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Completed

NCT Number: NCT05790005

The Effect of Therapeutic Play Before Dressing on Anxiety and Fear in Children

The goal of this experimental study is to determine the effect of therapeutic play method applied to hospitalized children aged 7-12 before the first surgical dressing attempt, on anxiety and fear. Researcher will compare the study and control groups to see if therapeutic play has an effect on anxiety and fear.

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Key information

Conditions

Anxiety Anxiety Disorders Fear Mental Disorders

Age range

7 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Celal Bayar University Hafsa Sultan Hospital

Manisa, Uncubozköy, 45010, Turkey (Türkiye)

About this study

G-Power 3.1.9.4 package program was used for sample size calculation in the study. Children will be assigned to the study and control groups using the www.randomizer.org program with a simple randomization method to ensure homogeneity between the study and control groups. Before dressing, a warm-up play will be played for 10 minutes with the study group, followed by a 20-minute therapeutic game in which the dramatization method will be used. The children in the control group will be subjected to the routine dressing procedure. The data of the research will be collected using the Child and Parent Information Form, Child Anxiety Scale-State Scale and Child Fear Scale.

During the evaluation of the data, the sociodemographic characteristics of the groups participating in the study will be stated as numbers and percentages, and the normal distribution of the anxiety scale and fear scale scores before the play, after the play and after the dressing process in the Intervention and control groups will be determined by looking at the skewness coefficients. The Factorial Anova Test will be used for mixed measurements in order to examine the anxiety and fear changes of the children in the Intervention and control groups before the play, after the play and after the dressing process. In addition, since this test does not measure the different changes between the groups, the Anova Test in Repeated Measurements will be used to compare the anxiety and fear scores of only the Intervention group and only the control group before the play, after the play and after the dressing process. If the data do not have a normal distribution, the Friedman Test, which is a nonparametric test, will be used.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Children in the 7-12 age group
  • Children who speak and understand Turkish
  • Children whose first dressing will be done in the service on the second day after the operation

Exclusion criteria

  • Children with hearing, vision and speech problems in themselves or their parents
  • Children with a mental disorder in themselves or in their parents
  • Children who had circumcision surgery (because the primary dressing was removed and crystallin spray was sprayed on the surgical area and the area was left open)
  • Children who should not move before dressing (having hypospadias surgery)
  • Children still in the intensive care unit at the time of the first surgical dressing
  • Children whose dressing had to be changed before the second postoperative day (wetting, bleeding, opening, etc.)
  • Children with previous play therapy experience

Treatment and study plan

Therapeutic Play

Other

2 days after the operation, 1 hour before the dressing, a warm-up game will be played with the child in the playroom of the pediatric surgery service, aiming to put the organs prepared by the researcher in their correct places on the picture for the first 10 minutes. Then, the teddy bear, which is given the appearance of an operation area by sewing a zipper on his stomach, will be given to the child and he will be asked to make the first dressing of the teddy bear. therapeutic game, in which the dramatization method is used, will last 20 minutes. During the 30-minute play practice, the child's questions will be answered.

Primary outcomes

  1. Child Anxiety Scale-State Scale

    Time frame: two hours before the surgical dressing

    The scale is shaped like a thermometer with 10 horizontal lines and has a score of 0-10, ranging from calm to very nervous. The child will be asked to mark the anxiety he feels at that moment.

  2. Child Anxiety Scale-State Scale

    Time frame: fifteen minutes before the surgical dressing

    The scale is shaped like a thermometer with 10 horizontal lines and has a score of 0-10, ranging from calm to very nervous. The child will be asked to mark the anxiety he feels at that moment.

  3. Child Anxiety Scale-State Scale

    Time frame: immediately after the surgical dressing

    The scale is shaped like a thermometer with 10 horizontal lines and has a score of 0-10, ranging from calm to very nervous. The child will be asked to mark the anxiety he feels at that moment.

  4. Child fear scale

    Time frame: two hours before the surgical dressing

    The scale consists of five facial expressions that differ from neutral to frightened expressions and scores between 0-4. The child will be asked to choose the facial expression that shows how much the dressing to be applied frightens him.

  5. Child fear scale

    Time frame: fifteen minutes before the surgical dressing

    The scale consists of five facial expressions that differ from neutral to frightened expressions and scores between 0-4. The child will be asked to choose the facial expression that shows how much the dressing to be applied frightens him.

  6. Child fear scale

    Time frame: immediately after the surgical dressing

    The scale consists of five facial expressions that differ from neutral to frightened expressions and scores between 0-4. The child will be asked to choose the facial expression that shows how much the dressing to be applied frightens him.

Sponsors and collaborators

Lead sponsor

Aydin Adnan Menderes University

Other

Registry information

Official study title

The Effect of the Therapeutic Play Applied Before Surgical Dressing on Anxiety and Fear in Children

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Mar 29, 2023
Registry last updated
Feb 13, 2024

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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