NCT03774303

Effectiveness of Mobile Application Intervention in Day Surgery

Completed NA Last updated 30 April 2021

What this trial tests

NA trial testing Mobile application in Pain in 71 participants. Completed in 31 December 2019.

Timeline

19 January 2018

Primary endpoint
31 December 2019

31 December 2019

Quick facts

Lead sponsor	University of Oulu
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	other
Enrollment	71
Start date	19 January 2018
Primary completion	31 December 2019
Estimated completion	31 December 2019
Sites	1 location across Finland

Drugs / interventions tested

• Mobile application
• current practice — full drug profile →

Conditions studied

• Pain — all drugs for Pain →
• Fear — all drugs for Fear →
• Stress — all drugs for Stress →
• Anxiety — all drugs for Anxiety →

Sponsor

University of Oulu

Who can join

Adults 2 to 6, any sex, with Pain or Fear. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

In Finland about 50% of surgical operations for all under 16 years of age are made as day surgery which means that the patient comes to the hospital and is discharged on the day of the operation. Day surgery will continue to grow in the next few years. Its benefits include shorter hospitalization, family reunion and rapid recovery. The preschool children and their parents who come in for day surgery feel fear, anxiety and stress, which depend on the amount of knowledge and its quality. By developing the preparation of preschool children and their parents for day surgery, and by testing new methods more attention can be paid to the special features of day surgery, supporting the families, and increasing family involvement in the whole process.

The purpose of this study is to describe and evaluate the effectiveness of a new mobile application intervention compared to the effectiveness of the traditional preparing method when measuring preschool children's fear and pain and their parents' anxiety and stress. The aim is to produce new information and to develop day surgery of preschool children.

The study consist of two phases. The first phase of the research is a systematic literature review and meta-analysis. The purpose of the review is to assess and describe the methods previously used in the preparation of parental day surgery and their effectiveness for preschool children fear and pain and parents' anxiety and stress. The second phase of the study is carried out as a randomized controlled trial (=RCT). The parents of the preschool children are randomized to the mobile application group (n = 50-60) and the control group (n = 50-60). The sample size is based on power-analysis, with anxiety as the primary outcome. The material for the second phase of the study is collected at the day surgery department of the Oulu University Hospital. The study group is prepared for day surgery with a new mobile application and the control group according to the traditional preparing method. The study examines the effectiveness of a new intervention compared to the effectiveness of the traditional preparing method when measuring preschool children's fear and pain and their parents' anxiety and stress. The collected data are analyzed using the Mann-Whitney, t-test, Khi square test, and Fisher's accurate test.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Effectiveness of a Mobile App Intervention for Preparing Preschool Children and Parents for Day Surgery: Randomized Controlled Trial.
   Kerimaa H, Hakala M, Haapea M, Vähänikkilä H, et al · · 2023 · cited 6× · PMID 37773624 · DOI 10.2196/46989
2. Effectiveness of Digital Counseling for Parents' Use of Nonpharmacological Pain-Relieving Methods in Pediatric Day Surgery.
   Kerimaa H, Pölkki T. · · 2025 · PMID 40410077 · DOI 10.1016/j.pmn.2025.04.011