- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06384274
The Effect of Emotional Freedom Technique and Virtual Reality Glasses on Anxiety and Vital Signs
The Effect of Emotional Freedom Technique and Virtual Reality Glasses on Anxiety and Vital Signs in Individuals Receiving Hyperbaric Oxygen Therapy: Randomized Controlled Trials
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: gülsüm GÜRSOY AÇIKGÖZ
- Phone Number: 05535553934
- Email: 2gulsum5@gmail.com
Study Locations
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Meram
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Konya, Meram, Turkey
- Gülsüm Gürsoy Açikgöz
-
Contact:
- gülsüm GÜRSOY AÇIKGÖZ
- Phone Number: 05535553934
- Email: 2gulsum5@gmail.com
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
İnclusion Criteria
- Applying HBO treatment for the first time,
- Volunteering to participate in the research,
- Those who are between the ages of 18 and 65,
- Able to speak and understand Turkish (patients who will not have communication problems),
- Without a psychiatric diagnosis,
- Those who have not received training on coping with anxiety and fear before,
- Those who have not attended a course on energy therapy before,
- Vital signs are within normal limits
Exclusion Criteria:
- Having hearing and vision problems,
- Urgently placed on HBO treatment,
- Patients without chronic diseases,
- Patients with impaired tissue integrity at EFT energy points
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Emotional Freedom Technique Group
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. |
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.
|
|
Experimental: Virtual Reality Glasses Group
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. |
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.
|
|
No Intervention: Control Group
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
State Anxiety Inventory (STAI)
Time Frame: 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.
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Blood Pressure
Time Frame: 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.
|
Blood pressure was evaluated with a sphygmomanometer.
Accepted normal values: Systolic blood pressure: 100-120 mmHg, Diastolic blood pressure: 60-80 mmHg.
|
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.
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Pulse
Time Frame: 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 was evaluated with a pulse oximeter device.
Accepted normal values: 60-100 pulse /min
|
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.
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|
Respiration
Time Frame: 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 was evaluated by observation.
Accepted normal values:12-20 respiration /min
|
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
Time Frame: 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.
|
It will be evaluated with a thermometer device.
Accepted normal values: 36-37 ° C
|
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.
|
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Oxygen Saturation
Time Frame: 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 was evaluated with a pulse oximetry device.
Accepted normal values: SpO2: 95-100%.
|
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.
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: gülsüm GÜRSOY AÇIKGÖZ, Necmettin Erbakan University
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- NEUniversity
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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