. Pittsburgh Sleep Quality Index (PSQI) [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"

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 75 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Firat University Elazıg Turkey

Sponsors and Collaborators

  • Ataturk University

Investigators

  • Study Director: Gülcan Bahçecioğlu Turan, PhD, Firat University

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
gülcan bahcecioğlu, Principal Investigator, Ataturk University
ClinicalTrials.gov Identifier:
NCT05552924
Other Study ID Numbers:
  • 2022/ 04 - 34
First Posted:
Sep 23, 2022
Last Update Posted:
Jan 25, 2023
Last Verified:
Jan 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by gülcan bahcecioğlu, Principal Investigator, Ataturk University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jan 25, 2023