The Effect of Using Interactive Mobile Application for the Management of Chemotherapy- Induced Nausea and Vomiting in Children
Primary Purpose
Oncology, Nausea and Vomiting Chemotherapy-Induced, Pediatric Cancer
Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
5inD
Sponsored by
About this trial
This is an interventional supportive care trial for Oncology
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,
Sites / Locations
- Trakya University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
5inD
Control group
Arm Description
All children receive routine antiemetic therapy before chemotherapy. Children in the experimental group will use the interactive mobile application (5inD) for seven days from the first day of chemotherapy. The games in this application will help distract their attention and manage their nausea and vomiting.
All children receive routine antiemetic therapy before chemotherapy.
Outcomes
Primary Outcome Measures
Adapted Rhodes Index of Nausea and Vomiting for Pediatrics
The instrument consists of a series of 5 statements (rated 0-4) for each of the 6 items representing the child's perceptions of the frequency of, duration of, and distress from nausea, and the frequency of, amount of, and distress from vomiting within the past 12 hours.
The ARINV includes 6 items. The first 3 items on the scale question the frequency of, amount of, and distress from vomiting during the last 12 hours and the remaining 3 items question the frequency of, duration of, and distress from nausea. The possible minimum and maximum scores to be obtained from the nausea or vomiting part of the ARINV vary between 0 and 24 per day. The possible minimum and maximum scores to be obtained from the whole ARINV vary between 0 and 48 per day.
Information Form
The information form developed by the researchers includes the socio-demographic characteristics of parents and children; mother's age, father's age, parents 'education level, parents' employment status, number of children, child's age, gender, time of diagnosis of the child, disease stage of the child, types of treatment received, the number of cycles. It consists of 20 questions.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04693832
Brief Title
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
2. Study Status
Record Verification Date
October 2022
Overall Recruitment Status
Completed
Study Start Date
January 1, 2019 (Actual)
Primary Completion Date
April 30, 2021 (Actual)
Study Completion Date
August 30, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Trakya University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Oncology, Nausea and Vomiting Chemotherapy-Induced, Pediatric Cancer, Mobile Application
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
62 (Actual)
8. Arms, Groups, and Interventions
Arm Title
5inD
Arm Type
Experimental
Arm Description
All children receive routine antiemetic therapy before chemotherapy. Children in the experimental group will use the interactive mobile application (5inD) for seven days from the first day of chemotherapy. The games in this application will help distract their attention and manage their nausea and vomiting.
Arm Title
Control group
Arm Type
No Intervention
Arm Description
All children receive routine antiemetic therapy before chemotherapy.
Intervention Type
Device
Intervention Name(s)
5inD
Intervention Description
Interactive Mobile Application which is includes five different game (mandala, puzzle, tetris, music, breath exercise)
Primary Outcome Measure Information:
Title
Adapted Rhodes Index of Nausea and Vomiting for Pediatrics
Description
The instrument consists of a series of 5 statements (rated 0-4) for each of the 6 items representing the child's perceptions of the frequency of, duration of, and distress from nausea, and the frequency of, amount of, and distress from vomiting within the past 12 hours.
The ARINV includes 6 items. The first 3 items on the scale question the frequency of, amount of, and distress from vomiting during the last 12 hours and the remaining 3 items question the frequency of, duration of, and distress from nausea. The possible minimum and maximum scores to be obtained from the nausea or vomiting part of the ARINV vary between 0 and 24 per day. The possible minimum and maximum scores to be obtained from the whole ARINV vary between 0 and 48 per day.
Time Frame
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.
Title
Information Form
Description
The information form developed by the researchers includes the socio-demographic characteristics of parents and children; mother's age, father's age, parents 'education level, parents' employment status, number of children, child's age, gender, time of diagnosis of the child, disease stage of the child, types of treatment received, the number of cycles. It consists of 20 questions.
Time Frame
Children and parents complete this form before the study.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
8 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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,
Facility Information:
Facility Name
Trakya University
City
Edirne
State/Province
Center
ZIP/Postal Code
22030
Country
Turkey
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
The Effect of Using Interactive Mobile Application for the Management of Chemotherapy- Induced Nausea and Vomiting in Children
We'll reach out to this number within 24 hrs