Effectiveness of Mobile Application Intervention in Day Surgery

Study Overview
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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.

Official Title
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Effectiveness of Mobile Application Intervention on Preschool Children's Fear and Pain and Their Parents' Anxiety and Stress in Day Surgery

Conditions
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Pain, Fear, Stress, Anxiety

Intervention / Treatment
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* Other: Mobile application
* Other: current practice


Participation Criteria
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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 Exclusion Criteria: INCLUSION CRITERIA NOT MET

Ages Eligible for Study
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Minimum Age: 2 Years
Maximum Age: 6 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: RCT
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: mobile intervention<br>families to be prepared for day surgery with a mobile application | Other: Mobile application<br>* A mobile application that will be used to prepare families for day surgery<br>|
| Active Comparator: control group<br>families to be prepared for day surgery with current practice | Other: current practice<br>* the current practice used to prepare families for day surgery<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Parents' Stress with VRSS | VRSS (short Verbal Rating Scale for Stress). The VRSS meter measures stress experienced by the parent. The meter consists of six claims: 0 = I did not feel stress at all 1 = I felt little stress 2 = I felt some stress 3 = I felt quite a lot of stress 4 = I felt a lot of stress 5 = I felt the worst stress imaginable. | first measurement at home before the procedure | 
| Parents' Stress with VRSS | VRSS (short Verbal Rating Scale for Stress). The VRSS meter measures stress experienced by the parent. The meter consists of six claims: 0 = I did not feel stress at all 1 = I felt little stress 2 = I felt some stress 3 = I felt quite a lot of stress 4 = I felt a lot of stress 5 = I felt the worst stress imaginable. | second measurement in the hospital before the procedure | 
| Parents' Stress with VRSS | VRSS (short Verbal Rating Scale for Stress). The VRSS meter measures stress experienced by the parent. The meter consists of six claims: 0 = I did not feel stress at all 1 = I felt little stress 2 = I felt some stress 3 = I felt quite a lot of stress 4 = I felt a lot of stress 5 = I felt the worst stress imaginable. | third measurement in the hospital before discharge | 
| Parents' Stress with VRSS | VRSS (short Verbal Rating Scale for Stress). The VRSS meter measures stress experienced by the parent. The meter consists of six claims: 0 = I did not feel stress at all 1 = I felt little stress 2 = I felt some stress 3 = I felt quite a lot of stress 4 = I felt a lot of stress 5 = I felt the worst stress imaginable. | fourth measurement at home within 1-7 days after the procedure | 
| Children's Fear with FAS | FAS (Facial Affective Scale). The FAS meter measures the child's fear with nine facial images and describes its intensity ranging from no fear to the worst possible fear. | first measurement at home before the procedure | 
| Children's Fear with FAS | FAS (Facial Affective Scale). The FAS meter measures the child's fear with nine facial images and describes its intensity ranging from no fear to the worst possible fear. | second measurement in the hospital before the procedure | 
| Children's Fear with FAS | FAS (Facial Affective Scale). The FAS meter measures the child's fear with nine facial images and describes its intensity ranging from no fear to the worst possible fear. | third measurement in the hospital before discharge | 
| Children's Fear with FAS | FAS (Facial Affective Scale). The FAS meter measures the child's fear with nine facial images and describes its intensity ranging from no fear to the worst possible fear. | fourth measurement at home within 1-7 days after the procedure | 
| Children's Pain with PPPM | PPPM (Parent's Postoperative Pain Measure). The PPPM meter measures pain behavior of children aged 1 to 6 years of age as assessed by their parents. The PPPM meter is divided into a section for 1-to 2 -year-old children and another section for 3- to 6 -year-olds. | first measurement at home before the procedure | 
| Children's Pain with PPPM | PPPM (Parent's Postoperative Pain Measure). The PPPM meter measures pain behavior of children aged 1 to 6 years of age as assessed by their parents. The PPPM meter is divided into a section for 1-to 2 -year-old children and another section for 3- to 6 -year-olds. | second measurement in the hospital before the procedure | 
| Children's Pain with PPPM | PPPM (Parent's Postoperative Pain Measure). The PPPM meter measures pain behavior of children aged 1 to 6 years of age as assessed by their parents. The PPPM meter is divided into a section for 1-to 2 -year-old children and another section for 3- to 6 -year-olds. | third measurement in the hospital before discharge | 
| Children's Pain with PPPM | PPPM (Parent's Postoperative Pain Measure). The PPPM meter measures pain behavior of children aged 1 to 6 years of age as assessed by their parents. The PPPM meter is divided into a section for 1-to 2 -year-old children and another section for 3- to 6 -year-olds. | fourth measurement at home within 1-7 days after the procedure | 
| Children's Pain with VAS | VAS (Visual Analogy Scale). The VAS scale allows the parents to evaluate the intensity of the pain of their children on a 10cm long scale that starts at zero meaning no pain at all and ends at 10 representing the worst possible pain. Preschool children evaluate their pain with a face scale, also where zero means no pain and ten means the worst possible pain. | first measurement at home before the procedure | 
| Children's Pain with VAS | VAS (Visual Analogy Scale). The VAS scale allows the parents to evaluate the intensity of the pain of their children on a 10cm long scale that starts at zero meaning no pain at all and ends at 10 representing the worst possible pain. Preschool children evaluate their pain with a face scale, also where zero means no pain and ten means the worst possible pain. | second measurement in the hospital before the procedure | 
| Children's Pain with VAS | VAS (Visual Analogy Scale). The VAS scale allows the parents to evaluate the intensity of the pain of their children on a 10cm long scale that starts at zero meaning no pain at all and ends at 10 representing the worst possible pain. Preschool children evaluate their pain with a face scale, also where zero means no pain and ten means the worst possible pain. | third measurement in the hospital before discharge | 
| Children's Pain with VAS | VAS (Visual Analogy Scale). The VAS scale allows the parents to evaluate the intensity of the pain of their children on a 10cm long scale that starts at zero meaning no pain at all and ends at 10 representing the worst possible pain. Preschool children evaluate their pain with a face scale, also where zero means no pain and ten means the worst possible pain. | fourth measurement at home within 1-7 days after the procedure |