Positive Language for Anesthesia Pain Reduction

Overseen By Aaron Berg, MD

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: University of Minnesota

Must not be taking: Chronic opioids

Disqualifiers: Previous epidural, BMI > 40, others

Compensation: Varies

Number of Visits: 1

Duration: 1 hour

30 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether positive language describing an epidural can reduce pain during the procedure. Participants will be divided into two groups: one will hear a negative description (Negative Connotation Language), and the other will hear a positive description (Positive Connotation Language) of the procedure. The goal is to determine if the explanation impacts pain perception. The trial seeks pregnant individuals requesting an epidural for the first time, without previous epidurals or certain medical conditions. As an unphased trial, this study offers a unique opportunity to contribute to understanding how language affects pain management during childbirth.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but if you are on chronic opioids, you would not be eligible to participate.

What prior data suggests that this protocol is safe for participants?

Research has shown that using positive words during medical procedures can help reduce pain perception. This involves using kind or reassuring language. Studies have found that such words can lessen the intensity of pain. While specific safety information about using positive language in medical settings is not available, changing the words used is unlikely to cause harm.

It is important to note that this trial focuses on language, not a physical treatment or drug. Therefore, there is no need to worry about side effects typically associated with medication or other medical treatments. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Positive Language for Anesthesia Pain Reduction trial because it explores a unique approach to pain management. Unlike traditional methods that rely on medications like opioids or NSAIDs to reduce pain, this trial investigates how the type of language used by medical professionals can influence a patient's pain perception. The study compares the effects of negative connotation language (Nocebo Group) with positive connotation language (Positive Connotation Group) during anesthesia. This innovative approach could offer a non-drug alternative to managing pain, potentially reducing reliance on medications and their associated side effects.

What evidence suggests that this trial's treatments could be effective for reducing pain during an epidural?

Research has shown that using positive language during medical procedures can reduce pain and anxiety. In this trial, participants in the Positive Connotation Group will receive the experimental treatment involving positive language. Speaking kindly or offering reassurance can lessen patients' pain. Conversely, participants in the Nocebo Group will receive the control treatment, which involves negative connotation language, as negative words can worsen discomfort. Studies suggest that doctors and nurses can relieve pain by providing positive messages that alter patients' expectations. Thus, using positive words can make the experience less painful for patients. ^{1 2 3 6 7}

Who Is on the Research Team?

Aaron Berg, MD

Principal Investigator

University of Minnesota

Are You a Good Fit for This Trial?

This trial is for pregnant individuals who are requesting an epidural for the first time and can speak English. It's not suitable for those with a history of opioid abuse, previous epidurals or lumbar spine surgery, a BMI over 40 kg/m^2, or chronic pain patients on opioids.

Inclusion Criteria

Pregnancy

I am requesting an epidural for the first time.

Exclusion Criteria

I have chronic pain or take opioids regularly.

I have had an epidural before.

I have had surgery on my lower back before.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive either the 'Poke and a burn' or 'numbing medication' script during epidural placement

1 hour

1 visit (in-person)

Follow-up

Participants are monitored for satisfaction and pain score after the epidural procedure

1 hour

What Are the Treatments Tested in This Trial?

Interventions

• Negative Connotation Language
• Positive Connotation Language

Trial Overview The study aims to find out if using positive language when describing an epidural procedure can help reduce the pain felt during the process compared to using negative language. Participants will be randomly assigned to hear either type of language.

How Is the Trial Designed?

Group I: Positive Connotation Group Experimental Treatment 1 Intervention

Participants in this group will receive the experimental treatment.

Group II: Nocebo Group Placebo Group 1 Intervention

Participants in this group will receive the control treatment

Who Is Running the Clinical Trial?

University of Minnesota

Lead Sponsor

Trials

1,459

Recruited

1,623,000+

Published Research Related to This Trial

Only 31% of 1021 Austrian citizens correctly identified the definition of a 'complication' in medical terms, indicating a significant misunderstanding of official medical definitions among the general population.

The study suggests that the complexity of current definitions for medical events like side effects and malpractice hinders understanding, highlighting the need for simpler definitions in patient education to improve comprehension.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Official definitions for undesirable medical events : Are they correctly applied in medicine? Smolle, C., Sendlhofer, G., Cambiaso-Daniel, J., et al.[2020]

A systematic review of adverse event (AE) reporting in clinical trials of intravenous and invasive pain treatments revealed no significant improvement in reporting quality since the 2004 CONSORT guidelines, with only 5 out of 10 reporting standards met on average.

Overall, 8% of the articles reviewed did not report any AE information, highlighting a critical need for better transparency and adherence to reporting standards in clinical trials to fully understand the risks associated with pain treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse Event Reporting in Clinical Trials of Intravenous and Invasive Pain Treatments: An ACTTION Systematic Review. Williams, MR., McKeown, A., Pressman, Z., et al.[2018]

The study emphasizes the importance of clear and consistent vocabulary in defining adverse events (AEs) in clinical research to avoid confusion and ambiguity, which can impact the assessment of risks.

AEs can be classified based on various factors such as predictability, frequency, gravity, causality, and severity, highlighting the need for standardized communication to improve understanding and reporting in clinical trials.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Confusions and ambiguities in the classification of adverse events in the clinical research]. Marodin, G., Goldim, JR.[2019]

Older adults exhibit a 'positivity effect' when recalling nonarousing words, remembering positive words better than negative ones, while younger adults remember negative nonarousing words more effectively.

For arousing words, both young and older adults recall positive and negative words equally well, indicating that aging does not affect the memory of emotionally charged information but does change how nonarousing information is processed.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Age differences in memory for arousing and nonarousing emotional words. Kensinger, EA.[2019]

The Wake-Up Safe (WUS) program, involving 19 institutions and 39 anesthesiologists, recorded a serious adverse event (SAE) rate of 1.4 per 1000 pediatric anesthetics, highlighting the importance of monitoring safety in pediatric anesthesia.

The program identified respiratory issues as the most common SAE, with medication errors and equipment dysfunction contributing to 89% of care escalations, demonstrating the need for targeted quality improvement and safety training in anesthesia departments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

National pediatric anesthesia safety quality improvement program in the United States. Kurth, CD., Tyler, D., Heitmiller, E., et al.[2021]

Manual incident reports significantly under-report adverse clinical events compared to automated data, highlighting a gap in capturing important clinical information.

In a study of 995 pediatric patients, the sensitivity of AIMS and CQI reports in documenting observed emesis events was very low, at 38% and 13% respectively, indicating that these reporting systems may not reliably capture significant clinical occurrences.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The reliability of manual reporting of clinical events in an anesthesia information management system (AIMS). Simpao, AF., Pruitt, EY., Cook-Sather, SD., et al.[2021]

Analysis of over 10,000 frequently used English words reveals a clear positive bias in the emotional tone of natural language, suggesting that people tend to use more positive words in communication.

The study examined four large and distinct word corpora, finding that the distribution of word positivity remains consistent regardless of how often the words are used.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Positivity of the English language. Kloumann, IM., Danforth, CM., Harris, KD., et al.[2021]

The study used magnetoencephalography to show that reading sentences with incongruous neutral adjectives in a negative emotional context elicited a significant N400m effect, indicating these adjectives were harder to integrate than incongruous positive ones.

The findings suggest that negative emotional contexts can influence semantic processing, leading to deeper processing of incongruous positive adjectives being bypassed, highlighting the complexity of how emotions affect language comprehension.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Examining the N400m in affectively negative sentences: A magnetoencephalography study. Parkes, L., Perry, C., Goodin, P.[2017]

Emotional words, whether positive or negative, are processed faster than neutral words, indicating that emotion plays a significant role in lexical processing.

This study controlled for non-emotional factors and found that the speed of processing emotional words is categorical and not influenced by emotional arousal, suggesting that the meanings of words are deeply connected to emotional experiences.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

How does emotional content affect lexical processing? Vinson, D., Ponari, M., Vigliocco, G.[2022]

In a study of 180 women after cesarean section, those asked to rate their comfort reported lower incidences of pain (54.4%) compared to those asked to rate their pain (68.9%), suggesting that the language used in pain assessment can influence patient perceptions.

Using positive language like 'comfort' instead of negative terms related to pain not only reduced the number of women reporting pain but also affected their perception of the surgical wound, indicating that how we ask about pain can impact the overall patient experience.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A randomized comparative study assessing efficacy of pain versus comfort scores. Jain, R., Grewal, A.[2020]

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]

Teaching communication skills to anaesthesia students positively influenced their pre-operative interactions with patients, which is important for managing patient anxiety and expectations before surgery.

Although the study did not find significant statistical differences in procedural and interpersonal skills ratings, the improved communication likely helped modulate patients' psychological responses to anaesthesia, potentially reducing post-operative pain experiences.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Introducing a teaching module to impart communication skills in the learning anaesthesiologists. Gadre, VN., Kelkar, KV., Kelkar, VS., et al.[2020]

A study analyzing 100,000 words across 24 different language corpora found that human language universally exhibits a positivity bias, meaning that positive words are more prevalent than negative ones.

The emotional content of words remains consistent across different languages, even when translated, and this positivity bias is not influenced by how frequently words are used.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Human language reveals a universal positivity bias. Dodds, PS., Clark, EM., Desu, S., et al.[2019]

Women who were asked to rate their pain after a Caesarean section reported higher pain scores and were more likely to feel bothered by their surgery compared to those who rated their comfort, indicating that the way questions are framed can significantly affect patient perceptions.

The study, involving 300 women, found that those in the pain assessment group not only reported greater discomfort but also requested more pain relief, suggesting that focusing on pain may increase anxiety and the perception of negative postoperative experiences.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pain vs comfort scores after Caesarean section: a randomized trial. Chooi, CS., White, AM., Tan, SG., et al.[2018]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10337411/

The Effect of Positive Therapeutic Communication on Pain ... A positive communication strategy, including positive, kind, or reassuring words, can reduce pain perception, while negative words can raise ...

2. withpower.com withpower.com/trial/phase-6-2021-22633

Positive Language for Anesthesia Pain Reduction Research shows that using positive language can reduce pain and anxiety, as negative words like 'pain' can increase discomfort.

3. journals.sagepub.com journals.sagepub.com/doi/pdf/10.1177/0310057X1103900117

The Effects of Positive or Negative Words when Assessing ... The primary outcomes were the presence or absence of reported pain and pain severity, as measured by the words used by the patient and the VNRS for pain. ...

4. philarchive.org philarchive.org/archive/HOWPMM

Positive messages may reduce patient pain: A meta-analysis Increasing evidence from clinical trials suggests that clinicians can enhance pain relief by delivering positive messages that modulate patients' expectations ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4483221/

Long-term results of therapeutic local anesthesia (neural ... After one year, in 60 patients pain was unchanged, 52 patients reported a slight improvement, 126 were considerably better, and 41 pain-free. At ...

6. mdpi.com mdpi.com/2075-4426/13/3/481

The Impact of the Need for Language Assistance Services ... We aimed to investigate the impact of the need for language assistance services (LAS) in acute postoperative pain management in patients undergoing oncologic ...

7. bjanaesthesia.org.uk bjanaesthesia.org.uk/article/S0007-0912(24)00400-8/fulltext

Effect of a comfort scale compared with a pain numerical ... In conclusion, using a comfort scale did not reduce opioid consumption when compared with a standard numerical pain scale in the PACU. However, ...