Developing a Mobile Application for the Care of Children With Gastrostomy and The Effect of the Application on Gastrostomy

Neuromuscular Diseases Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05831514
• Other study ID #: KoçVakfiBursu
• Secondary ID: 2023.6
• Status: Not yet recruiting
• Phase: N/A
• Start date: July 28, 2023
• Est. completion date: August 28, 2024

Study information

• Verified date: April 2023
• Source: Akdeniz University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: August 28, 2024
• Est. primary completion date: June 28, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 19 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Digestive System Diseases
• Gastrointestinal Diseases
• Neuromuscular Diseases

Intervention

Other:
• Mobile Application Supported Education Program (G-MUEP)
Parents who meet the inclusion criteria will use the Mobile Application Supported Education Program (G-MUEP).

Locations

Country	Name	City	State
Turkey	Turkey	Antalya

Sponsors (1)

Lead Sponsor	Collaborator
Akdeniz University

Country where clinical trial is conducted

Turkey, 

References & Publications (8)

Bischoff SC, Austin P, Boeykens K, Chourdakis M, Cuerda C, Jonkers-Schuitema C, Lichota M, Nyulasi I, Schneider SM, Stanga Z, Pironi L. ESPEN practical guideline: Home enteral nutrition. Clin Nutr. 2022 Feb;41(2):468-488. doi: 10.1016/j.clnu.2021.10.018. Epub 2021 Nov 24. — View Citation

Blumenstein I, Shastri YM, Stein J. Gastroenteric tube feeding: techniques, problems and solutions. World J Gastroenterol. 2014 Jul 14;20(26):8505-24. doi: 10.3748/wjg.v20.i26.8505. — View Citation

Choi EK, Jung E, Ji Y, Bae E. A 2-Step Integrative Education Program and mHealth for Self-Management in Korean Children with Spina Bifida: Feasibility Study. J Pediatr Nurs. 2019 Nov-Dec;49:e54-e62. doi: 10.1016/j.pedn.2019.09.002. Epub 2019 Sep 10. — View Citation

Fuchs S. Gastrostomy Tubes: Care and Feeding. Pediatr Emerg Care. 2017 Dec;33(12):787-791. doi: 10.1097/PEC.0000000000001332. — View Citation

Kahveci G, Akin S. Knowledge Levels and Practices About the Enteral Nutritional Practices of Informal Caregivers Caring for Patients Fed Through a Percutaneous Endoscopic Gastrostomy Tube: A Descriptive Observational Study. Gastroenterol Nurs. 2021 Sep-Oct 01;44(5):E80-E90. doi: 10.1097/SGA.0000000000000623. — View Citation

Pars H, Cavusoglu H. A Literature Review of Percutaneous Endoscopic Gastrostomy: Dealing With Complications. Gastroenterol Nurs. 2019 Jul/Aug;42(4):351-359. doi: 10.1097/SGA.0000000000000320. — View 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. — View Citation

Suluhan D, Yildiz D, Surer I, Fidanci Eren B, Balamtekin N. Effect of Gastrostomy Tube Feeding Education on Parents of Children with Gastrostomy. Nutr Clin Pract. 2021 Dec;36(6):1220-1229. doi: 10.1002/ncp.10586. Epub 2020 Oct 13. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Complication Checklist	A complication checklist consisting of 14 items was created by the researcher to determine the gastrostomy-related complications of the child with gastrostomy by reviewing the relevant literature.	3 Months
Primary	Zarit Caregiver Burden Scale	Zarit Caregiver Burden Scale was developed by Zarit, Reever and Bach Peterson in 1980. It is used to assess the distress experienced by caregivers of individuals in need of care. The scale is a Likert-type scale ranging from 1 to 5 as 'never', 'rarely', 'sometimes', 'often' or 'almost always'. Özlü, Yildiz & Aker (2009), who adapted the scale into Turkish, found the Cronbach's alpha coefficient of the scale to be 0.83 (Özlü, Yildiz, & Aker, 2009). A minimum score of zero and a maximum score of 76 can be obtained from the scale. The items in the scale are generally related to the social and emotional domain, and a high scale score indicates that the distress experienced is high.	3 Months
Primary	General Self-Efficacy Scale	The General Self-Efficacy Scale, developed by Schwarzer and Jarusalem in 1995 and validated by Aypay (2010) in Turkish, consists of 10 items in total. The scale, whose response category consists of a 4-point scale, is scored as "Completely wrong = 1 point", "Somewhat correct = 2 points", "Moderately correct = 3 points", and "Completely correct = 4 points". There are no reverse items and no cut-off points in the scale. The minimum score is 10 and the maximum score is 40. As the scale score increases, perceived self-efficacy increases. The Cronbach's alpha coefficient calculated in the Turkish validity-reliability study was found to be 0.83.	3 Months
Primary	State/Trait Anxiety Scale	State-Trait Anxiety Inventory will be used to measure the anxiety level of the parents. The State-Trait Anxiety Inventory was developed by Spielberger et al. (1970), translated into Turkish by Necla Öner and Le Compte in 1985, and its validity and reliability were tested in different groups. The scale can be applied to individuals over the age of 14. The State/Trait Anxiety Scale includes 40 statements that individuals can use to express their feelings. Depending on how the individual feels and the severity of his/her emotions, it is possible to rate them as "Not at all" (1), "A little" (2), "Quite a bit" (3), "Completely" (4) should mark one of the options.	3 Months