Preoperative CareNCT05538039
Reducing Anxiety of Children and Their Parents in the Pre-elective Surgery Process
A study testing Distract with play dough and Distract with play kaleidoscope in people with Preoperative Care and Child, run by Isparta University of Applied Sciences at 1 site in Turkey (Türkiye).
Trial summary
It is emphasized in the studies that the child and parent anxiety that occurs in pediatric surgery should be prevented or reduced. According to previous studies, one way to reduce child and parent anxiety in the preoperative process is distraction interventions the child and family with preoperative family-centered… Read more about this study
- Who is it for?
- Ages 5 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Preoperative Care, Child, Parent
- What is being tested?
- Distract with play dough and Distract with play kaleidoscope
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 210 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 16 Sep 2022to 28 Mar 2024
- 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 5 to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Being a child between the ages of 5 and 12 who is planned for elective surgery
- Being the parent of a 5-12 year old child scheduled for elective surgery
- Child and parent have no vision, hearing or speech problems
- Child and parent do not have a mental or neurological disability
- The child and parents do not have an anxiety disorder
- Child and parent can speak and understand Turkish
Who cannot join
- Change in surgical operation date
- Using another distraction technique
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of the Effectiveness of Two Different Distraction Interventions in Reducing Preoperative Anxiety of Children and Parents Who Are Scheduled for Elective Surgery: A Randomized Controlled Study
It is emphasized in the studies that the child and parent anxiety that occurs in pediatric surgery should be prevented or reduced. According to previous studies, one way to reduce child and parent anxiety in the preoperative process is distraction interventions the child and family with preoperative family-centered activities. Teaching children anxiety coping skills with the involvement of their parents can reduce preoperative anxiety. This study was planned to Comparison of the effectiveness of two different distraction interventions (distraction with play dough- distraction with kaleidoscope) in reducing preoperative anxiety of children and parents who are scheduled for elective surgery
Read the detailed description
Aim: This study was planned to Comparison of the effectiveness of two different distraction interventions (distraction with play dough- distraction with kaleidoscope) in reducing preoperative anxiety of children and parents who are scheduled for elective surgery
Method: This study was planned as a randomized controlled trial. The sample of the study will consist of 105 children aged 5-12, who will be operated on at Akdeniz University Hospital, and their parents. Randomization result; It was planned to include a total of 105 children and their parents in 3 groups: distraction with play dough group (intervention group 1)= 35, distraction with kaleidoscope group (intervention group 2)= 35 , and control group= 35 children and parents.
Child and parent information form will be used to collect data, Modified Yale Preoperative Anxiety Scale will be used to collect data in child sample, and Spielberger State Anxiety Scale will be used to collect data in parent sample.
Intervention and Data Collection: Randomization will be performed after the purpose of the study is explained to the child and parent who agreed to participate in the study and after obtaining consent. Immediately after the pre-test (first measurement) is given to the children assigned to intervention group 1 and their parents, attempts to distract attention with play dough will be applied for 10 minutes. If they wish, the child and parents will be told that they can continue to play with the play dough until premedication. Children assigned to intervention group 2 and their parents will be distracted with a kaleidoscope for 10 minutes immediately after the pre-test (first measurement) is done. If they wish, the child and parents will be told that they can continue to play with the kaleidoscope until premedication. Participants randomized to the control group will be given routine standard nursing care. The second measurement will be administered 15 minutes after the interventions (before premedication=post test), and the control group 25 minutes after the first measurement (before premedication=posttest). Thus, the effectiveness of the initiatives and their comparison with each other will be evaluated.
The data of the research will be analyzed using the Statistical Package of Social Science (SPSS) 23.0 software package program. The process of evaluating the data will be carried out with the support of a statistician.
- Conditions
- Preoperative Care, Child, Parent, Anxiety
- Being tested
- Distract with play dough, Distract with play kaleidoscope, Control group
- Keywords
- Preoperative Care, Child, Parents, Nursing care, Randomized controlled trial
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Distract with play doughOther
Distract with play dough
Distract with play kaleidoscopeOther
Distract with play kaleidoscope
Control groupOther
Routine nursing care
| Study group | Role | What they receive |
|---|---|---|
| Distract with play dough | Experimental | The intervention will begin approximately 30 minutes before premedication. The initiative will be applied to both the child and the parent participating in the research. Attempts to distract with play dough will be conducted under investigative coaching for at least 10 minutes. If after 10 minutes the child or parent wants to continue playing, they will be told that they can play as long as they want. Each family will be given 4 boxes of play dough. After the play is played, the play dough will not be put back in the package, and the child and parents will be told that they can keep the shapes they have made if they wish. The play dough used will be provided by the researchers and will be given to the participants after the intervention. Receives: Other: Distract with play dough |
| Distract with play kaleidoscope | Experimental | The intervention will begin approximately 30 minutes before premedication. The initiative will be applied to both the child and the parent participating in the research. Attempts to distract with the kaleidoscope will be conducted under investigative coaching for at least 10 minutes. It is a game tool that reproduces the outside image when viewed from inside the kaleidoscope. This image is obtained thanks to the glasses placed inside the kaleidoscope at different angles, and the images change as the kaleidoscope is rotated. If after 10 minutes the child or parent wants to continue playing, they will be told that they can play as long as they want. Each child and parent will be given a separate kaleidoscope. Receives: Other: Distract with play kaleidoscope |
| Control Group | Other | The participants in the control group will be given routine nursing care. Receives: Other: Control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reducing children's pre-operative anxiety
The decrease in anxiety levels of children whose attention is diverted with play dough and kaleidoscope is an outcome measure. This reduction will be measured with the "Modified Yale Preoperative Anxiety Scale". Outcome criteria will be evaluated twice, approximately 30 minutes before premedication and immediately before premedication (pretest-posttest) in the Pediatric Surgery Service. The scale consists of twenty-two items and five categories. Each category gets one point out of four. The higher the score on the scale, the greater the anxiety. In the post-test, it will be evaluated whether there is a decrease according to the pre-test score. Statistical significance will be set to p < 0.05.
Measured: Anxiety levels of children will be evaluated twice. The first measurement will be made 30 minutes before the premedication, and the last measurement will be made just before the premedication.
Reducing parent's pre-operative anxiety
The decrease in anxiety levels of parents of children whose attention is diverted with play dough and kaleidoscope is an outcome measure. This decrease will be measured by the "Spielberger State Anxiety Scale". Outcome criteria will be evaluated twice in Pediatric Surgery Service, approximately 30 minutes before premedication and just before premedication (pretest-posttest). The 4-point Likert-type scale, consisting of 20 items in total, measures the anxiety of the person at a certain time. For scores above 42 points, it indicates a high level of anxiety. In the post-test, it will be evaluated whether there is a decrease according to the pre-test score. Statistical significance will be set to p < 0.05.
Measured: Anxiety levels of parents will be evaluated twice. The first measurement will be made 30 minutes before the premedication, and the last measurement will be made just before the premedication.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2022
- Study start16 Sep 2022
- Primary completion28 Mar 2024
- Study completion28 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Preoperative CareStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Parallel Assignment
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 210 participants (actual)
Sponsor and investigators
- Lead sponsor
- Isparta University of Applied Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- Akdeniz University
- Responsible party
- Sponsor
- Investigators
- Fahriye RN PAZARCIKCI, PhD, Study director, Isparta University of Applied SciencesFatma RN TIRAŞ, Study chair, Akdeniz UniversityŞevkiye RN DİKMEN, Study chair, Akdeniz UniversityEmine RN EFE, Professor, Study chair, Akdeniz University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05538039
- Sponsor's protocol ID
- IspartaUAS
- Status last verified
- Mar 2024
- First submitted
- 8 Sep 2022
- Last updated
- 29 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Aytekin A, Doru O, Kucukoglu S. The Effects of Distraction on Preoperative Anxiety Level in Children. J Perianesth Nurs. 2016 Feb;31(1):56-62. doi: 10.1016/j.jopan.2014.11.016. Epub 2015 Nov 11.
PubMed 26847781Bulut M, Kucuk Alemdar D, Bulut A, Salci G. The Effect of Music Therapy, Hand Massage, and Kaleidoscope Usage on Postoperative Nausea and Vomiting, Pain, Fear, and Stress in Children: A Randomized Controlled Trial. J Perianesth Nurs. 2020 Dec;35(6):649-657. doi: 10.1016/j.jopan.2020.03.013. Epub 2020 Jul 20.
PubMed 32703758Dwairej DA, Obeidat HM, Aloweidi AS. Video game distraction and anesthesia mask practice reduces children's preoperative anxiety: A randomized clinical trial. J Spec Pediatr Nurs. 2020 Jan;25(1):e12272. doi: 10.1111/jspn.12272. Epub 2019 Oct 1.
PubMed 31576651Stewart B, Cazzell MA, Pearcy T. Single-Blinded Randomized Controlled Study on Use of Interactive Distraction Versus Oral Midazolam to Reduce Pediatric Preoperative Anxiety, Emergence Delirium, and Postanesthesia Length of Stay. J Perianesth Nurs. 2019 Jun;34(3):567-575. doi: 10.1016/j.jopan.2018.08.004. Epub 2018 Nov 7.
PubMed 30413359
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Effectiveness of Two Different Distraction Interventions in Reducing Preoperative Anxiety of Children and Parents Who Are Scheduled for Elective Surgery: A Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT05538039
- Acronym / sponsor ID
- IspartaUAS
- Conditions
- Preoperative Care, Child, Parent, Anxiety
- Keywords
- Preoperative Care, Child, Parents, Nursing care, Randomized controlled trial
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 210 participants (actual)
- Lead sponsor
- Isparta University of Applied SciencesUniversity, hospital or other
- Collaborators
- Akdeniz University
- Study start
- 16 Sep 2022 (actual)
- Primary completion
- 28 Mar 2024 (actual)
- Study completion
- 28 Mar 2024 (actual)
- First posted
- 13 Sep 2022 (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.
It is emphasized in the studies that the child and parent anxiety that occurs in pediatric surgery should be prevented or reduced. According to previous studies, one way to reduce child and parent anxiety in the preoperative process is distraction interventions the child and family with preoperative family-centered activities. Teaching children anxiety coping skills with the involvement of their parents can reduce preoperative anxiety. This study was planned to Comparison of the effectiveness of two different distraction interventions (distraction with play dough- distraction with kaleidoscope) in reducing preoperative anxiety of children and parents who are scheduled for elective surgery
Detailed description
Aim: This study was planned to Comparison of the effectiveness of two different distraction interventions (distraction with play dough- distraction with kaleidoscope) in reducing preoperative anxiety of children and parents who are scheduled for elective surgery
Method: This study was planned as a randomized controlled trial. The sample of the study will consist of 105 children aged 5-12, who will be operated on at Akdeniz University Hospital, and their parents. Randomization result; It was planned to include a total of 105 children and their parents in 3 groups: distraction with play dough group (intervention group 1)= 35, distraction with kaleidoscope group (intervention group 2)= 35 , and control group= 35 children and parents.
Child and parent information form will be used to collect data, Modified Yale Preoperative Anxiety Scale will be used to collect data in child sample, and Spielberger State Anxiety Scale will be used to collect data in parent sample.
Intervention and Data Collection: Randomization will be performed after the purpose of the study is explained to the child and parent who agreed to participate in the study and after obtaining consent. Immediately after the pre-test (first measurement) is given to the children assigned to intervention group 1 and their parents, attempts to distract attention with play dough will be applied for 10 minutes. If they wish, the child and parents will be told that they can continue to play with the play dough until premedication. Children assigned to intervention group 2 and their parents will be distracted with a kaleidoscope for 10 minutes immediately after the pre-test (first measurement) is done. If they wish, the child and parents will be told that they can continue to play with the kaleidoscope until premedication. Participants randomized to the control group will be given routine standard nursing care. The second measurement will be administered 15 minutes after the interventions (before premedication=post test), and the control group 25 minutes after the first measurement (before premedication=posttest). Thus, the effectiveness of the initiatives and their comparison with each other will be evaluated.
The data of the research will be analyzed using the Statistical Package of Social Science (SPSS) 23.0 software package program. The process of evaluating the data will be carried out with the support of a statistician.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
- Model description
- Parallel Assignment
| Arm | Type | Receives |
|---|---|---|
| Distract with play dough | Experimental | Other: Distract with play doughThe intervention will begin approximately 30 minutes before premedication. The initiative will be applied to both the child and the parent participating in the research. Attempts to distract with play dough will be conducted under investigative coaching for at least 10 minutes. If after 10 minutes the child or parent wants to continue playing, they will be told that they can play as long as they want. Each family will be given 4 boxes of play dough. After the play is played, the play dough will not be put back in the package, and the child and parents will be told that they can keep the shapes they have made if they wish. The play dough used will be provided by the researchers and will be given to the participants after the intervention. |
| Distract with play kaleidoscope | Experimental | Other: Distract with play kaleidoscopeThe intervention will begin approximately 30 minutes before premedication. The initiative will be applied to both the child and the parent participating in the research. Attempts to distract with the kaleidoscope will be conducted under investigative coaching for at least 10 minutes. It is a game tool that reproduces the outside image when viewed from inside the kaleidoscope. This image is obtained thanks to the glasses placed inside the kaleidoscope at different angles, and the images change as the kaleidoscope is rotated. If after 10 minutes the child or parent wants to continue playing, they will be told that they can play as long as they want. Each child and parent will be given a separate kaleidoscope. |
| Control Group | Other | Other: Control groupThe participants in the control group will be given routine nursing care. |
Who may qualify
- Ages
- 5 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- Being a child between the ages of 5 and 12 who is planned for elective surgery
- Being the parent of a 5-12 year old child scheduled for elective surgery
- Child and parent have no vision, hearing or speech problems
- Child and parent do not have a mental or neurological disability
- The child and parents do not have an anxiety disorder
Key exclusion criteria (2 listed)
- Change in surgical operation date
- Using another distraction technique
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 |
|---|---|---|
| Distract with play doughDistract with play dough | Other | Distract with play dough |
| Distract with play kaleidoscopeDistract with play kaleidoscope | Other | Distract with play kaleidoscope |
| Control groupRoutine nursing care | Other | Control Group |
Primary outcome
Reducing children's pre-operative anxiety
Time frame: Anxiety levels of children will be evaluated twice. The first measurement will be made 30 minutes before the premedication, and the last measurement will be made just before the premedication.
The decrease in anxiety levels of children whose attention is diverted with play dough and kaleidoscope is an outcome measure. This reduction will be measured with the "Modified Yale Preoperative Anxiety Scale". Outcome criteria will be evaluated twice, approximately 30 minutes before premedication and immediately before premedication (pretest-posttest) in the Pediatric Surgery Service. The scale consists of twenty-two items and five categories. Each category gets one point out of four. The higher the score on the scale, the greater the anxiety. In the post-test, it will be evaluated whether there is a decrease according to the pre-test score. Statistical significance will be set to p < 0.05.
Reducing parent's pre-operative anxiety
Time frame: Anxiety levels of parents will be evaluated twice. The first measurement will be made 30 minutes before the premedication, and the last measurement will be made just before the premedication.
The decrease in anxiety levels of parents of children whose attention is diverted with play dough and kaleidoscope is an outcome measure. This decrease will be measured by the "Spielberger State Anxiety Scale". Outcome criteria will be evaluated twice in Pediatric Surgery Service, approximately 30 minutes before premedication and just before premedication (pretest-posttest). The 4-point Likert-type scale, consisting of 20 items in total, measures the anxiety of the person at a certain time. For scores above 42 points, it indicates a high level of anxiety. In the post-test, it will be evaluated whether there is a decrease according to the pre-test score. Statistical significance will be set to p < 0.05.
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 29 Mar 2024.
- Background: PubMed 26847781Aytekin A, Doru O, Kucukoglu S. The Effects of Distraction on Preoperative Anxiety Level in Children. J Perianesth Nurs. 2016 Feb;31(1):56-62. doi: 10.1016/j.jopan.2014.11.016. Epub 2015 Nov 11.
- Background: PubMed 32703758Bulut M, Kucuk Alemdar D, Bulut A, Salci G. The Effect of Music Therapy, Hand Massage, and Kaleidoscope Usage on Postoperative Nausea and Vomiting, Pain, Fear, and Stress in Children: A Randomized Controlled Trial. J Perianesth Nurs. 2020 Dec;35(6):649-657. doi: 10.1016/j.jopan.2020.03.013. Epub 2020 Jul 20.
- Background: PubMed 31576651Dwairej DA, Obeidat HM, Aloweidi AS. Video game distraction and anesthesia mask practice reduces children's preoperative anxiety: A randomized clinical trial. J Spec Pediatr Nurs. 2020 Jan;25(1):e12272. doi: 10.1111/jspn.12272. Epub 2019 Oct 1.
- Background: PubMed 30413359Stewart B, Cazzell MA, Pearcy T. Single-Blinded Randomized Controlled Study on Use of Interactive Distraction Versus Oral Midazolam to Reduce Pediatric Preoperative Anxiety, Emergence Delirium, and Postanesthesia Length of Stay. J Perianesth Nurs. 2019 Jun;34(3):567-575. doi: 10.1016/j.jopan.2018.08.004. Epub 2018 Nov 7.
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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.
Fahriye RN PAZARCIKCI, PhD study director
Isparta University of Applied Sciences
Fatma RN TIRAŞ study chair
Akdeniz University
Şevkiye RN DİKMEN study chair
Akdeniz 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 Distract with play dough and Distract with play kaleidoscope in people with Preoperative Care and Child, run by Isparta University of Applied Sciences 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 2 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 29 Mar 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?
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?
Reducing children's pre-operative anxiety (time frame: Anxiety levels of children will be evaluated twice. The first measurement will be made 30 minutes before the premedication, and the last measurement will be made just before the premedication.). 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?
On the ClinicalTrials.gov record for NCT05538039, which also lists 4 linked publications.
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 29 Mar 2024.