Effect of informed consent on anxiety in patients undergoing diagnostic electrophysiology studies

Jeffrey Goldberger, J. Kruse, M. A. Parker, A. H. Kadish

Research output: Contribution to journalArticle

21 Citations (Scopus)

Abstract

The process of informed consent has been suspected to raise patient anxiety, but this supposition has not been well studied or validated. The aim of this study was to evaluate the effect of o detailed informed consent protocol on patient anxiety. Fifty patients (36 men, 14 women, mean age 55 ± 18 years) undergoing diagnostic cardiac electrophysiologic studies were enrolled. Patients were randomly assigned to receive either a consent that did not detail specific risks regarding the procedure (consent A) or one that detailed the risks (consent B). The Spielberger State-Trait Anxiety Inventory was administered before obtaining consent (state 1), immediately after the consent protocol (state 2), and after the electrophysiologic testing procedure, when the results of the test were known to the patient (state 3). Midazolam was administered during the procedure by staff who were blinded to the state/trait anxiety scores and the type of consent the patient had received. Patients receiving consent A had a significant decrease in state 2 anxiety compared with those who received consent B (adjusted mean difference 3.3; 95% confidence intervals 0.2 to 6.4). In the consent A group, 74% of patients received midazolam as opposed to 96% in the consent B group (p <0.02). Patients without inducible ventricular arrhythmias had a significant decrease in state 3 anxiety compared with those with inducible ventricular arrhythmias (adjusted mean difference 8.9; 95% confidence intervals 2.3 to 15.5). Thus detailed informed consent is associated with increased anxiety relative to a consent that does not detail specific risks. However, the difference in anxiety is mild and its clinical impact requires further exploration.

Original languageEnglish (US)
Pages (from-to)119-126
Number of pages8
JournalAmerican Heart Journal
Volume134
Issue number1
DOIs
StatePublished - Jan 1 1997
Externally publishedYes

Fingerprint

Electrophysiology
Informed Consent
Anxiety
Midazolam
Cardiac Arrhythmias
Confidence Intervals
Cardiac Electrophysiologic Techniques
Equipment and Supplies

ASJC Scopus subject areas

  • Cardiology and Cardiovascular Medicine

Cite this

Effect of informed consent on anxiety in patients undergoing diagnostic electrophysiology studies. / Goldberger, Jeffrey; Kruse, J.; Parker, M. A.; Kadish, A. H.

In: American Heart Journal, Vol. 134, No. 1, 01.01.1997, p. 119-126.

Research output: Contribution to journalArticle

@article{dc05ad791b0547ee8712c8365635d7fc,
title = "Effect of informed consent on anxiety in patients undergoing diagnostic electrophysiology studies",
abstract = "The process of informed consent has been suspected to raise patient anxiety, but this supposition has not been well studied or validated. The aim of this study was to evaluate the effect of o detailed informed consent protocol on patient anxiety. Fifty patients (36 men, 14 women, mean age 55 ± 18 years) undergoing diagnostic cardiac electrophysiologic studies were enrolled. Patients were randomly assigned to receive either a consent that did not detail specific risks regarding the procedure (consent A) or one that detailed the risks (consent B). The Spielberger State-Trait Anxiety Inventory was administered before obtaining consent (state 1), immediately after the consent protocol (state 2), and after the electrophysiologic testing procedure, when the results of the test were known to the patient (state 3). Midazolam was administered during the procedure by staff who were blinded to the state/trait anxiety scores and the type of consent the patient had received. Patients receiving consent A had a significant decrease in state 2 anxiety compared with those who received consent B (adjusted mean difference 3.3; 95{\%} confidence intervals 0.2 to 6.4). In the consent A group, 74{\%} of patients received midazolam as opposed to 96{\%} in the consent B group (p <0.02). Patients without inducible ventricular arrhythmias had a significant decrease in state 3 anxiety compared with those with inducible ventricular arrhythmias (adjusted mean difference 8.9; 95{\%} confidence intervals 2.3 to 15.5). Thus detailed informed consent is associated with increased anxiety relative to a consent that does not detail specific risks. However, the difference in anxiety is mild and its clinical impact requires further exploration.",
author = "Jeffrey Goldberger and J. Kruse and Parker, {M. A.} and Kadish, {A. H.}",
year = "1997",
month = "1",
day = "1",
doi = "10.1016/S0002-8703(97)70115-7",
language = "English (US)",
volume = "134",
pages = "119--126",
journal = "American Heart Journal",
issn = "0002-8703",
publisher = "Mosby Inc.",
number = "1",

}

TY - JOUR

T1 - Effect of informed consent on anxiety in patients undergoing diagnostic electrophysiology studies

AU - Goldberger, Jeffrey

AU - Kruse, J.

AU - Parker, M. A.

AU - Kadish, A. H.

PY - 1997/1/1

Y1 - 1997/1/1

N2 - The process of informed consent has been suspected to raise patient anxiety, but this supposition has not been well studied or validated. The aim of this study was to evaluate the effect of o detailed informed consent protocol on patient anxiety. Fifty patients (36 men, 14 women, mean age 55 ± 18 years) undergoing diagnostic cardiac electrophysiologic studies were enrolled. Patients were randomly assigned to receive either a consent that did not detail specific risks regarding the procedure (consent A) or one that detailed the risks (consent B). The Spielberger State-Trait Anxiety Inventory was administered before obtaining consent (state 1), immediately after the consent protocol (state 2), and after the electrophysiologic testing procedure, when the results of the test were known to the patient (state 3). Midazolam was administered during the procedure by staff who were blinded to the state/trait anxiety scores and the type of consent the patient had received. Patients receiving consent A had a significant decrease in state 2 anxiety compared with those who received consent B (adjusted mean difference 3.3; 95% confidence intervals 0.2 to 6.4). In the consent A group, 74% of patients received midazolam as opposed to 96% in the consent B group (p <0.02). Patients without inducible ventricular arrhythmias had a significant decrease in state 3 anxiety compared with those with inducible ventricular arrhythmias (adjusted mean difference 8.9; 95% confidence intervals 2.3 to 15.5). Thus detailed informed consent is associated with increased anxiety relative to a consent that does not detail specific risks. However, the difference in anxiety is mild and its clinical impact requires further exploration.

AB - The process of informed consent has been suspected to raise patient anxiety, but this supposition has not been well studied or validated. The aim of this study was to evaluate the effect of o detailed informed consent protocol on patient anxiety. Fifty patients (36 men, 14 women, mean age 55 ± 18 years) undergoing diagnostic cardiac electrophysiologic studies were enrolled. Patients were randomly assigned to receive either a consent that did not detail specific risks regarding the procedure (consent A) or one that detailed the risks (consent B). The Spielberger State-Trait Anxiety Inventory was administered before obtaining consent (state 1), immediately after the consent protocol (state 2), and after the electrophysiologic testing procedure, when the results of the test were known to the patient (state 3). Midazolam was administered during the procedure by staff who were blinded to the state/trait anxiety scores and the type of consent the patient had received. Patients receiving consent A had a significant decrease in state 2 anxiety compared with those who received consent B (adjusted mean difference 3.3; 95% confidence intervals 0.2 to 6.4). In the consent A group, 74% of patients received midazolam as opposed to 96% in the consent B group (p <0.02). Patients without inducible ventricular arrhythmias had a significant decrease in state 3 anxiety compared with those with inducible ventricular arrhythmias (adjusted mean difference 8.9; 95% confidence intervals 2.3 to 15.5). Thus detailed informed consent is associated with increased anxiety relative to a consent that does not detail specific risks. However, the difference in anxiety is mild and its clinical impact requires further exploration.

UR - http://www.scopus.com/inward/record.url?scp=0030755392&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=0030755392&partnerID=8YFLogxK

U2 - 10.1016/S0002-8703(97)70115-7

DO - 10.1016/S0002-8703(97)70115-7

M3 - Article

C2 - 9266792

AN - SCOPUS:0030755392

VL - 134

SP - 119

EP - 126

JO - American Heart Journal

JF - American Heart Journal

SN - 0002-8703

IS - 1

ER -