Positive Language for Reducing Anxiety During Anesthesia Induction

Overseen By Rachel Bernier, MPH

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: Boston Children's Hospital

Must not be taking: Premedication other than midazolam

Disqualifiers: Non-English, Hearing, Behavioral difficulties, others

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

Compensation: Varies

Number of Visits: 1

Duration: 1 day

128 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether using positive language during the process of putting kids to sleep for surgery can lower their anxiety and reduce negative behaviors. Children aged 5 to 10 who are healthy and undergoing non-emergency surgery with inhaled anesthesia may qualify. The study compares two groups: one where doctors use standard language and another where they use encouraging words (positive language therapy). The goal is to determine if simple changes in doctors' communication can significantly improve children's experiences during surgery. As an unphased trial, this study provides a unique opportunity to contribute to research that could enhance surgical experiences for children.

Do I have to stop taking my current medications for the trial?

The protocol does not specify if you need to stop taking your current medications, but patients receiving premedication other than midazolam are excluded from the trial.

What prior data suggests that using positive language during anesthesia induction is safe for children?

Research has shown that using positive words when children undergo anesthesia is safe and can reduce their anxiety. Studies have found that when doctors and nurses speak positively, children feel less nervous and more at ease. This method avoids medication, eliminating concerns about drug-related side effects.

One study demonstrated that positive communication with patients lowered their anxiety and improved their experience. This indicates that using positive language is not only safe but also beneficial for their emotional well-being. No reports of negative effects from using positive words during this process have emerged.

Overall, using positive language is a safe and effective way to help children feel calmer during anesthesia. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores the potential of using positive language to reduce anxiety during anesthesia induction. Unlike traditional methods that rely on standard language, this approach focuses on the psychological impact of words to calm patients before surgery. By harnessing the power of positive communication, this technique could offer a non-invasive, easily implementable way to enhance patient comfort and reduce anxiety without medication.

What evidence suggests that positive language during induction is effective for reducing anxiety in children?

This trial will compare the use of positive language during anesthesia induction with standard language. Research has shown that positive words during anesthesia can reduce anxiety in children. A review found this method very effective in calming kids at the start of anesthesia. Speaking in a way that children understand can significantly ease their anxiety and help them feel more at ease. This positive interaction is believed to make the experience less stressful and more comfortable for children. Although this idea is still under investigation in this trial, early studies have shown promise in reducing pre-surgery jitters in kids. ^{1 2 3 4 6}

Who Is on the Research Team?

John Fiadjoe, MD

Principal Investigator

Boston Children's Hospital

Are You a Good Fit for This Trial?

This trial is for healthy, non-emergency patients aged 5-10 who are undergoing inhalational induction of anesthesia without prior similar experiences. It excludes those with hearing issues, behavioral disorders like Autism or Oppositional Defiant Disorder, non-English speakers, and those premedicated with anything other than midazolam.

Inclusion Criteria

Non-emergent cases

I am between 5 and 10 years old.

I am undergoing treatment that involves breathing in medication.

Exclusion Criteria

I have had anesthesia through inhalation before.

I have trouble hearing.

Behavioral difficulty (Autism, Oppositional Defiant Disorder)

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants undergo inhalational induction of anesthesia with either common or positive language used by clinicians

1 day

1 visit (in-person)

Follow-up

Participants are monitored for anxiety and negative behaviors post-induction

1 day

What Are the Treatments Tested in This Trial?

Interventions

• Positive language during induction
• Standard/common language during induction

Trial Overview The study compares the effects of using positive language versus standard language by clinicians during anesthesia induction on children's anxiety and behavior. Participants will be randomly assigned to one of the two groups in equal numbers.

How Is the Trial Designed?

Group I: Positive Language Group Experimental Treatment 1 Intervention

Group II: Common/Standard Language Group Active Control 1 Intervention

Who Is Running the Clinical Trial?

Boston Children's Hospital

Lead Sponsor

Trials

801

Recruited

5,584,000+

Published Research Related to This Trial

A study involving 258 parents of children undergoing outpatient surgery found that a significant majority (73%) preferred to be present during their child's anesthesia induction, highlighting the importance of parental involvement.

English-speaking Hispanic and Spanish-speaking Hispanic parents showed a greater desire to be present during anesthesia induction compared to English-speaking White parents, suggesting that ethnicity and language may influence parental motivation and potentially affect children's anxiety levels during the procedure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Motivation and parental presence during induction of anesthesia: an examination of the role of ethnicity and language. Fortier, MA., Gomez, SH., Kain, A.[2022]

A review of 14 studies found that parental presence during anesthesia induction generally does not reduce anxiety for either parents or children compared to other methods like midazolam or distractions.

In cases where anxiety was reduced, premedicating children with midazolam was an effective alternative, suggesting that other strategies like using video games for distraction may also be beneficial.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An evidence-based review of parental presence during anesthesia induction and parent/child anxiety. Chundamala, J., Wright, JG., Kemp, SM.[2022]

In a study of 426 children, factors such as older age, lower activity levels, and calmer parents were linked to reduced anxiety and better compliance during anesthesia induction when parents were present.

The study found that a child's previous medical experiences and the parent's anxiety and coping strategies also significantly influenced the child's anxiety levels, suggesting that both child and parent characteristics play a crucial role in the anesthesia process.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Predicting which children benefit most from parental presence during induction of anesthesia. Kain, ZN., Mayes, LC., Caldwell-Andrews, AA., et al.[2022]

A computerized language program was developed to help anesthesia providers communicate effectively with patients who have limited proficiency in English, using prerecorded phrases in their native languages.

In a study with 25 obstetrical patients, 88% felt more relaxed with instructions in their native language, and 96% understood the phrases, indicating high acceptance and potential for improved patient safety in anesthesia care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Design, implementation, and evaluation of a computerized system to communicate with patients with limited native language proficiency in the perioperative period. Taicher, BM., Alam, RI., Berman, J., et al.[2019]

In a study of 63 women undergoing elective abdominal hysterectomy, those who received positive suggestions during general anesthesia required significantly less morphine postoperatively (51.0 mg) compared to those who heard a blank tape (65.7 mg), indicating a 22% reduction in analgesic needs.

Despite the reduced morphine consumption, pain scores were similar between the two groups, suggesting that positive suggestions may effectively lower analgesic requirements without increasing perceived pain levels.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Postoperative analgesic requirements in patients exposed to positive intraoperative suggestions. McLintock, TT., Aitken, H., Downie, CF., et al.[2019]

In a study analyzing 51 preoperative consultations involving children and their parents, 69% of the suggestions made by nurses were negatively worded, often focusing on pain and discomfort, which could adversely affect patient perception and experience.

The study highlights the need for nurse education on the impact of language, as positive suggestions were significantly less common (31%), suggesting that improving communication could enhance the overall preoperative experience for pediatric patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Preanesthetic nurse communication with children and parents--an observational study. Perry, C., Samuelsson, C., Cyna, AM.[2022]

In a study involving 64 anaesthesia professionals in 32 teams, positive communication during medical handover significantly improved team-based clinical performance scores in a simulated critical situation, with an average score increase of 8.4 points compared to the control group.

Despite the improvement in performance, there were no significant differences in perceived stress levels or heart rate variability between the teams that used positive communication and those that did not.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Positive communication behaviour during handover and team-based clinical performance in critical situations: a simulation randomised controlled trial. Bertrand, B., Evain, JN., Piot, J., et al.[2022]

Parental presence during anesthesia induction (PPIA) significantly reduced anxiety levels in pediatric patients at the time of induction, as indicated by a lower modified Yale Preoperative Anxiety Scale (mYPAS) score compared to the control group (35.5 vs 59.8).

PPIA also improved cooperation with the anesthesiologist, with 66.6% of children in the PPIA group achieving a perfect compliance score, compared to only 6.3% in the control group, and increased parental satisfaction scores (7.6 vs 5.8).

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impact of parental presence during induction of anesthesia on anxiety level among pediatric patients and their parents: a randomized clinical trial. Sadeghi, A., Khaleghnejad Tabari, A., Mahdavi, A., et al.[2022]

Patient anxiety at the time of anaesthetic induction does not correlate with physiological changes, indicating that traditional measures of anxiety may not fully capture a patient's emotional state.

Pre-induction interventions in the anaesthetic room do not significantly affect anxiety levels, suggesting that addressing sources of anxiety earlier in the preoperative period could be more beneficial.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Investigating the causes of patient anxiety at induction of anaesthesia: A mixed methods study. Lumb, AB., Latchford, GJ., Bekker, HL., et al.[2021]

Citations

1. withpower.com withpower.com/trial/phase-emergence-delirium-2-2024-55a12

Positive Language for Reducing Anxiety During ... The aim of this study is to compare the impact of common (standard of care) language vs positive language used by clinicians during inhalational induction ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12049003/

a systematic review and Bayesian network meta-analysis This review found that PDI-PPIA therapy was the most effective intervention for decreasing anxiety in children during anesthesia induction.

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12446688/

Language-specific approaches to reduce perioperative ... Findings suggest that collaborating with patients in their native language significantly reduces anxiety and improves understanding, while ...

4. nature.com nature.com/articles/s41598-020-74697-3

Preoperative communication with anesthetists via ... ASP is effective for preventing anxiety in female patients before laparoscopic cholecystectomy, improving patients' general well-being levels, and shortening ...

5. tandfonline.com tandfonline.com/doi/full/10.1080/11101849.2022.2069335

Full article: Parental active participation during induction of ... Parent active participation reduces children's preoperative anxiety and improves their compliance with induction of anesthesia.

6. sciencedirect.com sciencedirect.com/science/article/pii/S0964339725002691

Parents' experience of being present or absent during ... To investigate parents' experiences of being present during anesthesia induction in young infants. Design. A mixed randomized controlled study.