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NCT Number: NCT03774303

Effectiveness of Mobile Application Intervention in Day Surgery

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.

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Key information

Conditions

Pain Anxiety Anxiety Disorders Fear Mental Disorders Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms Stress

Age range

2 year–6 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Oulu University Hospital

Oulu, 90220, Finland

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Mobile application

Other

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

Current practice

Other

the current practice used to prepare families for day surgery

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

University of Oulu

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Dec 12, 2018
Registry last updated
Apr 30, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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