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Effectiveness of Mobile Application Intervention in Day Surgery

Primary Purpose

Pain, Fear, Stress

Status
Completed
Phase
Not Applicable
Locations
Finland
Study Type
Interventional
Intervention
Mobile application
current practice
Sponsored by
University of Oulu
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Pain

Eligibility Criteria

2 Years - 6 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Oulu University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

mobile intervention

control group

Arm Description

families to be prepared for day surgery with a mobile application

families to be prepared for day surgery with current practice

Outcomes

Primary Outcome Measures

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.
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.
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.
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.

Secondary Outcome Measures

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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.

Full Information

First Posted
November 27, 2018
Last Updated
April 29, 2021
Sponsor
University of Oulu
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1. Study Identification

Unique Protocol Identification Number
NCT03774303
Brief Title
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

2. Study Status

Record Verification Date
April 2021
Overall Recruitment Status
Completed
Study Start Date
January 19, 2018 (Actual)
Primary Completion Date
December 31, 2019 (Actual)
Study Completion Date
December 31, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Oulu

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Fear, Stress, Anxiety

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
RCT
Masking
None (Open Label)
Allocation
Randomized
Enrollment
71 (Actual)

8. Arms, Groups, and Interventions

Arm Title
mobile intervention
Arm Type
Experimental
Arm Description
families to be prepared for day surgery with a mobile application
Arm Title
control group
Arm Type
Active Comparator
Arm Description
families to be prepared for day surgery with current practice
Intervention Type
Other
Intervention Name(s)
Mobile application
Intervention Description
A mobile application that will be used to prepare families for day surgery
Intervention Type
Other
Intervention Name(s)
current practice
Intervention Description
the current practice used to prepare families for day surgery
Primary Outcome Measure Information:
Title
Parents' Anxiety measured with STAI-Y1.
Description
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.
Time Frame
first measurement at home before the procedure
Title
Parents' Anxiety measured with STAI-Y1.
Description
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.
Time Frame
second measurement in the hospital before the procedure
Title
Parents' Anxiety measured with STAI-Y1.
Description
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.
Time Frame
third measurement in the hospital before discharge
Title
Parents' Anxiety measured with STAI-Y1.
Description
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.
Time Frame
fourth measurement at home within 1-7 days after the procedure
Secondary Outcome Measure Information:
Title
Parents' Stress with VRSS
Description
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.
Time Frame
first measurement at home before the procedure
Title
Parents' Stress with VRSS
Description
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.
Time Frame
second measurement in the hospital before the procedure
Title
Parents' Stress with VRSS
Description
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.
Time Frame
third measurement in the hospital before discharge
Title
Parents' Stress with VRSS
Description
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.
Time Frame
fourth measurement at home within 1-7 days after the procedure
Title
Children's Fear with FAS
Description
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.
Time Frame
first measurement at home before the procedure
Title
Children's Fear with FAS
Description
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.
Time Frame
second measurement in the hospital before the procedure
Title
Children's Fear with FAS
Description
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.
Time Frame
third measurement in the hospital before discharge
Title
Children's Fear with FAS
Description
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.
Time Frame
fourth measurement at home within 1-7 days after the procedure
Title
Children's Pain with PPPM
Description
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.
Time Frame
first measurement at home before the procedure
Title
Children's Pain with PPPM
Description
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.
Time Frame
second measurement in the hospital before the procedure
Title
Children's Pain with PPPM
Description
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.
Time Frame
third measurement in the hospital before discharge
Title
Children's Pain with PPPM
Description
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.
Time Frame
fourth measurement at home within 1-7 days after the procedure
Title
Children's Pain with VAS
Description
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.
Time Frame
first measurement at home before the procedure
Title
Children's Pain with VAS
Description
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.
Time Frame
second measurement in the hospital before the procedure
Title
Children's Pain with VAS
Description
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.
Time Frame
third measurement in the hospital before discharge
Title
Children's Pain with VAS
Description
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.
Time Frame
fourth measurement at home within 1-7 days after the procedure

10. Eligibility

Sex
All
Minimum Age & Unit of Time
2 Years
Maximum Age & Unit of Time
6 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Oulu University Hospital
City
Oulu
ZIP/Postal Code
90220
Country
Finland

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Effectiveness of Mobile Application Intervention in Day Surgery

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