Anxiety Reduction Techniques for Surgery Preparation Anxiety

Overseen By Haley Nitchie, MHA

Age: < 18

Sex: Any

Trial Phase: Phase 4

Sponsor: Medical University of South Carolina

Must not be taking: Psychiatric medications

Disqualifiers: Previous surgery, Fear of dark, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 4

Duration: 1 day

240 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores different ways to reduce anxiety in young children undergoing outpatient surgery. Researchers are comparing three methods: a calming dark room with a star projector, the medication midazolam (also known as Versed, Hypnovel, or Dormicum), and the presence of a parent. The goal is to determine which method best eases anxiety, helps children accept the anesthesia mask, and reduces stress-related behavior after surgery. Children aged 2 to 6 who have not had surgery before and can have a parent present during anesthesia might be suitable candidates. As a Phase 4 trial, the treatments are already FDA-approved and proven effective, providing an opportunity to assess their benefits for more patients.

Will I have to stop taking my current medications?

The trial excludes patients who are currently using psychiatric medications, so if your child is taking any, they would not be eligible to participate.

What is the safety track record for these treatments?

Research has shown that using a darkened room with a star projector is generally well-received by children. This method is safe because it involves no medication, providing a calming environment to ease anxiety.

Studies have found preoperative midazolam to be a safe and effective medication for reducing anxiety in children. It is widely used for this purpose, and while it can cause minor side effects like slight drowsiness or mild breathing issues, these are rare. Overall, children tolerate midazolam well, and it helps them feel more at ease before surgery.

Both methods aim to make the surgical process less stressful for young children. ^{1 2 3 4 5}

Why are researchers enthusiastic about this trial?

Researchers are excited about the Anxiety Reduction Techniques for Surgery Preparation Anxiety trial because it's exploring innovative ways to ease pre-surgery anxiety, which is often managed with medications like midazolam. The trial is testing unique approaches such as using a darkened room with a star projector that creates a calming atmosphere, along with having a parent present. This method is different because it offers a non-pharmacological way to reduce anxiety, potentially minimizing the need for medication. Additionally, the trial includes comparing this to the standard use of preoperative midazolam combined with parental presence, and parental presence alone, to see which is most effective. By examining these techniques, researchers hope to identify new, effective methods that could be less invasive and more comforting for patients, especially children, undergoing surgery.

What evidence suggests that this trial's treatments could be effective for reducing surgery preparation anxiety in children?

Research has shown that midazolam, a medicine that helps children relax before surgery, can effectively reduce anxiety. Studies indicate it lowers anxiety levels and enhances the overall experience for patients. Children who take midazolam before surgery often feel less nervous and have a calmer experience. In this trial, some participants will receive preoperative midazolam along with parental presence.

Early findings suggest that a darkened room with a star projector can help reduce anxiety by creating a soothing and engaging environment. Although less research exists on this specific method, similar non-drug techniques have shown promise in reducing anxiety by providing a comforting atmosphere. Participants in this trial may experience this environment along with parental presence.

Having parents nearby has also been shown to reduce anxiety, as a familiar face can reassure children. In this trial, some participants will have parental presence alone as their anxiety reduction technique. Each of these approaches aims to create a calming effect, making the surgical experience less stressful for young patients. ^{1 6 7 8 9}

Who Is on the Research Team?

Natalie Barnett, MD

Principal Investigator

Medical University of South Carolina

Are You a Good Fit for This Trial?

This trial is for children aged 2-6 who are healthy (ASA I-II) and scheduled for elective outpatient surgery under general anesthesia. They must have a parent or guardian willing to be present during induction of anesthesia.

Inclusion Criteria

Parent or guardian willing to be present during induction

I am between 2 and 6 years old.

I am in good to moderate health according to anesthesia guidelines.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Preoperative Assessment

Participants are assessed for preoperative anxiety, mask acceptance, and behavioral changes

1 day

1 visit (in-person)

Treatment

Participants undergo the surgical procedure under general anesthesia with different interventions for anxiety management

1 day

1 visit (in-person)

Follow-up

Participants are monitored for behavioral changes and recovery post-operatively

30 days

2 visits (virtual)

What Are the Treatments Tested in This Trial?

Interventions

• Dark with star projector
• Parental Presence
• Preoperative midazolam

Trial Overview The study compares three methods to reduce preoperative anxiety in kids: one with a dark room and star projector, another using the sedative midazolam before surgery, and the last with just parental presence during anesthesia induction.

How Is the Trial Designed?

Group I: Darkened room and star projector with parental presence Active Control 2 Interventions

Subjects assigned to this arm, when in the operating room prior to the start of induction, the room will be darkened, and a star projector that lights up the ceiling and walls will be turned on. They will also have a parent in the room with them during induction of anesthesia.

Group II: Preoperative midazolam 0.5 mg/kg po and parental presence Active Control 2 Interventions

Subjects assigned to this arm will be given midazolam by mouth preoperatively, and will have a parent in the room with them during induction of anesthesia.

Group III: Parental presence alone Active Control 1 Intervention

Subjects assigned to this arm will have a parent in the room with them during induction of anesthesia.

Who Is Running the Clinical Trial?

Medical University of South Carolina

Lead Sponsor

Trials

994

Recruited

7,408,000+

Published Research Related to This Trial

In a study of 70 children aged 4-10 years, premedication with oral midazolam resulted in similar anxiety levels before surgery, regardless of whether the children had a history of previous surgery or anesthesia.

Both groups showed high rates of satisfactory parental separation and mask acceptance, indicating that midazolam is effective in managing preoperative anxiety in children, irrespective of their surgical history.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of premedication with oral midazolam on preoperative anxiety in children with history of previous surgery - A prospective study. Padhi, PP., Bhardwaj, N., Yaddanapudi, S.[2022]

A psychological strategy involving walking children through the operating room and playfully demonstrating anesthesia equipment significantly reduced preoperative anxiety compared to midazolam medication, as shown by a notable decrease in visual analogue scale (VAS) scores (P=0.045).

The psychological approach not only lowered anxiety levels in children but also prevented an increase in state anxiety observed in the medication group, highlighting its effectiveness in managing anxiety for both pediatric patients and their parents.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Psychology versus medication for preanesthesia preparation of children: a randomized controlled trial. Schmid, W., Marhofer, P., Ohmann, S., et al.[2021]

Smartphone interventions significantly reduce anxiety in pediatric patients on the day of surgery, showing a mean difference of -19.74 compared to standard care and -7.81 compared to oral midazolam, based on a meta-analysis of nine studies involving 785 subjects.

These findings suggest that smartphone interventions could be an effective alternative to traditional anxiolytics like midazolam for managing pre-surgery anxiety in children, although further research is needed to confirm these results.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Smartphone Interventions Effect in Pediatric Subjects on the Day of Surgery: A Meta-Analysis. Li, L., Ma, J., Ma, D., et al.[2023]

Audiovisual (AV) interventions, such as videos and interactive games, have been shown to effectively reduce preoperative anxiety in children undergoing elective surgery, based on a systematic review of 18 studies.

While AV interventions are promising for improving children's preoperative experiences, further well-designed randomized controlled trials are needed to identify the most effective components and mechanisms behind these interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Systematic Review: Audiovisual Interventions for Reducing Preoperative Anxiety in Children Undergoing Elective Surgery. Chow, CH., Van Lieshout, RJ., Schmidt, LA., et al.[2022]

The tablet-based interactive distraction (TBID) tool significantly reduced perioperative anxiety in children compared to oral midazolam, with a mean difference of -9 in anxiety levels at parental separation, indicating its effectiveness as a non-pharmacological intervention.

Children using the TBID tool experienced shorter recovery times, with a median time-to-PACU discharge of 87 minutes compared to 111 minutes for those receiving midazolam, along with lower rates of emergence delirium and higher parental satisfaction.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Tablet-based Interactive Distraction (TBID) vs oral midazolam to minimize perioperative anxiety in pediatric patients: a noninferiority randomized trial. Seiden, SC., McMullan, S., Sequera-Ramos, L., et al.[2022]

In a study involving 118 children aged 4-11, premedication with midazolam (MDZ) did not significantly reduce anxiety compared to using age-appropriate tablet game apps (TAB) during anaesthetic mask induction, indicating that both methods were similarly effective in managing anxiety.

The use of TAB as a non-pharmacological tool showed potential for reducing perioperative stress without the sedative effects associated with MDZ, suggesting it could be a safe alternative for managing anxiety in children undergoing surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Children and parental anxiolysis in paediatric ambulatory surgery: a randomized controlled study comparing 0.3 mg kg-1 midazolam to tablet computer based interactive distraction. Marechal, C., Berthiller, J., Tosetti, S., et al.[2018]

Distraction techniques significantly reduce preoperative anxiety in pediatric patients, with anxiety levels decreasing by an average of 5.34 points in the holding area and 15.28 points in the induction room compared to routine care.

The study analyzed 19 randomized controlled trials involving 1341 patients, confirming that distraction is an effective method for managing anxiety before elective surgeries, although there was high heterogeneity among the studies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effectiveness of distraction as preoperative anxiety management technique in pediatric patients: A systematic review and meta-analysis of randomized controlled trials. Wu, J., Yan, J., Zhang, L., et al.[2022]

In a study involving 135 children aged 2-12 years, both midazolam premedication and video distraction were effective in managing preoperative anxiety, with no significant differences in anxiety levels between the two methods.

The combination of midazolam and video distraction did not provide additional benefits over using either strategy alone, indicating that both approaches are equally effective for reducing preoperative distress in children.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Childhood preoperative anxiolysis: Is sedation and distraction better than either alone? A prospective randomized study. Sola, C., Lefauconnier, A., Bringuier, S., et al.[2018]

In a study involving 120 patients undergoing ophthalmic surgery, oral midazolam (7.5 mg and 15 mg) was found to significantly reduce anxiety and increase sedation compared to placebo, with the 15 mg dose showing the most pronounced effects.

Midazolam provided effective anxiolysis and sedation before surgery, but its sedative effects were shorter in duration compared to diazepam, indicating it may be a suitable option for premedication in local anesthesia.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Midazolam (Dormicum) as oral premedication for local anesthesia]. Lanz, E., Schäfer, M., Brünisholz, V.[2013]

In a study evaluating the use of a single 7.5 mg tablet of midazolam as a premedicant for minor oral surgery, no significant drop in arterial oxygen saturation was observed, indicating a low risk of hypoventilation.

However, the study found that midazolam did not provide significant anxiolytic (anxiety-reducing) or amnestic (memory-blocking) effects, suggesting that its therapeutic benefits at this dosage are minimal and not recommended for widespread use due to potential complications and impaired driving ability for 12 hours post-administration.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[The question of oral sedation using midazolam in outpatient dental surgery]. Wahlmann, UW., Dietrich, U., Fischer, W.[2013]

In a study of 88 patients undergoing outpatient surgery, preoperative administration of midazolam significantly reduced the incidence of postoperative nausea (25% vs. 50%) and increased overall patient satisfaction, with 85% of midazolam patients recommending it compared to only 42% in the placebo group.

Midazolam effectively alleviated anxiety without causing retrograde amnesia, demonstrating its dual benefit in enhancing the perioperative experience while maintaining safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Preoperative intravenous midazolam: benefits beyond anxiolysis. Bauer, KP., Dom, PM., Ramirez, AM., et al.[2022]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06144177

Study Details | NCT06144177 | Induction in the Dark They will be randomized to one of the following groups and assessed for preoperative anxiety, mask acceptance, and behavioral changes in the following week.

2. withpower.com withpower.com/trial/phase-4-anesthesia-induction-11-2023-d9da9

Anxiety Reduction Techniques for Surgery Preparation ... Trial Overview The study compares three methods to reduce preoperative anxiety in kids: one with a dark room and star projector, another using the sedative ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6135556/

A Retrospective Review of a Bed-mounted Projection ... Most children undergoing anesthesia experience significant preoperative anxiety. We developed a bedside entertainment and relaxation theater ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11269778/

Virtual parental presence with coaching for reducing ... Among non-pharmacological methods, Parental Presence at Induction of Anesthesia (PPIA) has been shown to reduce parent and patient anxiety without impeding ...

5. clinicaltrials.gov clinicaltrials.gov/study/NCT02950415

Does Virtual Parental Presence Reduce Preoperative ... measured using the modified Yale Preoperative Anxiety Scale (mYPAS), Day of surgery, immediately preceding surgery. Secondary Outcome Measures. Outcome Measure ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10454404/

Parental Accompaniment in Operating Rooms Reduces ... The presence of parents before the induction of anesthesia was effective in reducing anxiety among most patients and their parents.

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8603640/

Healthcare staff as promoters of parental presence at ... Surgical intervention is usually a traumatic event that causes stress and anxiety in the pediatric patient and the family environment.

8. childlife.scholasticahq.com childlife.scholasticahq.com/article/126782-evaluating-the-feasibility-and-acceptability-of-surgery-prep-a-virtual-reality-perioperative-walkthrough-designed-to-help-pediatric-patients-psycholo

Evaluating the Feasibility and Acceptability of Surgery Prep, a ... This study found that a VR app designed to reduce preoperative anxiety was feasible for deployment by CLS in a hospital and acceptable by pediatric patients ...

9. bmcpediatr.biomedcentral.com bmcpediatr.biomedcentral.com/articles/10.1186/s12887-022-03136-1

Effects of advance exposure to an animated surgery-related ... Home-reading an animated picture book to get familiar with the perioperative events earlier prior to surgery could effectively reduce the preoperative anxiety ...