NCT06434454

Brief 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.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
74

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

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

First Submitted

Initial submission to the registry

May 20, 2024

Completed
10 days until next milestone

First Posted

Study publicly available on registry

May 30, 2024

Completed
21 days until next milestone

Study Start

First participant enrolled

June 20, 2024

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 20, 2024

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 20, 2024

Completed
Last Updated

May 30, 2024

Status Verified

May 1, 2024

Enrollment Period

2 months

First QC Date

May 20, 2024

Last Update Submit

May 28, 2024

Conditions

Keywords

studentsleep qualıtyemotioanal freedom techniques

Outcome Measures

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

    1 months

Secondary Outcomes (1)

  • Epworth Sleepiness Scale (ESS)

    1 months

Other Outcomes (2)

  • Fatigue Severity Scale (FSS)

    one month

  • Pittsburgh Sleep Quality Index (PSQI)

    one month

Study Arms (2)

EXPERİMENTAL: EFT GROUP

EXPERIMENTAL

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

CONTROL GROUP

NO INTERVENTION

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

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
EXPERİMENTAL: EFT GROUP

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

  • Individuals who wish to withdraw from the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bezmialem Vakif Universty

Istanbul, Topkapı Mahallesi, 34093, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Sleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System DiseasesMental Disorders

Central Study Contacts

HANDAN ÖZCAN LECTURER

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: 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. The young individuals in the experimental 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
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
LECTURER

Study Record Dates

First Submitted

May 20, 2024

First Posted

May 30, 2024

Study Start

June 20, 2024

Primary Completion

August 20, 2024

Study Completion

September 20, 2024

Last Updated

May 30, 2024

Record last verified: 2024-05

Locations