Clinical trial NCT03774303: Effectiveness of Mobile Application Intervention in Day Surgery
Official title: Effectiveness of Mobile Application Intervention on Preschool Children's Fear and Pain and Their Parents' Anxiety and Stress in Day Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain
Fear
Stress
Anxiety
Lead sponsor: University of Oulu
Sponsor class: OTHER
First posted: 2018-12-12
Enrollment: 71
Sex: ALL
Minimum age (years): 2
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: RCT
Primary purpose: OTHER

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.


Eligibility criteria: 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

Exclusion Criteria:

* INCLUSION CRITERIA NOT MET

Primary outcomes:
measure: Parents' Anxiety measured with STAI-Y1.
timeFrame: first measurement at home before the procedure
measure: Parents' Anxiety measured with STAI-Y1.
timeFrame: second measurement in the hospital before the procedure
measure: Parents' Anxiety measured with STAI-Y1.
timeFrame: third measurement in the hospital before discharge
measure: Parents' Anxiety measured with STAI-Y1.
timeFrame: fourth measurement at home within 1-7 days after the procedure
Secondary outcomes:
measure: Parents' Stress with VRSS
timeFrame: first measurement at home before the procedure
measure: Parents' Stress with VRSS
timeFrame: second measurement in the hospital before the procedure
measure: Parents' Stress with VRSS
timeFrame: third measurement in the hospital before discharge
measure: Parents' Stress with VRSS
timeFrame: fourth measurement at home within 1-7 days after the procedure
measure: Children's Fear with FAS
timeFrame: first measurement at home before the procedure
measure: Children's Fear with FAS
timeFrame: second measurement in the hospital before the procedure
measure: Children's Fear with FAS
timeFrame: third measurement in the hospital before discharge
measure: Children's Fear with FAS
timeFrame: fourth measurement at home within 1-7 days after the procedure
measure: Children's Pain with PPPM
timeFrame: first measurement at home before the procedure
measure: Children's Pain with PPPM
timeFrame: second measurement in the hospital before the procedure
measure: Children's Pain with PPPM
timeFrame: third measurement in the hospital before discharge
measure: Children's Pain with PPPM
timeFrame: fourth measurement at home within 1-7 days after the procedure
measure: Children's Pain with VAS
timeFrame: first measurement at home before the procedure
measure: Children's Pain with VAS
timeFrame: second measurement in the hospital before the procedure
measure: Children's Pain with VAS
timeFrame: third measurement in the hospital before discharge
measure: Children's Pain with VAS
timeFrame: fourth measurement at home within 1-7 days after the procedure
Other outcomes:
Locations:
city: Oulu
country: Finland
facility: Oulu University Hospital
Study officials:
References: