Male CircumcisionNCT07094555
The Effect of Two Different Interventions Applied During the Transfer of Children to the Operating Room for Circumcision on Fear, Anxiety, Comfort and Pain Levels
A study testing Animal Assisted Practice and Kaleidoscope in people with Male Circumcision, run by MELİS CAN KESGİN GÜNGÖR at 1 site in Turkey (Türkiye).
Trial summary
The aim of this randomized controlled experimental study was to determine the effects of two different interventions on fear, anxiety, comfort, and pain levels during the transfer of children undergoing circumcision to the operating room. Read more about this study
- Who is it for?
- Ages 7 to 10 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Male Circumcision
- What is being tested?
- Animal Assisted Practice and Kaleidoscope
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 97 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Sep 2025to 17 Oct 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 7 to 10 years
- Men only
- Healthy volunteers accepted
- Child
Who may be able to join
- 7-10 age group
- Circumcision performed under general anesthesia or sedation
- Pain level 0 before surgery
- Child has literacy skills
- Child and parent volunteer to participate in the study
Who cannot join
- The child has had previous surgical experience
- The child is allergic to fish products or fish meal
- The child has a special condition that may cause difficulty understanding and perceiving
- Any complications develop in the postoperative period
- The child and parent wish to withdraw from the study
- The child's hemodynamic instability
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Kafkas University Faculty of Health Sciences
Merkez, Kars, 36100
About this study
Official title: The Effect of Two Different Interventions Applied During the Transfer of Children to the Operating Room for Circumcision on Fear, Anxiety, Comfort and Pain Levels: Randomized Controlled Trial
The aim of this randomized controlled experimental study was to determine the effects of two different interventions on fear, anxiety, comfort, and pain levels during the transfer of children undergoing circumcision to the operating room.
The main questions it aims to answer are:
Read more
- H1: Animal-assisted intervention during transfer to the operating room affects children's fear.
- H2: Animal-assisted intervention during transfer to the operating room affects children's anxiety.
- H3: Animal-assisted intervention during transfer to the operating room affects children's comfort.
- H4: Animal-assisted intervention during transfer to the operating room affects children's pain.
- H5: Playing with a kaleidoscope during transfer to the operating room affects children's fear.
- H6: Playing with a kaleidoscope during transfer to the operating room affects children's anxiety.
- H7: Playing with a kaleidoscope during transfer to the operating room affects children's comfort.
- H8: Playing with a kaleidoscope during transfer to the operating room affects children's pain.
Researchers will investigate the effects of animal-assisted intervention and kaleidoscopes on anxiety, fear, pain, and comfort during the transfer to the operating room in boys aged 7-10 undergoing circumcision. A comparison will be made with a control group to determine this effectiveness.
Participants:
- The animal-assisted intervention group will initiate interaction with a goldfish in a portable aquarium during the preoperative period and accompany them until they arrive in the operating room.
- The kaleidoscope group will be distracted with a kaleidoscope during the preoperative period and continue this intervention until they arrive in the operating room.
- The control group will follow the hospital's routine patient transfer procedure.
- Conditions
- Male Circumcision
- Being tested
- Animal Assisted Practice, Kaleidoscope
- Keywords
- Pain, Anxiety, Child, Kaleidoscope, Comfort, Fear, Animal Assisted Practice
- Medical subject headings
- Pain, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Animal Assisted PracticeBehavioural
The animal-assisted intervention group initiated interaction with a goldfish in a portable aquarium during the preoperative period and accompanied them until they reached the operating room.
KaleidoscopeBehavioural
The kaleidoscope group was distracted with a kaleidoscope during the preoperative period and continued this intervention until they reached the operating room.
| Study group | Role | What they receive |
|---|---|---|
| Animal Assisted Practice Group | Experimental | Not described Receives: Behavioral: Animal Assisted Practice |
| Kaleidoscope Group | Experimental | Not described Receives: Behavioral: Kaleidoscope |
| Control Group | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Animal-assisted therapy intervention applied during transfer to the operating room changes Child Anxiety Scale scores in the preoperative period.
Child Anxiety Scale: The score that can be obtained from the scale varies between 0 and 10 points. As the score increases, the anxiety level also increases.
Measured: 10 minutes before surgery
Animal-assisted therapy intervention applied during transfer to the operating room changes Child Fear Scale scores in the preoperative period.
Child Fear Scale: The score that can be obtained from the scale varies between 0 and 4 points. As the score increases, the fear level also increases.
Measured: 10 minutes before surgery
Animal-assisted therapy intervention applied during transfer to the operating room changes Wong-Baker pain scale scores in the postoperative period.
Wong-Baker Pain Scale: The score that can be obtained from the scale varies between 0 and 10 points. As the score increases, the pain level also increases.
Measured: up to the 1st postoperative hour
Animal-assisted therapy intervention applied during transfer to the operating room changes Comfort Behaviors Checklist scores in the postoperative period.
Comfort Behaviors Checklist: The score that can be obtained from the scale varies between 25 and 100 points. As the score increases, the comfort level also increases.
Measured: up to the 1st postoperative hour
Kaleidoscope intervention applied during transfer to the operating room changes Child Anxiety Scale scores in the preoperative period.
Child Anxiety Scale: The score that can be obtained from the scale varies between 0 and 10 points. As the score increases, the anxiety level also increases.
Measured: 10 minutes before surgery
Kaleidoscope intervention applied during transfer to the operating room changes Child Fear Scale scores in the preoperative period.
Child Fear Scale: The score that can be obtained from the scale varies between 0 and 4 points. As the score increases, the fear level also increases.
Measured: 10 minutes before surgery
Kaleidoscope intervention applied during transfer to the operating room changes Wong-Baker pain scale scores in the postoperative period.
Wong-Baker Pain Scale: The score that can be obtained from the scale varies between 0 and 10 points. As the score increases, the pain level also increases.
Measured: up to the 1st postoperative hour
Kaleidoscope intervention applied during transfer to the operating room changes Comfort Behaviors Checklist scores in the postoperative period.
Comfort Behaviors Checklist: The score that can be obtained from the scale varies between 25 and 100 points. As the score increases, the comfort level also increases.
Measured: up to the 1st postoperative hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2025
- Study start1 Sep 2025
- Primary completion16 Oct 2025
- Study completion17 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Male CircumcisionStudies 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
- 97 participants (actual)
Sponsor and investigators
- Lead sponsor
- MELİS CAN KESGİN GÜNGÖR
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, MELİS CAN KESGİN GÜNGÖR, Kafkas University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07094555
- Sponsor's protocol ID
- 81822950.903/142
- Status last verified
- Mar 2026
- First submitted
- 10 Jul 2025
- Last updated
- 3 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Two Different Interventions Applied During the Transfer of Children to the Operating Room for Circumcision on Fear, Anxiety, Comfort and Pain Levels: Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07094555
- Acronym / sponsor ID
- 81822950.903/142
- Conditions
- Male Circumcision
- Keywords
- Pain, Anxiety, Child, Kaleidoscope, Comfort, Fear, Animal Assisted Practice
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 97 participants (actual)
- Lead sponsor
- MELİS CAN KESGİN GÜNGÖRUniversity, hospital or other
- Study start
- 1 Sep 2025 (actual)
- Primary completion
- 16 Oct 2025 (actual)
- Study completion
- 17 Oct 2025 (actual)
- First posted
- 30 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.
The aim of this randomized controlled experimental study was to determine the effects of two different interventions on fear, anxiety, comfort, and pain levels during the transfer of children undergoing circumcision to the operating room.
The main questions it aims to answer are:
- H1: Animal-assisted intervention during transfer to the operating room affects children's fear.
- H2: Animal-assisted intervention during transfer to the operating room affects children's anxiety.
- H3: Animal-assisted intervention during transfer to the operating room affects children's comfort.
- H4: Animal-assisted intervention during transfer to the operating room affects children's pain.
- H5: Playing with a kaleidoscope during transfer to the operating room affects children's fear.
- H6: Playing with a kaleidoscope during transfer to the operating room affects children's anxiety.
- H7: Playing with a kaleidoscope during transfer to the operating room affects children's comfort.
- H8: Playing with a kaleidoscope during transfer to the operating room affects children's pain.
Researchers will investigate the effects of animal-assisted intervention and kaleidoscopes on anxiety, fear, pain, and comfort during the transfer to the operating room in boys aged 7-10 undergoing circumcision. A comparison will be made with a control group to determine this effectiveness.
Participants:
- The animal-assisted intervention group will initiate interaction with a goldfish in a portable aquarium during the preoperative period and accompany them until they arrive in the operating room.
- The kaleidoscope group will be distracted with a kaleidoscope during the preoperative period and continue this intervention until they arrive in the operating room.
- The control group will follow the hospital's routine patient transfer procedure.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Animal Assisted Practice Group | Experimental | Behavioral: Animal Assisted Practice |
| Kaleidoscope Group | Experimental | Behavioral: Kaleidoscope |
| Control Group | No intervention | – |
Who may qualify
- Ages
- 7 to 10 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 7-10 age group
- Circumcision performed under general anesthesia or sedation
- Pain level 0 before surgery
- Child has literacy skills
- Child and parent volunteer to participate in the study
Key exclusion criteria (6 listed)
- The child has had previous surgical experience
- The child is allergic to fish products or fish meal
- The child has a special condition that may cause difficulty understanding and perceiving
- Any complications develop in the postoperative period
- The child and parent wish to withdraw from the study
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 |
|---|---|---|
| Animal Assisted PracticeThe animal-assisted intervention group initiated interaction with a goldfish in a portable aquarium during the preoperative period and accompanied them until they reached the operating room. | Behavioural | Animal Assisted Practice Group |
| KaleidoscopeThe kaleidoscope group was distracted with a kaleidoscope during the preoperative period and continued this intervention until they reached the operating room. | Behavioural | Kaleidoscope Group |
Primary outcome
Animal-assisted therapy intervention applied during transfer to the operating room changes Child Anxiety Scale scores in the preoperative period.
Time frame: 10 minutes before surgery
Child Anxiety Scale: The score that can be obtained from the scale varies between 0 and 10 points. As the score increases, the anxiety level also increases.
Animal-assisted therapy intervention applied during transfer to the operating room changes Child Fear Scale scores in the preoperative period.
Time frame: 10 minutes before surgery
Child Fear Scale: The score that can be obtained from the scale varies between 0 and 4 points. As the score increases, the fear level also increases.
Animal-assisted therapy intervention applied during transfer to the operating room changes Wong-Baker pain scale scores in the postoperative period.
Time frame: up to the 1st postoperative hour
Wong-Baker Pain Scale: The score that can be obtained from the scale varies between 0 and 10 points. As the score increases, the pain level also increases.
Animal-assisted therapy intervention applied during transfer to the operating room changes Comfort Behaviors Checklist scores in the postoperative period.
Time frame: up to the 1st postoperative hour
Comfort Behaviors Checklist: The score that can be obtained from the scale varies between 25 and 100 points. As the score increases, the comfort level also increases.
Kaleidoscope intervention applied during transfer to the operating room changes Child Anxiety Scale scores in the preoperative period.
Time frame: 10 minutes before surgery
Child Anxiety Scale: The score that can be obtained from the scale varies between 0 and 10 points. As the score increases, the anxiety level also increases.
Kaleidoscope intervention applied during transfer to the operating room changes Child Fear Scale scores in the preoperative period.
Time frame: 10 minutes before surgery
Child Fear Scale: The score that can be obtained from the scale varies between 0 and 4 points. As the score increases, the fear level also increases.
Kaleidoscope intervention applied during transfer to the operating room changes Wong-Baker pain scale scores in the postoperative period.
Time frame: up to the 1st postoperative hour
Wong-Baker Pain Scale: The score that can be obtained from the scale varies between 0 and 10 points. As the score increases, the pain level also increases.
Kaleidoscope intervention applied during transfer to the operating room changes Comfort Behaviors Checklist scores in the postoperative period.
Time frame: up to the 1st postoperative hour
Comfort Behaviors Checklist: The score that can be obtained from the scale varies between 25 and 100 points. As the score increases, the comfort level also increases.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2026.
- Individual participant dataSharing planned: No
Related trials for Male Circumcision
Not yet recruitingObservational study
Preoperative Fasting and Perioperative Outcomes in Children Undergoing Elective Circumcision
Preoperative Fasting, Perioperative Anxiety
Active, not recruiting
A Study Comparing The Effect Of Local Application Of Polyfax Versus Coconut Oil On Outcome Of Plastibell Circumcision In A Tertiary Care Hospital
Circumcision, Male
Not yet recruiting
Effects of Therapeutic Touch and Music on Children's Anxiety, Pain, and Nausea Before and After Circumcision
Circumcision
Not yet recruitingPhase 2
Efficacy and Safety of Circumcision Alone on Risk of Febrile Urinary Tract Infections in Boys With Posterior Urethral Valves: a Prospective Randomized Open-label Multicentric Trial Enriched With Historic Controls.
Posterior Urethral Valves
Recruiting
Compared Reversed US-Guided Dorsal Penile Nerve Block (RUSDPNB) With DPNB in Circumcisions for Pediatric Patients
Circumcision, Ultrasound
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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Animal Assisted Practice and Kaleidoscope in people with Male Circumcision, run by MELİS CAN KESGİN GÜNGÖR 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 5 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: finished, as of the sponsor's last update on 3 Apr 2026. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Animal-assisted therapy intervention applied during transfer to the operating room changes Child Anxiety Scale scores in the preoperative period. (time frame: 10 minutes before surgery). The study lists 8 primary outcomes in all. 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 3 Apr 2026.