NCT07347158

Brief Summary

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.

Trial Health

75
On Track

Trial Health Score

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

Enrollment
70

participants targeted

Target at P50-P75 for not_applicable

Timeline
6mo left

Started Mar 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

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 Progress27%
Mar 2026Oct 2026

First Submitted

Initial submission to the registry

December 4, 2025

Completed
1 month until next milestone

First Posted

Study publicly available on registry

January 16, 2026

Completed
2 months until next milestone

Study Start

First participant enrolled

March 4, 2026

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2026

Last Updated

January 16, 2026

Status Verified

January 1, 2026

Enrollment Period

8 months

First QC Date

December 4, 2025

Last Update Submit

January 8, 2026

Conditions

Colon CancerColitis UlcerativeInflamatory Bowel Disease (Crohn's and Ulcerative Colitis)

Keywords

ostomyquality of lifeanxietydepressionNursing careHealth educationstoma care

Outcome Measures

Primary Outcomes (3)

  • Beck Depression Inventory

    Beck Depression Inventory

    Baseline and at 3 months

  • 36-Item Short Form Health Survey

    36-Item Short Form Health Survey

    Baseline and at 3 months

  • Beck anxiety inventory

    Beck anxiety inventory

    Baseline and at 3 months

Study Arms (2)

Health education by virtual and smart-glasses

EXPERIMENTAL

Health education (emotional care, mindfulness, jacobson, quality of life, social, sexual, ...). Method: psicosocial/holistic

Other: Health Education

Control

NO INTERVENTION

Interventions

Health EducationOTHER

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

Health education by virtual and smart-glasses

Eligibility Criteria

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

You may qualify if:

  • 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.

You may not qualify if:

  • Terminal patients
  • Patients with cognitive impairments

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Complejo Hospitalario Universitario de Santiago de Compostela

Santiago de Compostela, A Coruña, 15703, Spain

Location

MeSH Terms

Conditions

Colonic NeoplasmsColitis, UlcerativeAnxiety DisordersDepressionHealth Education

Condition Hierarchy (Ancestors)

Colorectal NeoplasmsIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesColitisGastroenteritisInflammatory Bowel DiseasesMental DisordersBehavioral SymptomsBehaviorAdherence InterventionsMedication AdherencePatient CompliancePatient Acceptance of Health CareTreatment Adherence and ComplianceHealth Behavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Tomás Mendoza Caamaño

Study Record Dates

First Submitted

December 4, 2025

First Posted

January 16, 2026

Study Start

March 4, 2026

Primary Completion (Estimated)

October 31, 2026

Study Completion (Estimated)

October 31, 2026

Last Updated

January 16, 2026

Record last verified: 2026-01

Locations

ES(1)