Nurse's RoleNCT06036940
Perioperative Anxiety in Children
A study testing Preoperative patient education given with three different methods in people with Nurse's Role, run by Namik Kemal University at 1 site in Turkey (Türkiye).
Trial summary
The study was conducted to evaluate the effect of preoperative patient education given by three different methods on the level of perioperative anxiety in children aged 4-7 years. Read more about this study
- Who is it for?
- Ages 4 to 7 years
- Conditions the study is for
- Nurse's Role
- What is being tested?
- Preoperative patient education given with three different methods
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jun 2021to 7 Feb 2022
- 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 7 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Planned elective surgery related to pediatric surgery,
- Having no problems in communicating,
- Volunteer to participate in the research
- Children aged 4-7 years
Who cannot join
- Children scheduled for emergency surgery
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Tekirdag Namık Kemal University
Tekirdağ, Suleymanpasa, 59000
About this study
Official title: COMPARISON OF 3 DIFFERENT METHODS FOR REDUCING THE LEVEL OF PERIOPERATIVE ANXIETY IN CHILDREN AGED 4-7: A RANDOMIZED CONTROLLED STUDY
The study was conducted to evaluate the effect of preoperative patient education given by three different methods on the level of perioperative anxiety in children aged 4-7 years. The research was carried out between 1 June - 31 November 2021 at Tekirdag Namık Kemal University Health Practice and Research Center, Department of Pediatric Surgery. A total of 66 patients, 22 patients in each group, who met the inclusion criteria and were included in the stratified randomization method, were included in the planned quasi-experimental study. Research data were obtained by using the "Patient Diagnosis Form" and the "Anxiety Scale in Preschool Children" administered before and after the surgery.
Read the detailed description
Pre-operative patient education was given to the children in the first experimental group by the service nurse. The children in the second experimental group were given pre-operative patient education by the service nurse, in addition, patient visits were provided by the operating room nurse and the operating room environment was explained through play. The children in the third experimental group were given pre-operative patient education by the service nurse, after which they listened to the mother's voice recording and loving words until they went to the operating room. It was determined that 69.7% of the mothers of the children participating in the study were 30 years and older, 81.8% were married, 37.9% were undergraduate graduates, and 51.5% were unemployed. The general anxiety disorder levels of those who had no previous surgery experience were found significantly higher than those who had previous surgery experience (p<0.05). In terms of affecting the anxiety level, there was a significant difference between the preoperative methods (p<0.05). It was determined that the education given by both the service nurse and the operating room nurse together was more effective than other methods in reducing the anxiety levels of children, and there was a statistically significant difference between them. (p<0.05)
- Conditions
- Nurse's Role
- Being tested
- Preoperative patient education given with three different methods
- Keywords
- Anxiety, child sick, surgical nursing
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Preoperative patient education given with three different methodsOther
To determine the effect of preoperative patient education given by three different methods on the level of perioperative anxiety in children aged 4-7 years.
| Study group | Role | What they receive |
|---|---|---|
| First Control Group | No intervention | The children in the first control group were given pre-operative patient education by the service nurse. |
| Second Experimental Group | Experimental | The children in the second experimental group were given pre-operative patient education by the service nurse, also patient visits were provided by the operating room nurse and the operating room environment was explained through play. Receives: Other: Preoperative patient education given with three different methods |
| Third Experimental Group | Experimental | The children in the third experimental group were given pre-operative patient education by the service nurse, and then the mother's voice recording was played until they went to the operating room. Receives: Other: Preoperative patient education given with three different methods |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient Diagnosis Form
This section consists of a total of 11 questions prepared by the researcher in the light of the literature, including the introductory characteristics of patients and mothers, their previous surgical experience and their expectations from nurses.
Measured: 5 month
Secondary outcomes (1)
Anxiety Scale in Preschool Children
Anxiety Scale for Preschool Children consists of a 5-point Likert scale. It is scored from 0 (not at all true), 1 (rarely true), 2 (sometimes true), 3 (quite true), 4 (very often true), from 0 to 4, and parents are expected to evaluate their children. The original scale measures 4 factors. These factors should consist of 4 sub-dimensions, social anxiety disorder, generalized anxiety disorder, separation anxiety disorder, and specific phobia. There are 29 items that are expected to be answered in total. Cronbach's Alpha values of the sub-dimensions range from .72 to .92.
Measured: 5 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2023
- Study start1 Jun 2021
- Primary completion30 Nov 2021
- Study completion7 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nurse's RoleStudies 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
- Single group
- Masking
- None (open label)
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- Namik Kemal University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tülin YILDIZ, Namik Kemal University
- Investigators
- Tülin YILDIZ, Prof. Dr., Principal investigator, Namik Kemal University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06036940
- Sponsor's protocol ID
- TYILDIZ
- Status last verified
- Sep 2023
- First submitted
- 7 Sep 2023
- Last updated
- 14 Sep 2023
- 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 14 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- COMPARISON OF 3 DIFFERENT METHODS FOR REDUCING THE LEVEL OF PERIOPERATIVE ANXIETY IN CHILDREN AGED 4-7: A RANDOMIZED CONTROLLED STUDY
- ClinicalTrials.gov ID
- NCT06036940
- Acronym / sponsor ID
- TYILDIZ
- Conditions
- Nurse's Role
- Keywords
- Anxiety, child sick, surgical nursing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- Namik Kemal UniversityUniversity, hospital or other
- Study start
- 1 Jun 2021 (actual)
- Primary completion
- 30 Nov 2021 (actual)
- Study completion
- 7 Feb 2022 (actual)
- First posted
- 14 Sep 2023 (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 study was conducted to evaluate the effect of preoperative patient education given by three different methods on the level of perioperative anxiety in children aged 4-7 years. The research was carried out between 1 June - 31 November 2021 at Tekirdag Namık Kemal University Health Practice and Research Center, Department of Pediatric Surgery. A total of 66 patients, 22 patients in each group, who met the inclusion criteria and were included in the stratified randomization method, were included in the planned quasi-experimental study. Research data were obtained by using the "Patient Diagnosis Form" and the "Anxiety Scale in Preschool Children" administered before and after the surgery.
Detailed description
Pre-operative patient education was given to the children in the first experimental group by the service nurse. The children in the second experimental group were given pre-operative patient education by the service nurse, in addition, patient visits were provided by the operating room nurse and the operating room environment was explained through play. The children in the third experimental group were given pre-operative patient education by the service nurse, after which they listened to the mother's voice recording and loving words until they went to the operating room. It was determined that 69.7% of the mothers of the children participating in the study were 30 years and older, 81.8% were married, 37.9% were undergraduate graduates, and 51.5% were unemployed. The general anxiety disorder levels of those who had no previous surgery experience were found significantly higher than those who had previous surgery experience (p<0.05). In terms of affecting the anxiety level, there was a significant difference between the preoperative methods (p<0.05). It was determined that the education given by both the service nurse and the operating room nurse together was more effective than other methods in reducing the anxiety levels of children, and there was a statistically significant difference between them. (p<0.05)
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| First Control Group | No intervention | –The children in the first control group were given pre-operative patient education by the service nurse. |
| Second Experimental Group | Experimental | Other: Preoperative patient education given with three different methodsThe children in the second experimental group were given pre-operative patient education by the service nurse, also patient visits were provided by the operating room nurse and the operating room environment was explained through play. |
| Third Experimental Group | Experimental | Other: Preoperative patient education given with three different methodsThe children in the third experimental group were given pre-operative patient education by the service nurse, and then the mother's voice recording was played until they went to the operating room. |
Who may qualify
- Ages
- 4 to 7 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Planned elective surgery related to pediatric surgery,
- Having no problems in communicating,
- Volunteer to participate in the research
- Children aged 4-7 years
Key exclusion criteria (1 listed)
- Children scheduled for emergency surgery
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 |
|---|---|---|
| Preoperative patient education given with three different methodsTo determine the effect of preoperative patient education given by three different methods on the level of perioperative anxiety in children aged 4-7 years. | Other | Second Experimental Group, Third Experimental Group |
Primary outcome
Patient Diagnosis Form
Time frame: 5 month
This section consists of a total of 11 questions prepared by the researcher in the light of the literature, including the introductory characteristics of patients and mothers, their previous surgical experience and their expectations from nurses.
1 secondary outcome
Anxiety Scale in Preschool Children
Time frame: 5 month
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 14 Sep 2023.
- 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.
Tülin YILDIZ, Prof. Dr. principal investigator
Namik Kemal University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Preoperative patient education given with three different methods in people with Nurse's Role, run by Namik Kemal 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 4 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: finished, as of the sponsor's last update on 14 Sep 2023. 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?
Patient Diagnosis Form (time frame: 5 month). 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 14 Sep 2023.