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Enrolling by Invitation

NCT Number: 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.

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.

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Key information

Conditions

Colon Cancer Adherence Interventions Anxiety Disorders Behavior Behavioral Symptoms Colitis Colitis Ulcerative Colitis, Ulcerative Colonic Diseases Colonic Neoplasms Colorectal Neoplasms Depression Digestive System Diseases Digestive System Neoplasms Gastroenteritis Gastrointestinal Diseases Gastrointestinal Neoplasms Health Behavior Health Education Inflamatory Bowel Disease (Crohn's and Ulcerative Colitis) Inflammatory Bowel Diseases Intestinal Diseases Intestinal Neoplasms Medication Adherence Mental Disorders Neoplasms Neoplasms by Site Patient Acceptance of Health Care Patient Compliance Treatment Adherence and Compliance

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Complejo Hospitalario Universitario de Santiago de Compostela

Santiago de Compostela, A Coruña, 15703, Spain

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Health education

Other

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

Primary outcomes

  1. Beck Depression Inventory

    Time frame: Baseline and at 3 months

    Beck Depression Inventory

  2. 36-Item Short Form Health Survey

    Time frame: Baseline and at 3 months

    36-Item Short Form Health Survey

  3. Beck anxiety inventory

    Time frame: Baseline and at 3 months

    Beck anxiety inventory

Sponsors and collaborators

Lead sponsor

Hospital Clinico Universitario de Santiago

Other

Collaborators

  • Hospital Clínico Universitario de Santiago de Compostela

Registry information

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Jan 16, 2026
Registry last updated
Jan 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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