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

Trial Summary

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 data supports the idea that Positive Language for Reducing Anxiety During Anesthesia Induction is an effective treatment?

The available research shows that positive language can influence patient perception and mood, especially in children and anxious patients. One study highlights that positive communication can lead to subconscious changes in how patients feel and behave, suggesting that it can help reduce anxiety. Another study indicates that positive suggestions during surgery can reduce the need for pain medication afterward, implying a calming effect. These findings suggest that using positive language during anesthesia induction can be an effective way to ease anxiety. ^{1 2 3 4 5}

What safety data exists for using positive language during anesthesia induction?

The provided research does not directly address safety data for positive language during anesthesia induction. The studies focus on communication challenges, parental presence, and its impact on anxiety during anesthesia induction, but do not evaluate the safety of positive language or supportive communication specifically. ^{1 5 6 7 8}

Is using positive language during anesthesia induction a promising treatment for reducing anxiety?

Yes, using positive language during anesthesia induction is a promising treatment. It can help reduce anxiety by creating a more supportive and calming environment for patients, especially children, during a stressful time. ^{2 5 6 7 9}

What is the purpose of this trial?

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 of anesthesia on anxiety and negative behaviors in children. This is a prospective randomized parallel group trial. Patients will be randomized 1:1 to the common/standard language group or the positive language group.

Research Team

John Fiadjoe, MD

Principal Investigator

Boston Children's Hospital

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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 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 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 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]

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]

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]

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]

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]

References

1. United States 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. [2019]

2. France pubmed.ncbi.nlm.nih.gov

Preanesthetic nurse communication with children and parents--an observational study. [2022]

3. England pubmed.ncbi.nlm.nih.gov

Postoperative analgesic requirements in patients exposed to positive intraoperative suggestions. [2019]

4. England pubmed.ncbi.nlm.nih.gov

Positive communication behaviour during handover and team-based clinical performance in critical situations: a simulation randomised controlled trial. [2022]

5. France pubmed.ncbi.nlm.nih.gov

Motivation and parental presence during induction of anesthesia: an examination of the role of ethnicity and language. [2022]

6. New Zealand 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. [2022]

7. United States pubmed.ncbi.nlm.nih.gov

An evidence-based review of parental presence during anesthesia induction and parent/child anxiety. [2022]

8. France pubmed.ncbi.nlm.nih.gov

Predicting which children benefit most from parental presence during induction of anesthesia. [2022]

9. England pubmed.ncbi.nlm.nih.gov

Investigating the causes of patient anxiety at induction of anaesthesia: A mixed methods study. [2021]