The Effect of Using Interactive Mobile Application for the Management of Chemotherapy- Induced Nausea and Vomiting in Children

NCT04693832 | Completed

• 1 other identifier: Remziye Semerci
• Study Type: interventional
• Target: 62
• Locations: 1 country
• Sites: 1

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.

Conditions

Oncology; Nausea and Vomiting Chemotherapy-Induced; Pediatric Cancer; Mobile Application

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

• 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.

  Children and parents complete this form before the study.

Study Arms (2)

5inD

EXPERIMENTAL

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.

Device: 5inD

Control group

NO INTERVENTION

All children receive routine antiemetic therapy before chemotherapy.

Interventions

5inD DEVICE

Interactive Mobile Application which is includes five different game (mandala, puzzle, tetris, music, breath exercise)

5inD

Eligibility Criteria

• Age: 8 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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,

Sponsors & Collaborators

• Trakya University: lead

Study Sites (1)

Trakya University

Edirne, Center, 22030, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Neoplasms; Nausea

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Assistant

Study Record Dates

• First Submitted: December 23, 2020
• First Posted: January 5, 2021
• Study Start: January 1, 2019
• Primary Completion: April 30, 2021
• Study Completion: August 30, 2021
• Last Updated: October 20, 2022

Record last verified: 2022-10

Locations

TU (1)