Prevalence and associated factors of obsessive compulsive symptoms among under graduate medical and health science students in Dilla university, Ethiopia: a cross-sectional study

Abstract

Background

Obsessive-Compulsive Disorder (OCD) is a debilitating mental health condition characterized by recurrent, intrusive thoughts and repetitive behaviors that significantly disrupt daily life. Medical students may be uniquely susceptible to obsessive compulsive symptoms due to their constant exposure to potential contaminants and infectious diseases during their training. Obsessive Compulsive symptoms among medical students are often overlooked, which can significantly impact their academic performance, well-being, and future career prospects. The prevalence and factors of obsessive compulsive symptom is not widely studied in low and middle income countries and there are limited studies in Ethiopia. Therefore, this study aimed to assess the prevalence and associated factors of obsessive compulsive symptoms among medical students.

Methods

This was a cross-sectional study conducted among 370 students. The outcome variable was assessed using the Obsessive-Compulsive Inventory-Revised scale (OCI-R). The collected data were entered using kobo collect tool box version 1.3 and analyzed using SPSS version 25. Bivariable and multivariable logistic analysis was conducted to identify factors associated with Obsessive Compulsive symptoms and variables with P-values less than 0.05 were considered to have significant association with 95% confidence interval.

Result

The probable prevalence of obsessive-compulsive disorder among medical and health science students was 28% with (95% CI: 26.4–32.7). Being female [AOR = 1.33(95%CI: 1.09, 2.18)], Depressive symptoms [AOR = 2.12(95%CI: 1.95, 4.06)], Maladaptive coping mechanism [AOR = 1.74 (95%CI: 1.23, 2.50)], and Poor sleep quality [(AOR = 1.48(95%CI: 1.08, 2.24)] were significantly associated with obsessive compulsive symptoms.

Conclusion

Obsessive Compulsive Symptom has a high probable prevalence among medical and health science students. Being female, experiencing depressive symptoms, employing maladaptive coping mechanisms, and having poor sleep quality were significantly associated with obsessive-compulsive disorder. Therefore, early detection, screening, and appropriate intervention for obsessive-compulsive symptoms in medical students are crucial.

Supplementary Information

The online version contains supplementary material available at 10.1186/s12888-025-06833-0.

Introduction

Obsessive-compulsive disorder (OCD) is a mental health condition characterized by recurrent, and intrusive thought (obsessions) that induce individuals to engage in repetitive behaviors or compulsions [1]. The most prevalent obsessions include fear of contamination, fears of aggression or harm, sexual fears, religious fears, and perfectionism, often leading to compulsion such as washing and cleaning, checking, repeating actions, and organizing and arranging objects [1, 2]. Obsessive compulsive symptom (OCS) which affects 2.5–3.0% of the general population and which associated with a health and economic burden [3]. The World Health Organization ranks OCS one of the top 20 most debilitating illnesses and If untreated, it can become chronic condition [4]. Globally, obsessive compulsive disorder is the fourth most common mental disorder, following depression, alcohol/substance misuse, and social phobia with a lifetime prevalence of 2.3% ranging from 1.1 to 3.3% [5]. The prevalence of OCS among medical students varies, in western countries ranges from 3.8 to 35.7% [6, 7] and in African countries, ranges from 13.3 to 43.1% [8].

Medical students are vulnerable to mental health challenges due to the high stress and prolonged nature of their clinical training, which can negatively impact academic performance and overall well-being [9]. Medical training significantly impacts the mental health of learners, often leading to psychological distress [10]. Obsessive compulsive disorder is relatively common among clinical medical students, exacerbating the psychological distress they experience during their education their training [11]. Obsessive Compulsive symptoms is often comorbid with psychiatric disorders, such as anxiety disorder, post-traumatic stress disorder, depression, substance use, eating disorder and learning disorders [12, 13]. Obsessive Compulsive Disorder also often linked to perfectionism which increases the risk of suicidal thoughts and behaviors among students. It impairs social functioning, personal well-being, quality of life and straining relationships with family and loved ones [8, 14], and it can also significantly impair daily functioning and poor quality of life [7, 13].

Studies from various countries reported high prevalence rates of obsessive-compulsive symptoms among medical and health science students, including in Nigeria 32.1% [11], Saudi Arabia 36.2% and 20% [15], Iraq 43% [16], Iran 32.4% [17], and in Brazil 3.8% [7]. Factors associated with OCS include sex, young age, single marital status, physical and sexual abuse, family history of mental illness; poor sleep quality, dry and cold environment conditions, psychosocial distress and poor social support [18–26]. Gender differences in OCS presentation are well-documented, studies suggesting that women more likely to exhibit contamination-related obsessions and cleaning compulsions [27]. Hormonal fluctuations such as estrogen and progesterone contribute to the onset and exacerbation of OCS [28]. Women with OCS are more likely to experience comorbid conditions like depression and anxiety, which can impact the presentation and course of the disorder [29]. Medical students, working in high-pressure environments, are prone to maladaptive coping mechanisms such as avoidance, rumination, and thought suppression, which can worsen OCS by reinforcing the cycle of obsessions and compulsions [10]. The challenging of medical school environment, characterized by high academic expectations and stress, can further increase the risk of developing OCS. Factors such as obsessive concerns about cleanliness, dissatisfaction with social interactions, and feelings of loneliness or lack of social support may also contribute to the emergence of OCS [30].

Obsessive compulsive symptoms had a negative impact on the academic performance of medical students [7, 11]. Despite the global prevalence and impact of OCS, there is a lack of data from low-income countries like Ethiopia, which has diverse ethnic and socio-cultural characteristics. To the best of our knowledge, there is no published study like OCS among undergraduate medical students in Ethiopia. Therefore, this study aimed to determine the prevalence and potential associated factors of OCS among undergraduate medical students at Dilla University.

Methods and materials

Study design, setting and periods

This was a cross-sectional study conducted at Dilla University in the Gedeo zone of the Southern region of Ethiopia. Dilla city administration is located 365 km away from the capital city, Addis Ababa. The university comprises four colleges: college of natural science and computational science, College of engineering and computer science, College of medicine and health sciences, and College of social and humanities sciences. The study was conducted from October to November 2024. Data were collected from college of medicine and health sciences.

Sampling technique and procedure

The sample size was calculated using single population proportion formula n = The sample size was calculated using single population proportion formula n = (Zα/₂)²* P (1-P)/d² with margin of error (5%), 95% confidence interval, considering the prevalence of OCS among medical students in Nigeria, P = 32.1% [11], by adding 10% non-response rate the final sample size was = 370.

Dilla University Teaching Hospital, which encompasses eight departments: Environmental Health, Medical Laboratory Science, Pharmacy, Public Health, Anesthesia, Medicine, Midwifery, Nursing, and Psychiatry. Data was collected from approximately 1036 undergraduate students across the first five years of their studies. The student numbers by year were: 275 (first year), 218 (second year), 199 (third year), 188 (fourth year), and 157 (fifth year). A systematic random sampling technique was used with a sampling interval of 3. This interval was calculated by dividing the total study population /Students (n = 1036) to the sample size (N = 370). The calculated sampling interval was 2.8. Based on this, participants were selected by including every 3 students from the sampling frame until the total sample size allocated for each year of student was reached. (Fig. 1)

Fig. 1.

Showing sampling technique and procedure for Prevalence and Associated factors of Obsessive Compulsive Symptoms among Under Graduate Medical and Health Science Students in Dilla University, Ethiopia

Data quality control

The questionnaire was initially prepared in English and then translated into local Amharic language. A back translation to English was conducted to ensure linguistic consistency. We also sought expert opinions from psychiatric professionals with several years of clinical experience in mental health and fluency in both English and Amharic. These experts contextualized the descriptions to align with the cultural norms and practices of the local population in the data collection area. To assess the clarity and suitability of the survey questions, we performed pre-test 5% (n = 18) students prior to the study from another colleges near the study area. Subsequently, minor modifications were made to the wording of some questions and their response options to enhance the clarity and applicability of the questionnaire. A two-day training session was conducted, focusing on the study’s objectives and the data collection process, before the participants began their activities and five trained psychiatric nurses facilitated the data. The Completeness and consistency of the collected data were verified daily.

Obsessive compulsive symptoms

In this study we used the Obsessive-Compulsive Inventory-Revised scale (OCI-R) to measure the outcome variables such as Obsessive Compulsive disorder symptoms [31]. The Obsessive-Compulsive Scale (OCS) is a self-reported questionnaire used to assess OCS. It consists of 18 questions rated on a 5-point Likert scale, with a total score range of 0–72. A score of 21 or higher suggests the presence of OCS, with a mean score of 28 for individuals with OCS [31]. This instrument has demonstrated satisfactory psychometric properties in the Nigerian population [32] and will be used to evaluate the type and severity of OCS. The Internal consistency:α = 0.81–0.88 [33, 34] and the reliability: r = 0.70–0.84 [33, 34]. In our study the Cronbach’s alpha coefficient for the OCI-R test was 0.73.

Depressive symptoms were assessed using the Beck Depression Inventory (BDI) [35]. The BDI consists of 21 self-report items, each rated on a 4-point Likert scale and scored from 0 to 3 (maximum score 63). A score of 18 or 19 is commonly used as individuals having major depressive disorder. In our study the Cronbach’s alpha coefficient for the BDI test was 0.752.

Social support

The Oslo Social Support Scale (OSSS-3) was used to assess social support. Scores ranged from 3 to 14, with 3–8 indicating poor support, 9–11 indicating moderate support, and 12–14 indicating great support. The OSSS-3 is a cost-effective and reliable scale with a Cronbach’s alpha of 0.64, indicating good internal consistency [36]. In our study the Cronbach’s alpha coefficient for the OSSS-3 test was 0.802.

Psychological distress

The Kessler Psychological Distress Scale (K-10) was used to assess psychological distress through 10 questions about emotional well-being, each with a five-point response. Scores on the K-10 categorize individuals into four groups: 10–19 suggests well-being, 20–24 indicates mild distress, 25–29 signifies moderate distress, and 30–50 predicts severe distress. This scale has a sensitivity of 70% and a specificity of 67% [37]. In our study the Cronbach’s alpha coefficient for the K-10 was 0.708.

Coping strategies was measured using Brief COPE Scale [38], The Brief COPE Scale is 28-item scale measures the extent to which individuals use various coping mechanisms in response to stress. This items are rated on a 4-point Likert scale and can be categorized into “adaptive” and “maladaptive” coping strategies based on principal components analysis [39]. Respondents rated items using a 4-point Likert scale, where 1 represents ‘I haven’t been doing this at all’ and 4 represents ‘I’ve been doing this a lot. In this study the Cronbach’s alpha coefficient for the Brief-COPE-28 test was 0.783.

Sleep Quality was measured using Pittsburgh Sleep Quality Index (PSQI): PSQI is a self-report measure comprising 19 items was used to assess sleep quality over the past month. The sensitivity and specificity of the PSQI were 82% and 56.2% respectively. The component score range from 0 to 3 and are combined to generate a global PSQI score, ranging from 0 to 21. Higher scores indicate a higher level of overall sleep disturbances. A global PSQI score equal to or exceeding 5 is indicative of poor sleep quality [40]. In this study Cronbach’s alpha coefficient for the PSQI test was 0.674.

Operation definition

Obsessive compulsive symptoms

Students who were found to score ≥ 21 on the Obsessive-Compulsive Inventory-Revised scale (OCI-R were considered to have Obsessive Compulsive symptoms [31].

Depressive symptoms were assessed using the Beck Depression Inventory (BDI) and students who were found to score ≥ 18 on the BDI were considered to have depressive symptoms [35].

Social support assessed using the Oslo Social Support Scale (OSSS-3) and was categorized poor social support ranges from 3 to 8,, moderate social support 9–11,and strong social support 12–14 [36].

Psychological distress

measured using the Kessler Psychological Distress Scale (K-10) and categorize well-being range from 10 to 19, mild distress 20–24, moderate distress 25–29, and severe distress 30–50 [37].

Data processing and analyses

The collected data were entered using Epi-Data version 3.1 and then exported to SPSS version 25, cleaned, coded and analyzed. Descriptive statistics, including frequency tables, percentages, and counts, were used to summarize the characteristics of the study participants and to illustrate the distribution of variables.

Bi-variable and multivariable analyses were performed to identify factors significantly associated with the outcomes variable (Obsessive compulsive disorder). In the Bi-variable analysis, variables with p-values less than 0.25 were considered for candidates for inclusion in the multivariable analysis to control potential confounding factors. In the final model, all the candidate variable were enter together and variables with p-values less than 0.05 were considered to have a statistically significant association, with a 95% confidence interval. We computed different models for outcome variables and potential associations between these outcomes were examined. The strength of these associations was assessed by using an adjusted odds ratio.

Result

Socio-demographic characteristics of students

In this study, a total of 370 students were participated and the response rate was100%. The mean age of the students was 23 ± 2.55 years, ranging from 19 to 35 years. More than half (54.9%) of students were females. The majority of students (92.4%) were single in marital status. (Table 1)

Table 1.

Socio-demographic characteristics of students at Dilla University, medical and health science college (n = 370)

Variables	Category	Frequency	Percentage
Gender	Female	203	54.9
	Male	167	45.1
Age	≤ 23	140	37.8
	> 23	230	62.2
Marital status	Married	28	7.6
	Single	342	92.4
Resident	Rural	194	52.4
	urban	176	47.6
Department	Environmental	36	9.7
	Medical laboratory	57	15.4
	pharmacy	36	9.7
	public health	30	8.1
	Anesthesia	38	10.3
	Medicine	85	23.0
	Midwifery	32	8.6
	Nurse	45	12.2
	Psychiatry	51	13.8
Year of students	First year	98	26.5
	Second year	78	21.1
	Third year	71	19.2
	Fourth years	67	18.1
	Fifth years	56	15.1

Psychosocial and clinical related characteristic of students

Regarding to psychological distress more than half (58.6%) of students experienced moderate psychological distress. About 38.6% of students had depressive symptoms. Nearly half (48.9%) of students had poor social support. More than two third (66.2%) of students had Poor sleep quality. The majority (61.9%) of students had adaptive stress coping mechanism. About 56 (15.1%) of students experienced drinking alcohol, about 6.5% of students had family history of mental illness (Table 2).

Table 2.

Psychosocial distress and clinical related characteristic of students at Dilla university, medical and health science collage (n = 370)

Variable	Category	Frequency	Percentage
Psychological distress	well being	19	5.1
	mild	104	28.1
	Moderate	217	58.6
	Sever	30	8.1
Depressive symptoms	Yes	143	38.6
	No	227	61.4
Social support	Poor social support	181	48.9
	moderate social support	144	38.9
	Strong social support	45	12.2
Sleep quality	Poor	245	66.2
	Good	125	33.8
Coping mechanism	adaptive	229	61.9
	maladaptive	141	38.1
	Yes	71	19.2
	No	299	80.8
Types of substance	Alcohol	56	15.1
	Khat	27	7.3
	Other	19	5.1
Presence of family history of mental illness	Yes	24	6.5
	No	346	93.5
Family history of Obsessive compulsive disorder	Yes	34	9.2
	No	336	90.8
History of past mental illness	Yes	12	3.2
	No	358	96.8
Presence of chronic medical illness	Yes	21	5.7
	No	349	94.3

Environmental related factors of students

In this study, more than half (62.7%) of students were affected by a change in their living environment. About 86 (23.2%) of students were affected by a lack of technology use. Nearly four out of five students (79.5%) were negatively impacted by the absence of a calm and quiet environment on campus. More than half (69.5%) of students negatively impacted by Dry and cold environment conditions (Table 3).

Table 3.

Environmental related characteristic of students at Dilla university, medical and health science collage (n = 370)

Variables	Category	Frequency	Percentage
Change in living environment	Yes	232	62.7
	No	138	37.3
Dry and cold environment conditions	Yes	257	69.5
	No	113	30.5
Lack of use of technology for recreation	Yes	86	23.2
	No	284	76.8
Absence of calm and quit environments around the campus	Yes	22	5.9
	No	348	94.1
Inadequate water supply	No	315	85.1
	Yes	55	14.9

The probable prevalence of obsessive compulsive disorder among medical and health science students

In this study, the probable prevalence of obsessive-compulsive disorder among medical and health science students was 28.4% with (95% CI: 26.4–32.7).

Factor associated with obsessive compulsive disorder among medical and health science students

For students, Age ≤ 23 Years, Female, Depressive symptoms, Poor social support, Poor sleep quality, and maladaptive coping mechanism had significantly associations with obsessive compulsive disorder (Table 4).

Table 4.

Bivariable and multivariable regression analysis of factors associated with obsessive compulsive disorder among medical and health science students (n = 370)

Variable	Category	Obsessive Compulsive Disorder		COR(95%CI)	AOR(95%CI)
		Yes	No
Age in year	≤ 23	112	128	1.48(1.01,2.16)	1.27(0.85–2.04)
	> 23	78	132	1	1
Gender	Female	107	96	1.54(1.02–2.33)	1.33(1.09,2.18)**
	Male	70	97	1	1
Social support	Poor social support	94	79	1.96( 1.01,3.84)	1.42( 0.88–3.44)
	moderate social support	60	94	1.037(0.514,2.093)	0.721(0.575,1.869)
	Strong social support	17	28	1	1
Depressive symptoms	Yes	75	68	2.81(1.81,4.35)	2.12(1.95,4.06)**
	No	64	163	1	1
Sleep quality	Poor	138	107	1.56(1.01,2.41)	1.48(1.08,2.24)***
	Good	57	69	1	1
Psychological factor	well being	15	4	1	1
	mild	60	44	2.750(0.854–8.856)	2.253(0.689–7.370)
	Moderate	120	97	3.031(0.974–9.430)	2.464(0.780–7.790)
	Sever	15	15	3.750(1.007–13.965)	3.185(0.835–12.151)
Personal history	No	203	7	1	1
	Yes	159	1	0.182(0.022–1.498)	0.230(0.027–1.970)
Coping mechanism	Maladaptive	142	87	1.75(1.15,2.68)	1.74(1.23,2.50)***
	Adaptive	68	73	1	1
Changing living environment	Yes	134	98	1.53(1.01–2.34)	1.41(0.98,2.18)
	No	66	74	1	1

AOR; Adjusted odds ratio COR; crude odds ratio, CI; confidence interval

Discussion

In the present study the probable prevalence of obsessive compulsive disorder was 28.4%. This finding was similar with studies done in Nigeria 32.1% [11], Iran 32.4% [17].

However, This finding is higher than the prevalence of OCD among medical students reported in previous studies conducted from India 8.5% [12], Saudi Arabia 26% [41] and 20% [15],Brazil 3.8% [7], Turkish 4.2% [42], and US 5.2% [43]. The possible discrepancy may be due to the use of different screening tools. The previous study conducted in the US and Turk, employed the Leyton Obsessional Inventory [43] and Turkish and India used Composite International Diagnostic Interview (CIDI, Section K) [12, 42]. The other variation might be socioeconomic statues and infrastructures.

In contrast, this finding is lower than those reported in studies conducted in Saudi Arabia 36.2% [15], and 61.6% [44], Iraq 43% [16], India 34.7% [45], and America 35.7% [13]. The discrepancy may be due to the use of different screening tools. A previous study conducted in Iraq during the COVID-19 pandemic suggested a potential link between the pandemic and increased levels of Obsessive-Compulsive Disorder (OCD) among medical students, specifically related to fears and stress concerning contamination [46]. Another variation in Iraq might be due to a difference in sample size. The previous study used a large sample size of 1644 medical students.

The discrepancy in obsessive compulsive disorder studies may be due to difference in sampling size, methodology, and population characteristics, such as (Taibah University and Nigerian medical students use obsessional compulsive inventory- Revised (OCI-R) to measure). On the contrary, the result of this study is lower than the study conducted in Pakistan (46%) [21], this may be due to the covid outbreak, variation in study populations and sampling size.

The second aim of this study was to identify factors associated with obsessive compulsive disorder of medical students. According to this finding female medical students are 1.33 times more likely to develop obsessive-compulsive disorder than male medical students. The finding is consistent with the study conducted in India [45], Saudi Arabia [15]. This potential disparity may be female medical students are more susceptible to anxiety and depression, conditions often linked to OCD [47]. Young women are typically two to three times more likely to experience anxiety disorders than young men. Hormonal fluctuations, the pressure to achieve perfectionism in medical school, and differences in stress response may increase the vulnerability of medical students to OCD.

Students had maladaptive coping mechanism are 1.74 times more likely to develop obsessive-compulsive disorder (OCD) compared to those have adaptive copy mechanism.The finding is consistent with the study conducted in Brazil [7], Previous research in Spanish has shown that maladaptive coping strategies are associated with the maintenance and exacerbation of OCD symptoms [48]. Maladaptive coping strategies, including substance abuse, avoidance, aggression, and excessive worrying, rumination, and emotional suppression, can significantly contribute to the development and persistence of Obsessive Compulsive Disorder (OCD). These unhealthy strategies for managing stress and anxiety can intensify underlying anxieties, leading to an increase in intrusive thoughts and compulsive behaviors. Excessive worrying can amplify obsessive thoughts, while avoidance can strengthen compulsive rituals as individuals try to prevent perceived threats. By hindering effective emotion regulation and increasing overall distress, these maladaptive coping mechanisms create a cycle that perpetuates OCD symptoms. Students experiencing Depressive symptoms are 2.12 times more likely to develop obsessive-compulsive disorder (OCD) compared to those have not depressive symptoms. The finding is consistent with the study conducted in Brazil [7], Saudi Arabia [15]. The report of previous studies indicated that the elevated rates of depression and stress observed during the COVID-19 pandemic [49, 50] may have contributed to an increased prevalence of OCD. Clinical [51, 52] and epidemiological [53, 54] research consistently identifies depressive disorder as the most frequent co-occurring condition with OCD, this association was anticipated. Both disorders share clinical and cognitive features, such as excessive guilt, indecisiveness, obsessions, distorted risk perception, and an exaggerated sense of personal responsibility. Individuals experiencing depressive symptoms tended to exhibit higher levels of cognitive distortions, such as impaired insight, reduced perceived control, lower self-competence, and a heightened focus on negative consequences [55]. Students had poor sleep quality are 1.628 times more likely to had obsessive compulsive disorder compared to good sleep quality. This study consistent with the study conducted in OCD patients [56]. Poor sleep quality may play a crucial role in the development and maintenance of OCD in medical students. Disrupted sleep can intensify obsessive thoughts and compulsive behaviors, leading to increased psychological distress.

Conclusion and recommendation

These findings indicate a high probable prevalence of obsessive-compulsive disorder among medical and health science students, exacerbating academic challenges. Obsessive compulsive disorder was significantly associated with female gender, depressive symptoms, poor sleep quality, and maladaptive coping strategies. Therefore, early detection, screening, and appropriate intervention for Obsessive-Compulsive Spectrum Disorders in medical students are crucial. Providing appropriate psychosocial support for affected students is essential, which includes addressing depressive symptoms, improving sleep quality, and developing healthy coping strategies. Further longitudinal research is crucial to deepen our understanding of the interplay between OCD and academic performance.

Limitation

This cross-sectional study can only establish associations between variables, not cause-and-effect relationships. We used the OCI-R screening scale is based on DSM-IV criteria for Obsessive-Compulsive Disorder (OCD), DSM-IV criteria were used for diagnosis instead of the more recent DSM-5 criteria. A comparison group of non-medical college students was not included in the study. This study only used self-reported standard methods to assess probable prevalence of OCD; it did not take into account clinical interviews, which may be one of its limitations.

Electronic supplementary material

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Abbreviations

CIDI

Composite International Diagnostic Interview

DSM

Diagnostic and Statistical Manual of Mental Disorder

ECA

Epidemiology Catchment Area

GHQ-12

General Health Questionnaire

OCD

Obsessive Compulsive Disorder

OCPD

Obsessive-Compulsive Personality Disorder

WHO

World Health Organization

Y-BOCS

Yale-Brown Obsessive Compulsive Scale

Author contributions

DM and ME: organized the original investigation; coordinated the collection of data; analysis, writing report and drafted the manuscript and revision of the Manuscript. AA, and MN equally contributed to the design of the study, performed the statistical analyses contributed to the statistical analyses. All the authors read and approved the final manuscript. BA: Draft a manuscript, coordinated the collection of data; analysis, writing final report.

Funding

No specific fund was secured for this study.

Data availability

All data generated or analyzed during this study are included in this published article. The data sets of the current study is available from Derebe Madoro email: derebemd@gmail.com; Mobile: +251910895760, Dilla university, Dilla upon reasonable request.

Declarations

Ethics approval and consent to participation

Ethics approval was obtained from Institutional Review Board (IRB) of Dilla University College of Health Sciences and medicine. After the purpose and objectives of the study had been informed, oral and written consent was obtained from each study participant before the start of the data collection. To maintain the anonymity and confidentiality of information, similar data collection procedure was in place. And all necessary methods were carried out in accordance with the guidelines of institutional and Declaration of Helsinki.

Consent for publication

N/A.

Competing interests

The authors declare no competing interests.

Clinical trial number

Not applicable.