## Protocol Section
### Identification Module
**NCT ID:** NCT06436079

**Brief Title:** Evaluation of the Effectiveness of a Nursing Intervention Program in Reducing Anxiety in Users Who Perform Scheduled Sessions in the Hyperbaric Chamber

**Official Title:** Evaluation of the Effectiveness of a Nursing Intervention Program in Reducing Anxiety in Users Who Perform Scheduled Sessions in the Hyperbaric Chamber

#### Organization Study ID Info
**ID:** 44519 ANSIETAT UMH
#### Organization
**Class:** OTHER
**Full Name:** Universitat de Girona
### Status Module
#### Completion Date
**Date:** 2025-12

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-30

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-28

**Overall Status:** RECRUITING

#### Primary Completion Date
**Date:** 2025-07

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-05-06

**Type:** ACTUAL

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-30
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-15
**Study First Submit QC Date:** 2024-05-28
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Universitat de Girona

#### Responsible Party

**Investigator Affiliation:** Universitat de Girona

**Investigator Full Name:** Lyudmila Andrusenko Kalchenko

**Investigator Title:** Clinical professor

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** True

### Description Module

**Brief 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.

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.

### Conditions Module

**Conditions:**

- Anxiety and Fear

- Nurse's Role

**Keywords:**

- Anxiety

- Nursing intervention

- Hyperbaric chamber

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** SINGLE

**Who Masked:**

- PARTICIPANT

**Primary Purpose:** SUPPORTIVE_CARE

#### Enrollment Info

**Count:** 42

**Type:** ESTIMATED

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** The experimental group will receive a nursing educational intervention with an explanation, with audiovisual support, of the operation of the hyperbaric chamber.

**Intervention Names:**

- Behavioral: Intervention group

**Label:** Audiovisual educational program on treatment in a hyperbaric chamber

**Type:** EXPERIMENTAL

#### Arm Group 2

**Description:** The control group will undergo the same procedure that is currently carried out, some basic explanations before entering the hyperbaric chamber.

**Intervention Names:**

- Behavioral: Intervention group

**Label:** Usual intervention

**Type:** ACTIVE_COMPARATOR

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Audiovisual educational program on treatment in a hyperbaric chamber

- Usual intervention

**Description:** 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.

**Name:** Intervention group

**Type:** BEHAVIORAL

### Outcomes Module

#### Primary Outcomes

**Description:** Feelings of fear, dread, and uneasiness that may occur as a reaction to stress.

**Measure:** Prevalence of anxiety measured with the STAI questionnaire.

**Time Frame:** First week of treatment in the hyperbaric chamber

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* Results in the Pfeiffer questionnaire\<2.
* That they understand Spanish or Catalan

Exclusion Criteria:

* That feel fear inside the hyperbaric chamber.

**Maximum Age:** 100 Years

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** dalmau.vila@udg.edu

**Name:** Dalmau Vila-Vidal, MsC

**Phone:** 972600160

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Palamós

**Contacts:**

***Contact 1:***

- **Email:** dalmau.vila@udg.edu

- **Name:** Dalmau Vila Vidal, MsC

- **Phone:** 972600160

- **Role:** CONTACT

**Country:** Spain

**Facility:** Hospital de Palamós

**State:** Girona

**Status:** RECRUITING

**Zip:** 17230

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000001523

- Term: Mental Disorders

### Condition Browse Module - Browse Branches

- Abbrev: BXM

- Name: Behaviors and Mental Disorders

- Abbrev: All

- Name: All Conditions

### Condition Browse Module - Browse Leaves

- ID: M4324

- Name: Anxiety Disorders

- Relevance: HIGH

- As Found: Anxiety

- ID: M4815

- Name: Mental Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M14473

- Name: Psychotic Disorders

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000001008

- Term: Anxiety Disorders

### Misc Info Module

- Version Holder: 2024-05-31
