ClinicalTrials.gg
Status unknownNCT06434454EFT STUDENTUpdated May 30, 2024

EFT AND SLEEP QUALITY

An interventional study of EFT Group:Emotional Free Technıcal in Sleep Quality, sponsored by Bezmialem Vakif University. Status unknown at 1 site in Turkey (Türkiye). Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-05-30.

Sponsored by Bezmialem Vakif University · Not applicable, Interventional, and Prevention

The sponsor has not verified this record recently (last verified May 2024), so the status shown — last known as Not yet recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
74
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Sleep Quality

Keywords

  • student
  • sleep qualıty
  • emotioanal freedom techniques
03

In context

Sleep Initiation and Maintenance Disorders

1,925 studies on the registry are indexed under Sleep Initiation and Maintenance Disorders; 612 are open to participants now.

This study's planned enrollment of 74 is close to the median of 72 across 1,689 interventional studies indexed under Sleep Initiation and Maintenance Disorders.

Browse Sleep Initiation and Maintenance Disorders studies →

Lead sponsor

Bezmialem Vakif University is the lead sponsor of 351 studies on the registry; 57 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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.
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
74 participants (estimated)

Study arms

  • 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.

    Behavioral: EFT Group: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.

Interventions

  • BehavioralEFT Group:Emotional Free Technıcal

    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.

    Also known as: emotional free technıcal

06

What researchers measure

Primary outcomes

  1. 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

    Time frame: 1 months

Secondary outcomes

  1. 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.

    Time frame: 1 months

Other outcomes

  1. 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.

    Time frame: one month

  2. 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.

    Time frame: one month

07

Study locations

1 site
  • Bezmialem Vakif Universty
    Istanbul, Topkapı Mahallesi 34093, Turkey (Türkiye)
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Jun 2024; primary completion for Aug 2024, 2 months later.

Of 825 non-industry interventional studies with no phase under Sleep Initiation and Maintenance Disorders, half reached primary completion within 20 months of starting (the median), counting those still running; a quarter within 9 and three quarters within 41. This study's planned 2 months is below that.

Counting every sponsor, half of 883 studies reached it within 19 months; a quarter within 7 and three quarters within 39.

How these figures are worked out, and which studies are left out of them.

Registered
May 20, 2024
First posted
May 30, 2024
StartEst.
Jun 20, 2024
Primary completionEst.
Aug 20, 2024
CompletionEst.
Sep 20, 2024
Last update
May 30, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on May 30, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06434454
Responsible party
Merve Meşedüzü (LECTURER, Bezmialem Vakif University) — Principal investigator
First posted
May 30, 2024
Start date
Jun 20, 2024 (estimated)
Primary completion
Aug 20, 2024 (estimated)
Completion
Sep 20, 2024 (estimated)
Last update
May 30, 2024

Study contacts

MERVE MESEDUZU
Contact
mervemeseduzu@gmail.com
800-555-5555
HANDAN ÖZCAN LECTURER
Contact
800-555-5555

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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