Effectiveness of Mobile Application Intervention in Day Surgery

NCT ID: NCT03774303

Last Updated: 2021-04-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

71 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-01-19

Study Completion Date

2019-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Pain Fear Stress Anxiety

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

RCT
Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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mobile intervention

families to be prepared for day surgery with a mobile application

Group Type EXPERIMENTAL

Mobile application

Intervention Type OTHER

A mobile application that will be used to prepare families for day surgery

control group

families to be prepared for day surgery with current practice

Group Type ACTIVE_COMPARATOR

current practice

Intervention Type OTHER

the current practice used to prepare families for day surgery

Interventions

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Mobile application

A mobile application that will be used to prepare families for day surgery

Intervention Type OTHER

current practice

the current practice used to prepare families for day surgery

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* ASA 1 or 2
* ELECTIVE DAY SURGIGAL PROCEDURE IN 3-4 WEEKS
* PARENT ABLE TO USE MOBILE INTERVENTION, UNDERSTANDS FINNISH AND WILLING TO PARTICIPATE IN PREPARING CHILD FOR DAY SURGERY
* GENERAL ANAESTHESIA
Minimum Eligible Age

2 Years

Maximum Eligible Age

6 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Oulu

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Oulu University Hospital

Oulu, , Finland

Site Status

Countries

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Finland

References

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Kerimaa H, Polkki T. Effectiveness of Digital Counseling for Parents' Use of Nonpharmacological Pain-Relieving Methods in Pediatric Day Surgery. Pain Manag Nurs. 2025 Oct;26(5):544-554. doi: 10.1016/j.pmn.2025.04.011. Epub 2025 May 22.

Reference Type DERIVED
PMID: 40410077 (View on PubMed)

Kerimaa H, Hakala M, Haapea M, Vahanikkila H, Serlo W, He HG, Polkki T. Effectiveness of a Mobile App Intervention for Preparing Preschool Children and Parents for Day Surgery: Randomized Controlled Trial. J Med Internet Res. 2023 Sep 29;25:e46989. doi: 10.2196/46989.

Reference Type DERIVED
PMID: 37773624 (View on PubMed)

Other Identifiers

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HAK

Identifier Type: -

Identifier Source: org_study_id

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