EFT AND SLEEP QUALITY (EFT STUDENT)

May 28, 2024 updated by: Merve Meşedüzü, Bezmialem Vakif University

EFT and Sleep Quality

The purpose of this clinical study is to determine whether the application of EFT (Emotional Freedom Techniques) is effective in reducing sleep problems among university students. Additionally, the study aims to gather information on the safety of EFT application. The primary questions it seeks to answer are:

Does EFT application reduce sleep problems among university students? Is EFT application feasible for addressing sleep problems in university students? Researchers will compare the effectiveness of EFT to traditional sleep education on non-pharmacological interventions for preventing sleep problems among university students.

Participants:

Pre-EFT application survey scale questions will be asked to university students.

EFT will be applied once by the researcher to university students. EFT will be applied a second time by the researcher to university students 15 days after the initial application.

For control, the same survey scale questions will be asked to the same students one day after the EFT application for post-test purposes.

The same procedures will be applied in the same manner to the control group that will receive education.

Study Overview

Status

Not yet recruiting

Conditions

Detailed Description

DATA COLLECTION TOOLS AND THEIR FEATURES For data collection, a questionnaire including socio-demographic characteristics, the Insomnia Severity Index, the Epworth Sleepiness Scale, and the Pittsburgh Sleep Quality Index will be used.

  1. Personal Information Form The personal information form, prepared by the researchers, includes questions about socio-demographic characteristics such as age and gender. The last part of the questionnaire consists of questions evaluating the sleep status of the participants.
  2. Insomnia Severity Index (ISI) This scale, developed to determine the severity of insomnia symptoms, can be used in both general population screenings and clinical assessments of insomnia. It is a seven-item, five-point Likert-type scale. Each item is scored between 0 and 4, with the total score ranging from 0 to 28. Scores of 0-7 indicate no clinically significant insomnia, 8-14 indicate subthreshold insomnia, 15-21 indicate clinical insomnia (moderate severity), and 22-28 indicate severe clinical insomnia.
  3. Epworth Sleepiness Scale (ESS) The ESS is an easy-to-administer and widely used scale. It is a four-point Likert-type scale. Each item is scored 0, 1, 2, or 3, with higher scores indicating greater daytime sleepiness. It aims to measure the general level of daytime sleepiness and is a simple self-report tool.
  4. Pittsburgh Sleep Quality Index (PSQI) The PSQI& index comprises 18 items grouped into 7 component scores. Each item is evaluated on a scale of 3 points. The sum of the seven component scores provides the total PSQI score, ranging from 0 to 21. Higher total scores indicate poorer sleep quality. A total PSQI score of 0-4 signifies good sleep quality, while scores between 5-21 indicate poor sleep quality.

    indicates and shows a serious deterioration in at least two components or moderate deterioration in three components of the PSQI.

  5. Fatigue Severity Scale (FSS) The FSS consists of 9 questions measuring the degree of fatigue experienced in the past week. Each question is rated on a scale from 0 (strongly disagree) to 7 (strongly agree), and the total score is the sum of these ratings. The highest possible total score is 63. A score of 36 or above indicates significant fatigue.
  6. Sleep Education (control group):

The sleep education content will be prepared by the researcher based on the literature and will be reviewed by at least three experts.

Study Type

Interventional

Enrollment (Estimated)

74

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 Contact

Study Contact Backup

  • Name: HANDAN ÖZCAN LECTURER
  • Phone Number: 800-555-5555

Study Locations

    • Topkapı Mahallesi
      • İ̇stanbul, Topkapı Mahallesi, Turkey, 34093
        • Bezmialem Vakif Universty
        • Contact:

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

  • Inclusion Criteria:

    • Görsel Analog Ölçeğe (VAS) göre 5 ve üzerinde uyku sorunu bildiren öğrenciler
    • 18-24 yaş aralığında olan öğrenciler
    • Herhangi bir kronik hastalığı bulunmayan öğrenciler
    • Araştırmaya gönüllü olarak katılmak isteyen öğrenciler yer almaktadır.
  • Exclusion Criteria:

    • Individuals who wish to withdraw from the study.

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: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: EXPERİMENTAL: EFT GROUP
The young individuals in the intervention group will be informed about the study, including its purpose and methodology, and their consent will be obtained. Emotional Freedom Techniques (EFT) will be applied to groups of 20 individuals to improve sleep quality, and all scales will be administered beforehand. EFT will be applied twice, with a 15-day interval between sessions, and the same scale questionnaires will be administered again after the second EFT session. Subsequently, the analysis will be conducted.
The young individuals in the intervention group will be informed about the study, including its purpose and methodology, and their consent will be obtained. Emotional Freedom Techniques (EFT) will be applied to groups of 20 individuals to improve sleep quality, and all scales will be administered beforehand. EFT will be applied twice, with a 15-day interval between sessions, and the same scale questionnaires will be administered again after the second EFT session. Subsequently, the analysis will be conducted.
Other Names:
  • emotional free technıcal
No Intervention: CONTROL GROUP
The young individuals in the control group will be informed about the study, including its purpose and methodology, and their consent will be obtained. The control group will receive sleep education, consisting of two educational presentations provided 15 days apart. The questionnaires of the scales used for analysis will be administered to assess their sleep problems. The content of the education will be prepared based on the literature and will be reviewed by at least three experts.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Insomnia Severity Index Scale
Time Frame: 1 months
This scale is a seven-item, five-point Likert-type scale. Each item is scored between 0 and 4, with the total score ranging from 0 to 28. Scores of 0-7 indicate no clinically significant insomnia, 8-14 indicate subthreshold insomnia, 15-21 indicate clinical insomnia (moderate severity), and 22-28 indicate severe clinical insomnia
1 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Epworth Sleepiness Scale (ESS)
Time Frame: 1 months
The ESS is a four-point Likert-type scale. Each item is scored 0, 1, 2, or 3, with higher scores indicating greater daytime sleepiness. It aims to measure the general level of daytime sleepiness and is a simple self-report tool.
1 months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Fatigue Severity Scale (FSS)
Time Frame: one month
The FSS consists of 9 questions measuring the degree of fatigue experienced in the past week. Each question is rated on a scale from 0 (strongly disagree) to 7 (strongly agree), and the total score is the sum of these ratings. The highest possible total score is 63. A score of 36 or above indicates significant fatigue.
one month
Pittsburgh Sleep Quality Index (PSQI)
Time Frame: one month
The index comprises 18 items grouped into 7 component scores. Each item is evaluated on a scale of 3 points. The sum of the seven component scores provides the total PSQI score, ranging from 0 to 21. Higher total scores indicate poorer sleep quality. A total PSQI score of 0-4 signifies good sleep quality, while scores between 5-21 indicate poor sleep quality. indicates and shows a serious deterioration in at least two components or moderate deterioration in three components of the PSQI.
one month

Collaborators and Investigators

This is where you will find people and organizations involved with this 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 (Estimated)

June 20, 2024

Primary Completion (Estimated)

August 20, 2024

Study Completion (Estimated)

September 20, 2024

Study Registration Dates

First Submitted

May 20, 2024

First Submitted That Met QC Criteria

May 28, 2024

First Posted (Actual)

May 30, 2024

Study Record Updates

Last Update Posted (Actual)

May 30, 2024

Last Update Submitted That Met QC Criteria

May 28, 2024

Last Verified

May 1, 2024

More Information

Terms related to this study

Other Study ID Numbers

  • E-54022451-050.04-137924
  • MMeseduzu (Other Identifier: BezmialemVU)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

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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