This is a randomized controlled trial that was performed in 2021 in Alzahra and Khorshid hospitals affiliated to Isfahan University of Medical Sciences. The current study was conducted on HCWs who suffer from acute insomnia. The study protocol was approved by the Research Committee of Isfahan University of Medical Sciences and the Ethics committee has confirmed it (Ethics code: IR.MUI.MED.REC.1399.1153, Iranian Registry for Clinical Trials (IRCT) code: IRCT20171219037964N4). The declaration of Helsinki was followed in every step. We report the results following the Consolidated Standards for Reporting Trials (CONSORT).
The inclusion criteria were age over 18 years, HCWs in Alzahra and Khorshid hospitals, having Insomnia Severity Index (ISI) score of 8 or higher and signing the written informed consent to participate in this study. The exclusion criteria were having any previous history of heart disease, seizure, bipolar disorders, narcolepsy, and other sleep disturbance disorders, or desire to start physical activity in the following months, or undergoing treatment with antiarrhythmic or beta-adrenergic blockade medications.
Considering a significance level of 0.05, an 80% power, and an insomnia severity index of 9.6 ± 4.99 for the intervention group and 12.56 ± 3.51 for the control group, the sample size was calculated as 31 per group [12].
An advertisement was published online in Alzahra and Khorshid hospitals' online channels, inviting HCWs who suffer from acute insomnia to participate in this study. After describing the study for those who enrolled, participants were recruited baed on the mentioned criteria.
Participants were randomly allocated into two groups of intervention and control using a simple randomization method (ratio, 1:1). A random sequence was produced using "randomization.com", available to the research assistant. Each person was given a unique code. The research assistant placed the person in the relevant groups by matching the person's code with the random sequence. The person in charge of follow-up and the one in charge of data analysis were unaware of the study groups.
Data on demographic variables including age, sex (male/ female), job (nurse/ physician or medical student/ other healthcare workers), education (diploma and less/higher education), having any comorbidities (yes/no), and using any medication (yes/ no) were gathered at the beginning of the study.
Participants in the intervention group were asked to complete a sleep diary sheet considering their sleep patterns in the previous two weeks. Then they were divided into groups of 2–3 to receive the one-shot CBT-I session. In the CBT-I session, the therapist evaluated the diaries, took a brief history, then explained the stimulus control and some cognitions about insomnia and maladaptive behaviors that may convert acute insomnia into chronic type. Sleep restriction strategy is applied, and some pamphlets that included information about insomnia and its treatment were given to them. No interventions were performed for the participants in the control group. Primary outcomes, including insomnia state and HRV, were evaluated before and one month after the intervention.
Insomnia state: The Iranian version of ISI was used to measure insomnia [19]. The ISI is a self-assessment scale designed by Morin et al. [20]. This scale consists of seven questions in a Likert scale (0: not at all, 5: all the time). The total score varies from zero to 28 and is divided into four categories; 0–7: no insomnia, 8–14: mild insomnia, 15–21: Moderate, and 22–28: severe insomnia.
HRV: During polysomnography (PSG), continuous raw ECG data were derived from a modified Lead-II configuration. ECG data from the PSG device were taken after 30 min of sitting in a relaxed situation. During recording the participant were lying down in a silent room. We recorded for 5 min and then the data were exported in European Data Format (EDF) format and was analyzed with MATLAB software that was capable of analyzing HRV for HRV analysis (Fig. 2) [21].
As recommended by the Task Force of the European Society of Cardiology and the North American Society of Pacing and Electrophysiology [20], 5-min HRV epochs were analyzed to obtain Power spectral estimates included low-frequency (LF) HRV (0.04–0.15 Hz) in ms2, normalized unit (NU), high-frequency (HF) power band (0.15–0.40 Hz) in ms2, NU, and the ratio of low frequency to high frequency (LF/HF ratio).
Data analysis:
Data were analyzed using SPSS version 22 (SPSS Inc., Chicago, IL, USA). Mean, and Standard deviation (SD) were used to describe continuous variables. Frequency was used to describe categorical variables. The Chi-square test was used to compare qualitative variables between two groups. The Mann-Whitney test was used to compare quantitative variables between two groups and before and after the intervention. The level of significance was set at 0.05.