Effectiveness of Health Education as a Nursing Intervention in Improving Quality of Life and Reducing Symptoms of Anxiety and Depression in Ostomy Patients Following Digestive Surgery: A Quasi-Experimental Study.

January 8, 2026 updated by: Tomás Mendoza Caamaño, Hospital Clinico Universitario de Santiago

The proposed project is a prospective quasi-experimental study to be conducted at the Ostomy Clinic of the University Hospital Complex of Santiago de Compostela. The primary objective is to evaluate the effectiveness of health education as a nursing intervention in reducing anxiety and depression and improving the quality of life of ostomy patients following digestive surgery. The study will focus on adult patients who have undergone an elimination ostomy, excluding terminal patients and those with cognitive impairments.

The study involves clinical follow-up of patients from hospital admission to several months after completing the health education program. Validated scales will be used to measure quality of life, anxiety, and depression. The intervention will consist of health education workshops and continuous follow-up by specialized nursing staff.

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

70

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
    • A Coruña
      • Santiago de Compostela, A Coruña, Spain, 15703
        • Complejo Hospitalario Universitario de Santiago de Compostela

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Adults
  • Patients with digestive ostomies, either permanent or temporary ostomies lasting more than 6 months, attending ostomy consultations.
  • Volunteers with permanent digestive ostomies from the Santiago and Barbanza healthcare area.
  • Patients who agree to participate in the study.

Exclusion Criteria:

  • Terminal patients
  • Patients with cognitive impairments

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control
Experimental: Health education by virtual and smart-glasses
Health education (emotional care, mindfulness, jacobson, quality of life, social, sexual, ...). Method: psicosocial/holistic
Other: Health Education

Session 1 (60 minutes) Patient Knowledge Assessment: Review understanding of ostomy care, including nutrition, device management, and early identification of stoma/skin complications.

Feedback and Support: Address gaps in knowledge based on ostomy consultations. Skills Workshop: Build confidence and self-efficacy in daily care, reducing anxiety about complications.

Session 2 (60 minutes) Mental Health and Quality of Life: Explain the link between ostomy and mental health; identify and manage anxiety/depression symptoms; promote healthy habits and social integration.

Mindfulness and Stress Management: Teach breathing and relaxation techniques to manage stress and improve body acceptance.

Guided Visualization: Focus on acceptance and confidence building. Action Plan: Summarize techniques and encourage regular practice. Session 3 Healthy Habits: Nutrition, exercise, rest, and stress management. Social Integration: Communication, participation, and support networks. Closing: Summary, resou

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Beck Depression Inventory
Time Frame: Baseline and at 3 months
Beck Depression Inventory
Baseline and at 3 months
36-Item Short Form Health Survey
Time Frame: Baseline and at 3 months
36-Item Short Form Health Survey
Baseline and at 3 months
Beck anxiety inventory
Time Frame: Baseline and at 3 months
Beck anxiety inventory
Baseline and at 3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital Clinico Universitario de Santiago

Collaborators

Hospital Clínico Universitario de Santiago de Compostela

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

March 4, 2026

Primary Completion (Estimated)

October 31, 2026

Study Completion (Estimated)

October 31, 2026

Study Registration Dates

First Submitted

December 4, 2025

First Submitted That Met QC Criteria

January 8, 2026

First Posted (Estimated)

January 16, 2026

Study Record Updates

Last Update Posted (Estimated)

January 16, 2026

Last Update Submitted That Met QC Criteria

January 8, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2024-389

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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.

Clinical Trials on Colon Cancer

Clinical Trials on Health Education

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Malaysia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe