- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06436079
Evaluation of the Effectiveness of a Nursing Intervention Program in Reducing Anxiety in Users Who Perform Scheduled Sessions in the Hyperbaric Chamber
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.
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Dalmau Vila-Vidal, MsC
- Phone Number: 972600160
- Email: dalmau.vila@udg.edu
Study Locations
-
-
Girona
-
Palamós, Girona, Spain, 17230
- Recruiting
- Hospital de Palamós
-
Contact:
- Dalmau Vila Vidal, MsC
- Phone Number: 972600160
- Email: dalmau.vila@udg.edu
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Results in the Pfeiffer questionnaire<2.
- That they understand Spanish or Catalan
Exclusion Criteria:
- That feel fear inside the hyperbaric chamber.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Audiovisual educational program on treatment in a hyperbaric chamber
The experimental group will receive a nursing educational intervention with an explanation, with audiovisual support, of the operation of the hyperbaric chamber.
|
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.
|
|
Active Comparator: Usual intervention
The control group will undergo the same procedure that is currently carried out, some basic explanations before entering the hyperbaric chamber.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
First week of treatment in the hyperbaric chamber
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 44519 ANSIETAT UMH
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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