Circumcision AdultNCT06793722
Technological Devices in Circumcision
A study testing Technological device in circumcision in people with Circumcision Adult and Circumcision, Male, run by Adiyaman University at 1 site in Turkey (Türkiye).
Trial summary
It aims to investigate the effect of circumcision on the pain and anxiety level of children who are circumcised by watching videos/playing games during the procedure. Previous studies have been conducted to explain the procedure with informative videos and games before circumcision, and reductions in anxiety and pain… Read more about this study
- Who is it for?
- Ages 6 to 18 years, men only
- Conditions the study is for
- Circumcision Adult, Circumcision, Male, Circumcision
- What is being tested?
- Technological device in circumcision
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 20 Jan 2025to 31 Dec 2025
- 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 6 to 18 years
- Men only
- No healthy volunteers
- Child, Adult
Who may be able to join
- Circumcision for medical or religious reasons.
Who cannot join
- Children with chronic diseases.
- Children with genital medical problems.
- Children with mental and communication disabilities and their parents.
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
Adıyaman University
Adıyaman, 02400
ADIYAMAN EDUCATION AND RESEARCH HOSPITAL, adiyamaneah1@saglik.gov.tr
About this study
Official title: The Effect of Technological Devices on the Child's Pain and Anxiety Level in Circumcision Performed With Local Anesthesia
It aims to investigate the effect of circumcision on the pain and anxiety level of children who are circumcised by watching videos/playing games during the procedure. Previous studies have been conducted to explain the procedure with informative videos and games before circumcision, and reductions in anxiety and pain levels have been detected. The research will start with hospitalization and end with a check-up after discharge.
- Conditions
- Circumcision Adult, Circumcision, Male, Circumcision
- Being tested
- Technological device in circumcision
- Keywords
- circumcision
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Technological device in circumcisionProcedure or surgery
Circumcision is performed by watching a video/playing a game during the procedure in children who are circumcised.
| Study group | Role | What they receive |
|---|---|---|
| circumcision by watching videos/playing games | Experimental | Not described Receives: Procedure: Technological device in circumcision |
| circumcision without visual or verbal stimulation | No intervention | Not providing any visual or verbal stimulation to circumcised children |
What is being measured
The primary outcome is the main question the study is designed to answer.
change of child anxiety and worry
Anxiety levels will be assessed with scales to determine changes in anxiety.
Wong Baker Facial Pain Scale:
" 0 " Very happy because no pain, " 1 " A little pain, " 2 " A little more pain, " 3 " More pain, " 4 " Quite a lot of pain, " 5 " The worst pain you can imagine. Situational Anxiety Scale: The scale, which has been translated into Turkish and adapted, consists of a total of 20 items. The highest score that can be obtained from the scale is 80, and the lowest is 20.
Child fear scale:This scale includes 5 different facial expressions. This scale is scored between 0-4.
Measured: immediately after the intervention/procedure/surgery
Secondary outcomes (1)
Changes in anxiety and worry among parents.
Anxiety levels will be assessed with scales to determine changes in anxiety. The Beck Anxiety Inventory (BAI) consists of 21 self-reported items (four-point scale) used to assess the intensity of physical and cognitive anxiety symptoms during the past week. Scores may range from 0 to 63: minimal anxiety levels (0-7), mild anxiety (8-15), moderate anxiety (16-25), and severe anxiety (26-63).
Measured: immediately after the intervention/procedure/surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2025
- Study start20 Jan 2025
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Circumcision AdultStudies 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
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Adiyaman University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bedreddin Kalyenci, Adiyaman University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06793722
- Sponsor's protocol ID
- HRÜ/24.21.25
- Status last verified
- Sep 2025
- First submitted
- 20 Jan 2025
- Last updated
- 2 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Technological Devices on the Child's Pain and Anxiety Level in Circumcision Performed With Local Anesthesia
- ClinicalTrials.gov ID
- NCT06793722
- Acronym / sponsor ID
- HRÜ/24.21.25
- Conditions
- Circumcision Adult, Circumcision, Male, Circumcision
- Keywords
- circumcision
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Adiyaman UniversityUniversity, hospital or other
- Study start
- 20 Jan 2025 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 27 Jan 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.
It aims to investigate the effect of circumcision on the pain and anxiety level of children who are circumcised by watching videos/playing games during the procedure. Previous studies have been conducted to explain the procedure with informative videos and games before circumcision, and reductions in anxiety and pain levels have been detected. The research will start with hospitalization and end with a check-up after discharge.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| circumcision by watching videos/playing games | Experimental | Procedure: Technological device in circumcision |
| circumcision without visual or verbal stimulation | No intervention | –Not providing any visual or verbal stimulation to circumcised children |
Who may qualify
- Ages
- 6 to 18 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- Circumcision for medical or religious reasons.
Key exclusion criteria (3 listed)
- Children with chronic diseases.
- Children with genital medical problems.
- Children with mental and communication disabilities and their parents.
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 |
|---|---|---|
| Technological device in circumcisionCircumcision is performed by watching a video/playing a game during the procedure in children who are circumcised. | Procedure or surgery | circumcision by watching videos/playing games |
Primary outcome
change of child anxiety and worry
Time frame: immediately after the intervention/procedure/surgery
Anxiety levels will be assessed with scales to determine changes in anxiety. Wong Baker Facial Pain Scale: " 0 " Very happy because no pain, " 1 " A little pain, " 2 " A little more pain, " 3 " More pain, " 4 " Quite a lot of pain, " 5 " The worst pain you can imagine. Situational Anxiety Scale: The scale, which has been translated into Turkish and adapted, consists of a total of 20 items. The highest score that can be obtained from the scale is 80, and the lowest is 20. Child fear scale:This scale includes 5 different facial expressions. This scale is scored between 0-4.
1 secondary outcome
Changes in anxiety and worry among parents.
Time frame: immediately after the intervention/procedure/surgery
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 2 Oct 2025.
- Individual participant dataSharing planned: Yes
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Technological device in circumcision in people with Circumcision Adult and Circumcision, Male, run by Adiyaman University 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 1 inclusion and 3 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 2 Oct 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 Bedreddin Kalyenci (+905554859583, bedreddin84@windowslive.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
change of child anxiety and worry (time frame: immediately after the intervention/procedure/surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 2 Oct 2025.