EFT AND SLEEP QUALITY

Sleep Quality Clinical Trial

— EFT STUDENT  

Official title:

EFT and Sleep Quality

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06434454
• Other study ID #: E-54022451-050.04-137924
• Secondary ID: MMeseduzu
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 20, 2024
• Est. completion date: September 20, 2024

Study information

• Verified date: May 2024
• Source: Bezmialem Vakif University
• Contact: MERVE MESEDUZU
• Phone: 800-555-5555
• Email: mervemeseduzu[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 74
• Est. completion date: September 20, 2024
• Est. primary completion date: August 20, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

• Inclusion Criteria:

• Görsel Analog Ölçege (VAS) göre 5 ve üzerinde uyku sorunu bildiren ögrenciler

• 18-24 yas araliginda olan ögrenciler

• Herhangi bir kronik hastaligi bulunmayan ögrenciler

• Arastirmaya gönüllü olarak katilmak isteyen ögrenciler yer almaktadir.

• Exclusion Criteria:

• Individuals who wish to withdraw from the study.

Related Conditions & MeSH terms

• Sleep Quality

Intervention

Behavioral:
• EFT Group:Emotional Free Technical
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.

Locations

Country	Name	City	State
Turkey	Bezmialem Vakif Universty	I?stanbul	Topkapi Mahallesi

Sponsors (1)

Lead Sponsor	Collaborator
Bezmialem Vakif University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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.	one month
Other	Pittsburgh Sleep Quality Index (PSQI)	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
Primary	Insomnia Severity Index Scale	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	Epworth Sleepiness Scale (ESS)	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