The Effect of Parental Holding and Therapeutic Play with Spiky Ball on Postoperative Anxiety and Physiological responses of children in the Recovery Room

1. Background
Registration Number	INA-XB4E0PR
Date of registry approval	04-03-2024
Registration Date	28-02-2024
Secondary identifiers	No
Name of issuing authority (for example protocol number, other registries, etc)
Secondary identifier number
Scientific study title	The Effect of Parental Holding and Therapeutic Play with Spiky Ball on Postoperative Anxiety and Physiological responses of children in the Recovery Room
Public (popular study title)	The Effect of Parental Holding and Therapeutic Play with Spiky Ball on Postoperative Anxiety and Physiological responses of children in the Recovery Room

2. Sponsor and Funding
Primary Sponsor	KEMENKES RI
Source(s) of monetary or material support	KEMENKES RI
Other partners	-

3. Contact details
Principal Investigator
Principal investigator	Endang Puspita Sari, S.Kep., Ners
City	KABUPATEN BANDUNG
Country	Indonesia
Principal investigator's affiliation	Faculty of Nursing, Universitas Indonesia
Principal Investigator's email address	endang.puspita@ui.ac.id
Public Queries
Contact person name for public queries	ENDANG PUSPITA SARI
Address for public queries	PERMATA KOPO BLOK C NO. 72
City	KABUPATEN BANDUNG
Country	Indonesia
ZIP	40228
Affiliation for public queries	Faculty of Nursing, Universitas Indonesia
Email address for public queries	endang.puspita@ui.ac.id
Phone number for public queries	+6281224506054
Scientific Queries
Name of Contact for scientific queries	Siti Chodidjah, S.Kp., M.N., Ph.D
Address for scientific queries	Jl. Prof. Dr. Bahder Djohan
City	Depok
Country	West Java
ZIP	16424
Affiliation of scientific queries contact	Faculty of Nursing, Universitas Indonesia
Email address for scientific queries	s.chodidjah@ui.ac.id

4. IRB & Regulatory
Ethical Approval number	KET-016/UN2.F12.D1.2.1/PPM.00.02/2024
Name of Ethics committee	Komite Etik FIK UI
Date of Ethic approval	19-01-2024
Contact details of Ethic Committee (phone, email, and office)	Phone: 6221 78849120 Fax: 6221 7864124 Email: publicrelation-nursing@ui.ac.id Gedung Fakultas Ilmu Keperawatan Kampus UI, Depok Jawa Barat, 16424
Number of Persetujuan Pelaksanaan Uji Klinik (PPUK)/Persetujuan Protokol Uji BE (PPUB)	Not applicable

5. Status
Countries of recruitment	Indonesia
Study sites in Indonesia	Bandung, West Java
Recruitment status	Initial
Date of first enrollment	29-02-2024
Targeted Sample size	00078 -
Number of enrolled participants	78
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)	postoperative children
Purpose of the study	Supportive care
Study type	Interventional
Interventional Study category	Clinical trial
Study phase	Phase 1
Method of allocation	Randomized allocation
Description of the allocation concealment mechanism and sequence generation	The recruited children were assigned into three groups randomly, based on the randomizer.org. The paper for group identification was inserted in an opaque, sealed, and sequentially numbered envelope. Subject dan observer (pediatric nursing) were blinded to group assignment.
Masking	double-blind intervention design: Subject dan observer (pediatric nursing) were blinded to group assignment
Study intervention (study arm)	In this study, 3 groups were observed, the parental holding intervention group, the spiky ball playing intervention group, and the control group which received the standard intervention of the presence of parents next to the patient. In this study, anxiety and physiological responses (oxygen saturation, heart rate, respiratory rate and body temperature) were measured 15 minutes before the intervention and the first minute after the 15 minute intervention.
Control intervention (control arm)	The control group which received the standard intervention of the presence of parents next to the patient. In this study, anxiety and physiological responses (oxygen saturation, heart rate, respiratory rate and body temperature) were measured 15 minutes before the intervention and the first minute after the 15 minute intervention.
Intervention assignment	Parallel

7. Eligibility Criteria
Gender inclusion criteria	Male, Female
Minimum age	4 years
Maximum age	12 years
Inclusion criteria	Children aged 4-12 years, Children with an American Society of Anesthesiologists (ASA) 1 or 2, children with elective surgery and general anesthesia, children and parents who can speak Indonesian.
Exclusion criteria	Children with hearing and vision impairments, Children with attention deficit disorder (ADHD, ASD, Down syndrome), Postoperative patients in critical condition, Patients who received surgery on the palms and fingers, parents who cannot be present on the day of the child's surgery.

8. Study Outcome
Primary Outcome
Name of primary outcome	Anxiety and physiological responses (oxygen saturation, heart rate, respiratory rate and body temperature)
Metric/method of measurement	observation anxiety with PACBIS scale (Perioperative Adult and Child Behavioral Interaction Scale) and physiological responses (oxygen saturation, heart rate, respiratory rate and body temperature) with bed-site monitor in recovery room
Timepoint(s) of measurement	Baseline or pre test evaluate on the first patient post surgery transfer to recovery room and children status compos mentis. Then intervention is 15 minuts and evaluation post intervention is in the first after intervension.

9. Study Results
Brief summary of study results
Date of results summaries
Participant flow
Baseline characteristic	Children aged 4-12 years, Children with an American Society of Anesthesiologists (ASA) 1 or 2, children with elective surgery and general anesthesia, children and parents who can speak Indonesian.
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