TonsillectomyNCT06763276
Preoperative VR Cartoon Viewing Reduces Postoperative Pain and Anxiety in Pediatric Tonsillectomy Patient
A study testing Virtual Reality Group in people with Tonsillectomy and Adenoidectomy, run by Izmir Tinaztepe University at 1 site in Turkey (Türkiye).
Trial summary
The aim of this study is to determine the effect of watching a cartoon with a virtual reality headset before surgery on the pain and anxiety levels of children aged 7-12 years. Read more about this study
- Who is it for?
- Ages 7 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Tonsillectomy, Adenoidectomy
- What is being tested?
- Virtual Reality Group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 102 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 10 Nov 2023to 13 Jul 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 7 to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Child's criteria:
- Children aged between 7 and 12 years
- Ability to understand pain and anxiety scales
- Possession of communication skills
- Absence of mental issues
- Absence of physical illnesses
Show all 9Show fewer
- Absence of chronic illnesses
- Willingness of the child and family to participate in the study
- No visual, hearing, or speech problems
Who cannot join
- Children younger than 7 years or older than 12 years
- Presence of any chronic illness that could affect pain and anxiety levels
- Presence of psychosocial issues
- Children or parents who meet the inclusion criteria but do not wish to wear the virtual reality headset (VRH) glasses
- Children who need to wear glasses other than the virtual reality headset (VRH)
- Children with hearing problems
- Children who do not wish to watch the shrek cartoon
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Preoperative Virtual Reality Cartoon Viewing on Postoperative Pain and Anxiety in Children Undergoing Tonsillectomy and Adenoidectomy
The aim of this study is to determine the effect of watching a cartoon with a virtual reality headset before surgery on the pain and anxiety levels of children aged 7-12 years.
Read the detailed description
The aim of this study is to determine the effect of watching a cartoon with a virtual reality headset before surgery on the pain and anxiety levels of children aged 7-12 years. In line with this aim, children aged 7-12 who were scheduled for tonsillectomy and adenoidectomy at the Ear, Nose, and Throat Department of Uşak University Education and Research Hospital were shown a cartoon with a virtual reality headset before surgery, and their pain and anxiety levels were examined. The study was conducted as a randomized controlled experimental study at the Ear, Nose, and Throat Unit of Uşak University Education and Research Hospital. The population of the study consisted of children aged 7-12 who applied for tonsillectomy and adenoidectomy surgery at the Ear, Nose, and Throat Unit of Uşak University Education and Research Hospital. The sample of the study included a total of 102 children, with 51 in the experimental group and 51 in the control group, who met the research criteria and volunteered to participate in the study between November 10, 2023, and June 1, 2024. Data collection tools included the informed consent form, sociodemographic questionnaire, vital signs assessment form, Visual Analog Scale, and the Perioperative Multidimensional Anxiety Scale for children.
- Conditions
- Tonsillectomy, Adenoidectomy
- Being tested
- Virtual Reality Group
- Keywords
- Virtual Reality, Cartoon, Pain Level, Anxiety Level
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual Reality GroupOther
In the study, a 400-gram virtual reality (VR) headset with an anti-reflective lens system was used, compatible with all earphones with screens ranging from 4.5 to 7.0 inches. The virtual reality (VR) headset, which was lightweight enough for children to wear, was supported on three sides to fit securely on the children's heads and was disinfected after each use. For the experimental group, the compartment at the front of the virtual reality (VR) headset was removed. The earphone was placed into the removed compartment, which was then reinserted. Subsequently, the YouTube virtual reality (VR) feature was activated on the phone, making it ready for viewing.
| Study group | Role | What they receive |
|---|---|---|
| Virtual Reality Group | Experimental | A meeting was conducted with the children and their parents. Information about the content of the research was provided. Consent forms were completed by the children and their parents. Instructions on how to use the virtual reality headset were given to the children and their parents.
Mothers were asked to comfort and caress their children during the preoperative period.
The first 15-20 minutes of the cartoon were shown to the children before the surgery. After watching the cartoon, the children were sent for tonsillectomy and adenoidectomy surgery. The remainder of the cartoon was shown one hour after the surgery once the child had settled in the recovery room.
Before the tonsillectomy and adenoidectomy surgery, immediately after the child returned to the ward post-surgery, and 8 hours after the surgery:
The child's vital signs were recorded. The child's anxiety and pain scores were assessed. Receives: Other: Virtual Reality Group |
| Control Group | No intervention | Consent forms were completed by the children and their parents. Mothers were asked to comfort and caress their children. Before the tonsillectomy and adenoidectomy surgery, immediately after the child returned to the ward post-surgery, and 8 hours after the surgery: The child's vital signs were recorded. The child's anxiety and pain scores were assessed. The children in the control group were allowed to watch the cartoon via virtual reality (VR) after all data for the research had been collected to ensure ethical equality. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Vital signs
Systolic Blood Pressure (mmHg) Description: Systolic blood pressure levels measured during the perioperative period.
Measured: Preoperative, immediately postoperative, and 8 hours postoperative.
Diastolic Blood Pressure (mmHg)
Diastolic blood pressure levels will be measured to assess changes in blood pressure during the perioperative period.
Measured: Preoperative, immediately postoperative, and 8 hours postoperative
Heart Rate (bpm)
Heart rate will be measured to monitor cardiac activity during the perioperative period.
Measured: Preoperative, immediately postoperative, and 8 hours postoperative
Body Temperature (°C)
Body temperature will be measured to observe temperature changes during the perioperative period.
Measured: Preoperative, immediately postoperative, and 8 hours postoperative
Hemoglobin (g/dL)
Hemoglobin levels will be measured preoperatively and within 24 hours postoperatively to evaluate changes in blood parameters during the perioperative period.
Measured: Preoperative and 24 hours postoperative
Creatinine (mg/dL)
Creatinine levels will be measured preoperatively and within 24 hours postoperatively to monitor renal function during the perioperative period.
Measured: Preoperative and 24 hours postoperative
Glucose (mg/dL)
Glucose levels will be measured preoperatively and within 24 hours postoperatively to assess perioperative glucose regulation
Measured: Preoperative and 24 hours postoperative
Secondary outcomes (1)
Secondary Outcome Measure
Pain Score: The Visual Analog Scale (VAS) was used to measure pain intensity in children during the postoperative period following tonsillectomy and adenoidectomy. The children were assessed using the Visual Analog Scale (VAS) before surgery, immediately after returning to the ward post-surgery, and 8 hours after surgery.The Visual Analog Scale (VAS) ranges from 0 to 10, with 0 indicating no pain and 10 representing the worst possible pain. Higher scores indicate greater pain intensity.
Measured: Preoperative, immediately postoperative, 8 hours postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2025
- Study start10 Nov 2023
- Primary completion4 Jun 2024
- Study completion13 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for TonsillectomyStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 102 participants (actual)
Sponsor and investigators
- Lead sponsor
- Izmir Tinaztepe University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Berna Dizer, Izmir Tinaztepe University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06763276
- Sponsor's protocol ID
- İzmirTınaztepeÜ-B.Dizer-001
- Status last verified
- Jan 2025
- First submitted
- 26 Jul 2024
- Last updated
- 8 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Mersin SK, Dizer B, Tuna A. Effect of preoperative virtual reality cartoon viewing on postoperative pain and anxiety in children undergoing tonsillectomy and adenoidectomy: A randomized controlled trial. PLoS One. 2025 Sep 11;20(9):e0331793. doi: 10.1371/journal.pone.0331793. eCollection 2025.
PubMed 40934240
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Preoperative Virtual Reality Cartoon Viewing on Postoperative Pain and Anxiety in Children Undergoing Tonsillectomy and Adenoidectomy
- ClinicalTrials.gov ID
- NCT06763276
- Acronym / sponsor ID
- İzmirTınaztepeÜ-B.Dizer-001
- Conditions
- Tonsillectomy, Adenoidectomy
- Keywords
- Virtual Reality, Cartoon, Pain Level, Anxiety Level
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 102 participants (actual)
- Lead sponsor
- Izmir Tinaztepe UniversityUniversity, hospital or other
- Study start
- 10 Nov 2023 (actual)
- Primary completion
- 4 Jun 2024 (actual)
- Study completion
- 13 Jul 2024 (actual)
- First posted
- 8 Jan 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.
The aim of this study is to determine the effect of watching a cartoon with a virtual reality headset before surgery on the pain and anxiety levels of children aged 7-12 years.
Detailed description
The aim of this study is to determine the effect of watching a cartoon with a virtual reality headset before surgery on the pain and anxiety levels of children aged 7-12 years. In line with this aim, children aged 7-12 who were scheduled for tonsillectomy and adenoidectomy at the Ear, Nose, and Throat Department of Uşak University Education and Research Hospital were shown a cartoon with a virtual reality headset before surgery, and their pain and anxiety levels were examined. The study was conducted as a randomized controlled experimental study at the Ear, Nose, and Throat Unit of Uşak University Education and Research Hospital. The population of the study consisted of children aged 7-12 who applied for tonsillectomy and adenoidectomy surgery at the Ear, Nose, and Throat Unit of Uşak University Education and Research Hospital. The sample of the study included a total of 102 children, with 51 in the experimental group and 51 in the control group, who met the research criteria and volunteered to participate in the study between November 10, 2023, and June 1, 2024. Data collection tools included the informed consent form, sociodemographic questionnaire, vital signs assessment form, Visual Analog Scale, and the Perioperative Multidimensional Anxiety Scale for children.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Virtual Reality Group | Experimental | Other: Virtual Reality GroupA meeting was conducted with the children and their parents. Information about the content of the research was provided. Consent forms were completed by the children and their parents. Instructions on how to use the virtual reality headset were given to the children and their parents. Mothers were asked to comfort and caress their children during the preoperative period. The first 15-20 minutes of the cartoon were shown to the children before the surgery. After watching the cartoon, the children were sent for tonsillectomy and adenoidectomy surgery. The remainder of the cartoon was shown one hour after the surgery once the child had settled in the recovery room. Before the tonsillectomy and adenoidectomy surgery, immediately after the child returned to the ward post-surgery, and 8 hours after the surgery: The child's vital signs were recorded. The child's anxiety and pain scores were assessed. |
| Control Group | No intervention | –Consent forms were completed by the children and their parents. Mothers were asked to comfort and caress their children. Before the tonsillectomy and adenoidectomy surgery, immediately after the child returned to the ward post-surgery, and 8 hours after the surgery: The child's vital signs were recorded. The child's anxiety and pain scores were assessed. The children in the control group were allowed to watch the cartoon via virtual reality (VR) after all data for the research had been collected to ensure ethical equality. |
Who may qualify
- Ages
- 7 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (9 listed)
- Children aged between 7 and 12 years
- Ability to understand pain and anxiety scales
- Possession of communication skills
- Absence of mental issues
- Absence of physical illnesses
Key exclusion criteria (7 listed)
- Children younger than 7 years or older than 12 years
- Presence of any chronic illness that could affect pain and anxiety levels
- Presence of psychosocial issues
- Children or parents who meet the inclusion criteria but do not wish to wear the virtual reality headset (VRH) glasses
- Children who need to wear glasses other than the virtual reality headset (VRH)
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 |
|---|---|---|
| Virtual Reality GroupIn the study, a 400-gram virtual reality (VR) headset with an anti-reflective lens system was used, compatible with all earphones with screens ranging from 4.5 to 7.0 inches. The virtual reality (VR) headset, which was lightweight enough for children to wear, was supported on three sides to fit securely on the children's heads and was disinfected after each use. For the experimental group, the compartment at the front of the virtual reality (VR) headset was removed. The earphone was placed into the removed compartment, which was then reinserted. Subsequently, the YouTube virtual reality (VR) feature was activated on the phone, making it ready for viewing. | Other | Virtual Reality Group |
Primary outcome
Vital signs
Time frame: Preoperative, immediately postoperative, and 8 hours postoperative.
Systolic Blood Pressure (mmHg) Description: Systolic blood pressure levels measured during the perioperative period.
Diastolic Blood Pressure (mmHg)
Time frame: Preoperative, immediately postoperative, and 8 hours postoperative
Diastolic blood pressure levels will be measured to assess changes in blood pressure during the perioperative period.
Heart Rate (bpm)
Time frame: Preoperative, immediately postoperative, and 8 hours postoperative
Heart rate will be measured to monitor cardiac activity during the perioperative period.
Body Temperature (°C)
Time frame: Preoperative, immediately postoperative, and 8 hours postoperative
Body temperature will be measured to observe temperature changes during the perioperative period.
Hemoglobin (g/dL)
Time frame: Preoperative and 24 hours postoperative
Hemoglobin levels will be measured preoperatively and within 24 hours postoperatively to evaluate changes in blood parameters during the perioperative period.
Creatinine (mg/dL)
Time frame: Preoperative and 24 hours postoperative
Creatinine levels will be measured preoperatively and within 24 hours postoperatively to monitor renal function during the perioperative period.
Glucose (mg/dL)
Time frame: Preoperative and 24 hours postoperative
Glucose levels will be measured preoperatively and within 24 hours postoperatively to assess perioperative glucose regulation
1 secondary outcome
Secondary Outcome Measure
Time frame: Preoperative, immediately postoperative, 8 hours 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 8 Jan 2025.
- Derived from this study: PubMed 40934240Mersin SK, Dizer B, Tuna A. Effect of preoperative virtual reality cartoon viewing on postoperative pain and anxiety in children undergoing tonsillectomy and adenoidectomy: A randomized controlled trial. PLoS One. 2025 Sep 11;20(9):e0331793. doi: 10.1371/journal.pone.0331793. eCollection 2025.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Virtual Reality Group in people with Tonsillectomy and Adenoidectomy, run by Izmir Tinaztepe 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 9 inclusion and 7 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 8 Jan 2025. 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?
Vital signs (time frame: Preoperative, immediately postoperative, and 8 hours postoperative.). The study lists 7 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 NCT06763276, which also lists 1 linked publication.
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 8 Jan 2025.