The effect of continuous care model-based intervention on the quality of sleep in menopausal women: A clinical trial study

BACKGROUND Sleep disorder, brings in many physical, behavioral, and mental problems. Applying continuous care model leads to proper recognition of the patient’s problems and involves the patient in solving health problems. This study aimed to determine the effect of continuous care model on the quality of sleep in menopausal women. METHODS AND MATERIALS A random clinical trial study was carried out with participation of 110 menopausal women visiting Kermanshah-based clinics (the west of Iran) in 2017. The participants were randomly assigned to intervention (n=55) and control (n=55) groups. The control group received the routine cares and in addition to the routine cares the intervention group attended four weekly group consultation sessions (60-90min). The quality of sleep in the two groups was assessed using Pittsburg Sleep Quality Index before, immediately after, and one month after the intervention. Data analyses were done using independent t-test, ANOVA with frequent measures, Friedman’s test, Wilcoxon’s post hoc test, and X2 test in SPSS (24). RESULTS The mean scores of quality of sleep before and after the intervention were significantly different in the intervention group (p=0.001). There was no significant difference between the two groups in terms of quality of sleep before (p=0.140) and immediately after the intervention (p=0.168). However, one month after, the difference between the two groups was significant (P<0.001). CONCLUSION Implementation of the continuous care model led to an improvement of quality of sleep in the menopausal women.

women's health include vasomotor symptoms, vaginal urine atrophy (urogenital) osteoporosis, cardiovascular diseases, cancer, decrease in cognitive function, and sexual problems (4). Among these symptoms, sleep problem is one of the main challenges (5). Sleeping is a physiological need that is good for health and accelerates recovery from diseases (6). Sleeping has a critical role in the cardiovascular function (7) so that the risk of cardiac ischemic attacks is higher in individual with low quality of sleep. In addition, there is a relationship between insomnia and cardiac ischemic diseases (8). Sleep refreshes mental, spiritual, and physical energy so that it is renowned as one of the most vital needs of man (9). Along with cognitive problems, sleep deprivation negatively affects the physiological systems (including immunity system), which in return affects the whole physical health.
There are also evidences that sleep deprivation attenuates glucose level, increases sympathetic neural system activity, and increases cortisol. Thus, sleep deprivation might be effective in development of disorders like diabetes, blood pressure, and obesity (10). Quality and quantity of sleep affects individual's quality of life not to mention disorders or mental and social functions and inter-personal interactions (11). According to the national sleep foundation (NSF) the sleep disorder that happens during menopausal period does not necessarily influence the quantity of sleep, and the problem may appear as poor quality sleep (6). One way to improve quality of life is to provide education to individuals through proper educational models and theories. A model was designed in Iran by Ahmadi in 2001. It is consisted of four stages of introduction, creating sensitivity, control, and assessment. The care-seeker in this model acts as the agent of continuous and effective care (12).
Continuous care in the model is a regular process to create an effective and continuous interaction between the care-seeker (as the agent of continuous care) and nurse or midwife (as the provider of health care services). The process tries to recognize the needs and problems and creates sensitivity in the care-seekers to accept and continue healthy behaviors and improve their health in a continuous process. Therefore, a key feature of this type of care is a continuous, dynamic, and effective care relationship that is perfectly matched with the specification of chronic diseases and dynamism of the problems caused by them. Nurse's expert intervention is emphasized in the model as a dynamic and continuous factor (13). Using the model enables the practitioners to recognize the patient's problems and motivate and involve the patient in solving the problem (14). Studies have supported the positive effect of the model on the quality of sleep of hemodialysis patients and blood pressure in diabetics (12-14). Using the model leads to proper recognition of the patient's problems, motivation, and involvement of the patient in solving the problem (14). In light of the above introduction, the present study is an attempt to determine the effect of interventions based on continuous care model on the quality of sleep of menopausal women visiting Kermanshah-based clinics.

Study setting and design:
A randomized clinical trial study was carried out on 110 menopausal women who visited Kermanshahbased clinics. The participants were randomly assigned to control (n = 55) and intervention (n = 55) groups ( Fig.1).
In this study, a simple randomization method was used to implement random allocation.
In this way, 110 cards matched in appearance were prepared. Fifty five of them were coded "1", which specifies the intervention group, and fifty five of them were coded "2", which specifies the control group. Then, each eligible entry person randomly selected one of these cards, thus the random allocation of patients to each group was determined without the participants being aware of the nature of the numbers 1 or 2.
Sampling was carried out from May 2017 to September 2017. Inclusion criteria were at least three and at most four years since the last menstrual cycle, no mental disease (based on medical file), no history of smoking, drinking, or drug abuse, no history of hormone therapy over the past six months, Pittsburg Sleep Quality Index (PSQI) score >5, no malignant disease (cancer, thyroid, epilepsy, diabetes) according to the attending physician's examinations, reading and writing literacy, and using no drug effective on sleep (Antihypertensive, benzodiazepines, antihistamines, etc.). Exclusion criteria were reluctance to participate, experiencing sad and traumatizing experiences, diagnosed with mental disorder, and missing more than one session In addition to the routine cares provided to menopausal women in the clinics, the intervention group (n = 55) attended four weekly group (n = 11) consultation sessions (60-90min). The control group only received the routine interventions. Immediately and one month after the last intervention sessions, the questionnaires were filled in by the participants. The content of the session and the steps of intervention are listed in Table 1.
To avoid observer bias, random allocation and assigned participants to intervention and control groups and the whole process of distributing and collecting the questionnaires was perform by a third person who had no role in the study.

Sampling techniques:
Following Mehdizadeh et al. (2010), and assuming δ1 = 5.12, µ1 = 15.31, δ2 = 5.3, µ2 = 11.86, α = 0.05, and β = 0.1(17), the sample size was estimated to be 48. Taking into account probable leaves, 55 participants were selected for each group. Initially, in order to select the clinics, the geography of Kermanshah city was divided into 4 geographic categories according to the socio-economic status, which includes 20 clinics. Then a clinic was randomly selected from each region and the required number of samples based on the quotas of each clinic were selected by the convenient sampling.
Finally the participants were randomly assigned to control (n = 55) and intervention (n = 55) groups. .

Data collection:
Data gathering tools were a demographics form and PSQI. The latter is featured with 90% sensitivity, and specificity of 87%. Several studies have supported validity and reliability of the questionnaire for a wide spectrum of patients and healthy individuals (15).

Data analysis:
Data analyses were performed in SPSS (24) using descriptive statistics (frequency, mean, SD) and analytical tests (independent t-test, ANOVA with multiple measures, Friedman's test, Wilcoxon Post Hoc Test, and X 2 test). (P<0.05).

Ethics:
In observance of ethical concerns, the participants were briefed on the objectives of study and signed an informed letter of consent. The time and place of consultation sessions were determined by the participants and they were ensured about confidentiality of their information. Participation was voluntarily and they could leave the study at any stage.

Results
Married participants constituted 90% of the sample group and education level of 81% of the participants was lower than high school diploma. In addition, 98% of the participants were living in city and 91% had a monthly income of 1-3 million Tomans. In general, 68% of the women had three or four children and 91% had one or two married kids. Moreover, 11% of the participants had a history of using medicines and 48% had a normal body mass index (BMI). There was one drug addict in family of 2% of the participants. There was no significant differences between the two groups in terms of demographical information ( Table 2).
The mean and standard deviation of sleep quality score and the subscales before, immediately after, and one month after the intervention for the intervention and control groups are listed in Table 3  As the results showed, before and one month after the intervention, a significant difference appeared between the two groups in terms of the mean score of the subscales mental quality of sleep, delay in falling asleep, effectiveness of sleep, and disorder in performing daily activities, and the scale quality of sleep. However, the intervention was not effective on subscales length of sleep, sleep disorders, and using sleep medicines.
Golafroz (2012), found a significant difference between intervention and control group in terms of the mean score of quality of sleep in the subscales mental quality of sleep, length of useful sleep, delay in falling asleep, and disorder in performing daily functions. However, the difference between the two groups in terms of using sleep medicine after the intervention was not significant (19). Mahdizadeh

Consent for publication
Not applicable.

Availability of data and materials
The datasets used and/or analyzed during the current study are available from the corresponding author on reasonable request.

Competing interests
The authors declare that they have no competing interests     Figure 1 The chart of the study protocol

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