SurgeryNCT06148844
Interactive Robot on Pre-operative Anxiety and Fear of Children
A study testing interactive robot group in people with Surgery, run by Karamanoğlu Mehmetbey University at 1 site in Turkey (Türkiye).
Trial summary
The aim of this study is to determine the effect of preoperative preparation applied with an interactive robot on children's preoperative anxiety and fear levels. Hypothesis; H1: Pre-operative preparation with an interactive robot has an effect on the anxiety level of children H2: Pre-operative preparation with an… Read more about this study
- Who is it for?
- Ages 5 to 10 years
- Conditions the study is for
- Surgery
- What is being tested?
- interactive robot group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 74 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 18 Sep 2023to 18 Nov 2023
- 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 10 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Those between the ages of 5-10,
- having planned day surgery,
- scheduled for general anesthesia
- have not had surgery before,
- Those who can speak Turkish
Who cannot join
- Children have mental-cognitive problems,
- Children have hearing, vision and/or speech disabilities
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Karaman Education and Research Hospital
Karaman, 70200
About this study
Official title: The Effect of Interactive Robot on Pre-operative Anxiety and Fear of Children
The aim of this study is to determine the effect of preoperative preparation applied with an interactive robot on children's preoperative anxiety and fear levels.
Hypothesis;
H1: Pre-operative preparation with an interactive robot has an effect on the anxiety level of children H2: Pre-operative preparation with an interactive robot has an effect on the fear level of children H3: The anxiety levels of children in intervention and control groups are different after the pre-operative preparation H4: The fear levels of children in intervention and control groups are different after the pre-operative preparation
Read the detailed description
The use of interactive robots can be preferred as a remarkable method of communication with hospitalized children. In this way, it will be easier for the children to understand the procedure and they will be able to communicate easily with healthcare professionals. Children may develop a sense of control and the level of anxiety and fear they experience may decrease when they interact with robots. It is reported in the literature that children show more interest in robots than they do in adults. In addition, children see social robots as living creatures, not as devices, and children who spend time with them for a long time adopt them as friends. In a study, a social humanoid robot was used to prepare children aged 7-12 (n = 11) regarding the cancer diagnosis process and interventional procedures. According to the results of the study, the children's stress, depression, and anger during the treatment decreased significantly. Interactive robots positively affect postoperative mobilization in children undergoing day surgery and reduce the anxiety level of children before mobilization. As a result, it may be easier for children to cope with stress with the use of interactive and humanoid robots. Also, interactive robots can facilitate cooperation between the child and the nurse by playing an intermediary role in communication with children. Determining the effects of interactive robots on children by using them before the surgical procedure is important to ensure the active participation of children in the surgical process in pediatric surgery clinics. It is thought that this research is important in terms of interventions which appropriate to the supportive care role of nurses and will contribute to the literature.
- Conditions
- Surgery
- Being tested
- interactive robot group
- Keywords
- minor surgical procedures, nursing, interactive robot, chlidren
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
interactive robot groupOther
Intervention group will receive one day pre-operative preparation intervention applied by researcher. Preparation will be 30-40 minutes long
| Study group | Role | What they receive |
|---|---|---|
| Control Group | No intervention | The routine preparation procedure in this group in the hospital will be applied by the nurses responsible for preoperative preparation. After pre-operative preparation, the child, parent and nurse will be asked to fill out the anxiety and fear scales to evaluate the child's anxiety and fear levels. |
| Interactive robot group | Experimental | In addition to the routine preparation procedure interactive robot will be used to preparation as a therapeutic approach. The interactive robot will accompany to the child the preparation for the surgery. Then, the features of the interactive robot will be explained to the children and parents and it will be introduced to the children. The interactive robot will meet the child with its speech feature and the robot will accompany to child to the operating room entrance. The child will be informed that he/she can request the interactive robot to follow him/her if he/she wishes. The child will be transferred to the operating room accompanied by the nurse, researcher and robot. After pre-operative preparation, the child, parent and nurse will be asked to fill out the anxiety and fear scales to evaluate the child's anxiety and fear levels. Receives: Other: interactive robot group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Anxiety
Children's State Anxiety Scale: Validated scale used for evaluation of 4-10 aged children's anxiety level. Scale score ranges between 0-10.
Measured: one day
Fear
Children's Fear Scale: Validated scale used for evaluation of 5-10 aged children's fear level. Scale score ranges between 0-4.
Measured: one day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Nov 2023
- Study start18 Sep 2023
- Primary completion18 Nov 2023
- Study completion18 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SurgeryStudies 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
- Parallel groups
- Model description
- Two group with conventional therapy control group
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 74 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karamanoğlu Mehmetbey University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tuba Arpacı, Karamanoğlu Mehmetbey University
- Investigators
- Tuba ARPACI, PhD, Principal investigator, Karamanoğlu Mehmetbey University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06148844
- Sponsor's protocol ID
- KMU-SBF-TA-01
- Status last verified
- Nov 2023
- First submitted
- 20 Nov 2023
- Last updated
- 28 Nov 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 28 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Interactive Robot on Pre-operative Anxiety and Fear of Children
- ClinicalTrials.gov ID
- NCT06148844
- Acronym / sponsor ID
- KMU-SBF-TA-01
- Conditions
- Surgery
- Keywords
- minor surgical procedures, nursing, interactive robot, chlidren
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 74 participants (actual)
- Lead sponsor
- Karamanoğlu Mehmetbey UniversityUniversity, hospital or other
- Study start
- 18 Sep 2023 (actual)
- Primary completion
- 18 Nov 2023 (actual)
- Study completion
- 18 Nov 2023 (actual)
- First posted
- 28 Nov 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 aim of this study is to determine the effect of preoperative preparation applied with an interactive robot on children's preoperative anxiety and fear levels.
Hypothesis;
H1: Pre-operative preparation with an interactive robot has an effect on the anxiety level of children H2: Pre-operative preparation with an interactive robot has an effect on the fear level of children H3: The anxiety levels of children in intervention and control groups are different after the pre-operative preparation H4: The fear levels of children in intervention and control groups are different after the pre-operative preparation
Detailed description
The use of interactive robots can be preferred as a remarkable method of communication with hospitalized children. In this way, it will be easier for the children to understand the procedure and they will be able to communicate easily with healthcare professionals. Children may develop a sense of control and the level of anxiety and fear they experience may decrease when they interact with robots. It is reported in the literature that children show more interest in robots than they do in adults. In addition, children see social robots as living creatures, not as devices, and children who spend time with them for a long time adopt them as friends. In a study, a social humanoid robot was used to prepare children aged 7-12 (n = 11) regarding the cancer diagnosis process and interventional procedures. According to the results of the study, the children's stress, depression, and anger during the treatment decreased significantly. Interactive robots positively affect postoperative mobilization in children undergoing day surgery and reduce the anxiety level of children before mobilization. As a result, it may be easier for children to cope with stress with the use of interactive and humanoid robots. Also, interactive robots can facilitate cooperation between the child and the nurse by playing an intermediary role in communication with children. Determining the effects of interactive robots on children by using them before the surgical procedure is important to ensure the active participation of children in the surgical process in pediatric surgery clinics. It is thought that this research is important in terms of interventions which appropriate to the supportive care role of nurses and will contribute to the literature.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Two group with conventional therapy control group
| Arm | Type | Receives |
|---|---|---|
| Control Group | No intervention | –The routine preparation procedure in this group in the hospital will be applied by the nurses responsible for preoperative preparation. After pre-operative preparation, the child, parent and nurse will be asked to fill out the anxiety and fear scales to evaluate the child's anxiety and fear levels. |
| Interactive robot group | Experimental | Other: interactive robot groupIn addition to the routine preparation procedure interactive robot will be used to preparation as a therapeutic approach. The interactive robot will accompany to the child the preparation for the surgery. Then, the features of the interactive robot will be explained to the children and parents and it will be introduced to the children. The interactive robot will meet the child with its speech feature and the robot will accompany to child to the operating room entrance. The child will be informed that he/she can request the interactive robot to follow him/her if he/she wishes. The child will be transferred to the operating room accompanied by the nurse, researcher and robot. After pre-operative preparation, the child, parent and nurse will be asked to fill out the anxiety and fear scales to evaluate the child's anxiety and fear levels. |
Who may qualify
- Ages
- 5 to 10 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Those between the ages of 5-10,
- having planned day surgery,
- scheduled for general anesthesia
- have not had surgery before,
- Those who can speak Turkish
Key exclusion criteria (2 listed)
- Children have mental-cognitive problems,
- Children have hearing, vision and/or speech disabilities
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 |
|---|---|---|
| interactive robot groupIntervention group will receive one day pre-operative preparation intervention applied by researcher. Preparation will be 30-40 minutes long | Other | Interactive robot group |
Primary outcome
Anxiety
Time frame: one day
Children's State Anxiety Scale: Validated scale used for evaluation of 4-10 aged children's anxiety level. Scale score ranges between 0-10.
Fear
Time frame: one day
Children's Fear Scale: Validated scale used for evaluation of 5-10 aged children's fear level. Scale score ranges between 0-4.
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 Nov 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.
Tuba ARPACI, PhD principal investigator
Karamanoğlu Mehmetbey 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 interactive robot group in people with Surgery, run by Karamanoğlu Mehmetbey 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 5 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 28 Nov 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?
Anxiety (time frame: one day). 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 28 Nov 2023.