NCT06672211

Brief Summary

Objective: The aim of this study is to evaluate the effects of video-assisted stoma care training given to patients with stoma on postoperative anxiety, stoma compliance and complications. Materials and Methods: This study was conducted as a double-blind randomized controlled interventional study within the scope of a doctoral thesis between January 2021 and September 2022 at the General Surgery Clinics of Aydın Atatürk State Hospital, Aydın State Hospital and Aydın Adnan Menderes University Practice and Research Hospital with 42 patients, 21 in the intervention group (who received video-assisted stoma care training in the postoperative period) and 21 in the control group, who met the sampling criteria. In the postoperative period, patients in the intervention group were given video-assisted stoma care training, while patients in the control group were given training using plain narration and demonstration methods. During the research process, patients were visited at 3 different time periods to determine the patients' anxiety levels, evaluate their compliance with the stoma and complications, and the patient follow-up was concluded.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
42

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2021

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 10, 2021

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 10, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 10, 2022

Completed
2.1 years until next milestone

First Submitted

Initial submission to the registry

October 21, 2024

Completed
14 days until next milestone

First Posted

Study publicly available on registry

November 4, 2024

Completed
Last Updated

November 4, 2024

Status Verified

November 1, 2024

Enrollment Period

1.7 years

First QC Date

October 21, 2024

Last Update Submit

November 1, 2024

Conditions

Keywords

stomaİleostomiColostomyEducation of Patients

Outcome Measures

Primary Outcomes (1)

  • State-Trait Anxiety Scale

    The State Anxiety Inventory (STAI-I) was developed by Spielberger in 1970 and its Turkish form was adapted by Öner N. et al. for validity and reliability studies. While the anxiety level is scored as "(1) never, (2) a little, (3) a lot, and (4) completely" in the STAI-I, the options in the Trait Anxiety Inventory (STAI-II) are (1) almost never, (2) sometimes, (3) a lot, and (4) almost always. The scales include "straight" and reversed statements.

    Pre-training 1 day and Post-training 1 day

Secondary Outcomes (2)

  • Adaptation Scale for Individuals with Stoma

    1 day Pre-training and Post-training 1 day

  • Pittman Ostomy Complication Severity Index

    Post-training 1 week

Study Arms (2)

Experimental group

EXPERIMENTAL

Group receiving standard stoma care training + video-supported training

Other: video-supported training

control group

NO INTERVENTION

Group receiving standard stoma care training

Interventions

Patients with stomas were provided with video-supported training in addition to standard stoma care training.

Experimental group

Eligibility Criteria

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

You may qualify if:

  • Having a stoma
  • Being over 18 years old
  • Having no complications from the stoma

You may not qualify if:

  • Having developed any complications in the stoma

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Adnan Menderes University Health Sciences Institute

Aydin, Merkez, 48000, Turkey (Türkiye)

Location

Related Links

Study Officials

  • Senem GÜNEŞ KARA, Ph.D

    Adnan Menderes Üniversity

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Wound Care Service Manager

Study Record Dates

First Submitted

October 21, 2024

First Posted

November 4, 2024

Study Start

January 10, 2021

Primary Completion

September 10, 2022

Study Completion

September 10, 2022

Last Updated

November 4, 2024

Record last verified: 2024-11

Data Sharing

IPD Sharing
Will not share

Locations