Reducing Anxiety of Children and Their Parents in the Pre-elective Surgery Process

Study Overview
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Brief Summary
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It is emphasized in the studies that the child and parent anxiety that occurs in pediatric surgery should be prevented or reduced. According to previous studies, one way to reduce child and parent anxiety in the preoperative process is distraction interventions the child and family with preoperative family-centered activities. Teaching children anxiety coping skills with the involvement of their parents can reduce preoperative anxiety. This study was planned to Comparison of the effectiveness of two different distraction interventions (distraction with play dough- distraction with kaleidoscope) in reducing preoperative anxiety of children and parents who are scheduled for elective surgery

Detailed Description
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Aim: This study was planned to Comparison of the effectiveness of two different distraction interventions (distraction with play dough- distraction with kaleidoscope) in reducing preoperative anxiety of children and parents who are scheduled for elective surgery Method: This study was planned as a randomized controlled trial. The sample of the study will consist of 105 children aged 5-12, who will be operated on at Akdeniz University Hospital, and their parents. Randomization result; It was planned to include a total of 105 children and their parents in 3 groups: distraction with play dough group (intervention group 1)= 35, distraction with kaleidoscope group (intervention group 2)= 35 , and control group= 35 children and parents. Child and parent information form will be used to collect data, Modified Yale Preoperative Anxiety Scale will be used to collect data in child sample, and Spielberger State Anxiety Scale will be used to collect data in parent sample. Intervention and Data Collection: Randomization will be performed after the purpose of the study is explained to the child and parent who agreed to participate in the study and after obtaining consent. Immediately after the pre-test (first measurement) is given to the children assigned to intervention group 1 and their parents, attempts to distract attention with play dough will be applied for 10 minutes. If they wish, the child and parents will be told that they can continue to play with the play dough until premedication. Children assigned to intervention group 2 and their parents will be distracted with a kaleidoscope for 10 minutes immediately after the pre-test (first measurement) is done. If they wish, the child and parents will be told that they can continue to play with the kaleidoscope until premedication. Participants randomized to the control group will be given routine standard nursing care. The second measurement will be administered 15 minutes after the interventions (before premedication=post test), and the control group 25 minutes after the first measurement (before premedication=posttest). Thus, the effectiveness of the initiatives and their comparison with each other will be evaluated. The data of the research will be analyzed using the Statistical Package of Social Science (SPSS) 23.0 software package program. The process of evaluating the data will be carried out with the support of a statistician.

Official Title
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Comparison of the Effectiveness of Two Different Distraction Interventions in Reducing Preoperative Anxiety of Children and Parents Who Are Scheduled for Elective Surgery: A Randomized Controlled Study

Conditions
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Preoperative Care, Child, Parent, Anxiety

Intervention / Treatment
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* Other: Distract with play dough
* Other: Distract with play kaleidoscope
* Other: Control group


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Being a child between the ages of 5 and 12 who is planned for elective surgery Being the parent of a 5-12 year old child scheduled for elective surgery Child and parent have no vision, hearing or speech problems Child and parent do not have a mental or neurological disability The child and parents do not have an anxiety disorder Child and parent can speak and understand Turkish Exclusion Criteria: Change in surgical operation date Using another distraction technique

Ages Eligible for Study
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Minimum Age: 5 Years
Maximum Age: 12 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Distract with play dough<br>The intervention will begin approximately 30 minutes before premedication. The initiative will be applied to both the child and the parent participating in the research. Attempts to distract with play dough will be conducted under investigative coaching for at least 10 minutes. If after 10 minutes the child or parent wants to continue playing, they will be told that they can play as long as they want. Each family will be given 4 boxes of play dough. After the play is played, the play dough will not be put back in the package, and the child and parents will be told that they can keep the shapes they have made if they wish. The play dough used will be provided by the researchers and will be given to the participants after the intervention. | Other: Distract with play dough<br>* Distract with play dough<br>|
| Experimental: Distract with play kaleidoscope<br>The intervention will begin approximately 30 minutes before premedication. The initiative will be applied to both the child and the parent participating in the research. Attempts to distract with the kaleidoscope will be conducted under investigative coaching for at least 10 minutes. It is a game tool that reproduces the outside image when viewed from inside the kaleidoscope. This image is obtained thanks to the glasses placed inside the kaleidoscope at different angles, and the images change as the kaleidoscope is rotated. If after 10 minutes the child or parent wants to continue playing, they will be told that they can play as long as they want. Each child and parent will be given a separate kaleidoscope. | Other: Distract with play kaleidoscope<br>* Distract with play kaleidoscope<br>|
| Other: Control Group<br>The participants in the control group will be given routine nursing care. | Other: Control group<br>* Routine nursing care<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reducing children's pre-operative anxiety | The decrease in anxiety levels of children whose attention is diverted with play dough and kaleidoscope is an outcome measure. This reduction will be measured with the Modified Yale Preoperative Anxiety Scale. Outcome criteria will be evaluated twice, approximately 30 minutes before premedication and immediately before premedication (pretest-posttest) in the Pediatric Surgery Service. The scale consists of twenty-two items and five categories. Each category gets one point out of four. The higher the score on the scale, the greater the anxiety. In the post-test, it will be evaluated whether there is a decrease according to the pre-test score. Statistical significance will be set to p < 0.05. | Anxiety levels of children will be evaluated twice. The first measurement will be made 30 minutes before the premedication, and the last measurement will be made just before the premedication. | 
| Reducing parent's pre-operative anxiety | The decrease in anxiety levels of parents of children whose attention is diverted with play dough and kaleidoscope is an outcome measure. This decrease will be measured by the Spielberger State Anxiety Scale. Outcome criteria will be evaluated twice in Pediatric Surgery Service, approximately 30 minutes before premedication and just before premedication (pretest-posttest). The 4-point Likert-type scale, consisting of 20 items in total, measures the anxiety of the person at a certain time. For scores above 42 points, it indicates a high level of anxiety. In the post-test, it will be evaluated whether there is a decrease according to the pre-test score. Statistical significance will be set to p < 0.05. | Anxiety levels of parents will be evaluated twice. The first measurement will be made 30 minutes before the premedication, and the last measurement will be made just before the premedication. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Preoperative Care, Child, Parents, Nursing care, Randomized controlled trial