The effect of increasing duration of family members' presence on sleep status in patients with acute coronary syndrome in cardiac care unit: A randomized controlled trial

Abstract

Aim

To investigate the effect of increasing duration of family members' presence on sleep status in patients with acute coronary syndrome (ACS) admitted to the cardiac care unit.

Design

Randomized controlled trial.

Methods

Ninety patients with ACS randomly assigned into two groups. No intervention was performed in control group. In the intervention group, the time of family members presence was changed from 1 h per day to 2 h per day from the second to the fourth day. Then, ST Mary's Hospital Sleep Questionnaire was completed by the patients every day during the study.

Results

The patients in the intervention group had statistically significantly better sleep status during the course of intervention compared to the control group.

Patient or Public Contribution

The increasing duration of family members' presence can improve the sleep quality and quantity of ACS patients.

1. BACKGROUND

Cardiovascular diseases (CVDs) are one of the most common diseases, and the number of patients with CVDs has increased in the recent decade (Roth et al., 2020). These diseases are responsible for the highest rate of mortality, disability and financial burden on healthcare systems (Raigan et al., 2018). According to reports, CVDs are the first cause of death in Iran, claiming over 46% of deaths (Khosravi et al., 2010).

Among the CVDs, acute coronary syndrome (ACS) is characterized by unstable angina and acute myocardial infarction (Piegas et al., 2013). Early days after ACS and the following hospitalization, patients experience a range of physical and psychological consequences such as sleep disturbance (Prado et al., 2019). It is believed that sleep disturbance can have harmful effects on ACS patients including physical stress, restlessness, aggression, reduced physical and cognitive function, mood instability and emotional distress (Bagheri et al., 2022; Farokhnezhad Afshar et al., 2017). All these increase the heart rate, respiratory rate, blood pressure, myocardial oxygen demand and cardiac dysrhythmia and can eventually lead to spreading ischemia and a second heart attack (Najafi Ghezeljeh, 2018). In addition, despite controlling for environmental factors, different patients have different sleep structures, which may be due to inflammatory or physiological changes or the nature of the disease (BaHammam, 2006). In a study by Sepahvand (2015), 81% of ACS patients referring to the cardiac care unit (CCU) reported sleep disturbance. In another study, only 35% of CCU patients had good sleep quality.

Currently, the most common way to treat sleep disturbance is by taking medications. Although the efficacy of non‐pharmacological treatments is slower than sleep medications, they are more durable and often have few side effects and risks (Bagheri et al., 2021). One of the non‐pharmacological interventions in the CCU is providing social and psychosocial support by patients' family and friends (Kaplow & Hardin, 2007). It has been shown that one of the psychological stress factors in patients admitted to the critical care unit (CCU) is being separated from family members and lack of a defined time for family visits in the ward (Schlenker, 1999). In this regard, evidence from two clinical trial studies revealed family visits were associated with a significant reduction in anxiety levels in the patients admitted to CCU (Fumagalli et al., 2006; Lolaty et al., 2014). Additionally, in a 3‐year follow‐up study on 2330 patients with myocardial infarction, it was found that the level of stress associated with disease, loneliness and being away from family and friends are three factors influencing the mortality of patients admitted to CCU. Patients with both types of stress had a nearly twofold mortality rate (Eriksson et al., 2011).

Today, a comprehensive care includes patients and families (Abbas‐Zadeh et al., 2000). However, some believe that regular and constant presence of family members on the patient's bedside can disturb the patient's rest (Ahmadian et al., 2013). Meanwhile, a study by Medves et al. (2009) found that free presence of family members can have a positive effect on patients' mental health and safety, while also reducing the patients' anxiety and blood pressure. In addition, another study reported that unrestricted visiting policy and increasing the time of patients' visit would reduce patients' cardiovascular complications and anxiety.

Although the patient's visit is influenced by cultural and social factors, the schedule for visiting patients in different departments is more dependent on the specifications and rules of hospitals or medical departments, while they do not pay attention to patients' personal factors such as attitude, beliefs and type of disease (Marco et al., 2006). Fortunately, there is an increasing tendency to eliminate the ban on patient visits in various healthcare departments and wards (Giannini et al., 2013).

Considering the high prevalence of sleep disturbance in ACS patients admitted to the CCU and complications of hypnotic drugs, the need to adopt appropriate strategies to improve quality and quantity of patients' sleep and due to lack of a similar study, this study was conducted to examine the effect of increasing the presence time of family members at the patient's bedside on the sleep quality of patients with ACS admitted to CCU. The research hypothesis was as follows:

The increasing duration of family members' presence is effective on the sleep status in patients with acute coronary syndrome (ACS) admitted to the CCU.

2. METHODS

2.1. Study design

This study was a single‐centre, single‐blind, two‐armed, parallel randomized controlled trial conducted on patients with ACS admitted to the CCU of a teaching hospital in an urban area of Iran from September 2018 to June 2019.

2.2. Participants and sampling

Inclusion criteria in this study were patients with the diagnosis of ACS and need for hospitalization in the CCU at least 4 days according to physicians' initial diagnosis, age over 18 years, ability to communicate and speak Farsi, healthy eyesight and hearing or use of visual or hearing assistive devices, access to the family member of the patient including the father, mother, sister, spouse and child. On the other hand, exclusion criteria included having cognitive impairments such as dementia based on the doctor's diagnosis, presence of sleep disorders such as sleep apnoea, alcoholism, use of psychosocial drugs, the patient's visit for more than 1 h and unexpected visits.

The sample size required for this study was determined as 45 patients in each study group according to the Bagheri‐Nesami et al.'s study (2015) using the following formula with 95% confidence interval and 90% power and considering 15% dropout rate.

$$\begin{array}{c}\text{Sample size based on sleep quality score}=\hfill \\ \frac{{\left(z_{\left(1-\alpha /2\right)}+z_{\left(1-\beta \right)}\right)}^2\left({\sigma }_1^2+{\sigma }_2^2\right)}{{\left({\mu }_1-{\mu }_2\right)}^2}=\frac{{\left(1.96+1.28\right)}^2\left({1.8}^2+{2.2}^2\right)}{{\left(7-5.5\right)}^2}=38\hfill \end{array}$$

$$\begin{array}{c}\text{Sample size based on sleep quantity score}=\hfill \\ \frac{{\left(z_{\left(1-\alpha /2\right)}+z_{\left(1-\beta \right)}\right)}^2\left({\sigma }_1^2+{\sigma }_2^2\right)}{{\left({\mu }_1-{\mu }_2\right)}^2}=\frac{{\left(1.96+1.28\right)}^2\left({4.1}^2+{5.1}^2\right)}{{\left(25.9-29.6\right)}^2}=33\hfill \end{array}$$

In this study, a convenience sampling method was used. First, patients were enrolled according to the inclusion criteria. Next, they were randomly assigned into the intervention (n = 45) and the control (n = 45) groups using block randomization as follows: code ‘A’ was given to the control group and code ‘B’ was assigned to the intervention group. Then, the statistical adviser of the study (fifth author) determined the random allocation sequence with 21 quadruple blocks and one sextuple block using https://www.sealedenvelope.com website. Next, according to these blocks, the eligible participants were allocated to the intervention and control groups by the second author. Concealment was performed using sequentially numbered sealed opaque envelopes. Each card (‘A’ or ‘B’) of the allocation sequence was placed in an envelope. Then, an envelope was opened for each participant based on the time of entry to the study and assigned to the target group. The study flow diagram is presented in Figure 1.

FIGURE 1.

The process of the study according to the CONSORT flow diagram (2010).

2.3. Data collection

Data collection tools were the demographic questionnaire and ST Mary's Hospital Sleep Questionnaire (SMHSQ).

2.3.1. Demographic questionnaire

This questionnaire was designed by researchers which captured questions about age, gender, education level, occupation, marital status, tobacco and opiate use and the history of somniferous drug use.

2.3.2. St Mary's Hospital Sleep Questionnaire (SMHSQ)

Hospital sleep quality was assessed using the SMHSQ. Ellis et al. (1981) designed this questionnaire and assessed the test–retest reliability and reported it as 70%–96%. The Farsi version of this questionnaire was evaluated in terms of the reliability using the calculation of the Cronbach's alpha coefficient which was reported to be 91% (Moeini et al., 2010). This questionnaire was a systematic sleep questionnaire for examining last night sleep quality and could be repeated. The questionnaire consists of 14 items for assessing subjective sleep time and quality on a Likert scale. The validity and reliability of the SMHSQ were approved in previous studies (Bagheri‐Nesami et al., 2015; Leigh et al., 1988). As there is no standard rating for this questionnaire, in this study, the questionnaire was scored according to the previous study (Bagheri‐Nesami et al., 2015). The scores would range from 10 to 50. A score of 10 meant no sleep disturbance. Scores 11–22 showed a mild sleep disturbance, 23–36 revealed a moderate sleep disturbance and a score 37–50 indicated a severe sleep disturbance. The questionnaire included questions about the hour of getting ready for sleeping, falling asleep, waking up hours, sleep hours, depth of sleep, sleep quality, wakefulness at night, night sleep rate, sleep rate per day, sleep satisfaction, feeling of a person after waking up, early waking up and inability to sleep again, difficulty in falling asleep and duration of sleep.

2.4. Procedure

According to the hospital's routine, family members could meet their patients for 1 h in the evening from 15 to 16 o'clock every day. In the control group, the presence of family members was according to the hospital's routine. However, in the intervention group, the hours of the presence of family members of patients were changed from 1 h per day (routine) to 2 h per day. So that family members of patients presented at the patient's bedside 1 h according to the hospital's routine and 1 h in the early night within the hours of 17–21 o'clock from the second to the fourth day of study. On the first night, no intervention was performed in the intervention group. For assessing patient's sleep status in two study groups, the SMHSQ was filled out in the morning of the second, third, fourth, and fifth days, at 7 o'clock.

The average length of stay of the patients with ACS in the CCU was between 5 and 6 days. The provision of nursing care and giving medicines in the CCU was planned so that patients could rest undisturbed between 12:00 PM and 6:00 AM unless there was an emergency situation. Nevertheless, the admission of emergency patients and the noises of devices such as monitors could cause sleep disturbances in the ward.

The CCU structural environment in this study had two corridors separated by a wall. Thus, in order to avoid the contamination between participants in the intervention and control groups that could affect the results of the study, the patients in the control and intervention groups were always admitted to different corridors of the CCU ward.

2.5. Ethical considerations

This research was supported and approved under the ethical code of IR.SHMU.REC.1396.201 and was registered in the clinical trial system by the code of IRCT20100114003064N11. All participants were informed about the aim, process and confidentiality of data. Also, written informed consent form was signed by willing participants.

2.6. Data analysis

In this study, the data analyser was blinded to study groups. Descriptive and inferential statistics were used for data analysis via the SPSS version 25 software (IBM® SPSS Statistics). The Kolmogorov–Smirnov test and the homogeneity of variances were performed to assess the distribution of data in terms of normality. Although the sample size was high, the multivariate normality of the data was also assessed using the generalized Shapiro–Wilks test. Considering the normal distribution of data, parametric tests were performed. Repeated measures ANOVA was conducted to investigate the changes in sleep quality and quantity with time of study in each group. In this regard, the sphericity assumption was examined in the analysis, and in the absence of sphericity, the Greenhouse–Geisser correction was used. In addition, for comparison of pre‐ and post‐intervention sleep quality and quantity on each day of study between the study groups, interdependent sample t‐test was used. Also, p‐value 0.05 was considered as the significance level.

3. RESULTS

Out of 155 participants that were assessed for eligibility, 90 eligible participants were randomly allocated to the intervention (n = 45) and control (n = 45) groups. All participants completed the study. Thus, the data obtained from all participants were included in the final analysis (Figure 1). The mean age of the patients in the intervention and control groups was 64.26 and 63.58 respectively. In addition, the majority of participants in the intervention group were females (57.8%), but in the control group they were males (53.3%). Other demographic characteristics of the study participants are presented in Table 1.

TABLE 1.

The demographic characteristics of the patients in the groups.

Variables	Intervention group	Control group
	n (%)	n (%)
Age
Mean (SD)	64.26 (13.95)	63.58 (13.12)
Gender
Male	19 (42.2)	24 (53.3)
Female	26 (57.8)	21 (46.7)
Occupation
Employed	15 (33.3)	14 (31)
Retired	6 (13.3)	10 (22.2)
Housewife	24 (53.4)	21 (46.8)
Education level
Illiterate	21 (46.8)	18 (40)
Under diploma	20 (44.4)	21 (46.7)
Diploma and higher	4 (8.8)	6 (13.3)
Marital status
Married	45 (100)	44 (97.8)
Single	0	1 (2.2)
Tobacco and opiate use
Yes	12 (26.7)	11 (24.4)
No	33 (73.3)	34 (75.6)
History of somniferous drug use
Yes	5 (11.1)	10 (22.2)
No	40 (88.9)	35 (77.8)

According to Table 2, the repeated measures ANOVA for each group showed separately that sleep quality was improved with the time in the intervention group, which was statistically significant (p < 0.001), but there was no statistically significant difference in the control group (p = 0.33). In addition, the patients in the intervention group had significantly better sleep quality during the course of the intervention compared to the control group (all p < 0.001; Figure 2). In the intervention group, the results of the Bonferroni test revealed that there were differences in the sleep quality score of the first night of hospitalization with the first night of intervention (p < 0.001), the second night of intervention (p < 0.001) and the third night of intervention (p < 0.001); after the first night of the intervention, they had better sleep quality. A repeated measure analysis was used to simultaneously analyse the sleep quality of the two groups at the four times of measurement. The condition of sphericity of variances was not met due to the significance of Mauchly's test (p = 0.01). Thus, in order to investigate the effect of time and the interaction effect of time and groups, univariate results were reported with epsilon correction. The results of Greenhouse–Geisser test indicated that there was a significant difference in sleep quality between the two groups (p < 0.001, F = 88.58, df = 1) and sleep quality over time (p < 0.001, F = 9.94, 71). In addition, the interaction effect of time and group was also significant (p < 0.001, F = 18.81, df = 2.71). Furthermore, the results of independent t‐test showed that the patients in both groups had the least amount of sleep quality on the first night (p = 0.44). However, sleep quality was higher in the intervention group in all three intervention nights (p < 0.001).

TABLE 2.

Comparison of sleep quality scores on the first night of hospitalization and three nights after intervention in two study groups.

Sleep quality	First night of hospitalization	First night after intervention	Second night after intervention	Third night after intervention	Repeated measures ANOVA
	Mean (SD)	Mean (SD)	Mean (SD)	Mean (SD)
Intervention N = 45	25.02 (6.33)	17.88 (4.46)	17.17 (4.30)	16.20(3.35)	F = 44.45 p < 0.001
Control N = 45	26.13 (7.16)	26.08 (6.92)	27.48 (6.66)	28.02(7.31)	F = 1.15 p = 0.334
Independent sample t‐test	t = −0.780 p = 0.44	t = −6.68 p < 0.001	t = −8.73 p < 0.001	t = −9.86 p < 0.001

FIGURE 2.

Sleep quality and quantity in four stages of measurements in two study groups.

According to Table 3, the repeated measures ANOVA for each group indicated separately that sleep quantity significantly improved with time in the intervention group (p < 0.001), but there was no statistically significant difference in the control group (p = 0.35). Also, the participants in the intervention group had significantly better sleep quantity during the course of the intervention compared to the control group (all p < 0.001). Therefore, Bonferroni's test was used for pairwise comparison in each group on the first night of hospitalization and during the intervention nights in terms of sleep quantity score. The results showed that in the intervention group, there were significant differences in the sleep quantity score of the first night of hospitalization with the first night of intervention (p = 0.008), the second night of intervention (p = 0.004) and the third night of intervention (p = 0.003). This means that in this group of patients, they had a higher amount of sleep after the first night of the intervention. No statistically significant difference was observed in the amount of sleep of the control group over time (p = 0.35). A repeated measure analysis was employed to simultaneously analyse the amount of sleep of the two groups at the four mentioned times. To investigate the condition of sphericity of variances, the Mauchly's test was used and due to the significance of the Mauchly's test (p = 0.03), the condition of sphericity of variances was not established. Therefore, in order to explore the effect of time and the interaction effect of time and groups, univariate results were reported with epsilon correction. The results of Greenhouse–Geisser test revealed that there was a significant difference between the two groups regarding the amount of sleep (p < 0.001, F = 37.72, df = 1). There was also a significant difference in the amount of sleep over time (p < 0.001, F = 5.66, df = 2.72), where the interaction effect of time and group was also significant (p = 0.01, F = 3.63, df = 2.72). Furthermore, independent t‐test was utilized to compare the sleep quantity scores of the two groups on the first night of hospitalization and on the third night of the intervention. The results showed that the sleep quality of the patients on the first night of hospitalization in the two groups did not differ significantly (p = 0.20). However, the comparison of sleep quantity scores in two groups with independent t‐test in all three intervention nights was significant (p < 0.001). Also, based on the average sleep quantity scores, it is concluded that at all three nights of the intervention, the sleep quantity was higher in the intervention group. (Table 3, Figure 2).

TABLE 3.

Comparison of sleep quantity scores (hours) on the first night in hospital and three nights after intervention in the case and control groups.

Sleep quantity	First night of hospitalization	First night after intervention	Second night after intervention	Third night after intervention	Repeated measures ANOVA
	Mean (SD)	Mean (SD)	Mean (SD)	Mean (SD)
Intervention N = 45	6.92 (1.81)	7.89 (0.88)	7.92 (0.88)	8.01 (0.82)	F = 9.81 p < 0.001
Control N = 45	6.50 (1.27)	6.91 (1.56)	6.65 (1.52)	6.54 (1.540	F = 1.10 p = 0.35
Independent sample t‐test	t = 1.28 p = 0.20	t = 3.70 p < 0.001	t = 4.87 p < 0.001	t = 6.01 p < 0.001

4. DISCUSSION

Due to diminished sleep quality in patients with the ACS hospitalized in the CCU (Daneshmandi et al., 2012), this study was carried out to determine the effect of increasing family members' presence time from 1 to 2 h on sleep quality in patients with ACS admitted to the CCU. In this study, participants in the intervention group had significantly better sleep quality and quantity during the course of the intervention compared to the control group. Also, the quality and quantity of patients' sleep in the intervention group significantly improved with time, but no significant change was observed in the control group.

Previous research has well documented that sleep problems of patients in intensive care units are associated with high levels of stress and anxiety (White & Parotto, 2019). One of the important stressors for patients in the ICU is the short duration of family member presences (Bashti et al., 2016). Hospital policies of limiting presence of family members and relatives could also increase the anxiety and stress levels of these patients (Kherad et al., 2017). Prolongation of visitation hours from 1 h to 2 h leads to increased presence of family members on the patient's bedside (Bashti et al., 2016). Bashti et al. (2016) in their study increased the time of family member presence to 2 h per day in ACS patients, and observed a significant reduction in patients' anxiety. Thus, the presence of family or friends can improve the sense of well‐being and reduce patients' anxiety (Lolaty et al., 2014) and stress (Smith et al., 2009). Also, according to the results of this study, it could improve the sleep status of these patients. Similar to the results of this study, findings of Kherad et al.'s study (2017) revealed that the regular presence of family members at the patient's bedside would reduce anxiety and improve sleep quality of burn patients.

Redeker and Stein (2006) concluded that patients with CVDs at the beginning of admission had sleep disturbance and low quantity of sleep, but with longer presence of close relatives, the patients would experience improved quality and quantity of sleep. Khaleghparast et al. (2016) in a qualitative study entitled ‘visiting hour's policies in intensive care units: exploring participants' views, participants’ stated that the presence of family members and unlimited visits could reduce stress, create a sense of security, improve mental health and most importantly improve sleep quality and provide more comfortable sleep for their patients. A previous study suggested that the presence of the patient's family at the patient's bedside during hospitalization would control negative factors of patients including nervousness, anxiety and stress and gradually improve sleep quality and quantity (Radman et al., 2015). In addition, another study revealed that social support by patients' companions played a key role in improving the sleep quality of patients with CVDs (Ranjbaran et al., 2014).

In ACS patients, family presence, as an element of family‐centred care (Davidson et al., 2014), can help patients better cope with stress factors during hospitalization (Baharoon et al., 2017). In addition, family presence can create a sense of security in patients and reduce the severity of pain in patients admitted to the ICU (Bell, 2017). Further, flexible visitation policies in hospitals can encourage family involvement in non‐pharmacological interventions for sleep hygiene (Teixeira & Rosa, 2018). Also, the presence of family members during day hours encourages patients to stay awake. Likewise, patients may not have trouble starting or maintaining sleep at night as they have not napped during the day (Owens et al., 2017).

Furthermore, in the Iranian culture, there are strong emotional ties between family members and patient visits are considered as honourable behaviour because of religious beliefs. As such, the presence of family members affects the patient's condition and regular presence of family can empower and strengthen the mood of patients, and have a positive effect on improving their quality of sleep and well‐being (Rezaie et al., 2016).

4.1. Strengths and limitations

This has been a novel study about the effects of family presence on sleep patterns of hospitalized patients. In addition, an experimental study has been carried out, which provides a higher level of evidence compared to other cross sectional or analytical studies. However, this study had some limitations that should be addressed in future research. First, this study was conducted on a small sample size in a single centre; accordingly, the finding of this study should be confirmed by future studies with a larger sample size in multiple centres. Secondly, this study was not able to control the effect of other factors that can affect sleep quality in patients hospitalized in CCU such as pain, light and noise. Additionally, in this study, the interaction between the family members and the patient may influence the results of this study. Finally, this research was conducted in the Iranian culture which may reduce its generalizability to patients of other cultures.

4.2. Implications for practice

Patients' sleep is considered as an essential element of healing which is often ignored in a critical care setting. Thus, hospitalized patients in these units may not have the sleep required for recovery (Fontana & Pittiglio, 2010). The findings of this study can be used by nursing and hospital managers to develop an appropriate plan for improving the health and sleep quality of patients in intensive care units, by increasing the time of presence of patients' family members.

5. CONCLUSION

According to the results of this study, increasing the duration of family members' presence can improve the sleep quality and quantity of ACS patients. Therefore, it is suggested to facilitate longer presence of family members and relatives at the patient's bedside to improve the sleep status of these patients in the CCU.

AUTHOR CONTRIBUTIONS

All authors discussed the study design. HB, FN and SR wrote the first draft of this article. SG, AM and MM analysed and interpreted the study data. AM, HE and MM edited this article.

CONFLICT OF INTEREST STATEMENT

No conflict of interest is declared by the authors.

FUNDING INFORMATION

This research received no external funding.

ETHICS STATEMENT

This study was approved by the Shahroud University of Medical Sciences (approval number IR.SHMU.REC.1396.201). Informed consent was obtained from all participants in the study.

REGISTRATION NUMBER

Iranian Registry of Clinical Trials (IRCT20100114003064N11).

Bagheri, H. , Norouzi, F. , Maleki, M. , Rezaie, S. , Goli, S. , Ebrahimi, H. , & Mardani, A. (2024). The effect of increasing duration of family members' presence on sleep status in patients with acute coronary syndrome in cardiac care unit: A randomized controlled trial. Nursing Open, 11, e2114. 10.1002/nop2.2114

DATA AVAILABILITY STATEMENT

The data sets used for this study are available from the corresponding author on reasonable request.