Therapeutic ClownNCT07525388
The Effect of Progressive Relaxation Exercises With Therapeutic Clown
A study testing Relaxation exercise group led by a therapeutic clown and The relaxation exercise group led by a research nurse in people with Therapeutic Clown and Relaxation Exercise, run by Ataturk University at 1 site in Turkey (Türkiye).
Trial summary
This study was conducted to investigate the effects of progressive relaxation exercises, performed with the assistance of a therapeutic clown during the pre-operative period, on fear, anxiety and physiological parameters in children. Read more about this study
- Who is it for?
- Ages 6 to 10 years, men only
- Conditions the study is for
- Therapeutic Clown, Relaxation Exercise, Anxiety
- What is being tested?
- Relaxation exercise group led by a therapeutic clown and The relaxation exercise group led by a research nurse
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 162 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 25 Mar 2025to 30 Jun 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 6 to 10 years
- Men only
- No healthy volunteers
- Child
Who may be able to join
- Aged between 6 and 10 years,
- Willing to participate in the study,
- Admitted to the clinic for elective circumcision surgery,
- Accessible prior to surgery,
- With no cognitive impairments,
- With no vision or hearing problems were included in the study.
Who cannot join
- Children who wished to withdraw from the study during the study period were excluded.
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
Paediatric Surgery Clinic, Atatürk University Health Research and Training Hospital
Erzurum, 25240
About this study
Official title: The Effect of Progressive Relaxation Exercises With Therapeutic Clown in Preoperative Period on Fear Anxiety and Physiological Parameters in Children
This study was conducted to investigate the effects of progressive relaxation exercises, performed with the assistance of a therapeutic clown during the pre-operative period, on fear, anxiety and physiological parameters in children. This randomised controlled trial included children aged 6-10 years undergoing circumcision surgery. The children were randomised into three groups: a progressive relaxation exercise group led by a therapeutic clown, a progressive relaxation group led by a nurse, and a control group. Fear, anxiety and physiological parameters (heart rate, respiratory rate, blood pressure, oxygen saturation) were assessed before and after the procedure.
- Conditions
- Therapeutic Clown, Relaxation Exercise, Anxiety, Fear, Surgery
- Being tested
- Relaxation exercise group led by a therapeutic clown, The relaxation exercise group led by a research nurse
- Keywords
- therapeutic clown, relaxation exercise, fear, anxiety, surgery
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Relaxation exercise group led by a therapeutic clownOther
Relaxation exercises help to reduce psychological pressure and tension in individuals by highlighting the difference between relaxation and tension. The therapeutic clown facilitates the release of endorphins, thereby promoting relaxation in situations that cause psychological tension. The combination of the two can create a synergistic effect.
The relaxation exercise group led by a research nurseOther
Relaxation exercises help to reduce psychological pressure and tension in individuals by highlighting the difference between relaxation and muscle tension.
| Study group | Role | What they receive |
|---|---|---|
| Therapeutic clown | Experimental | Relaxation exercise group with a therapeutic clown Receives: Other: Relaxation exercise group led by a therapeutic clown |
| Nurse group | Experimental | Relaxation exercise group led by a research nurse Receives: Other: The relaxation exercise group led by a research nurse |
| Routine nursing care group | No intervention | Routine nursing care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Children's Anxiety Scale
The Children's Anxiety Scale - State Anxiety Scale measures state anxiety in children. The CAS-S (State Anxiety) is designed in the form of a thermometer. It consists of a bulb at the bottom and horizontal lines extending upwards. Each horizontal line represents one point, and the thermometer has a total of 10 points.
Measured: up to 1 year
Children's Fear Scale
The Paediatric Fear Scale is used to measure fear in children undergoing painful medical procedures. The Paediatric Fear Scale is a 0-4 scale featuring five faces ranging from a neutral expression (0 = no anxiety) to a fearful face (4 = severe anxiety).
Measured: up to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2026
- Study start25 Mar 2025
- Primary completion1 Apr 2026
- Study completion30 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Therapeutic ClownStudies of the same condition, open and under way.
- More trials run by Ataturk UniversityThe sponsor's other registered studies.
- 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
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 162 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ataturk University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sümeyye EKİCİ, Ataturk University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07525388
- Sponsor's protocol ID
- PhD Thesis
- Status last verified
- Oct 2025
- First submitted
- 7 Apr 2026
- Last updated
- 7 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- 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 7 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Progressive Relaxation Exercises With Therapeutic Clown in Preoperative Period on Fear Anxiety and Physiological Parameters in Children
- ClinicalTrials.gov ID
- NCT07525388
- Acronym / sponsor ID
- PhD Thesis
- Conditions
- Therapeutic Clown, Relaxation Exercise, Anxiety, Fear, Surgery
- Keywords
- therapeutic clown, relaxation exercise, fear, anxiety, surgery
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 162 participants (estimated)
- Lead sponsor
- Ataturk UniversityUniversity, hospital or other
- Study start
- 25 Mar 2025 (actual)
- Primary completion
- 1 Apr 2026 (actual)
- Study completion
- 30 Jun 2026 (estimated)
- First posted
- 13 Apr 2026 (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 conducted to investigate the effects of progressive relaxation exercises, performed with the assistance of a therapeutic clown during the pre-operative period, on fear, anxiety and physiological parameters in children. This randomised controlled trial included children aged 6-10 years undergoing circumcision surgery. The children were randomised into three groups: a progressive relaxation exercise group led by a therapeutic clown, a progressive relaxation group led by a nurse, and a control group. Fear, anxiety and physiological parameters (heart rate, respiratory rate, blood pressure, oxygen saturation) were assessed before and after the procedure.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Therapeutic clown | Experimental | Other: Relaxation exercise group led by a therapeutic clownRelaxation exercise group with a therapeutic clown |
| Nurse group | Experimental | Other: The relaxation exercise group led by a research nurseRelaxation exercise group led by a research nurse |
| Routine nursing care group | No intervention | –Routine nursing care |
Who may qualify
- Ages
- 6 to 10 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- Aged between 6 and 10 years,
- Willing to participate in the study,
- Admitted to the clinic for elective circumcision surgery,
- Accessible prior to surgery,
- With no cognitive impairments,
Key exclusion criteria (1 listed)
- Children who wished to withdraw from the study during the study period were excluded.
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 |
|---|---|---|
| Relaxation exercise group led by a therapeutic clownRelaxation exercises help to reduce psychological pressure and tension in individuals by highlighting the difference between relaxation and tension. The therapeutic clown facilitates the release of endorphins, thereby promoting relaxation in situations that cause psychological tension. The combination of the two can create a synergistic effect. | Other | Therapeutic clown |
| The relaxation exercise group led by a research nurseRelaxation exercises help to reduce psychological pressure and tension in individuals by highlighting the difference between relaxation and muscle tension. | Other | Nurse group |
Primary outcome
Children's Anxiety Scale
Time frame: up to 1 year
The Children's Anxiety Scale - State Anxiety Scale measures state anxiety in children. The CAS-S (State Anxiety) is designed in the form of a thermometer. It consists of a bulb at the bottom and horizontal lines extending upwards. Each horizontal line represents one point, and the thermometer has a total of 10 points.
Children's Fear Scale
Time frame: up to 1 year
The Paediatric Fear Scale is used to measure fear in children undergoing painful medical procedures. The Paediatric Fear Scale is a 0-4 scale featuring five faces ranging from a neutral expression (0 = no anxiety) to a fearful face (4 = severe anxiety).
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 7 Jul 2026.
- Individual participant dataSharing planned: No
Related trials for Therapeutic Clown
Recruiting
Effectiveness of Clown Therapy in Facilitating Dental Visits for Children With Autism Spectrum Disorder
Autism Spectrum Disorder (ASD
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 Relaxation exercise group led by a therapeutic clown and The relaxation exercise group led by a research nurse in people with Therapeutic Clown and Relaxation Exercise, run by Ataturk 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 6 inclusion and 1 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 7 Jul 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?
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 Sümeyye Ekici (+90442231111, ekicisumeyye@atauni.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Children's Anxiety Scale (time frame: up to 1 year). The study lists 2 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 7 Jul 2026.