AnxietyNCT06404879
The Effect of Parental Anxiety Level on the Child's Anxiety Level and Postoperative Pain in Children Undergoing Surgery.
An observational study of Anxiety and Children, run by Giresun University at 1 site in Turkey (Türkiye).
Trial summary
The aim of this prospective study is to investigate whether the anxiety levels of parents of children aged 2-6 years who will undergo inguinal area surgery have an effect on the child\'s preoperative anxiety level and postoperative pain level. Read more about this study
- Who is it for?
- Ages 2 to 6 yearsHealthy volunteers can take part
- What is being tested?
- determining scores with tests
- How many people
- 81 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2025to 16 May 2025
- How long will I take part?
- 1 Day
- Phase
- Observational
- 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 2 to 6 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: Children who are planned to undergo surgery under general anesthesia due to inguinal area pathology
Who may be able to join
- The child is between the ages of 2-6
- Patients scheduled for surgery under general anesthesia due to inguinal area pathology
- Surgery performed as planned
- There is no mental or neurological disorder in both the mother and the child.
- There are no vision, hearing or speech problems in both the mother and the child.
- Parents and children who volunteer to participate in the research
- Children with ASA I
Who cannot join
- Not volunteering to participate in the study (those for whom parental consent cannot be obtained)
- Those who underwent surgery with a pathology other than the inguinal area
- Having emergency surgery
- Children at risk with ASA 2 and above
- Having a pathology that may cause difficulty in communicating with both the family and the child (such as mental retardation, neurological problem).
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Giresun Gynecology and Pediatrics Training Research Hospital
Giresun, Centre, 28000
About this study
Official title: The Relationship Between Pre-operative Parental Anxiety Level and the Child's Anxiety Level and Its Effect on Postoperative Pain in Children Aged 2-6 Years Who Will Undergo Inguinal Area Surgery.
The aim of this prospective study is to investigate whether the anxiety levels of parents of children aged 2-6 years who will undergo inguinal area surgery have an effect on the child\'s preoperative anxiety level and postoperative pain level.
Read the detailed description
Hospitalization of children for any health problem or treatment is a complex and difficult process that negatively affects the child and his family and creates stress. Surgical treatment in children can be planned or unplanned, minor or major, invasive or non-invasive, but every type of surgery is considered a stressful experience. Studies have shown that by controlling the anxiety and fear experienced in the preoperative period, children can achieve faster recovery in the postoperative period, better pain tolerance and earlier discharge. For this reason, we aim to contribute to the literature by investigating whether the anxiety levels of the parents of children aged 2-6 who will undergo inguinal area surgery affect the child\'s preoperative anxiety level and postoperative pain level.
- Being tested
- determining scores with tests
- Keywords
- children, anxiety, analgesia, pediatric, anaesthesia
- Medical subject headings
- Anxiety Disorders, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
determining scores with testsOther
Parents of children preparing for the operation will be given a child and family information form and STAI-I and STAI-II (State-Trait Anxiety Scale) scale forms and will be asked to fill them out themselves.
An anesthesia technician blind to the content of the study will calculate and take notes on the children\'s anxiety levels, according to the m-YPAS (modified Yale Preoperative Anxiety) scale, in the preoperative waiting room (T1) and when the anesthesia ventilation mask is shown (T4).
FLACC (Face, Legs, Activity, Cry, Consolabilityscale) scores and spO2, pulse values and complications such as nausea, vomiting and desaturation at the 5th, 10th, 20th and 30th minutes of all children taken to the recovery unit in the postoperative period will be recorded by the recovery unit nurse. . Children who are thought to have pain according to the FLACC score will be given 0.5 mg/kg meperidine as rescue analgesia and a note will be taken.
| Study group | Role | What they receive |
|---|---|---|
| children group | Are between the ages of 2-6, are planned to undergo surgery under general anesthesia due to inguinal area pathology, No mental or neurological disorders in both mother and child No vision, hearing or speech problems in both mother and child Parents and children who volunteer to participate in the research will be included in the study.
Those who did not volunteer to participate in the study, Undergoing surgery with a pathology other than the inguinal area, Having emergency surgery Children with pathologies (mental retardation, neurological problems, etc.) that may cause difficulty in communicating with both the family and the child will not be included in the study. Receives: Other: determining scores with tests |
What is being measured
The primary outcome is the main question the study is designed to answer.
Anxiety level of parents
It will be measured with STAI-I and STAI-II (State-Trait Anxiety Scale) scale forms.
Measured: preoperative period
Anxiety level of the child undergoing surgery
According to the m-YPAS (modified Yale Preoperative Anxiety) scale, children's anxiety levels will be calculated in the preoperative waiting room (T1) and when the anesthesia ventilation mask is shown (T4).
Measured: preoperative and intraoperative period
Pain levels of children undergoing surgery
Pain levels of all children taken to the recovery unit will be measured with the FLACC (Face, Legs, Activity, Cry, Consolabilityscale) score at the 5th, 10th, 20th and 30th minutes.
Measured: postoperative period
Secondary outcomes (3)
heart rate
beats/min
Measured: intraoperative period
heart rate
beats/min
Measured: up to 8 hour postoperative
complication
such as nausea, vomiting and desaturation
Measured: up to 24 hour postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2024
- Study start1 Jan 2025
- Primary completion1 Apr 2025
- Study completion16 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnxietyStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 81 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Giresun University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dilek Yeniay, Giresun University
- Investigators
- Dilek YENİAY, Principal investigator, Department of Anesthesiolgy, Giresun University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06404879
- Sponsor's protocol ID
- 25.09.2023/07
- Status last verified
- Jan 2026
- First submitted
- 29 Apr 2024
- Last updated
- 28 Jan 2026
- Results posted
- 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 28 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Relationship Between Pre-operative Parental Anxiety Level and the Child's Anxiety Level and Its Effect on Postoperative Pain in Children Aged 2-6 Years Who Will Undergo Inguinal Area Surgery.
- ClinicalTrials.gov ID
- NCT06404879
- Acronym / sponsor ID
- 25.09.2023/07
- Keywords
- children, anxiety, analgesia, pediatric, anaesthesia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 81 participants (actual)
- Lead sponsor
- Giresun UniversityUniversity, hospital or other
- Study start
- 1 Jan 2025 (actual)
- Primary completion
- 1 Apr 2025 (actual)
- Study completion
- 16 May 2025 (actual)
- First posted
- 8 May 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 aim of this prospective study is to investigate whether the anxiety levels of parents of children aged 2-6 years who will undergo inguinal area surgery have an effect on the child\'s preoperative anxiety level and postoperative pain level.
Detailed description
Hospitalization of children for any health problem or treatment is a complex and difficult process that negatively affects the child and his family and creates stress. Surgical treatment in children can be planned or unplanned, minor or major, invasive or non-invasive, but every type of surgery is considered a stressful experience. Studies have shown that by controlling the anxiety and fear experienced in the preoperative period, children can achieve faster recovery in the postoperative period, better pain tolerance and earlier discharge. For this reason, we aim to contribute to the literature by investigating whether the anxiety levels of the parents of children aged 2-6 who will undergo inguinal area surgery affect the child\'s preoperative anxiety level and postoperative pain level.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Day
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| children group | – | Other: determining scores with testsAre between the ages of 2-6, are planned to undergo surgery under general anesthesia due to inguinal area pathology, No mental or neurological disorders in both mother and child No vision, hearing or speech problems in both mother and child Parents and children who volunteer to participate in the research will be included in the study. Those who did not volunteer to participate in the study, Undergoing surgery with a pathology other than the inguinal area, Having emergency surgery Children with pathologies (mental retardation, neurological problems, etc.) that may cause difficulty in communicating with both the family and the child will not be included in the study. |
Who may qualify
- Ages
- 2 to 6 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Children who are planned to undergo surgery under general anesthesia due to inguinal area pathology
Key inclusion criteria (7 listed)
- The child is between the ages of 2-6
- Patients scheduled for surgery under general anesthesia due to inguinal area pathology
- Surgery performed as planned
- There is no mental or neurological disorder in both the mother and the child.
- There are no vision, hearing or speech problems in both the mother and the child.
Key exclusion criteria (5 listed)
- Not volunteering to participate in the study (those for whom parental consent cannot be obtained)
- Those who underwent surgery with a pathology other than the inguinal area
- Having emergency surgery
- Children at risk with ASA 2 and above
- Having a pathology that may cause difficulty in communicating with both the family and the child (such as mental retardation, neurological problem).
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 |
|---|---|---|
| determining scores with testsParents of children preparing for the operation will be given a child and family information form and STAI-I and STAI-II (State-Trait Anxiety Scale) scale forms and will be asked to fill them out themselves. An anesthesia technician blind to the content of the study will calculate and take notes on the children\'s anxiety levels, according to the m-YPAS (modified Yale Preoperative Anxiety) scale, in the preoperative waiting room (T1) and when the anesthesia ventilation mask is shown (T4). FLACC (Face, Legs, Activity, Cry, Consolabilityscale) scores and spO2, pulse values and complications such as nausea, vomiting and desaturation at the 5th, 10th, 20th and 30th minutes of all children taken to the recovery unit in the postoperative period will be recorded by the recovery unit nurse. . Children who are thought to have pain according to the FLACC score will be given 0.5 mg/kg meperidine as rescue analgesia and a note will be taken. | Other | children group |
Primary outcome
Anxiety level of parents
Time frame: preoperative period
It will be measured with STAI-I and STAI-II (State-Trait Anxiety Scale) scale forms.
Anxiety level of the child undergoing surgery
Time frame: preoperative and intraoperative period
According to the m-YPAS (modified Yale Preoperative Anxiety) scale, children's anxiety levels will be calculated in the preoperative waiting room (T1) and when the anesthesia ventilation mask is shown (T4).
Pain levels of children undergoing surgery
Time frame: postoperative period
Pain levels of all children taken to the recovery unit will be measured with the FLACC (Face, Legs, Activity, Cry, Consolabilityscale) score at the 5th, 10th, 20th and 30th minutes.
3 secondary outcomes
heart rate
Time frame: intraoperative period
heart rate
Time frame: up to 8 hour postoperative
complication
Time frame: up to 24 hour postoperative
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 28 Jan 2026.
- 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.
Dilek YENİAY principal investigator
Department of Anesthesiolgy, Giresun University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Anxiety and Children, run by Giresun 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 7 inclusion and 5 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 28 Jan 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?
Anxiety level of parents (time frame: preoperative period). The study lists 3 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 28 Jan 2026.