Efektivitas Penggunaan Virtual Reality Terhadap Peningkatan Nafsu Makan Pada Anak yang Dirawat di Rumah Sakit

1. Background
Registration Number	INA-4348PE49
Date of registry approval	07-03-2025
Registration Date	07-03-2025
Secondary identifiers	No
Name of issuing authority (for example protocol number, other registries, etc)
Secondary identifier number
Scientific study title	Efektivitas Penggunaan Virtual Reality Terhadap Peningkatan Nafsu Makan Pada Anak yang Dirawat di Rumah Sakit
Public (popular study title)	Efektivitas Penggunaan Virtual Reality Terhadap Peningkatan Nafsu Makan Pada Anak yang Dirawat di Rumah Sakit

2. Sponsor and Funding
Primary Sponsor	Yelly Sari Arifin
Source(s) of monetary or material support	Universitas indonesia
Other partners	Not Specified

3. Contact details
Principal Investigator
Principal investigator	Yelly Sari Arifin
City	Depok
Country	Indonesia
Principal investigator's affiliation	Yelly Sari Arifin
Principal Investigator's email address	yelly.sari@ui.ac.id
Public Queries
Contact person name for public queries	Yelly Sari Arifin
Address for public queries	Perumahan Amaris Residence, Cimanggis Blok B N0.10 RT 02 RW 07, Kabupaten Bogor, Jawa Barat, Indonesia
City	Bogor
Country	Indonesia
ZIP	16424
Affiliation for public queries	Yelly Sari Arifin
Email address for public queries	yellysaria@gmail.com
Phone number for public queries	081276590211
Scientific Queries
Name of Contact for scientific queries	Yelly Sari Arifin
Address for scientific queries	Perumahan Amaris Residence, Cimanggis Blok B N0.10 RT 02 RW 07, Kabupaten Bogor, Jawa Barat, Indonesia
City	Bogor
Country	Indonesia
ZIP	16920
Affiliation of scientific queries contact	Universitas indonesia, Fakultas Ilmu Keperawatan
Email address for scientific queries	yelly.sari@ui.ac.id / yellysaria@gmail.com

4. IRB & Regulatory
Ethical Approval number	07/KOMETHUK/II/2025
Name of Ethics committee	Komite Etik Penelitian Kesehatan RSUD Pasar Minggu
Date of Ethic approval	17-02-2025
Contact details of Ethic Committee (phone, email, and office)	Phone:(021) 29407035 Email:rsudpasarminggu@jakarta.go.id Office Address:RSUD Pasar Minggu, Jl. TB. Simatupang No. 1, Kelurahan Ragunan, Kecamatan Pasar Minggu, Jakarta, Indonesia, Kode Pos: 12550
Number of Persetujuan Pelaksanaan Uji Klinik (PPUK)/Persetujuan Protokol Uji BE (PPUB)	Not applicable

5. Status
Countries of recruitment	Not Specified
Study sites in Indonesia	RSUD Pasar Minggu, Jakarta Selatan
Recruitment status	Recruit
Date of first enrollment	20-02-2025
Targeted Sample size	00052 -
Number of enrolled participants	10
Date of study completion (last participant, last visit)

6. Study Design & Purpose
Primary health condition(s) or problem(s) studied (e.g., depression, breast cancer,medication error)	Nafsu Makan Rendah pada Anak
Purpose of the study	Treatment
Study type	Interventional
Interventional Study category	Interventional, other than clinical trial
Method of allocation	Non-randomized allocation
Description of the allocation concealment mechanism and sequence generation
Masking	No (open)
Study intervention (study arm)	Virtual Reality Therapy for Appetite Stimulation
Control intervention (control arm)	Not Specified
Intervention assignment	Single arm

7. Eligibility Criteria
Gender inclusion criteria	Not specified
Minimum age	5 years
Maximum age	12 years
Inclusion criteria	Children aged 5 to 12 years (have cognitive abilities that are able to receive instructions), stable medical status, able to use VR devices and tolerate one VR session for 3 days with a duration of 5 minutes, obtain written consent from parents or guardians, experience decreased appetite during hospitalization, do not have severe visual or hearing impairments.
Exclusion criteria	Children aged 5 to 12 years (have cognitive abilities that are able to receive instructions), Stable medical status, Able to use VR devices and tolerate one VR session for 3 days with a duration of 5 minutes, Obtain written consent from parents or guardians, Experience decreased appetite during hospitalization, Do not have severe visual or hearing impairments.

8. Study Outcome
Primary Outcome
Name of primary outcome	Children's Appetite Expressed Through the Visual Analogue Scale (VAS)
Metric/method of measurement	Visual Analogue Scale (VAS) to measure appetite
Timepoint(s) of measurement	35 minutes before meals, with a duration of 5 minutes of VR, one session per day for 3 days.

9. Study Results
Brief summary of study results
Date of results summaries
Participant flow
Baseline characteristic	Average age of participants 5-12 YEARS, gender (male and female), pre-existing medical conditions
Adverse events
Outcome measures

10. Publication
URL hyperlink(s) related to results and publications
IPD sharing statement (Statement regarding the intended sharing of deidentified individual clinical trial participant-level data (IPD))	No
Plan for IPD sharing (what IPD will be shared, when, by what mechanism, with whom, and for what types of analyses)
Other important informations	PThis study aims to explore the effectiveness of virtual reality intervention in improving appetite in children with decreased appetite. All procedures will be carried out in accordance with research ethics guidelines and have been approved by the relevant ethics committees.