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Effectiveness of Mobile Application Intervention in Day Surgery

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ClinicalTrials.gov Identifier: NCT03774303
Recruitment Status : Recruiting
First Posted : December 12, 2018
Last Update Posted : December 12, 2018
Sponsor:
Information provided by (Responsible Party):
University of Oulu

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.


Condition or disease Intervention/treatment Phase
Pain Fear Stress Anxiety Other: Mobile application Other: current practice Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: RCT
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Effectiveness of Mobile Application Intervention on Preschool Children's Fear and Pain and Their Parents' Anxiety and Stress in Day Surgery
Actual Study Start Date : January 19, 2018
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety

Arm Intervention/treatment
Experimental: mobile intervention
families to be prepared for day surgery with a mobile application
Other: Mobile application
A mobile application that will be used to prepare families for day surgery

Active Comparator: control group
families to be prepared for day surgery with current practice
Other: current practice
the current practice used to prepare families for day surgery




Primary Outcome Measures :
  1. Parents' Anxiety measured with STAI-Y1. [ Time Frame: first measurement at home before the procedure ]
    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.

  2. Parents' Anxiety measured with STAI-Y1. [ Time Frame: second measurement in the hospital before the procedure ]
    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.

  3. Parents' Anxiety measured with STAI-Y1. [ Time Frame: third measurement in the hospital before discharge ]
    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.

  4. Parents' Anxiety measured with STAI-Y1. [ Time Frame: fourth measurement at home within 1-7 days after the procedure ]
    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 :
  1. Parents' Stress with VRSS [ Time Frame: first measurement at home before the procedure ]
    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.

  2. Parents' Stress with VRSS [ Time Frame: second measurement in the hospital before the procedure ]
    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.

  3. Parents' Stress with VRSS [ Time Frame: third measurement in the hospital before discharge ]
    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.

  4. Parents' Stress with VRSS [ Time Frame: fourth measurement at home within 1-7 days after the procedure ]
    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.

  5. Children's Fear with FAS [ Time Frame: first measurement at home before the procedure ]
    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.

  6. Children's Fear with FAS [ Time Frame: second measurement in the hospital before the procedure ]
    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.

  7. Children's Fear with FAS [ Time Frame: third measurement in the hospital before discharge ]
    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.

  8. Children's Fear with FAS [ Time Frame: fourth measurement at home within 1-7 days after the procedure ]
    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.

  9. Children's Pain with PPPM [ Time Frame: first measurement at home before the procedure ]
    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.

  10. Children's Pain with PPPM [ Time Frame: second measurement in the hospital before the procedure ]
    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.

  11. Children's Pain with PPPM [ Time Frame: third measurement in the hospital before discharge ]
    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.

  12. Children's Pain with PPPM [ Time Frame: fourth measurement at home within 1-7 days after the procedure ]
    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.

  13. Children's Pain with VAS [ Time Frame: first measurement at home before the procedure ]
    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.

  14. Children's Pain with VAS [ Time Frame: second measurement in the hospital before the procedure ]
    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.

  15. Children's Pain with VAS [ Time Frame: third measurement in the hospital before discharge ]
    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.

  16. Children's Pain with VAS [ Time Frame: fourth measurement at home within 1-7 days after the procedure ]
    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.



Information from the National Library of Medicine

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Ages Eligible for Study:   2 Years to 6 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03774303


Contacts
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Contact: Heli A Kerimaa, MSc. +358443569183 heli.kerimaa@gmail.com
Contact: Tarja Pölkki, Docent +358405817069 tarja.polkki@ppshp.fi

Locations
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Finland
Oulu University Hospital Recruiting
Oulu, Finland, 90220
Contact: Tarja Pölkki, Docent    0358405817069    tarja.polkki@ppshp.fi   
Contact: Willy Serlo, Professor    +35883155189    willy.serlo@ppshp.fi   
Principal Investigator: Heli A Kerimaa, MSc.         
Sponsors and Collaborators
University of Oulu
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Responsible Party: University of Oulu
ClinicalTrials.gov Identifier: NCT03774303    
Other Study ID Numbers: HAK
First Posted: December 12, 2018    Key Record Dates
Last Update Posted: December 12, 2018
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Anxiety Disorders
Mental Disorders