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

NCT07052955 | Recruiting

• 1 other identifier: Health Riddles in Pediatry
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Circumcision, Male

Keywords

Child; anxiety; fear; pain; circumcision; health riddles

Outcome Measures

Primary Outcomes (4)

• Introductory Information Form

  The introductory information form prepared by the researchers consists of items related to the child's age, gender, height, weight, place of residence, number of siblings, previous hospitalization, previous surgery, mother's age, education status, father's age, education status and the family's economic status.

  Baseline

• Child Fear Scale (CFS)

  This scale was developed by McMurtry and colleagues in 2011 and was adapted to Turkish by Gerçeker and his team in 2018 and validated. Designed for children between the ages of 5 and 10, this scale presents facial muscle changes in fearful expressions with a graphic artist's drawings based on photographs of frightened faces. The scale can be used by the family, child, or researcher to evaluate children. The scale shows the child a scale containing five facial expressions scored between 0 and 4. These expressions are interpreted as follows: 0: Neutral expression (no fear), 1: Very little fear, 2: Some fear, 3: More fear, 4: Highest level of fear. This scale can be used to measure the child's level of fear before and during the procedure.

  Baseline and up to 4 weeks

• Child Anxiety Scale-State (CAS-D)

  The "Child Anxiety Scale-State" (CAS-D) scale, developed by Ersig and his colleagues in 2013, is used to measure the situational anxiety of children between the ages of 4-10. Its validity was provided by Gerçeker and his team in 2018. CAS-D is designed in the shape of a thermometer and has a bulb chamber at the bottom and horizontal lines upwards. Each horizontal line represents one point, and there are 10 points in total. The bottom line represents a score of 0 and indicates a situation where there is no anxiety. The anxiety level increases as you go higher, and the top line represents the highest anxiety with a score of 10.

  Baseline and up to 4 weeks

• Wong Baker Pain Rating Scale

  The Wong-Baker Faces Pain Rating Scale is an adaptation of the Faces Rating Scale, a picture projection technique that uses 6 pictures of a child's facial expressions in pain to assess the child's level of pain. This scale is used to best describe the child's current level of pain. The child is asked to choose the face that best describes their pain. The descriptions of the faces are as follows: Face 0: Depicts a painless, happy face, meaning "I'm very happy, I'm in no pain." Face 5: Depicts a crying face, meaning "it hurts as much as you can imagine, but you don't have to cry to feel that bad." The responses on this 5-point scale range from 0 (very happy, no pain) to 5 (it hurts as much as you can imagine) and help determine the child's level of pain.

  Baseline and up to 4 weeks

Study Arms (2)

Control Group

NO INTERVENTION

The control group will receive routine clinical care. No intervention will be made.

Experimental Group

EXPERIMENTAL

Before the circumcision, children will be shown a video animation show and will be made to play games with health riddles and normal riddle books.

Other: The Normal Riddles Book; Other: Health Riddles Group

Interventions

The Normal Riddles Book OTHER

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 with the researcher/nurse. The application period is planned as approximately 20-30 minutes. The children's fear, anxiety and pain levels will be measured before and after the application. During the application process, the children's attention level, interest in the book and general behavior will be observed and recorded.

Experimental Group

Health Riddles Group OTHER

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 levels will be measured with the Introductory Information Form, Child Fear Scale, Child Anxiety Scale-State and Wong-Baker Face Pain Scale. The data obtained from the health riddles group will be compared with the data obtained from the normal riddle and control groups and the unique effect of the riddles containing health information on fear, anxiety and pain will be analyzed.

Experimental Group

Eligibility Criteria

• Age: 4 Years - 6 Years
• Gender Eligibility Details: Male
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Gümüşhane Universıty: lead

Study Sites (1)

Baglarbasi District Shahbenders District Cluster Houses No.56/B Center/Gumushane

Gümüşhane, Center, 29000, Turkey (Türkiye)

RECRUITING

Related Publications (1)

• 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 BACKGROUND

Related Links

• Randomized Controlled Trial

MeSH Terms

Conditions

Anxiety Disorders; Pain

Condition Hierarchy (Ancestors)

Mental Disorders; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Hatice OĞUZHAN, 1

  Gümüşhane Universıty

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hatice OĞUZHAN, 1

CONTACT

+90505 715 19 25; haticeoguzhan61@gmail.com

Fatma GÜDÜCÜ TÜFEKCİ, 2

CONTACT

+90505 215 76 72; fatma.guducutufekci@atauni.edu.tr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer

Study Record Dates

• First Submitted: June 30, 2025
• First Posted: July 8, 2025
• Study Start: July 10, 2025
• Primary Completion (Estimated): October 10, 2026
• Study Completion (Estimated): November 10, 2026
• Last Updated: July 8, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)