Anxiety and FearNCT06436079
Evaluation of the Effectiveness of a Nursing Intervention Program in Reducing Anxiety in Users Who Perform Scheduled Sessions in the Hyperbaric Chamber
A study testing Intervention group in people with Anxiety and Fear and Nurse's Role, run by Universitat de Girona at 1 site in Spain.
Trial summary
The objective of this experimental study is to determine if the application of a nursing educational intervention reduces the anxiety of patients who are going to undergo treatment in the hyperbaric chamber. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Anxiety and Fear, Nurse's Role
- What is being tested?
- Intervention group
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteSpain
- Study dates
- 6 Jan 2024to 15 Sep 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Results in the Pfeiffer questionnaire<2.
- That they understand Spanish or Catalan
Who cannot join
- That feel fear inside the hyperbaric chamber.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Spain1 site, 1 recruiting
- Recruiting
Hospital de Palamós
Palamós, Girona, 17230
Dalmau Vila Vidal, MsC, 972600160, dalmau.vila@udg.edu
About this study
The objective of this experimental study is to determine if the application of a nursing educational intervention reduces the anxiety of patients who are going to undergo treatment in the hyperbaric chamber.
The researchers will compare the nursing educational intervention with the usual practice that is currently carried out in the unit for patients who are going to begin treatment in the hyperbaric chamber.
Participants will:
- Receive explanatory information through a camera triptych when the treatment is indicated.
- Come half an hour before the first session to receive a nursing educational intervention, with audiovisual support, on the operation of the camera.
Read the detailed description
The objective of this experimental study is to determine if the application of a nursing educational intervention reduces the anxiety of patients who are going to undergo treatment in the hyperbaric chamber.
An educational intervention will be applied to the intervention group that will begin on the same day that the treatment is indicated. That day, you will be given an informative brochure about the most important aspects you should know about the hyperbaric chamber. On the first day of the session, you will be asked to come half an hour early to explain, in more detail, what the hyperbaric chamber consists of and important aspects that you should take into account.
The control group will receive the same intervention that is currently being carried out. Once treatment is prescribed in the chamber, they come on the first day and receive a brief explanation of how it works before entering.
- Conditions
- Anxiety and Fear, Nurse's Role
- Being tested
- Intervention group
- Keywords
- Anxiety, Nursing intervention, Hyperbaric chamber
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intervention groupBehavioural
Patients who begin the first session in the hyperbaric chamber will receive a nursing educational intervention, with audiovisual support, about the operation of the chamber and aspects that must be taken into account once inside.
| Study group | Role | What they receive |
|---|---|---|
| Audiovisual educational program on treatment in a hyperbaric chamber | Experimental | The experimental group will receive a nursing educational intervention with an explanation, with audiovisual support, of the operation of the hyperbaric chamber. Receives: Behavioral: Intervention group |
| Usual intervention | Active comparator | The control group will undergo the same procedure that is currently carried out, some basic explanations before entering the hyperbaric chamber. Receives: Behavioral: Intervention group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of anxiety measured with the STAI questionnaire.
Feelings of fear, dread, and uneasiness that may occur as a reaction to stress.
Measured: First week of treatment in the hyperbaric chamber
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2024
- Study start6 Jan 2024
- Primary completion15 May 2026 (estimated)
- Study completion15 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anxiety and FearStudies of the same condition, open and under way.
- 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
- Participant
- Enrolment
- 42 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universitat de Girona
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lyudmila Andrusenko Kalchenko, Universitat de Girona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06436079
- Sponsor's protocol ID
- 44519 ANSIETAT UMH
- Status last verified
- Apr 2026
- First submitted
- 15 May 2024
- Last updated
- 6 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effectiveness of a Nursing Intervention Program in Reducing Anxiety in Users Who Perform Scheduled Sessions in the Hyperbaric Chamber
- ClinicalTrials.gov ID
- NCT06436079
- Acronym / sponsor ID
- 44519 ANSIETAT UMH
- Conditions
- Anxiety and Fear, Nurse's Role
- Keywords
- Anxiety, Nursing intervention, Hyperbaric chamber
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 42 participants (estimated)
- Lead sponsor
- Universitat de GironaUniversity, hospital or other
- Study start
- 6 Jan 2024 (actual)
- Primary completion
- 15 May 2026 (estimated)
- Study completion
- 15 Sep 2026 (estimated)
- First posted
- 30 May 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 objective of this experimental study is to determine if the application of a nursing educational intervention reduces the anxiety of patients who are going to undergo treatment in the hyperbaric chamber.
The researchers will compare the nursing educational intervention with the usual practice that is currently carried out in the unit for patients who are going to begin treatment in the hyperbaric chamber.
Participants will:
- Receive explanatory information through a camera triptych when the treatment is indicated.
- Come half an hour before the first session to receive a nursing educational intervention, with audiovisual support, on the operation of the camera.
Detailed description
The objective of this experimental study is to determine if the application of a nursing educational intervention reduces the anxiety of patients who are going to undergo treatment in the hyperbaric chamber.
An educational intervention will be applied to the intervention group that will begin on the same day that the treatment is indicated. That day, you will be given an informative brochure about the most important aspects you should know about the hyperbaric chamber. On the first day of the session, you will be asked to come half an hour early to explain, in more detail, what the hyperbaric chamber consists of and important aspects that you should take into account.
The control group will receive the same intervention that is currently being carried out. Once treatment is prescribed in the chamber, they come on the first day and receive a brief explanation of how it works before entering.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Audiovisual educational program on treatment in a hyperbaric chamber | Experimental | Behavioral: Intervention groupThe experimental group will receive a nursing educational intervention with an explanation, with audiovisual support, of the operation of the hyperbaric chamber. |
| Usual intervention | Active comparator | Behavioral: Intervention groupThe control group will undergo the same procedure that is currently carried out, some basic explanations before entering the hyperbaric chamber. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Results in the Pfeiffer questionnaire<2.
- That they understand Spanish or Catalan
Key exclusion criteria (1 listed)
- That feel fear inside the hyperbaric chamber.
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 |
|---|---|---|
| Intervention groupPatients who begin the first session in the hyperbaric chamber will receive a nursing educational intervention, with audiovisual support, about the operation of the chamber and aspects that must be taken into account once inside. | Behavioural | Audiovisual educational program on treatment in a hyperbaric chamber, Usual intervention |
Primary outcome
Prevalence of anxiety measured with the STAI questionnaire.
Time frame: First week of treatment in the hyperbaric chamber
Feelings of fear, dread, and uneasiness that may occur as a reaction to stress.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2026.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intervention group in people with Anxiety and Fear and Nurse's Role, run by Universitat de Girona at 1 site in Spain.
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 2 inclusion and 1 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: looking for participants now, as of the sponsor's last update on 6 May 2026. 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 Spain. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Dalmau Vila-Vidal, MsC (972600160, dalmau.vila@udg.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of anxiety measured with the STAI questionnaire. (time frame: First week of treatment in the hyperbaric chamber). 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 6 May 2026; AzTrials last refreshed its copy on 6 Nov 2026.