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

NCT ID: NCT04693832

Last Updated: 2022-10-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 62 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-01-01
• Study Completion Date: 2021-08-30

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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

5inD

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.

Group Type: EXPERIMENTAL

5inD

Intervention Type: DEVICE

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

Control group

All children receive routine antiemetic therapy before chemotherapy.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

5inD

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

Intervention Type: DEVICE

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,

• Minimum Eligible Age: 8 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Trakya University

OTHER

Sponsor Role: lead

Responsible Party

Remziye Semerci

Research Assistant

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Trakya University

Edirne, Center, Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

Remziye Semerci

Identifier Type: -

Identifier Source: org_study_id