Clinical trial NCT05831514: Developing a Mobile Application for the Care of Children With Gastrostomy and The Effect of the Application on Gastrostomy
Official title: Developing a Mobile Application for the Care of Children With Gastrostomy and The Effect of the Application on Gastrostomy Complications, Parental Care Burden, Self-Efficacy, and Anxiety Levels
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Neuromuscular Diseases
Gastrointestinal Diseases
Keywords: Care burden
Parent education
Gastrostomy, Nursing
M-health application
Self-efficacy
Lead sponsor: Akdeniz University
Sponsor class: OTHER
First posted: 2023-04-26
Enrollment: 60
Sex: ALL
Minimum age (years): 19
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The research type is a pre-test-repeated post-test randomized controlled single blind study.
Primary purpose: SUPPORTIVE_CARE

Brief summary: Parents of children with gastrostomy have problems with the selection and preparation of nutritional products and catheter care during home care. Parents express that they want to receive practical training in the process of home care of the child with gastrostomy, they want to communicate more with the team and they need continuous monitoring to solve the problems encountered effectively. In this context, it is aimed to establish an appropriate training programme for the care of children with gastrostomy, to provide counselling and follow-up.

Digital health technologies are divided into different sub-branches. Mobile health applications constitute one of these structures. Mobile health applications are used in elective surgical interventions in pediatric surgery (tonsillectomy, hernia repair, circumcision, etc.) and in the home care process after organ transplantation. In pediatric surgery, many mobile health applications have been developed to support pain management, symptom monitoring, medication adherence, support care processes, postoperative follow-up and self-management processes. In mobile health applications, no mobile application has been found for the use of parents of children with gastrostomy. In Turkey, there is no known nursing study for the use of parents of children with gastrostomy. The aim of this study is to develop a mobile application for the care of children with gastrostomy and to determine the effect of the application on gastrostomy complications, care burden of parents, self-efficacy and anxiety level.

Detailed description: Parents of children with gastrostomy have problems with the selection and preparation of nutritional products and catheter care during home care. Parents express that they want to receive practical training in the process of home care of the child with gastrostomy, they want to communicate more with the team and they need continuous monitoring to solve the problems encountered effectively. In this context, it is aimed to establish an appropriate training programme for the care of children with gastrostomy, to provide counselling and follow-up.

Digital health technologies are divided into different sub-branches. Mobile health applications constitute one of these structures. Mobile health applications are used in elective surgical interventions in pediatric surgery (tonsillectomy, hernia repair, circumcision, etc.) and in the home care process after organ transplantation. In pediatric surgery, many mobile health applications have been developed to support pain management, symptom monitoring, medication adherence, support care processes, postoperative follow-up and self-management processes. In mobile health applications, no mobile application has been found for the use of parents of children with gastrostomy. In Turkey, there is no known nursing study for the use of parents of children with gastrostomy. The aim of this study is to develop a mobile application for the care of children with gastrostomy and to determine the effect of the application on gastrostomy complications, care burden of parents, self-efficacy and anxiety level.

This research was planned in two stages as follows:

In the first stage, it was aimed to develop a mobile application supported education programme (G-MUEP) for the care of children with gastrostomy.

In the second stage, it was aimed to evaluate the effectiveness of G-MUEP.

For this purpose, the hypotheses of the research are as follows:

Parents using G-MUEP are more effective than the parents in the control group; Hypothesis 1 (H1): care burden is less. Hypothesis 2 (H1): their self-efficacy is higher. Hypothesis 3 (H1): anxiety levels are lower. Compared to the children in the control group, the children of the parents using G-MUEP; Hypothesis 1 (H1): gastrostomy-related complication findings are less.

Eligibility criteria: Inclusion Criteria:

* The gastrostomy was opened for the child within the last six months,
* The parent's willingness to participate in the study,
* The parent is literate in Turkish,
* Parental use of mobile devices,
* The parent has internet access,
* The parent has no communication barriers.

Exclusion Criteria:

-The parent has internet access problems.

Primary outcomes:
measure: Complication Checklist
timeFrame: 3 Months
measure: Zarit Caregiver Burden Scale
timeFrame: 3 Months
measure: General Self-Efficacy Scale
timeFrame: 3 Months
measure: State/Trait Anxiety Scale
timeFrame: 3 Months
Secondary outcomes:
Other outcomes:
Locations:
city: Antalya
country: Turkey
facility: Turkey
Study officials:
References:
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citation: Pars H, Soyer T. Home Gastrostomy Feeding Education Program: Effects on the Caregiving Burden, Knowledge, and Anxiety Level of Mothers. JPEN J Parenter Enteral Nutr. 2020 Aug;44(6):1029-1037. doi: 10.1002/jpen.1747. Epub 2019 Nov 21.