Discussion 3: Nurse-led psychological intervention

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 administered at baseline, 6 and 12 months after PCI. The

F I G U R E 1 Study flowchart

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| 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 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.Discussion 3: Nurse-led psychological intervention

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- 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

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). Discussion 3: Nurse-led psychological intervention

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 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. Discussion 3: Nurse-led psychological intervention