Virtual reality for Tonsil Hypertrophy

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Nationwide Children's Hospital, Columbus, OH
Tonsil Hypertrophy+2 More
Virtual reality - Other
Eligibility
< 18
All Sexes
Eligible conditions
Select

Study Summary

This study is evaluating whether a virtual reality tool can improve the experience of families of children undergoing surgery.

See full description

Eligible Conditions

  • Tonsil Hypertrophy
  • Surgical Procedure, Unspecified

Treatment Effectiveness

Study Objectives

This trial is evaluating whether Virtual reality will improve 4 primary outcomes and 1 secondary outcome in patients with Tonsil Hypertrophy. Measurement will happen over the course of Immediately prior to discharge.

Baseline
Parent Pre-op Anxiety Score
Patient Pre-op Anxiety Score
Immediately prior to discharge
Parent Post-op Anxiety Score
Parent Satisfaction Score
Patient Post-op Anxiety Score

Trial Safety

Trial Design

2 Treatment Groups

Control
1 of 2
Virtual Reality
1 of 2
Active Control
Experimental Treatment

This trial requires 160 total participants across 2 different treatment groups

This trial involves 2 different treatments. Virtual Reality is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are not being studied for commercial purposes.

Virtual Reality
Other
Virtual reality (VR) will be provided to families of patients undergoing ambulatory pediatric surgery. VR will provide personalized education to patients and their families about the entire continuum of the child's surgical experience. This will range from the hospital registration, the peri-operative experience, including the separation of the child from the parent in the pre-operative area and the anesthetic induction process, and the post-operative hospital ward.
ControlFamilies will receive standard pre-operative instructions.

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: baseline
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly baseline for reporting.

Who is running the study

Principal Investigator
B. W.
Prof. Brittany Willer, Assistant Professor of Anesthesiology
Nationwide Children's Hospital

Closest Location

Nationwide Children's Hospital - Columbus, OH

Eligibility Criteria

This trial is for patients born any sex aged 18 and younger. There is one eligibility criterion to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
Children undergoing tonsillectomy/adenotonsillectomy ± ear tubes in the ambulatory setting

Patient Q&A Section

What are common treatments for hypertrophy?

"There is limited evidence to support the most efficacious and safe medications for the treatment of hypertrophy. Exercise therapy and lifestyle modification are highly effective treatments for this condition, even in the most severely affected individuals. Physicians and nurses should be familiar with these principles to manage the physical and psychosocial demands of the condition." - Anonymous Online Contributor

Unverified Answer

Can hypertrophy be cured?

"Hypertrophy cannot be cured, even if a significant improvement is achieved. The best way to reduce the amount of pain and to improve function is to achieve a good remission." - Anonymous Online Contributor

Unverified Answer

What is hypertrophy?

"hypotrophy is a medical term that indicates an overdevelopment of tissue in which a decrease exists. For example, cardiac [hypothyroidism](https://www.withpower.com/clinical-trials/hypothyroidism) describes a condition in which the body's thyroid gland does not produce enough thyroid hormone to help control an overdevelopment of the heart muscle. The term hypertrophy is often used to denote a state of physiological hyperplasia, but it can be used to describe a pathological process that is characterised by an increased tissue size." - Anonymous Online Contributor

Unverified Answer

How many people get hypertrophy a year in the United States?

"Approximately 26,000 cases of myocardial hypertrophy occur in the US each year. This makes it the most frequent condition in which a patient is referred to a cardiologist." - Anonymous Online Contributor

Unverified Answer

What causes hypertrophy?

"There are many possible causes of hypertrophy, the most commonly named as over-exertion and lack of exercise. Most hypertrophy is due to an adaptation to a change in lifestyle, rather than being a pathology, and is therefore generally considered a beneficial change." - Anonymous Online Contributor

Unverified Answer

What are the signs of hypertrophy?

"Hypertrophy is a change in muscle and fat tissues, which cause the chest to grow and expand. It can happen to one's waist, rib space, and neck size. There might be a link between hypertrophy and chest wall deformities because it increases the tension on the diaphragm and the intercostals.\n" - Anonymous Online Contributor

Unverified Answer

Have there been any new discoveries for treating hypertrophy?

"There has been no new insights into treatments for hypertrophy of soft tissues. Only small, well-controlled studies with subjects complaining of stiffness after exercise have been reported. The limited evidence in these cases do not justify large placebo-controlled studies. Moreover, soft tissue hypertrophy is a normal adaptive response to strenuous exercise; this evidence does not support recommendations for specific therapeutic measures." - Anonymous Online Contributor

Unverified Answer

Is virtual reality typically used in combination with any other treatments?

"This was the first study of VR combined with an alternative technique. While the results of the study suggest that VR and some conventional therapies are effective for pain, the study did not examine how VR is used in the everyday clinical situation. In a recent study, findings points to the difficulty of assessing combined practices." - Anonymous Online Contributor

Unverified Answer

What are the latest developments in virtual reality for therapeutic use?

"This paper discusses the latest developments in therapeutic use of virtual reality; it specifically describes the state-of-the-art in the field. As demonstrated in the preceding section, the use of virtual reality to treat brain injuries has been growing rapidly over the last decade or more. Despite considerable effort and funding in research with therapeutic use in mind, the field is not yet in a place to fully develop sufficiently robust evidence base for therapeutic benefit." - Anonymous Online Contributor

Unverified Answer

What is the latest research for hypertrophy?

"The pathophysiology and treatment of this condition are currently subject to scientific investigation. The most recent research indicates that there may be an association with the [diabetes syndrome] and [nonalcoholic fatty liver disease, or steatohepatitis] (especially [nonalcoholic fatty liver disease, which also includes nonalcoholic steatohepatitis] and insulin resistance) with the clinical presentation of this condition, which has been described in the scientific literature under various terms, including [hepatocellular carcinoma], [fatty liver disease] and [diabetes-related fatty liver disease] (see 'External links')." - Anonymous Online Contributor

Unverified Answer

Is virtual reality safe for people?

"VR can pose a potentially serious health risk to patients with pre-existing cardiac disease or history of recent heart attacks, or patients with unstable vital signs." - Anonymous Online Contributor

Unverified Answer

How does virtual reality work?

"VR should be included in the algorithm of the diagnostic work-up of pelvic floor disorders, because it seems to be a fast, effective, and inexpensive technique that allows the visualization of PF dysfunction in very specific, well described anatomical sites." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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