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Emotions and Health

Findings From a Randomized Clinical Trial on Psychoeducational Nursing to Patients With Implantable Cardioverter Defibrillator

Kikkenborg Berg, Selina PhD; Støier, Louise RN; Moons, Philip PhD; Zwisler, Ann-Dorthe PhD; Winkel, Per MD; Ulrich Pedersen, Preben PhD

Journal of Cardiovascular Nursing: May/June 2015 - Volume 30 - Issue 3 - p 197–204
doi: 10.1097/JCN.0000000000000132
ARTICLES
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Background: Serious illness will inevitably lead to a fundamental emotional reaction. Traditionally, in interventional treatment or rehabilitation trials, the psychological status of patients with implantable cardioverter defibrillators has been evaluated with anxiety and depression as outcome measures. In caring for these patients, the aim of nursing is to help patients manage life with complex heart disease. The early detection and management of negative emotional response might prevent the development of pathological conditions such as depression.

Objective: The aims of this study were to (a) describe the trajectory of primary emotions over time in patients with implantable cardioverter defibrillators and (b) examine the potential effects of psychoeducational nursing on primary emotions.

Methods: During the inclusion period (October 2007 to November 2009), 196 patients with implantable cardioverter defibrillator were randomized (1:1) to rehabilitation versus usual care. Rehabilitation consisted of a psychoeducational nursing component and an exercise training component. This article concerns phase 1, psychoeducational nursing, guided by a theory of nursing, Rosemary Rizzo Parses Human Becoming Practice Methodologies. The outcome measure is the Emotions and Health Scale. The scale consists of 8 primary emotions: joy, agreeableness, surprise, fear, sadness, disgust, anger, and anticipation.

Results: Mean (SD) age was 58 (13) years, and 79% of the participants were men. Significant improvements were found in primary emotional responses over time (P < .05) when combining groups. However, no difference in emotional intensity was found between the groups after 3 months of psychoeducational nursing intervention (P > .05).

Conclusions: Primary emotions are affected after implantable cardioverter defibrillator implantation. Improvements over time were found. However, it was not possible to detect any effect of a short-term psychoeducational nursing intervention. Evaluating the primary emotions might be a good way for nurses to monitor patients’ psychological outcomes because the instrument is sensitive to changes over a short period. Further development of early psychoeducational nursing interventions for patients with implantable cardioverter defibrillators is needed.

Selina Kikkenborg Berg, PhD Postdoc, The Heart Centre, University of Copenhagen, Denmark.

Louise Støier, RN Clinical Nurse Specialist, Department of Cardiology, Bispebjerg University Hospital, Copenhagen NV, Denmark.

Philip Moons, PhD Professor, Centre for Health Services and Nursing Research, KU Leuven, University of Leuven, Belgium.

Ann-Dorthe Zwisler, PhD Senior Researcher, The Heart Centre, University of Copenhagen, Denmark.

Per Winkel, MD Senior Researcher, The Copenhagen Trial Unit, Centre for Clinical Intervention Research Unit 3344, Copenhagen University Hospital, Denmark.

Preben Ulrich Pedersen, PhD Professor, Faculty of Health Sciences, University of Aalborg, Denmark.

Author contributions: S.K.B., in collaboration with A.D.Z. and P.U.P., designed the study. P.W., S.K.B., and L.S. conducted the statistical analyses. S.K.B. drafted the manuscript. All revised the manuscript critically.

This study was funded by the Novo Nordisk Foundation, the Oticon Foundation, the Danish Heart Foundation, the AP Møller and Chastine Mc-Kinney Møller Foundation, Helsefonden, the Tryg Foundation, Krista and the Viggo Petersens Foundation, The Danish Cardiovascular Research School, King Christian X Foundation, and Copenhagen University Hospital, Rigshospitalet. None of the funders were involved in the trial.

The authors have no conflicts of interest to disclose.

Correspondence Selina Kikkenborg Berg, PhD, Copenhagen University Hospital, Rigshospitalet, The Heart Centre, Unit 2152, Blegdamsvej 9, 2100 Copenhagen, Denmark (selina@rh.dk).

An implantable cardioverter defibrillator (ICD) is a subcutaneously implanted device that automatically detects and treats ventricular tachyarrhythmias by antitachycardia pacing or by shock therapy. Left untreated, such arrhythmias can lead to sudden cardiac death. Treatment with ICD has reduced mortality remarkably over the past 20 years. The average ICD implantation rate in Europe is 140 per million. In the United States, this rate is considerably higher, 416 per million.1 Although highly effective in preventing arrhythmic death, patients receiving an ICD may still experience psychological difficulties such as fear of shock, reduced quality of life, mood disturbances, and avoidance behavior, such as social isolation and avoidance of physical activity.2–6

Traditionally, nursing interventions aimed at reducing the mental burden of living with heart disease have been evaluated with a reduction in anxiety and/or depression as outcomes.7 Anxiety and depression are severe mental conditions that can be diagnosed. However, attention should also be given to patients struggling with an emotional reaction that has not yet developed into anxiety or depression. Despite a fundamental acceptance of emotions as a significant part of the human condition, there is little disease-specific clinical knowledge about how the emotions influence coping with an illness process.8 Serious illness such as cardiac disease and the accompanying experiences will inevitably lead to a fundamental emotional reaction. The primary emotional reaction might be a defense mechanism, linked to a healthy survival strategy. But the reaction may also give expression to patients’ needs for coping.8

Emotion can affect how patients cope with illness. Patients with a more emotional reaction have been found to suffer more from stress and have difficulty in coping with an injury9 or in adapting to life with an ICD.10

We previously found that the intensity of the experienced primary emotions differed significantly11 between a healthy population and patients with a newly implanted ICD. A central aim of nursing is to help patients manage life with disease. Monitoring primary emotional responses could be a helpful way of exploring patients’ emotional reactions to disease in practice and might be a focus for intervention and outcome measuring in caring sciences.

The Copenhagen Outpatient ProgrammE-ICD trial was initiated in 2007, including 196 ICD patients in a randomized (1:1) controlled rehabilitation trial.12 The complex intervention consisted of an exercise training component and a psychoeducational nursing component that included mental coping strategies. The primary outcomes were exercise capacity and general health, which were found to be significantly better in the intervention group compared with the control group.13 No previous trial has studied the impact of psychoeducative nursing outpatient follow-up on primary emotions in a randomized design. Therefore, this was included as a predefined exploratory outcome.12 The aims of the present study were, therefore, (a) to examine the potential effects of a short psychoeducational nursing intervention on primary emotions and (b) to describe the trajectory of primary emotions over time in patients with ICD.

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Materials and Methods

The design and methods of the COPE-ICD trial have been described in detail elsewhere.12 However, the present article concerns only phase 1 of the trial, the first 3 months of psychoeducational intervention, which is described briefly below.

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Participants

Patients were included at a large university hospital with a volume of approximately 300 first-time ICD implantations per year. Patients were eligible for inclusion if they received a first-time ICD implant, agreed to participate in the entire program, and were randomized before hospital discharge. Patients were excluded if they did not understand the study instructions, were younger than 18 years, were diagnosed with a psychiatric disease or a somatic disease where the disease per se or its recovery might have influenced the study, or were not given permission by their treating physician to participate in the physical training program. Patients already enrolled in clinical trials that prohibited participation in additional trials were also excluded.

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Interventions

The nurse-led intervention included a comprehensive cardiac rehabilitation program with exercise training and psychoeducational nursing. The psychoeducation was initiated right after hospital discharge and continued during the following 3 months, 1 hour each month, for a total of 3 consultations. This was phase 1. The exercise training component was initiated after phase 1 and is therefore not included in the present article.

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Psychoeducational Intervention

The program was based on a humanistic approach, focusing on psychosocial support and education. The program was directed toward the parameters that ICD reportedly affects, such as fear of ICD shock, emotional responses, and impact on daily living.7 The content was made up of information and education focused on managing life with an ICD, including emotional reactions (Table 1) using a holistic view on the person and establishment of a joint approach to disease management and coping. Nursing care was inspired by Rosemarie Rizzo Parse’s “Human Becoming Practice Methodologies” 3 dimensions,14 which are interpreted as follows: (1) discuss and give meaning to the past, present, and future, (2) explore and discuss events and possibilities, and (3) move along with envisioned possibilities. According to this theory, there are 3 ways of changing health: creative imaging, that is, see, hear and feel what a situation might be like if lived in a different way; affirming personal patterns and value priorities; and shedding light on paradoxes, that is, looking at the incongruence in a situation and changing the view held of something. Thus, both emotional-focused and problem-focused coping strategies were used to try to have an impact on emotional stress responses. The nurse was truly present in the process through discussions, silent immersion, and reflection. The consultations took place in a quiet setting at the outpatient clinic. The nurse was able to facilitate contact to or seek advice with a physician or a technician.

TABLE 1

TABLE 1

The patients consulted the nurse in person or by telephone once a month for 3 months. The decision about frequency was based on clinical experience where transportation to the hospital and the need for psychoeducational support were considered. Relatives were invited to participate if needed. The psychoeducational intervention was performed by 2 nurses with 10 years of clinical experience each in care for patients with ICDs. The nurses did not care for ICD patients in the hospital ward during the project period to prevent “contamination” of the control group. The patients in the intervention group also received “treatment as usual.”

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Treatment as Usual for the Control Group

This included medical follow-up and standard treatment according to disease-specific guidelines as decided by the physician and an invitation to participate in one 2-hour group session, which included information about the ICD and exchange of experiences among patients. In the treatment as usual group, no individual psychoeducational follow-up was provided.

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Data Collection

Demographic and clinical data were obtained directly from the patients or from the medical records during hospitalization. The Emotion and Health Scale was administered at baseline and after 3 months of psychoeducational intervention.

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The Emotions and Health Scale

The Emotion and Health Scale was developed based on the concept of primary emotions.15 The questionnaire measures the intensity of the primary emotions and is based on the assumption that each emotion influences the behavior of individuals and evokes different motivational goals, which directly affect adaptation to the new situation. The Emotion and Health Scale consists of 24 questions that represent the 8 primary emotions: joy, agreeableness, surprise, sadness, fear, disgust, anger, and anticipation. Each emotion is identified by 3 questions scored on a Likert scale ranging from “not at all” (1) to “intensely” (5). The values of the 3 questions that all represented the same feeling were merged, which is the reason the total minimum score for each emotion is 3 and the maximum score is 15. The Emotion and Health Scale was tested for reliability and has acceptable internal consistency, with a Cronbach’s α of >.8. Construct validity was checked by comparing a healthy group of subjects with a group of post–myocardial infarction (MI) patients. Significant differences were observed between the healthy and post-MI cohorts in illness-attributed sadness, anger, disgust, and surprise. Convergent and discriminant validity was evaluated against the Hospital Anxiety and Depression Scale.15 The scale was content validated and face validated in Danish.

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Validity and Reliability

To use the Emotion and Health Scale in a Danish context, the questionnaire was translated into Danish. The translation was done by ethnographic translation to maintain cultural meaning and significance. To validate the translated material, the questionnaire was translated back into English by a noninvolved translator so that discrepancies could be identified and corrected.16 The reliability of the translated questionnaire was tested with Cronbach’s α for each of the 8 emotions, which produced scores ranging from .32 to .75.

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Data Analysis

The general linear univariate model was used. For each feeling, 2 regression analyses were carried out. One (analysis 1) included the intervention indicator as the independent variable (a factor) and the 3-month score as the dependent variable. This analysis was repeated with the baseline score included as a covariate. If the assumptions of analysis 1 (approximate normal distribution of the residuals and variance homogeneity) were violated, the 2 groups were compared using the nonparametric Mann-Whitney test. Eight paired t tests, 1 for each of the 8 feelings, were done. The delta value was calculated as the patient’s answer after 3 months minus the patient’s answer at baseline. The paired t test was supplemented by the signed rank test. Because no effect of the intervention was detected (see Results), the 2 groups were then combined.

A significance level of .05 and 2-sided tests were used. All analyses are exploratory using SAS 9.1 (SAS institute, Cary, North Carolina).

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Ethical Considerations

Patients gave written informed consent after receiving oral and written information. All data material was treated with confidentiality and patients were assured anonymity. The trial followed the recommendations of the Declaration of Helsinki II17 and was approved by the Regional Ethics Committee (H-B-2007-014) and the National Agency for Data Security (2007-41-0932). The trial is registered at ClinicalTrials.gov (ID: NCT00569478).

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Results

Recruitment and Patient Flow

During the inclusion period from October 2007 to November 2009, 610 patients received a first-time ICD implantation at the hospital. A total of 196 patients were included, 99 of whom were randomized to the comprehensive cardiac rehabilitation group and 97 to the control group (Figure). After 3 months, there were 86 patients remaining in the intervention group (withdrawal = 12, death = 1) and 79 remaining in the control group (withdrawal = 17, death = 1).12

FIGURE. F

FIGURE. F

The baseline demographics and clinical characteristics of the 2 groups are shown in Table 2. The groups are well matched.

TABLE 2

TABLE 2

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Outcomes

Table 3 shows the number, the mean, the minimum, and the maximum of each group at baseline and at 3 months for each of the 8 feelings. The scores for baseline versus 3 months, respectively, were as follows— joy: intervention, 10.5 versus 11.0; control, 11.0 versus 10.8; agreeableness: intervention, 8.5 versus 10.4; control, 8.9 versus 10.2; surprise: intervention, 9.4 versus 8.7; control, 10.0 versus 9.2; fear: intervention, 7.6 versus 6.8; control, 7.49 versus 6.94; sadness: intervention, 8.66 versus 8.15; control, 9.1 versus 7.6; disgust: intervention, 5.9 versus 4.6; control, 5.8 versus 5.0; anger: intervention, 6.8 versus 5.7; control, 7.3 versus 6.0; and anticipation: intervention, 10.8 versus 8.34; control, 10.3 versus 8.8. Table 3 also shows the results of the comparisons between the 2 groups. No significant differences were noted. However, Table 4 shows the results of the paired t tests of the combined groups. For each feeling, the mean and the 95% confidence interval of the delta value (value at 3 month minus value at baseline) are shown. Several highly significant results were found, with increasing scores in agreeableness and decreasing scores in surprise, sadness, fear, disgust, anger, and anticipation (P < .05).

TABLE 3

TABLE 3

TABLE 4

TABLE 4

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Discussion

We report on the largest comprehensive cardiac rehabilitation trial for patients with ICD to date. Primary emotions are affected after ICD implantation. Improvements over time were found in both rehabilitation and usual care groups. However, no effect of a short-term psychoeducational nursing intervention was found.

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Interpretation

Intervention

Short-term nursing interventions have previously been successful in reducing anxiety and improving quality of life.18,19 However, in our trial, no significant difference in primary emotions was found between groups after 3 months of psychoeducational intervention. Possible explanations could be that the nursing intervention was not strong enough to promote change or that the questionnaire was not sensitive to the changes. The latter seems unlikely because a significant change within the groups was found, suggesting that the Emotion and Health Scale is sensitive to changes over time in this population. The intervention was designed as a 12-month psychoeducational intervention. However, this exploratory questionnaire was distributed only at baseline and after phase 1 (3 months) because we wanted an evaluation of the short-term psychoeducative intervention and the total quantity of questionnaires was too large to administer throughout the 12 months. An experimental effect of the 12-month intervention was found in mental health.13 However, this was not significantly reflected in these results after only 3 months of the intervention, phase 1.

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Trajectory Over Time

Seen as a healthy survival strategy, with the emotional reaction used as a defense against the experience of illness, it is to be expected that the emotional reaction will stabilize over time.10 As shown in Table 2, there is a change in the intensity of all the experienced emotions except for the experience of joy. However, compared with the intensity of primary emotions in a healthy population, as Bowman and colleagues15 report, the intensity of the primary emotions is still increased 3 months after receiving an ICD, except for the experience of disgust.

The experience of joy is increased for patients who recently survived an MI (mean [SD], 10.7 [1.8]), as it is also for ICD patients, compared with the experience of joy in a healthy population (mean [SD], 9.3 [2.2]).11,15 Patients after an MI can have an increased feeling of joy related to the fact that they survived an MI,15 which has also been reported previously for ICD patients.20–22

Patients with a newly implanted ICD experience a decreasing intensity of sadness during the first 3 months. This pattern of an increased level of concern or sadness just before and after implantation of an ICD,23 decreasing over time, has also been found before.21,22 The slowing down of mental and physical function that accompanies sadness communicates that all is not well. Sadness can develop into depression or it can motivate the person to a more adaptive process. Sadness associates motivational hope, whereas withdrawal and hopelessness are characteristics of depression. Sadness can be seen as a reflective period for the patient and a time to engage them in hope and positive adaption.15

The intensity of fear has been found to be increased in patients just after implantation of the ICD compared with a healthy population.11 Fear can be interpreted as a response to threat to personal security or safety. It is triggered when the individual becomes uncertain of his/her ability to avoid harm or injury.15 Fear of ICD shock may contribute to fear. We found a decrease in the score after 3 months, which is supported by earlier findings.20

All patients in the trial had an exercise test after 1 month. This exercise test may have influenced the patients’ experience of fear if they, because of exercise testing in a safe environment, achieved a sense of security. In addition, the experience that everything works fine over the months may contribute to decreasing fear.

The adaptive function of anger is to regulate physical and mental processes in self-defense. Anger can be interpreted as a positive sign that the individual wants to gain control over his/her life.15 The experience of anger decreases over time, but after 3 months, the experience of anger in patients with an ICD is still remarkably increased compared with that in a healthy population. The mean (SD) intensity of anger is 3.8 (1.4) in a healthy population15 compared with 6.0 (3.1) in the ICD population at 3 months. The feeling of being confronted with physical limitation has been reported to trigger anger among patients with an ICD.24

The results show that patients get more used to life with a new device over time. These findings are confirmed by findings from other studies.20,22,25

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Limitations

A total of 196 patients were included in the trial. The dropout rate of 28.6% is not unusual in cardiac rehabilitation.18,26 Telephone voice-response was used as a randomization method, which increases internal validity.27

Study limitations include the fact that a selection bias may exist because we did not include patients if they were already participating in a pharmaceutical trial. One might expect that patients who were already recruited in other studies may have been more interested in their own healthcare situation (“super responders”). However, this effect would not be likely to have influenced our results because it would have been equally represented in the 2 treatment groups. Furthermore, the control group may have been contaminated by the information given during the project inclusion, which emphasized that psychoeducational assistance and exercise training might be beneficial after ICD implantation.

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Generalizability

External validity is high because this population complied with the guidelines for ICD implantation from 2006.28 Accordingly, a high percentage of the patients had their ICD based on a primary prophylactic ICD indication due to ischemic heart disease, reduced left ventricular function, and heart failure. The baseline variables were in accordance with studies conducted in the United States and Europe.18,19,29,30 The protocol was published12 and is reproducible.

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Clinical Implications

The importance of this study is found in the evidence it produces that primary emotions are affected by receiving an ICD and that primary emotions are sensitive to changes over time. Even though the short psychoeducational nursing intervention was not strong enough to promote changes in primary emotions, the changes that did occur over time send a signal that this is an effective way of monitoring patients’ emotional health. Monitoring primary emotions can be an effective way of evaluating patients’ mental health in a clinical nursing setting to detect a negative emotional development, or a continued negative state, before it develops into depression. The emotional status examined by the Emotion and Health Scale could be used as a tool to discover which patients are in need of psychoeducational intervention and could be a basis for the dialogue about patient’s experiences and concerns, as well as an evaluation instrument in caring science. The intervention tested here was not strong enough to improve emotional outcomes. In the following phases of the COPE-ICD intervention, the psychoeducational intervention continued and stopped after 12 months. We did not administer the Emotions and Health Scale after 12 months but we did see a difference between the intervention and control groups in mental health measured on the Short Form-36 scale after 12 months,13 indicating that a longer intervention is needed. The Emotion and Health Scale is currently used in other interventional rehabilitation trials,31–33 and it will be interesting to see if a difference after 6 months of intervention will be detected.31 Furthermore, we carried out a qualitative interview study with 10 patients from the intervention group and learned that patients were happy about the nursing consultations. They discovered that they have to rethink some of their strategies of living and they experience support in the reflection and coping needed for that.34 Thus, we still believe in the intervention, but the present results indicate that a longer duration than 3 months is needed.

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Conclusion

In conclusion, basic emotions are affected after ICD implantation. Improvements over time were found in both the rehabilitation and usual care groups; however, no effect arising from a short-term psychoeducational nursing intervention was found.

Because this study is explorative, the beneficial effects of psychoeducational nursing interventions should be tested further. The emotional influence of receiving and living with an ICD is apparent, and nurses play a central role in evaluating emotional status and supporting patients in managing life with an ICD.

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What’s New and Important

  • Significant improvements were found in primary emotional responses during the initial 3 months in ICD patients. However, no difference in emotional intensity was found between the rehabilitation and usual care groups after 3 months of psychoeducational nursing intervention.
  • Evaluating the primary emotions might be a good way for nurses to monitor ICD patients’ psychological outcomes because the instrument is sensitive to changes over a short time.
  • A stronger and more extensive nursing intervention is needed to effectively reduce the emotional burden of ICD patients to prevent pathological anxiety and depression.
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Keywords:

emotions; exercise training; ICD; nursing; psychoeducation; rehabilitation

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