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Completed

NCT Number: NCT05540041

Reducing Anxiety of Children and Their Parents in the Pre-Operative Process With Therapeutic Play

It is emphasized in studies that child and parent anxiety that arises in pediatric surgery should be prevented or reduced. According to previous studies, one way to reduce child and parent anxiety in the preoperative period is therapeutic play interventions. This study was planned to compare the effectiveness of two different therapeutic play interventions (bubble breathing play therapy and tell-show-do play therapy) in reducing preoperative anxiety of children and parents who are scheduled for elective surgery.

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Key information

Conditions

Preoperative Care Anxiety Anxiety Disorders Child Mental Disorders Parents

Age range

5 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Akdeniz University

Antalya, Antalya/Merkez, Turkey (Türkiye)

About this study

Aim: This study was planned to comparison of the effectiveness of two different therapeutic play interventions (bubble breathing play therapy and tell-show-do play therapy) 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: bubble breathing play therapy group (intervention group 1)= 35, tell-show-do play therapy 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 pretest (first measurement) is given to the children assigned to intervention group 1 and their parents, attempts to bubble breathing play therapy will be applied for 5-10 minutes. If they wish, the child and parents will be told that they can continue to play with the bubble toys until premedication. Children assigned to intervention group 2 and their parents will be tell-show-do play therapy for 10-15 minutes immediately after the pre-test (first measurement) is done. Participants randomized to the control group will be given routine standard nursing care. The second measurement will be just before premedication (post test). 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.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Being a child between the ages of 5-12 for which a surgical operation is planned
  • Being the parent of a child between the ages of 5 and 12 whose surgical operation is planned
  • Not having vision, hearing or speech problems
  • Not have a mental or neurological disability
  • Not being diagnosed with an anxiety disorder
  • Children and parents who can speak and understand Turkish will be included in the study

Exclusion criteria

  • Change in surgical operation date
  • Using another distraction technique

Treatment and study plan

Bubble breathing play therapy group

Other

The efficacy of bubble breathing play therapy in the preoperative anxiety children and their parent.

Tell-show-do play therapy group

Other

The efficacy of tell-show-do play therapy in the preoperative anxiety children and their parent.

No intervention

Other

Routine nursing care

Primary outcomes

  1. Preoperative anxiety of children

    Time frame: 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.

    The decrease in anxiety levels of children whose attention is diverted with play dough and kaleidoscope is an outcome measure. This decrease will be measured with the "Modified Yale Preoperative Anxiety Scale". Outcome criteria will be evaluated twice in Pediatric Surgery Service, approximately 30 minutes before premedication and just before premedication (pretest-posttest). 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 anxiety. In the post-test, it will be evaluated whether there is a decrease according to the pre-test score. If there is a decrease in the "posttest" scores compared to the "pretest" scores, it can be said that distraction positively affects preoperative anxiety. Statistical significance will be set to p < 0.05.

  2. Preoperative anxiety of parent

    Time frame: 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.

    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. If there is a decrease in the "posttest" scores compared to the "pretest" scores, it can be said that distraction positively affects preoperative anxiety. Statistical significance will be set to p < 0.05.

Sponsors and collaborators

Lead sponsor

Isparta University of Applied Sciences

Other

Collaborators

  • Akdeniz University

Registry information

Official study title

The Efficacy of Bubble Breathing Play Therapy and Tell-show-do Play Therapy in the Preoperative Anxiety Children and Their Parent

Important dates

Study start
2022
Primary completion
2026
Study completion
2026
First posted
Sep 14, 2022
Registry last updated
Mar 27, 2026

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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