Circumcision, MaleNCT07052955
The Effect of Health Riddles on Fear, Anxiety, and Pain in Circumcised Children
A study testing The Normal Riddles Book and Health Riddles Group in people with Circumcision, Male, run by Gümüşhane Universıty at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 4 to 6 years, men only
- Conditions the study is for
- Circumcision, Male
- What is being tested?
- The Normal Riddles Book and Health Riddles Group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 10 Jul 2025to 10 Nov 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 to 6 years
- Men only
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Baglarbasi District Shahbenders District Cluster Houses No.56/B Center/Gumushane
Gümüşhane, Center, 29000
Hatice OĞUZHAN, 1, +90 505 715 19 25, haticeoguzhan61@gmail.com
About this study
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.
Read the 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.
- Conditions
- Circumcision, Male
- Being tested
- The Normal Riddles Book, Health Riddles Group
- Keywords
- Child, anxiety, fear, pain, circumcision, health riddles
- Medical subject headings
- Anxiety Disorders, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The Normal Riddles BookOther
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.
Health Riddles GroupOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: The Normal Riddles Book; Other: Health Riddles Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline and up to 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2025
- Study start10 Jul 2025 (estimated)
- Primary completion10 Oct 2026 (estimated)
- Study completion10 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Circumcision, MaleStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Gümüşhane Universıty
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hatice Oğuzhan, Gümüşhane Universıty
- Investigators
- Hatice OĞUZHAN, 1, Principal investigator, Gümüşhane Universıty
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07052955
- Sponsor's protocol ID
- Health Riddles in Pediatry
- Status last verified
- Jun 2025
- First submitted
- 30 Jun 2025
- Last updated
- 8 Jul 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 36999456
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Health Riddles on Fear, Anxiety, and Pain in Circumcised Children
- ClinicalTrials.gov ID
- NCT07052955
- Acronym / sponsor ID
- Health Riddles in Pediatry
- Conditions
- Circumcision, Male
- Keywords
- Child, anxiety, fear, pain, circumcision, health riddles
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Gümüşhane UniversıtyUniversity, hospital or other
- Study start
- 10 Jul 2025 (estimated)
- Primary completion
- 10 Oct 2026 (estimated)
- Study completion
- 10 Nov 2026 (estimated)
- First posted
- 8 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Group | No intervention | –The control group will receive routine clinical care. No intervention will be made. |
| Experimental Group | Experimental | Other: The Normal Riddles Book, Other: Health Riddles GroupBefore the circumcision, children will be shown a video animation show and will be made to play games with health riddles and normal riddle books. |
Who may qualify
- Ages
- 4 to 6 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| The Normal Riddles BookThe 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. | Other | Experimental Group |
| Health Riddles GroupThe 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. | Other | Experimental Group |
Primary outcome
Introductory Information Form
Time frame: Baseline
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.
Child Fear Scale (CFS)
Time frame: Baseline and up to 4 weeks
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.
Child Anxiety Scale-State (CAS-D)
Time frame: Baseline and up to 4 weeks
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.
Wong Baker Pain Rating Scale
Time frame: Baseline and up to 4 weeks
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2025.
- Results publication: PubMed 36999456Tuncay 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.
- Randomized Controlled TrialLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Hatice OĞUZHAN, 1 principal investigator
Gümüşhane Universıty
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing The Normal Riddles Book and Health Riddles Group in people with Circumcision, Male, run by Gümüşhane Universıty at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 8 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Hatice OĞUZHAN, 1 (+90505 715 19 25, haticeoguzhan61@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Introductory Information Form (time frame: Baseline). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07052955, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jul 2025; AzTrials last refreshed its copy on 8 Nov 2026.