Vıdeo-Assısted Stoma Care Traınıng Gıven To Patıents Wıth Stoma Adaptıng To Stoma and Complıcatıons
Effect of Video-Assisted Stoma Care Education Given to Patients With Stoma on Postoperative Anxiety, Adapting to Stoma and Complications: A Randomized Controlled Trial
1 other identifier
interventional
42
1 country
1
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
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jan 2021
1 active site
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 Start
First participant enrolled
January 10, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 10, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
September 10, 2022
CompletedFirst Submitted
Initial submission to the registry
October 21, 2024
CompletedFirst Posted
Study publicly available on registry
November 4, 2024
CompletedNovember 4, 2024
November 1, 2024
1.7 years
October 21, 2024
November 1, 2024
Conditions
Keywords
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
EXPERIMENTALGroup receiving standard stoma care training + video-supported training
control group
NO INTERVENTIONGroup receiving standard stoma care training
Interventions
Patients with stomas were provided with video-supported training in addition to standard stoma care training.
Eligibility Criteria
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)
Related Links
Study Officials
- STUDY CHAIR
Senem GÜNEŞ KARA, Ph.D
Adnan Menderes Üniversity
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