Effectiveness of Mobile Application Intervention in Day Surgery

NCT03774303 | Completed

• 1 other identifier: HAK
• Study Type: interventional
• Target: 71
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Pain; Fear; Stress; Anxiety

Outcome Measures

Primary Outcomes (4)

• Parents' Anxiety measured with STAI-Y1.

  The STAI meter is a two-part adult anxiety meter developed by Charles D. Spielberg and his research team (1983). It separates situation related anxiety (STATE-A = Y1) from character related tendency towards anxiety (TRAIT-A). In this study, the most commonly used version of the STAI meter and only it's STATE-A section is utilized. Here, the parent evaluates his own current anxiety on a four-step scale with twenty questions. The respondents choose from the following options at each question: 1 = no anxiety at all, 2 = slight anxiety, 3 = some anxiety 4 = very much anxiety.

  first measurement at home before the procedure

• Parents' Anxiety measured with STAI-Y1.

  The STAI meter is a two-part adult anxiety meter developed by Charles D. Spielberg and his research team (1983). It separates situation related anxiety (STATE-A = Y1) from character related tendency towards anxiety (TRAIT-A). In this study, the most commonly used version of the STAI meter and only it's STATE-A section is utilized. Here, the parent evaluates his own current anxiety on a four-step scale with twenty questions. The respondents choose from the following options at each question: 1 = no anxiety at all, 2 = slight anxiety, 3 = some anxiety 4 = very much anxiety.

  second measurement in the hospital before the procedure

• Parents' Anxiety measured with STAI-Y1.

  The STAI meter is a two-part adult anxiety meter developed by Charles D. Spielberg and his research team (1983). It separates situation related anxiety (STATE-A = Y1) from character related tendency towards anxiety (TRAIT-A). In this study, the most commonly used version of the STAI meter and only it's STATE-A section is utilized. Here, the parent evaluates his own current anxiety on a four-step scale with twenty questions. The respondents choose from the following options at each question: 1 = no anxiety at all, 2 = slight anxiety, 3 = some anxiety 4 = very much anxiety.

  third measurement in the hospital before discharge

• Parents' Anxiety measured with STAI-Y1.

  The STAI meter is a two-part adult anxiety meter developed by Charles D. Spielberg and his research team (1983). It separates situation related anxiety (STATE-A = Y1) from character related tendency towards anxiety (TRAIT-A). In this study, the most commonly used version of the STAI meter and only it's STATE-A section is utilized. Here, the parent evaluates his own current anxiety on a four-step scale with twenty questions. The respondents choose from the following options at each question: 1 = no anxiety at all, 2 = slight anxiety, 3 = some anxiety 4 = very much anxiety.

  fourth measurement at home within 1-7 days after the procedure

Secondary Outcomes (16)

• Parents' Stress with VRSS

  first measurement at home before the procedure

• Parents' Stress with VRSS

  second measurement in the hospital before the procedure

• Parents' Stress with VRSS

  third measurement in the hospital before discharge

• Parents' Stress with VRSS

  fourth measurement at home within 1-7 days after the procedure

• Children's Fear with FAS

  first measurement at home before the procedure

Study Arms (2)

mobile intervention

EXPERIMENTAL

families to be prepared for day surgery with a mobile application

Other: Mobile application

control group

ACTIVE COMPARATOR

families to be prepared for day surgery with current practice

Other: current practice

Interventions

Mobile application OTHER

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

mobile intervention

current practice OTHER

the current practice used to prepare families for day surgery

control group

Eligibility Criteria

• Age: 2 Years - 6 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

Sponsors & Collaborators

• University of Oulu: lead

Study Sites (1)

Oulu University Hospital

Oulu, 90220, Finland

Location

Related Publications (2)

• 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.

  PMID: 40410077 DERIVED

• 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.

  PMID: 37773624 DERIVED

MeSH Terms

Conditions

Pain; Anxiety Disorders

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: RCT

Study Record Dates

• First Submitted: November 27, 2018
• First Posted: December 12, 2018
• Study Start: January 19, 2018
• Primary Completion: December 31, 2019
• Study Completion: December 31, 2019
• Last Updated: April 30, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share

Locations

FI (1)