NCT06436079

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
42

participants targeted

Target at P25-P50 for not_applicable

Timeline
5mo left

Started Jan 2024

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress87%
Jan 2024Sep 2026

Study Start

First participant enrolled

January 6, 2024

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

May 15, 2024

Completed
15 days until next milestone

First Posted

Study publicly available on registry

May 30, 2024

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 15, 2026

Expected
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 15, 2026

Last Updated

May 6, 2026

Status Verified

April 1, 2026

Enrollment Period

2.4 years

First QC Date

May 15, 2024

Last Update Submit

April 30, 2026

Conditions

Keywords

AnxietyNursing interventionHyperbaric chamber

Outcome Measures

Primary Outcomes (1)

  • Prevalence of anxiety measured with the STAI questionnaire.

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

    First week of treatment in the hyperbaric chamber

Study Arms (2)

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.

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.

Behavioral: Intervention group

Interventions

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.

Audiovisual educational program on treatment in a hyperbaric chamberUsual intervention

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • That feel fear inside the hyperbaric chamber.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital de Palamós

Palamós, Girona, 17230, Spain

RECRUITING

MeSH Terms

Conditions

Anxiety Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Central Study Contacts

Dalmau Vila-Vidal, MsC

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical professor

Study Record Dates

First Submitted

May 15, 2024

First Posted

May 30, 2024

Study Start

January 6, 2024

Primary Completion (Estimated)

May 15, 2026

Study Completion (Estimated)

September 15, 2026

Last Updated

May 6, 2026

Record last verified: 2026-04

Locations