NCT06384274

Brief Summary

The aim of the study was to examine the effects of the emotional freedom technique and virtual reality glasses applied to individuals receiving hyperbaric oxygen therapy for the first time on anxiety and vital signs. The hypotheses of this research are that there is a difference between the emotional liberation technique and virtual reality glasses groups and the control group in terms of anxiety and vital signs.

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
75

participants targeted

Target at P25-P50 for not_applicable anxiety

Timeline
Completed

Started Oct 2024

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

April 6, 2024

Completed
19 days until next milestone

First Posted

Study publicly available on registry

April 25, 2024

Completed
5 months until next milestone

Study Start

First participant enrolled

October 1, 2024

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2024

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2025

Completed
Last Updated

April 25, 2024

Status Verified

April 1, 2024

Enrollment Period

Same day

First QC Date

April 6, 2024

Last Update Submit

April 24, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • State Anxiety Inventory (STAI)

    In the State Anxiety Inventory, the individual evaluates how he or she feels "at the moment" and according to the severity of the emotions or behaviors expressed in the items (1) "never", (2) "a little", (3) "a lot" and (4) "a lot". are asked to choose one of the statements "completely". The highest score of 4 is given for choosing the phrase "completely", and the lowest score is 1 for choosing the phrase "not at all". The lowest total score that can be obtained from the State Anxiety Scale is 20, and the highest total score is 80. A high score indicates a high level of anxiety, and a low score indicates a low level of anxiety.

    It will be applied within the first 10 minutes when the patient arrives at the Hyperbaric Oxygen treatment center, 10 minutes before the treatment and 10 minutes after the treatment.

Secondary Outcomes (5)

  • Blood Pressure

    It will be applied within the first 10 minutes when the patient arrives at the Hyperbaric Oxygen treatment center, 10 minutes before the treatment and 10 minutes after the treatment.

  • Pulse

    It will be applied within the first 10 minutes when the patient arrives at the Hyperbaric Oxygen treatment center, 10 minutes before the treatment and 10 minutes after the treatment.

  • Respiration

    It will be applied within the first 10 minutes when the patient arrives at the Hyperbaric Oxygen treatment center, 10 minutes before the treatment and 10 minutes after the treatment.

  • Body Temperature

    It will be applied within the first 10 minutes when the patient arrives at the Hyperbaric Oxygen treatment center, 10 minutes before the treatment and 10 minutes after the treatment.

  • Oxygen Saturation

    It will be applied within the first 10 minutes when the patient arrives at the Hyperbaric Oxygen treatment center, 10 minutes before the treatment and 10 minutes after the treatment.

Study Arms (3)

Emotional Freedom Technique Group

EXPERIMENTAL

When the patient, who was determined to be in the emotional liberation group, was admitted to the unit, the patient's consent was first obtained; In the first 10 minutes, the patient will fill out the Patient Introduction Form, State Anxiety Scale, Subjective Disturbance Unit Scale and Vital Signs Form in the Unit. Emotional liberation technique will be applied and then the subjective disturbance unit score will be recorded. Then the patient will fill out the State Anxiety Scale and Vital Signs Forms and the patient will be informed about the treatment. He will then be taken into treatment. When the patient leaves the treatment, the process will be completed by filling out the State Anxiety Scale, Subjective Disturbance Unit Scale and Vital Signs Form again within 10 minutes.

Other: Emotional Freedom Technique

Virtual Reality Glasses Group

EXPERIMENTAL

Consent was first obtained for admission differences to the patient unit, which was noted to have virtual reality limits; Patient Introduction Form, State Anxiety Scale, Subjective Disturbance Unit Scale and Vital Tests Form will be filled in the unit. Then the virtual reality of life will be explained and glasses will be purchased. Forest/beach/sea video images can be watched in virtual reality. The video is planned to last approximately 10 minutes. The application is planned to take 20-25 minutes. Before the session, the State Anxiety Scale, SUBJECTIVE DISORDER UNIT SCALE and Vital Tests Form will be filled in again, the patient will be informed and then the treatment will be administered. Once the treatment is completed, the patient will take a third measurement within 10 minutes and the State Anxiety Scale, Subjective Disturbance Unit Scale and Life Parameters Form will be filled out again.

Other: Virtual Reality Glasses

Control Group

NO INTERVENTION

When the patient determined to be in the control group is admitted to the unit, patient consent was obtained within the first 10 minutes and the Patient Introduction Form, State Anxiety Scale, Subjective Disturbance Unit Scale and Vital Signs Form will be filled in the unit. The patient will be prepared for the treatment, will be given special clothing for the treatment, and will be given standard training for the treatment. Then, the second measurement will be taken just before the patient enters the session. There will be at least 20 minutes between the second measurement and the first measurement. The State Anxiety Scale, Subjective Disturbance Unit Scale and Vital Signs Form will be filled out again. After the treatment process is completed, the patient will be measured for the third time and the process will be completed by filling out the State Anxiety Scale, Subjective Disturbance Unit Scale and Vital Signs Form again.

Interventions

All people have an energy body. If the energy flow is interrupted, emotions such as stress and fear arise. By clicking on energy points to improve energy flow, the individual gets rid of energy blockages.

Emotional Freedom Technique Group

It is aimed to reduce the patient's anxiety by making her feel like she7 he is there by watching and listening to relaxing content of the beach and nature.

Virtual Reality Glasses Group

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may not qualify if:

  • Having hearing and vision problems,
  • Urgently placed on HBO treatment,
  • Patients without chronic diseases,
  • Patients with impaired tissue integrity at EFT energy points

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gülsüm Gürsoy Açikgöz

Konya, Meram, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Anxiety Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Study Officials

  • gülsüm GÜRSOY AÇIKGÖZ

    Necmettin Erbakan University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Gülsüm GÜRSOY AÇIKGÖZ

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

April 6, 2024

First Posted

April 25, 2024

Study Start

October 1, 2024

Primary Completion

October 1, 2024

Study Completion

June 1, 2025

Last Updated

April 25, 2024

Record last verified: 2024-04

Data Sharing

IPD Sharing
Will not share

Locations