ChildrenNCT07151131
Cartoons and Reflexology for Postoperative Nausea, Pain, and Anxiety in Children
A study testing Watching Cartoons and Reflexology in people with Children and Pain Management, run by Sakarya University.
Trial summary
Preoperative anxiety arises as a physiological response of the body to stressors and is pathophysiologically associated with stimulation of the autonomic nervous system and increased catecholamine release (Durgut, 2021). Read more about this study
- Who is it for?
- Ages 4 to 6 yearsHealthy volunteers can take part
- Conditions the study is for
- Children, Pain Management, Nausea, Postoperative
- What is being tested?
- Watching Cartoons and Reflexology
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 105 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2025to 1 Dec 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 6 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Participants were included in the study if they met all of the following conditions:
- The child was hospitalized in the pediatric surgical clinic for a planned (elective) surgery,
- The child was aged between 4 and 6 years,
- The child was scheduled to receive general anesthesia,
- Neither the child nor the primary caregiver had any visual, hearing, or cognitive impairments,
- The child had no anatomical abnormalities or tissue integrity issues in the feet,
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- Verbal assent was obtained from the child,
- Both parents provided written and verbal informed consent for participation,
- Both the child and parents were willing and voluntarily agreed to participate in the study.
Who cannot join
- Participants were excluded from the study if any of the following conditions occurred:
- Postoperative bleeding tendency developed in the child,
- The child required postoperative intensive care,
- A high-risk complication developed after surgery,
- The child failed to initiate spontaneous respiration postoperatively,
- Intraoperative death (exitus) occurred,
- The child experienced prolonged unconsciousness due to anesthesia,
- The child underwent surgical procedures involving the feet.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Preoperative anxiety arises as a physiological response of the body to stressors and is pathophysiologically associated with stimulation of the autonomic nervous system and increased catecholamine release (Durgut, 2021). As a result, elevated levels of cortisol and epinephrine in the body can cause cytotoxic effects at the cellular level. This physiological mechanism may lead to hypertension, arrhythmia, tachycardia, and tachypnea in children (Dehghan et al., 2019; Durgut, 2021).
Due to these effects, recent evidence-based studies have focused on the use of non-pharmacological approaches with fewer side effects to manage anxiety in children (Kavak et al., 2019). According to the literature, various techniques have been identified as effective interventions for reducing preoperative anxiety in children, including:
Read more
Listening to music,
Playing games,
Using dramatic puppets,
Interactive play,
Virtual reality applications,
Watching cartoons,
Playing favorite video games,
Video presentations,
Hospital clowns,
Storybooks,
Visual and auditory stimuli
- Conditions
- Children, Pain Management, Nausea, Postoperative
- Being tested
- Watching Cartoons, Reflexology
- Medical subject headings
- Agnosia, Postoperative Nausea and Vomiting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Watching CartoonsOther
Cartoon Group Intervention Children assigned to the cartoon group will be taken from the clinic to the preoperative room. Approximately 30 minutes before being transferred to the operating room, children will be allowed to watch a cartoon of their choice on a 60-inch screen TV placed approximately 200 cm away. The duration of the cartoon viewing session will be limited to 20 minutes.
The measurement tools used in the study will be administered at five different time points:
Immediately before watching the cartoon,
Immediately after watching the cartoon but before being transferred to the operating room,
In the postoperative period at the 60th minute,
At the 120th minute postoperatively,
And finally, at the discharge phase.
ReflexologyOther
Massage Group Intervention Children assigned to the massage group will be transferred from the clinic to the preoperative room. Approximately 30 minutes before being taken to the operating room, reflexology massage will be applied by the researcher physician Xxx XXXXX, who holds a valid reflexology certification. The massage will be administered to both the right and left feet, with 10 minutes per foot, for a total duration of 20 minutes.
The measurement tools used in the study will be applied at five distinct time points:
Before the massage,
Immediately after the massage but before operating room transfer,
In the postoperative period at the 60th minute,
At the 120th minute postoperatively,
And finally, during the discharge phase.
| Study group | Role | What they receive |
|---|---|---|
| intervention group | Experimental | Watching Cartoons and Reflexology Massage Receives: Other: Watching Cartoons; Other: Reflexology |
| Control Group | No intervention | Control Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Anxiety Tool: Preoperative Anxiety Scale
Measured: Baseline, Postoperative 60th and 120th minutes
Pain Tool: Wong-Baker FACES Pain Rating Scale
Measured: Postoperative 60th and 120th minutes
Nausea Tool: standardized observational nausea scale
Measured: Postoperative 60th and 120th minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Sep 2025
- Study start1 Sep 2025 (estimated)
- Primary completion1 Sep 2025 (estimated)
- Study completion1 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ChildrenStudies of the same condition, open and under way.
- More trials run by Sakarya UniversityThe sponsor's other registered studies.
- 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 105 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sakarya University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, öznur tiryaki, Sakarya University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07151131
- Sponsor's protocol ID
- Hava Tetik Özel
- Status last verified
- Aug 2025
- First submitted
- 18 Jul 2025
- Last updated
- 3 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Ethically, patient information can be shared upon reasonable request without revealing their identities for security reasons.
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cartoons and Reflexology for Postoperative Nausea, Pain, and Anxiety in Children
- ClinicalTrials.gov ID
- NCT07151131
- Acronym / sponsor ID
- Hava Tetik Özel
- Conditions
- Children, Pain Management, Nausea, Postoperative
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 105 participants (estimated)
- Lead sponsor
- Sakarya UniversityUniversity, hospital or other
- Study start
- 1 Sep 2025 (estimated)
- Primary completion
- 1 Sep 2025 (estimated)
- Study completion
- 1 Dec 2025 (estimated)
- First posted
- 3 Sep 2025 (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.
Preoperative anxiety arises as a physiological response of the body to stressors and is pathophysiologically associated with stimulation of the autonomic nervous system and increased catecholamine release (Durgut, 2021). As a result, elevated levels of cortisol and epinephrine in the body can cause cytotoxic effects at the cellular level. This physiological mechanism may lead to hypertension, arrhythmia, tachycardia, and tachypnea in children (Dehghan et al., 2019; Durgut, 2021).
Due to these effects, recent evidence-based studies have focused on the use of non-pharmacological approaches with fewer side effects to manage anxiety in children (Kavak et al., 2019). According to the literature, various techniques have been identified as effective interventions for reducing preoperative anxiety in children, including:
Listening to music,
Playing games,
Using dramatic puppets,
Interactive play,
Virtual reality applications,
Watching cartoons,
Playing favorite video games,
Video presentations,
Hospital clowns,
Storybooks,
Visual and auditory stimuli
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| intervention group | Experimental | Other: Watching Cartoons, Other: ReflexologyWatching Cartoons and Reflexology Massage |
| Control Group | No intervention | –Control Group |
Who may qualify
- Ages
- 4 to 6 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (9 listed)
- The child was hospitalized in the pediatric surgical clinic for a planned (elective) surgery,
- The child was aged between 4 and 6 years,
- The child was scheduled to receive general anesthesia,
- Neither the child nor the primary caregiver had any visual, hearing, or cognitive impairments,
- The child had no anatomical abnormalities or tissue integrity issues in the feet,
Key exclusion criteria (8 listed)
- Postoperative bleeding tendency developed in the child,
- The child required postoperative intensive care,
- A high-risk complication developed after surgery,
- The child failed to initiate spontaneous respiration postoperatively,
- Intraoperative death (exitus) occurred,
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 |
|---|---|---|
| Watching CartoonsCartoon Group Intervention Children assigned to the cartoon group will be taken from the clinic to the preoperative room. Approximately 30 minutes before being transferred to the operating room, children will be allowed to watch a cartoon of their choice on a 60-inch screen TV placed approximately 200 cm away. The duration of the cartoon viewing session will be limited to 20 minutes. The measurement tools used in the study will be administered at five different time points: Immediately before watching the cartoon, Immediately after watching the cartoon but before being transferred to the operating room, In the postoperative period at the 60th minute, At the 120th minute postoperatively, And finally, at the discharge phase. | Other | intervention group |
| ReflexologyMassage Group Intervention Children assigned to the massage group will be transferred from the clinic to the preoperative room. Approximately 30 minutes before being taken to the operating room, reflexology massage will be applied by the researcher physician Xxx XXXXX, who holds a valid reflexology certification. The massage will be administered to both the right and left feet, with 10 minutes per foot, for a total duration of 20 minutes. The measurement tools used in the study will be applied at five distinct time points: Before the massage, Immediately after the massage but before operating room transfer, In the postoperative period at the 60th minute, At the 120th minute postoperatively, And finally, during the discharge phase. | Other | intervention group |
Primary outcome
Anxiety Tool: Preoperative Anxiety Scale
Time frame: Baseline, Postoperative 60th and 120th minutes
Pain Tool: Wong-Baker FACES Pain Rating Scale
Time frame: Postoperative 60th and 120th minutes
Nausea Tool: standardized observational nausea scale
Time frame: Postoperative 60th and 120th minutes
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Sep 2025.
- Individual participant dataSharing planned: No. Ethically, patient information can be shared upon reasonable request without revealing their identities for security reasons.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Watching Cartoons and Reflexology in people with Children and Pain Management, run by Sakarya University.
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 9 inclusion and 8 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: opening soon, as of the sponsor's last update on 3 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Öznur Tiryaki, Asoss.Prof. (+90264 295 7271, oznuritiryaki@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Anxiety Tool: Preoperative Anxiety Scale (time frame: Baseline, Postoperative 60th and 120th minutes). 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 3 Sep 2025.