AnxietyNCT06384274
The Effect of Emotional Freedom Technique and Virtual Reality Glasses on Anxiety and Vital Signs
A study testing Emotional Freedom Technique and Virtual Reality Glasses in people with Anxiety, run by Necmettin Erbakan University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Anxiety
- What is being tested?
- Emotional Freedom Technique and Virtual Reality Glasses
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Oct 2024to 1 Jun 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
None listed.
Who cannot join
- Having hearing and vision problems,
- Urgently placed on HBO treatment,
- Patients without chronic diseases,
- Patients with impaired tissue integrity at EFT energy points
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Gülsüm Gürsoy Açikgöz
Konya, Meram
gülsüm GÜRSOY AÇIKGÖZ, 05535553934, 2gulsum5@gmail.com
About this study
Official title: The Effect of Emotional Freedom Technique and Virtual Reality Glasses on Anxiety and Vital Signs in Individuals Receiving Hyperbaric Oxygen Therapy: Randomized Controlled Trials
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.
Read the detailed description
This study was designed as a pretest-posttest regular parallel group, randomized controlled experimental. The research will be carried out in Konya City Hospital Hyperbaric Oxygen Therapy Unit. Patients will be randomly assigned to three groups: emotional freedom technique group (25), virtual reality glasses group (25) and control group (25). For Emotional Freedom Technique Group: The emotional freedom technique will be applied by the researcher who has received the practitioner training certificate. For Virtual Reality Glasses Group: The video containing the nature walk will be watched by virtual reality. For the Control Group: No intervention will be made in the control group. Standard care will be given. The primary result of this study is to determine the patients' anxiety scores. Secondary results of the research are to determine the patients' vital signs.
- Conditions
- Anxiety
- Being tested
- Emotional Freedom Technique, Virtual Reality Glasses
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Emotional Freedom TechniqueOther
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.
Virtual Reality GlassesOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Blood pressure was evaluated with a sphygmomanometer. Accepted normal values: Systolic blood pressure: 100-120 mmHg, Diastolic blood pressure: 60-80 mmHg.
Measured: 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
Pulse was evaluated with a pulse oximeter device. Accepted normal values: 60-100 pulse /min
Measured: 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
Respiration was evaluated by observation. Accepted normal values:12-20 respiration /min
Measured: 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 evaluated with a thermometer device. Accepted normal values: 36-37 ° C
Measured: 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
Oxygen saturation was evaluated with a pulse oximetry device. Accepted normal values: SpO2: 95-100%.
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2024
- Study start1 Oct 2024 (estimated)
- Primary completion1 Oct 2024 (estimated)
- Study completion1 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnxietyStudies of the same condition, open and under way.
- More trials run by Necmettin Erbakan UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 75 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Necmettin Erbakan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gülsüm Gürsoy Açıkgöz, Necmettin Erbakan University
- Investigators
- gülsüm GÜRSOY AÇIKGÖZ, Principal investigator, Necmettin Erbakan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06384274
- Sponsor's protocol ID
- NEUniversity
- Status last verified
- Apr 2024
- First submitted
- 6 Apr 2024
- Last updated
- 25 Apr 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Emotional Freedom Technique and Virtual Reality Glasses on Anxiety and Vital Signs in Individuals Receiving Hyperbaric Oxygen Therapy: Randomized Controlled Trials
- ClinicalTrials.gov ID
- NCT06384274
- Acronym / sponsor ID
- NEUniversity
- Conditions
- Anxiety
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- Necmettin Erbakan UniversityUniversity, hospital or other
- Study start
- 1 Oct 2024 (estimated)
- Primary completion
- 1 Oct 2024 (estimated)
- Study completion
- 1 Jun 2025 (estimated)
- First posted
- 25 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This study was designed as a pretest-posttest regular parallel group, randomized controlled experimental. The research will be carried out in Konya City Hospital Hyperbaric Oxygen Therapy Unit. Patients will be randomly assigned to three groups: emotional freedom technique group (25), virtual reality glasses group (25) and control group (25). For Emotional Freedom Technique Group: The emotional freedom technique will be applied by the researcher who has received the practitioner training certificate. For Virtual Reality Glasses Group: The video containing the nature walk will be watched by virtual reality. For the Control Group: No intervention will be made in the control group. Standard care will be given. The primary result of this study is to determine the patients' anxiety scores. Secondary results of the research are to determine the patients' vital signs.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Emotional Freedom Technique Group | Experimental | Other: Emotional Freedom TechniqueWhen 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. |
| Virtual Reality Glasses Group | Experimental | Other: Virtual Reality GlassesConsent 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. |
| 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. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (0 listed)
Key exclusion criteria (4 listed)
- Having hearing and vision problems,
- Urgently placed on HBO treatment,
- Patients without chronic diseases,
- Patients with impaired tissue integrity at EFT energy points
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Emotional Freedom TechniqueAll 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. | Other | Emotional Freedom Technique Group |
| Virtual Reality GlassesIt 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. | Other | Virtual Reality Glasses Group |
Primary outcome
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.
5 secondary outcomes
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.
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.
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.
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.
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Apr 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
gülsüm GÜRSOY AÇIKGÖZ principal investigator
Necmettin Erbakan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Emotional Freedom Technique and Virtual Reality Glasses in people with Anxiety, run by Necmettin Erbakan University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Gülsüm GÜRSOY AÇIKGÖZ (05535553934, 2gulsum5@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Apr 2024.