2. Correspondence
Professor Le-xin Wang, Department of
Cardiology, Liaocheng People's Hospital,
Liaocheng City, Shandong 252000, China.
Email: [email protected]
Abstract
Objective: To study the effect of nurse-led counselling on the
anxiety symptoms and
the quality of life following percutaneous coronary intervention
for stable coronary
artery disease.
Design: Randomised control trial.
Setting: Rural and remote China.
Participants: Rural and remote patients were consecutively
recruited from a medical
centre located in China between January and December 2014.
Interventions: The control group received standard pre-
procedure information from a
ward nurse on the processes of the hospitalisation and
percutaneous coronary intervention,
and post-procedural care. The intervention group received a
structured 30-minute coun-
selling session the day before and 24 hours after the
percutaneous coronary intervention,
by nurse consultants with qualifications in psychological
therapies and counselling. The
health outcomes were assessed by a SF-12 scale and the Seattle
Angina Questionnaire at
6 and 12 months after percutaneous coronary intervention. The
anxiety and depression
symptoms were evaluated by a Zung anxiety and depression
questionnaire.
Main outcome measures: Cardiac outcomes, quality of life and
mental health status.
Results: Eighty patients were randomly divided into control
3. (n = 40) and interven-
tion groups (n = 40). There was a significant increase in the
scores of the three
domains of Seattle Angina Questionnaire 12 months after
percutaneous coronary in-
tervention in the intervention group (P < .01). The mental health
and physical health
scores also increased (P < .01). In the control group, the mean
scores of Zung self-
rating anxiety scale 12 months following percutaneous coronary
intervention were
higher than the baseline scores, and higher than in the
intervention group (P < .01).
Conclusions: Counselling by a clinician qualified in
psychological therapies and
counselling significantly reduces anxiety symptoms and
improves quality of life.
K E Y W O R D S
cardiovascular medicine, education and remote practice,
international health, mental health, nurse
practitioners
https://orcid.org/0000-0001-7592-832X
mailto:
https://orcid.org/0000-0002-9760-7436
mailto:[email protected]
| 125CHANG et Al.
1 | I N T R O D U C T I O N
Cardiovascular disease is a leading cause of morbidity and
mortality around the globe, responsible for one-third of the
deaths worldwide.1,2 In the past three decades, there have
been tremendous advances in the management of coronary
4. artery disease and percutaneous coronary intervention (PCI).
This has led to a significant improvement in cardiac out-
comes in patients suffering from acute coronary syndrome or
myocardial infarction.3
However, the impact of PCI on health-related quality of
life (QoL), specifically mental health status, is not well un-
derstood.4,5 While some studies show improvement in the
QoL shortly after PCI, others indicate that the short-term
improvement in QoL is not sustainable beyond 1 year.4,5
The factors determining the post-PCI QoL are yet to be de-
termined. However, age, lifestyle measures, such as smok-
ing and diet, as well as post-procedural self-care are thought
to influence a patient's QoL following successful PCI.6,7
Patients' mental health status is associated with the outcomes
of cardiovascular disease, with depression or anxiety at the
time of PCI being related to a higher rate of post-procedural
mortality than patients without mental illnesses.8 However, it
is unclear whether anxiety or depression has any significant
influence on QoL following PCI.
There is limited literature on the effectiveness of pre- and
post-procedural counselling on the anxiety symptoms and the
QoL following PCI, even though studies have identified that
anxiety management is justified before and following PCI.9
While there has been extensive research on the benefits of
cardiac rehabilitation following surgery,10 which often have
poor rural and remote patient participation, there is a scarcity
of quick and effective pre-procedural psychological inter-
ventions aimed at a temporary rural and remote population.
However, a recent study appears to confirm the belief that a
psychological intervention program improves patient mental
health following PCI.11 The researchers found that compared
to the control group, patients in the intervention group had
significantly better mental health, coupled with improved cop-
ing styles and reduced levels of cortisol. This study included
5. a single metropolitan based population, with regular access
to other interventions. As such, its generalisability is limited,
with other studies required to confirm the benefits of a psy-
chological intervention on patients who received a PCI.11
The main objectives of this study are to determine the ef-
fect of nurse-led counselling on the anxiety symptoms and
the QoL following PCI for stable coronary artery disease; and
to determine whether there was a general improvement in the
cardiac outcomes, QoL and mental health status in rural and
remote patients who have received PCI for stable coronary
artery disease. Furthermore, the determining factors for post-
PCI QoL were also analysed in order to improve the care and
outcomes of these patients.
2 | M E T H O D
2.1 | Recruitment of participants
Patients were consecutively recruited from a single medical
centre (Figure 1) located in rural and remote China between
January and December 2014 (12 months). Those selected for
inclusion included those aged 18 years or older who were
scheduled for elective PCI for stable coronary artery disease.
Coronary artery disease was defined as a stenosis of more
than 70% in at least one major coronary artery with clini-
cal or laboratory evidence of myocardial ischaemia (eg, ST
segment depression on ECG during angina or stress testing).
Exclusion criteria included the following: (a) unable to give a
written informed consent; (b) unable to participate in regular
follow-ups at our hospital clinics; (c) a history of psychologi -
cal disorders or mental health illnesses; and (d) a history of
other chronic illnesses or heart failure (left ventricular ejec -
tion fraction <45%).
Participants’ age, sex, level of education, monthly in-
comes, general medical history, and current medications
were recorded at baseline. The participants were ran-
6. domised by an administration staff member into control and
intervention group by a computer-generated randomisation
program. Participants were randomised so that there were
no statistically significant differences in age, sex, baseline
clinical data and coronary disease status between the two
What is already known on this subject:
• Percutaneous coronary intervention is associated
with an increased risk of post-procedural anxiety
and depression. However, it is unclear whether a
nurse-led psychological intervention reduces anx-
iety and depression and improves quality of life
after percutaneous coronary intervention.
What this study adds:
• A nurse-led psychological intervention before and
immediately after percutaneous coronary inter-
vention was associated with a significant reduc-
tion in anxiety and depression symptoms, and
improved quality of life 12 months after percuta-
neous coronary intervention.
• Nurse-led psychological intervention and educa-
tion should be an integrated part of the care for
rural and remote patients undergoing percutane-
ous coronary intervention for coronary artery
disease, who do not have access to traditional re-
habilitation services.
126 | CHANG et Al.
groups. The clinical staff were blinded to the patient ran-
domisation process.
7. 2.2 | Method of evaluation
Three evaluation instruments were administered, at base-
line, 6 and 12 months after PCI, by the nursing investigators
(Chang ZC, Guo AQ and Zhou AX). Data were collected via
face-to-face interviews when patients attended our outpa-
tient clinics. Information about their tobacco use, physical
activity, diet, mental health status, chest pain and compli-
ance to medications was recorded. QoL was assessed with
a short form (SF)-12 survey form. The SF-12 survey has 12
items that cover questions on physical functioning, physical
health-related role limitations, pain, general health percep-
tions, energy levels, emotional problems and general men-
tal health. The answers to the questions on the SF-12 are
calculated to generate a mental health score and physical
health score. Higher scores indicate less physical or mental
disability.12,13
The Seattle Angina Questionnaire (SAQ) was used to as-
sess disease-specific health status.14 The SAQ has 19 items
that measure coronary artery disease-related health status,
with scores ranging from 0 to 100 for each of the five do-
mains, covering frequency of angina, restrictions to physical
activity, satisfactory to treatment, stability of angina chest
pain and QoL. In each domain, a higher score indicates bet-
ter health status, with fewer symptoms and better survival.14
Angina frequency scale was defined as no angina (score,
100), monthly angina (score, 70-90), weekly angina (score,
40-60) or daily angina (score, <40). To reduce the workload
of the investigators of this study, only frequency of angina,
restrictions to physical activity and QoL scores were col -
lected and analysed.
To evaluate the impact of generalised anxiety symp-
toms, a Zung self-rating depression and anxiety scale was
8. administered at baseline, 6 and 12 months after PCI. The
F I G U R E 1 Study flowchart
| 127CHANG et Al.
Zung self-rating depression and anxiety scales were 20-item,
self-administered questionnaires for the assessment of depres-
sion and anxiety symptoms. They were reliable and validated
instrument among Chinese populations.15,16 The 20 items on
each scale give a total score from 20 to 80. A higher score
denotes more depression or anxiety symptoms. A depression
score of 50-59, 60-69 and 70-80 indicates mild, moderate
and severe depression, respectively.15, 16 An anxiety score of
45-59 and 60-80 denotes moderate to severe anxiety.15,16
2.3 | Psychological intervention
The control and intervention groups both received standard
pre-PCI care and general counselling about the procedure to
be undertaken. The general counselling was conducted by the
ward nurse on duty over a brief visit and consisted of com-
municating the hospitalisation process and the procedure to
be undertaken (ie PCI), and post-procedural care. No indi-
vidualised psychological intervention was provided prior to
PCI in the control group.
In addition to this standard counselling, the interven-
tion group also received a structured 30-minute counselling
session the day before and 24 hours after the PCI, by nurse
consultants with qualifications of psychological therapies
and counselling. The psychological interventions were
comprised of individualised cognitive behavioural thera-
pies and teaching of relaxation techniques. These measures
included identifying the causes of anxiety, challenging and
changing unhelpful thoughts or attitudes that may trigger or
9. aggravate anxiety, and the development of personal coping
strategies for anxiety prevention and treatment. The nurse
consultants also used this time to answer any of the patients
procedural and post-PCI concerns or questions. The post-
PCI counselling focused on improving the patients’ com-
fort level and confidence in participating in post-PCI care
recommendations.
2.4 | Data analysis
To detect a 10-point difference in the physical or mental
health scores on the SF-12 scale, and in the three domains
of the SAQ, a minimum of 34 patients were required for
this study, to achieve a significance of 0.05 with a power
of 80%. QoL measures were analysed by an analysis of
variance (ANOVA) at 6 and 12 months following PCI.
Categorical data were analysed using a chi-square test.
Multivariate logistic regression analysis was conducted
to ascertain factors (age, sex, smoking, hypertension, hy-
perlipidaemia, diabetes and SAS scores) against the QoL
scores. Statistical significance was determined at a P level
of <.05.
2.5 | Ethics approval
The study protocols received approval from our institutional
review board: Human Ethics Committee, Liaocheng People's
Hospital (approval number 201338). Written consent was
obtained from all participating patients. This study complied
with the CONSORT guidelines, however, was not required
to be a registered trail, reflective of local customs in China.
3 | R E S U LT S
3.1 | Patient population
There were 20 females and 60 males with a mean age of
59.7 ± 8.7 years (range, 42-79 years; Table 1). Twenty-one
(26.25%) patients had primary school education or less, with
34 (42.5%) having a high school education, with the remain-
10. ing 25 (31.25%) having a tertiary education.
The majority of patients had a single or double coronary
artery disease, with 11.2% having simultaneous involvement
of the three main coronary arteries (Table 1). The left anterior
descending coronary artery was involved in more than 83%
of the patients (Table 1). None of the patients had a known
history of mental health illness, such as depression or anxi -
ety, nor were they on any antidepressants. However, six pa-
tients (7.5%) had a Zung self-rating depression score of 59
and above at baseline (Table 2), suggesting moderate to severe
depression. Five patients (6.3%) had a Zung self-rating anxi-
ety score of 45 and above, indicating the presence of anxiety.
3.2 | Cardiac outcomes of PCI
Percutaneous coronary intervention was successful in all pa-
tients. The number of coronary stents received by each patient
ranged from one to six (median = 2). Thirty-six patients (45%)
received bare-metal stents, and 44 (55%) had drug-eluting
stents.
Antiplatelet therapy with clopidogrel and aspirin was adminis-
tered to all patients following PCI. There was no statistically
significant difference in patients who received bare-metal or
drug-
eluting stents between the study and control groups (P > .05).
Patients were followed up at our outpatient clinics monthly
for 12 months after the procedures. None of the patient expe-
rienced myocardial infarction, heart failure, stroke or cardiac
arrest. Three (3.8%) patients were admitted to hospital for
non-cardiac reasons.
3.3 | Quality of life measures
As shown in Table 2, there was a significant increase in the
three domains of SAQ, angina frequency, physical limitations
11. 128 | CHANG et Al.
and QoL, 12 months after PCI in the study and control groups
(P < .01, Table 2). The physical limitations and QoL scores in
the intervention group were higher than in the control group
(P < .05, Table 2). Twelve months following PCI, only two
(2.5%) patients experienced occasional angina chest pain and
repeat coronary angiogram did not reveal any stenotic lesions
in the coronary arteries.
The mental health scores and physical health scores
on the SF-12 scale were also increased 12 months after
the PCI (P < .01, Table 2). The increase in the interven-
tion group was higher than in the control group (P < .01,
Table 2).
3.4 | Depression and anxiety symptoms
following PCI
There was no statistically significant difference in the Zung
self-rating depression scores before and after PCI in the inter -
vention group or control group (P > .05, Table 2).
The mean scores of Zung self-rating anxiety scales in
the control group were higher than in the intervention group
following PCI (P < .01, Table 2). In the control group, the
number of patients with anxiety symptoms and the mean anx-
iety rating scores following PCI were higher than the baseline
values (P < .05, Table 2).
3.5 | Factors for post-PCI quality of life
Logistic regression analysis was performed to assess the fac-
tors influencing post-PCI QoL measures, that is QoL scores in
the SAQ, the mental health scores and physical health scores
12. in the SF-12 survey. Age, sex, education levels, monthly
incomes, co-morbidities, number of coronary lesions, types
of coronary stents and post-PCI depression scores were not
correlated to the measures for QoL. In the control group,
an inverse correlation between Zung anxiety scores and the
three QoL measures was identified (r = .822, .781 and .594,
respectively, P < .01) following PCI.
Logistic regression analysis was performed to assess the
factors influencing post-PCI Zung anxiety scores. Baseline
Zung anxiety scores and lower monthly incomes were found
to be correlated to the post-PCI Zung anxiety scores (r = .609
and .513, respectively, P < .01).
4 | D I S C U S S I O N
This study indicated that PCI or coronary stenting is as-
sociated with a significant improvement in QoL at 6 and
12 months in both the control (40.7 vs 63.7) and interven-
tion (40.1 vs 83.6) groups, with a significant reduction in
the monthly angina frequency in both groups following the
procedure (control = 12.5% vs 2.5%; intervention = 22.5%
vs 2.5%). In the control group, there was a significant in-
crease in the Zung self-rating depression scores (45.7 vs
47.0) and an increase in the number of patients who ex-
perienced generalised anxiety symptoms within the first
12 months of PCI (36.0 vs 47.1), whereas the intervention
group significantly decreased their Zung self-rating de-
pression scores (44.1 vs 24.5) and reduced their general -
ised anxiety symptoms within the first 12 months of PCI
(38.6 vs 18.9). Furthermore, anxiety symptoms prior to
PCI and lower monthly incomes appeared to increase the
risk of post-PCI anxiety.
T A B L E 1 Baseline data of the patients
Indices Study (n = 40) Control (n = 40)
13. Age (y) 59.7 ± 8.7 59.0 ± 7.7
Male/Female 30/10 30/10
Level of education (%)
Primary school or less 10 (25) 11 (27.5)
High school 18 (45.0) 16 (40.0)
Tertiary 12 (30.0) 13 (32.5)
Monthly incomes ($USD; %)
<150 10 (25.0) 12 (30.0)
150-299 16 (40.0) 15 (37.5.0)
>300 14 (35.0) 13 (32.5)
Clinical (%)
Smoking 5 (12.5) 4 (10.0)
Diabetes 13 (32.5) 11 (27.5)
Hypertension 35 (87.5) 34 (85.0)
Hyperlipidaemia 31 (77.5) 28 (70.0)
COPD 7 (17.5) 4 (10.0)
Prior MI or percutaneous
coronary intervention
14. 1 (2.5) 2 (5.0)
History of CHF 2 (5.0) 1 (2.6)
Previous stroke 1 (2.6) 0
Peripheral vascular
disease
4 (10.0) 3 (4.5)
Angiographic (%)
Single vessel disease
(LAD or RCA or left
main)
20 (50) 21 (52.5)
Double vessel disease
(LAD and RCA, or
left main plus LAD or
RCA)
15 (37.5) 12 (30.0)
Triple vessel disease
(LAD, RCA and left
main)
5 (12.5) 7 (17.5)
Abbreviations: COPD, chronic obstructive lung disease; LAD,
left descending
coronary artery; NS, no statistical significance; RCA, right
coronary artery.
15. | 129CHANG et Al.
Percutaneous coronary intervention has become a nor-
mal therapy for patients with acute coronary syndrome.
It is also used to provide relief of angina in patients with
stable coronary disease.17 PCI and optimised medical ther-
apy have been found to reduce the frequency of angina and
improve self-assessed health status.17 In line with previous
studies, we found that PCI in patients with stable coronary
artery disease was associated with significant improve-
ment in generic and disease-specific QoL measures. The
physical and mental health scores improved within the
first 12 months of PCI, and the frequency of angina was
significantly reduced, which translated into improvements
in physical limitations and QoL on the Seattle Angina
Questionnaires. These results may help with clinical de-
cision making on the role of PCI in the treatment of stable
coronary artery disease.
Depression and anxiety are very common mental illness
in all societies. Patients with coronary artery disease were
found to have an increased cardiovascular morbidity and
mortality when depression or anxiety was present. Some
evidence has suggested that post-procedural mental illness
may have an impact on the major cardiovascular events after
PCI. Reduced positive affect was independently associated
with a 1.5-fold increased risk of all-cause mortality 7 years
post-PCI.8 The prevalence and clinical significance of de-
pression or anxiety in patients with stable coronary artery
disease treated with PCI are not clear. In the present study,
depression and anxiety were found in 7.5% and 6.3% of the
patients, respectively, prior to PCI. After PCI, there was a
16. significant increase in the Zung anxiety scores and the pro-
portion of patients who met the criteria for generalised anx-
iety disorder 12 months after PCI within the control group.
Further analysis in these patients revealed that the pre-PCI
anxiety scores and low monthly incomes were associated
with post-PCI anxiety symptoms. This is an important find-
ing and supports research that has shown that mental disor-
ders are associated with lower levels of income. Specifically,
people with a household income of <$20 000 per year are
at an increased risk of developing a mood disorder within
3 years, as compared to those with income of $70 000 or
more per year.18 Furthermore, our results are supported by
a recent study, where low levels of education and pre-proce-
dural apprehension were some of the determining factors for
post-procedural mental health disorders.19
The clarification of factors that determine post-PCI QoL
has important clinical implications. A reduced frequency of
angina is often associated with a better QoL after PCI.20 Other
factors that are associated with a better post-procedural QoL
are non-smoking status, cardiac rehabilitation,10 and lack of
co-morbidities, such as heart failure.20 Depression compro-
mises the QoL following PCI.20 In the present study, age, sex,
level of education, monthly incomes, co-morbidities, location
Baseline 12 mo
Intervention Control Intervention Control
Seattle Angina Questionnaire (SAQ)
Angina frequency 61.9 ± 7.2 60.2 ± 6.0 96.9 ± 4.1 97.6 ± 5.2
Physical limitations 63.1 ± 8.6 62.9 ± 8.0 83.1 ± 6.0 72.0 ± 6.3*
18. T A B L E 2 Quality of life measures of
the 80 patients at baseline and 12 mo after
percutaneous coronary intervention
130 | CHANG et Al.
and severity of coronary lesions were not associated with the
post-procedural measures for QoL. However, the post-PCI anx-
iety scores were inversely correlated with the generic and dis-
ease-specific measures for QoL, indicating anxiety may have
a negative impact on the QoL in patients treated with PCI for
stable coronary artery disease.
An important finding in this study is that brief psychologi -
cal counselling by trained nurses the day before and after PCI
was associated with a significantly reduced anxiety scores,
and higher scores of qualities of life measures. These data
indicate that integration of psychological intervention into
pre- and post-PCI care may improve patient's mental health
following the procedure, particularly in those patients of a
low socio-economic background.
This study was limited by the small number of partici-
pants, limited to a single geographical area. Future studies are
required to refine the intervention protocol, and to extend to
other rural and remote populations without regular access to
ongoing pre- and post-rehabilitation services. Furthermore,
we were unable to determine why more males were referred
to our service, however we suspect it is because these rural
male populations have increased cardiovascular disease risk
factors, such as smoking. However, future research will need
to determine why more males are referred for PCI in this pop-
ulation setting.
19. 5 | C O N C L U S I O N
In this randomised controlled study, we have found that in pa-
tients with stable coronary artery disease, PCI elicits a signif-
icant improvement in QoL, with reduced angina frequency,
and increased physical and mental well-being. However,
there is also a significant increase in anxiety symptoms fol -
lowing PCI, and these symptoms were negatively correlated
with the scores of qualities of life measures. A nurse-led,
brief psychological intervention before and after PCI was as -
sociated a reduction in anxiety scores and improvement in
quality of life measures. These data suggest that a greater
effort should be made in screen for mental health disorders,
such as anxiety, before PCI. Brief psychological intervention
before and after PCI may further improve the outcomes in
patients with stable coronary artery disease.
O RC I D
Fergus W. Gardiner https://orcid.
org/0000-0001-7592-832X
Le-xin Wang https://orcid.org/0000-0002-9760-7436
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How to cite this article: Chang Z, Guo A, Zhou A,
et al. Nurse-led psychological intervention reduces
anxiety symptoms and improves quality of life
following percutaneous coronary intervention for
stable coronary artery disease. Aust J Rural Health.
2020;28:124–131. https ://doi.org/10.1111/ajr.12587
https://doi.org/10.1111/ajr.12587
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· Were the measurement instruments reliable and valid? Why or
why not?
· Was treatment fidelity for the intervention ensured? Why or
why not?
· Were the conclusions of the study were supported by the
statistical results, as indicated by the variable values and the p-
values if reported?
Note: References must be in APA format (7th Edition) and no
older than 2018