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Recruiting NCT07052955

The Effect of Health Riddles on Fear, Anxiety, and Pain in Circumcised Children

No phase Interventional Circumcision, Male

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: The Normal Riddles Book, Health Riddles Group.
Who it may be relevant to
Registry conditions: Circumcision, Male. Basic parameters: 4 years — 6 years · Male.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Turkey (Türkiye)
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Overview

This study was designed as a randomized controlled experimental method to examine the effects of health puzzles on the fear, anxiety and pain levels that occur in the pre- and postoperative periods in children who underwent circumcision.

Detailed description

In the study, children aged 4-6 who came to be circumcised were divided into three groups: the Normal Circumcision Control Group, which received standard care and information, the Normal Riddle Group, which was supported by general fun riddles that did not contain health content, and the Health Riddles Group, which received an intervention that included health information and aimed to reduce children's fear and anxiety levels. The children's fear, anxiety and pain levels before and after the surgery will be measured using the Introductory Information Form, the Children's Fear Scale, the Children's Anxiety Scale-State and the Wong-Baker Facial Pain Scale as data collection tools.

Interventions

  • Other The Normal Riddles Book
    The distribution of the participating children to the experimental and control groups will be carried out by simple random sampling method. Children included in the Normal Riddle Book group will be introduced to a book containing general, entertaining riddles that are not related to health during the pre-circumcision period. The book will be given to the children approximately 1 hour before the circumcision operation and the children will be allowed to read the puzzles, solve them or interact w
  • Other Health Riddles Group
    The children included in this group will be presented with the Health Riddles Book, which contains health information and is prepared to reduce fear and anxiety before the circumcision. The book will be given to the children approximately 1 hour before the circumcision procedure and the children will be allowed to read the riddles or interact with the researcher/nurse. The application time is planned to be 20-30 minutes. Before and after the application, the children's fear, anxiety and pain le

Primary outcome measures

  • Introductory Information Form [Time frame: Baseline]
  • Child Fear Scale (CFS) [Time frame: Baseline and up to 4 weeks]
  • Child Anxiety Scale-State (CAS-D) [Time frame: Baseline and up to 4 weeks]
  • Wong Baker Pain Rating Scale [Time frame: Baseline and up to 4 weeks]

Eligibility criteria

Inclusion criteria

  • Children who apply to Gümüşhane State Hospital Pediatric Surgery Department for circumcision
  • Children between the ages of 4-6
  • Not having had any previous surgical intervention
  • Not having any problems with vision, hearing or speech
  • Written consent given by a parent or legal guardian
  • Not having health problems that could affect the research results, such as chronic disease or developmental delay
  • The child and his/her family being open to communication and willing to cooperate during the study participation process

Exclusion criteria

  • If the child or family does not want to continue the research
  • If there is a sudden and serious deterioration in the child's health
  • If participants do not comply with the research protocol, do not use the provided materials or do not participate in the measurements and do not continue
  • If unexpected complications develop during the circumcision procedure
  • If it is determined that the rights of the participants have been violated in accordance with ethical rules
  • In these cases, the participant will be removed from the research and appropriate health care will be provided where necessary.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Supportive care

Study locations

Turkey (Türkiye) · 1 center
  • Baglarbasi District Shahbenders District Cluster Houses No.56/B Center/Gumushane — Gümüşhane

Publications

  • Tuncay S, Tufekci FG. The effect of nursing interventions with therapeutic play and video animations prepared with psychodrama technique in reducing fear, anxiety, and pain of children at male circumcision: A randomized controlled study. Int J Urol. 2023 Jul;30(7):592-599. doi: 10.1111/iju.15184. Epub 2023 Mar 31. PMID 36999456

Identifiers

NCT: NCT07052955 · Health Riddles in Pediatry

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗