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Enrolling by invitation NCT07347158

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.

No phase Interventional Colon Cancer Inflamatory Bowel Disease (Crohn's and Ulcerative Colitis) Colitis Ulcerative

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Health Education.
Who it may be relevant to
Registry conditions: Colon Cancer, Inflamatory Bowel Disease (Crohn's and Ulcerative Colitis), Colitis Ulcerative. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Spain
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

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.

Interventions

  • 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 a

Primary outcome measures

  • Beck Depression Inventory [Time frame: Baseline and at 3 months]
  • 36-Item Short Form Health Survey [Time frame: Baseline and at 3 months]
  • Beck anxiety inventory [Time frame: Baseline and at 3 months]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Supportive care

Study locations

Spain · 1 center
  • Complejo Hospitalario Universitario de Santiago de Compostela — Santiago de Compostela

Identifiers

NCT: NCT07347158 · 2024-389

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗