Clinical trial NCT04693832: The Effect of Using Interactive Mobile Application for the Management of Chemotherapy- Induced Nausea and Vomiting in Children
Official title: Trakya University, Scientific Research Projects Unit
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Oncology
Nausea and Vomiting Chemotherapy-Induced
Pediatric Cancer
Mobile Application
Lead sponsor: Trakya University
Sponsor class: OTHER
First posted: 2021-01-05
Enrollment: 62
Sex: ALL
Minimum age (years): 8
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The aim of this study was to develop an interactive mobile application and to investigate the effect of this application on the management of nausea and vomiting symptoms by using it during chemotherapy treatment.

Detailed description: Intensive chemotherapy protocols are the most commonly used treatments in childhood cancers. While these protocols increase recovery rates, they may also cause some undesirable side effects. Nausea and vomiting are one of the most common toxic side effects associated with chemotherapy. The aim of this study was to develop an interactive mobile application and to investigate the effect of this application on the management of nausea and vomiting symptoms by using it during chemotherapy treatment.

The study will be conducted with 61 children between 8-18 years of age who received chemotherapy in the Pediatric Hematology-Oncology Clinic at Trakya University Health Research and Application Center. The study was planned as a randomized controlled study. Data will be collected with the "Information Form" and "Rhodes Adapted Rhodes Nausea and Vomiting Scale for Children". The interactive mobile application will be downloaded to the phones of the experimental group and this device will be used from the first chemotherapy day to the seventh day. While the experimental group evaluates their nausea and vomiting via mobile application twice a day, every 12 hours for one week, the control group will record their nausea and vomiting experiences in the "Nausea and Vomiting Diary". While the experimental group will be able to use the mobile application which consists of diverting attention, routine control will be applied to the control group.

Eligibility criteria: Inclusion Criteria:

* Taking chemotherapy treatment,
* To be in the age range of 8-18,
* Volunteering to participate in research,
* Having the first course of chemotherapy,

Exclusion Criteria:

* Having a mental problem,
* Absence of vision, hearing and speech problems,
* Absence of problems with the gastrointestinal system,
* Being in the terminal period,
* Receiving sedation therapy,

Primary outcomes:
measure: Adapted Rhodes Index of Nausea and Vomiting for Pediatrics
timeFrame: Both children and their mother's assess children's frequency of the nause and vomiting twice a day, every 12 hours during one week from the first chemotherap' day to the seventh day.
measure: Information Form
timeFrame: Children and parents complete this form before the study.
Secondary outcomes:
Other outcomes:
Locations:
city: Edirne
country: Turkey
facility: Trakya University
state: Center
Study officials:
References: