Evaluation of Therapeutic Play Methods on Preoperative Anxiety and Acute Postoperative Symptoms i… (NCT07353697) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Evaluation of Therapeutic Play Methods on Preoperative Anxiety and Acute Postoperative Symptoms in School-Age Children
Turkey (Türkiye)76 participantsStarted 2024-05-10
Plain-language summary
This study aims to evaluate the effect of different therapeutic play methods (finger puppet play, virtual reality glasses, and smartphone games) applied to children aged 6-12 years during the preoperative period on their anxiety levels and postoperative acute symptoms. The study has a randomized controlled design conducted in a pediatric surgery clinic. The research seeks to answer the following question: "Are different therapeutic play methods effective in reducing anxiety, fear, pain, and other acute symptoms in children during the surgical process?"
Who can participate
Age range
6 Years – 12 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Children aged 6 to 12 years
* Hospitalized at Bilecik Training and Research Hospital, Department of Pediatric Surgery, for an elective surgical procedure
* Able to read and write
* Able to communicate in Turkish
* No visual, hearing, or speech impairments
* No intellectual disability or physical or surgical condition that would interfere with participation
* Voluntary participation with written informed consent obtained from the child and the parent or legal guardian
Exclusion Criteria:
* Children referred to the intensive care unit
* Children requiring repeat surgical intervention
* Children with a hospital stay of two days or longer
* Children with severe psychiatric disorders
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Changes in State Anxiety Scores in Children During the Preoperative Period
Timeframe: Preoperative baseline (Day 0); immediately after the preoperative therapeutic play intervention (Day 0, before surgery); 2 hours after surgery (Day 0); approximately 30 minutes before discharge (Day 1)