Anxiety, PreoperativeNCT06250816
The Effects of Wearing Operation Gown With Cartoon Characters on Reducing Preoperative Anxiety in Children: Randomized Controlled Study
A study testing The hospital gown with cartoon characters in people with Anxiety, Preoperative, run by Uludag University at 1 site in Turkey (Türkiye).
Trial summary
The operating room environment can be frightening for pediatric patients. Many techniques have been used to make the operating room environment less intimidating, including allowing parents to accompany part of this procedure, play therapy and various distraction strategies during the entrance to the operating room. Read more about this study
- Who is it for?
- Ages 4 to 12 years
- Conditions the study is for
- Anxiety, Preoperative
- What is being tested?
- The hospital gown with cartoon characters
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Feb 2024to 1 Feb 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 4 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Patients who are planned to have elective orthopedic surgery
- Patients whose American Society of Anesthesiologists (ASA) physical status classification are between 1-3
- Patients who have approved the informed consent form
Who cannot join
- Motor and/or mentally retarded patients
- Patients with hearing-speech impairment
- Patients whose ASA physical status classification IV-V
- Patients who do not accept informed consent and/or refused to participate in the study
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Uludağ Üniversitesi
Bursa
Leman Gökçenur Aydın
About this study
The operating room environment can be frightening for pediatric patients. Many techniques have been used to make the operating room environment less intimidating, including allowing parents to accompany part of this procedure, play therapy and various distraction strategies during the entrance to the operating room. In a survey study, it was reported that parents were expected to create hospital conditions with a more child-friendly atmosphere. In this context, it is thought that creating a warmer environment for children, including the clothes worn in the operating room, may reduce the anxiety level of children. In this study, investigators' aim was to investigate the effect of wearing an hospital gown with cartoon characters on the reduction of preoperative anxiety in children scheduled for Orthopedic surgery by in the operating room.
Read the detailed description
Pediatric patients aged between 4-12 years, who are planned to be operated by the Orthopedic Surgery Clinic in Bursa Uludag University Faculty of Medicine Hospital Surgical Theatre, will be randomized preoperatively by closed envelope method. One group will have a preoperative visit, the investigator will meet the patient and assess the child's anxiety level using the modified Yale Preoperative Anxiety Scale (m-YPAS). Afterwards, the patient will be asked to choose one of the hospital gowns they want to wear and put it on with parental assistance. The other group also will have a preoperative visit, the investigator will meet the patient and assess the child's anxiety level using m-YPAS. The patient will be asked to wear the hospital gown used in the hospital in routine practice with parental assistance. Then the patients will be taken to the operating room as in the routine procedure. Before induction of anesthesia in the operating room, another investigator will re-evaluate the child's anxiety level using the m-YPAS scale. Vital signs, analgesic use and duration of surgery will be recorded during the operation. Afterwards, the satisfaction level of the parents will be evaluated.
- Conditions
- Anxiety, Preoperative
- Being tested
- The hospital gown with cartoon characters
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The hospital gown with cartoon charactersOther
The patient will be asked to choose one of the hospital gowns with cartoon characters they want to wear and put it on with parental assistance.
| Study group | Role | What they receive |
|---|---|---|
| Children wearing the hospital gown with cartoon characters | Experimental | The experimental group will have a preoperative visit, the investigator will meet the patient and assess the child's anxiety level using the modified Yale Preoperative Anxiety Scale (m-YPAS). Afterwards, the patient will be asked to choose one of the hospital gowns they want to wear and put it on with parental assistance. Receives: Other: The hospital gown with cartoon characters |
| Children with standard hospital gown | No intervention | The control group will have a preoperative visit, the investigator will meet the patient and assess the child's anxiety level using m-YPAS. The patient will be asked to wear the hospital gown used in the hospital in routine practice with parental assistance. |
What is being measured
The primary outcome is the main question the study is designed to answer.
modified Yale Preoperative Anxiety Scale
investigators evaluate children using the verified Turkish version of modified Yale Preoperative Anxiety Scale.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2024
- Study start1 Feb 2024
- Primary completion1 Jan 2025 (estimated)
- Study completion1 Feb 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anxiety, PreoperativeStudies 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Uludag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Selcan Akesen, Uludag University
- Investigators
- Selcan Akesen, MD, Principal investigator, Uludağ ÜniversitesiLeman Gökçenur Aydın, MD, Study director, Uludağ Üniversitesi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06250816
- Sponsor's protocol ID
- 2023-28/21
- Status last verified
- Oct 2024
- First submitted
- 20 Dec 2023
- Last updated
- 8 Oct 2024
- 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 8 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Wearing Operation Gown With Cartoon Characters on Reducing Preoperative Anxiety in Children: Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT06250816
- Acronym / sponsor ID
- 2023-28/21
- Conditions
- Anxiety, Preoperative
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- Uludag UniversityUniversity, hospital or other
- Study start
- 1 Feb 2024 (actual)
- Primary completion
- 1 Jan 2025 (estimated)
- Study completion
- 1 Feb 2025 (estimated)
- First posted
- 9 Feb 2024 (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 operating room environment can be frightening for pediatric patients. Many techniques have been used to make the operating room environment less intimidating, including allowing parents to accompany part of this procedure, play therapy and various distraction strategies during the entrance to the operating room. In a survey study, it was reported that parents were expected to create hospital conditions with a more child-friendly atmosphere. In this context, it is thought that creating a warmer environment for children, including the clothes worn in the operating room, may reduce the anxiety level of children. In this study, investigators' aim was to investigate the effect of wearing an hospital gown with cartoon characters on the reduction of preoperative anxiety in children scheduled for Orthopedic surgery by in the operating room.
Detailed description
Pediatric patients aged between 4-12 years, who are planned to be operated by the Orthopedic Surgery Clinic in Bursa Uludag University Faculty of Medicine Hospital Surgical Theatre, will be randomized preoperatively by closed envelope method. One group will have a preoperative visit, the investigator will meet the patient and assess the child's anxiety level using the modified Yale Preoperative Anxiety Scale (m-YPAS). Afterwards, the patient will be asked to choose one of the hospital gowns they want to wear and put it on with parental assistance. The other group also will have a preoperative visit, the investigator will meet the patient and assess the child's anxiety level using m-YPAS. The patient will be asked to wear the hospital gown used in the hospital in routine practice with parental assistance. Then the patients will be taken to the operating room as in the routine procedure. Before induction of anesthesia in the operating room, another investigator will re-evaluate the child's anxiety level using the m-YPAS scale. Vital signs, analgesic use and duration of surgery will be recorded during the operation. Afterwards, the satisfaction level of the parents will be evaluated.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Children wearing the hospital gown with cartoon characters | Experimental | Other: The hospital gown with cartoon charactersThe experimental group will have a preoperative visit, the investigator will meet the patient and assess the child's anxiety level using the modified Yale Preoperative Anxiety Scale (m-YPAS). Afterwards, the patient will be asked to choose one of the hospital gowns they want to wear and put it on with parental assistance. |
| Children with standard hospital gown | No intervention | –The control group will have a preoperative visit, the investigator will meet the patient and assess the child's anxiety level using m-YPAS. The patient will be asked to wear the hospital gown used in the hospital in routine practice with parental assistance. |
Who may qualify
- Ages
- 4 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Patients who are planned to have elective orthopedic surgery
- Patients whose American Society of Anesthesiologists (ASA) physical status classification are between 1-3
- Patients who have approved the informed consent form
Key exclusion criteria (4 listed)
- Motor and/or mentally retarded patients
- Patients with hearing-speech impairment
- Patients whose ASA physical status classification IV-V
- Patients who do not accept informed consent and/or refused to participate in 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 |
|---|---|---|
| The hospital gown with cartoon charactersThe patient will be asked to choose one of the hospital gowns with cartoon characters they want to wear and put it on with parental assistance. | Other | Children wearing the hospital gown with cartoon characters |
Primary outcome
modified Yale Preoperative Anxiety Scale
Time frame: 1 day
investigators evaluate children using the verified Turkish version of modified Yale Preoperative Anxiety Scale.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2024.
- 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. This study is not recruiting at the moment.
Selcan Akesen, MD principal investigator
Uludağ Üniversitesi
Leman Gökçenur Aydın, MD study director
Uludağ Üniversitesi
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 hospital gown with cartoon characters in people with Anxiety, Preoperative, run by Uludag 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 3 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 8 Oct 2024. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Leman Gökçenur Aydın, MD (+905532043332, lgaydin@uludag.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
modified Yale Preoperative Anxiety Scale (time frame: 1 day). 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 8 Oct 2024.