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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06384274
Other study ID # NEUniversity
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date October 1, 2024
Est. completion date June 1, 2025

Study information

Verified date April 2024
Source Necmettin Erbakan University
Contact Gülsüm GÜRSOY AÇIKGÖZ
Phone 05535553934
Email 2gulsum5@gmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. 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.


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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 75
Est. completion date June 1, 2025
Est. primary completion date October 1, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 60 Years
Eligibility Inclusion 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 Design


Related Conditions & MeSH terms


Intervention

Other:
Emotional Freedom Technique
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 Glasses
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.

Locations

Country Name City State
Turkey Gülsüm Gürsoy Açikgöz Konya Meram

Sponsors (1)

Lead Sponsor Collaborator
Necmettin Erbakan University

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Blood Pressure 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.
Secondary Pulse 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.
Secondary Respiration 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.
Secondary Body Temperature 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.
Secondary Oxygen Saturation 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.
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