Caregivers Tracheal Aspiration Training

Sponsor
Uludag University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05434442
Collaborator
(none)
66
1
3
8.3
7.9

Study Details

Study Description

Brief Summary

The aim of this study is to determine the effects of animation-based mobile application and simulation-based training methods on tracheal aspiration knowledge and skills of patient relatives who care for patients with tracheostomy/tracheotomy. Experimental pre-test-post-test control group study design was planned.

Condition or Disease Intervention/Treatment Phase
  • Other: simulation model training
  • Other: mobile app training
  • Other: control group
N/A

Detailed Description

The study aims to determine the effect of tracheal aspiration training given to caregivers of patients with tracheostomy and tracheotomy. The effects of training given using clinical routine training, animation-based mobile application and simulation-based training methods on the knowledge and skills of caregivers will be evaluated. Experimental pre-test-post-test control group study design was planned. This study will be carried out as a multicenter in Bursa, Turkey.The centers where the study will be conducted are Bursa Uludağ University Health Research and Application Center and Bursa City Hospital. In calculating the sample size, the effect size was determined as 0.4 for 80% power and 5% significance level. In this direction, it is aimed to include 22 patient relatives in each group in order to compare the knowledge and skill levels between the mobile application, simulation training and control groups. A total of 66 patient relatives will be included in the study. The caregivers to be assigned to the groups will be selected using the block randomized method.

The plan to be implemented in the research;

  1. Pre-Training: "Introductory Characteristics Form" and "Information Evaluation Form" will be filled in for caregivers in all groups.

  2. Training: An animation-based mobile application will be installed on the phones of the caregivers assigned to the "mobile application group" and will be introduced and made available to their use by the researcher Yeliz ŞAPULU ALAKAN.

Tracheal aspiration training of caregivers assigned to the "simulation training group" will be given to the same standard by researcher Yeliz ŞAPULU ALAKAN. It will be shown in practice on the tracheostomy care simulator.

Caregivers assigned to the "control group" will not undergo any training other than routine in-clinic training on tracheostomy aspiration.

Caregivers in the all group will also undergo routine training of the clinic

  1. After the training: Caregivers in all groups will fill out the "Training Evaluation Form" and "Information Evaluation Form." The video of the caregiver taken during the tracheal aspiration procedure will be evaluated by the researchers using the "Skill Evaluation Form".

  2. One month after the training: Caregivers in all groups will fill in the "Information Evaluation Form" and "Result Evaluation Form".The video of the caregiver taken during the tracheal aspiration procedure will be evaluated by the researchers using the "Skill Evaluation Form".

Study Design

Study Type:
Interventional
Anticipated Enrollment :
66 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Caregivers will be assigned to control, simulation and mobile application groups by block randomization method. An equal number of caregivers from each clinic will be assigned to each group.Caregivers will be assigned to control, simulation and mobile application groups by block randomization method. An equal number of caregivers from each clinic will be assigned to each group.
Masking:
Double (Investigator, Outcomes Assessor)
Masking Description:
Caregivers will be assigned to control, simulation and mobile application groups by block randomization method, and communication between groups will be controlled. Caregivers assigned to groups by block randomization method will be numbered. Skill evaluation videos will be taken by a researcher. Skill assessments will also be made by another blinded researcher to the groups.
Primary Purpose:
Supportive Care
Official Title:
Evaluation of the Effectiveness of the Simulation Model and Mobile Application in Teaching Tracheostomy Aspiration Application to the Caregivers of Patients With Tracheostomy and Tracheotomy
Anticipated Study Start Date :
Jun 30, 2022
Anticipated Primary Completion Date :
Dec 10, 2022
Anticipated Study Completion Date :
Mar 10, 2023

Arms and Interventions

Arm Intervention/Treatment
Other: 1-simulation model training

Tracheal aspiration training of caregivers assigned to the "simulation training group" will be given to the same standard by researcher. It will be shown in practice on the tracheostomy care simulator. They will also receive clinical routine training

Other: simulation model training
Tracheal aspiration training of caregivers assigned to the "simulation training group" will be given to the same standard by researcher. It will be shown in practice on the tracheostomy care simulator.

Other: control group
Clinical routine training will be given to caregivers in this group.

Other: 2-mobile app training

An animation-based mobile application will be installed on the phones of the caregivers assigned to the "mobile application group" and will be introduced and made available to their use by the researcher. They will also receive clinical routine training

Other: mobile app training
An animation-based mobile application will be installed on the phones of the caregivers assigned to the "mobile application group" and will be introduced and made available to their use by the researcher.

Other: control group
Clinical routine training will be given to caregivers in this group.

Other: 3-control group

Clinical routine training will be given to caregivers in this group.

Other: control group
Clinical routine training will be given to caregivers in this group.

Outcome Measures

Primary Outcome Measures

  1. To determine the effects of simulation model, mobile application and routine training methods on the knowledge scores of the caregivers of patients with tracheostomy before the training, after the training and one month after the training. [through study completion, an average of 1 year]

    Getting at least 50 points from each part of the "knowledge evaluation form", which includes questions about the procedure.

  2. To determine the effects of simulation model, mobile application and routine training methods on the skill levels of caregivers of patients with tracheostomy before, after and one month after training. [through study completion, an average of 1 year]

    Caregivers will be evaluated according to the "skill evaluation form" during the aspiration process from the tracheostomy.

Secondary Outcome Measures

  1. Satisfaction with different training methods [through study completion, an average of 1 year]

    To be measured using the "Satisfaction Evaluation Form"

  2. One month after the different trainings, the effects of caregivers on the aspiration application will be evaluated using the "Results Evaluation Form". [through study completion, an average of 1 year]

    The effect of different training methods will be evaluated.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
  • Being the primary caregiver of the patient who will undergo a tracheotomy or tracheostomy, which is expected to last at least one month,

  • Primary care will be continued by the same caregiver for a period of one month.

  • Volunteering to participate in the research

  • Being over 18 years old,

  • Absence of a diagnosed psychiatric illness that may interfere with communication

  • Owning and being able to use a smart mobile phone

Exclusion Criteria:
  • Not being the primary caregiver of the patient who will undergo tracheostomy or tracheotomy,

  • Change of primary caregiver in less than a month

  • Closing the tracheotomy in less than a month

  • Not volunteering to participate in the research

  • Be under the age of 18,

  • Having a diagnosed psychiatric illness that may interfere with communication

  • Not having or being unable to use a smart mobile phone

Contacts and Locations

Locations

Site City State Country Postal Code
1 Yeliz Bursa Nilüfer Turkey

Sponsors and Collaborators

  • Uludag University

Investigators

  • Principal Investigator: yeliz Şapulu Alakan, Uludag Universty
  • Study Director: Neriman Akansel, Uludag Universty

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

Responsible Party:
Yeliz Sapulu Alakan, Lecturer, Uludag University
ClinicalTrials.gov Identifier:
NCT05434442
Other Study ID Numbers:
  • Uludag Universty
First Posted:
Jun 28, 2022
Last Update Posted:
Jun 28, 2022
Last Verified:
Jun 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Yeliz Sapulu Alakan, Lecturer, Uludag University

Study Results

No Results Posted as of Jun 28, 2022