Anxiety, depression, stress and fear of COVID-19 in non-syndromic oral cleft children' parents and caregivers

doi:10.21203/rs.3.rs-2502382/v1

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Research Article

Anxiety, depression, stress and fear of COVID-19 in non-syndromic oral cleft children' parents and caregivers

https://doi.org/10.21203/rs.3.rs-2502382/v1

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Objectives

to assess the levels of anxiety, depression, stress and fear of COVID-19 in non-syndromic cleft lip and/or palate (NSCL/P) children parents and caregivers.

Materials and Methods

Cross-sectional case-control study conducted at a Craniofacial Anomalies Rehabilitation Center, Brazil. Non-probabilistic convenience sampling was used and data were collected between October 2021 and November 2022. Variables were assessed by Depression, Anxiety and Stress Scale (DASS-21) and Fear of COVID-19 Scale (FC-19S). Pearson's chi-square test and multivariate binary logistic regression model have been performed.

Results

Data were obtained of 80 NSCL/P parents group and 130 by control group. Severe symptoms were higher in NSCL/P parents indicated by rates (8.8% vs 69% to anxiety; 12.5% vs 8.5% to depression and 17.5% vs 10.0% to stress). As for the predilection in case group there was an association (p < 0.05) for manifestation of mild stress (OR: 4.09; _95%CI 1.28–13.06). Control group caregivers were more fear of COVID-19 (43.8% vs 28.7% p < 0.05).

Conclusion

There were no significant differences in anxiety, depression, and stress levels between groups. NSCL/P children parents and caregivers were less fear of COVID-19. There is a predilection for severe symptoms in the case group.

Clinical Relevance:

This is the first cross-sectional study analyzing fear of COVID-19 in NSCL/P children parents and caregivers. These people should receive greater attention by multiprofessional team due to the predisposition of illness in mental health.

Cleft lip

Cleft palate

Anxiety

Depression

Stress

Cleft lip and/or palate (CL/P) are congenital craniofacial anomalies most prevalent in the world. In 70% of the cases the CL/P are nonsyndromic (NSCL/P) [1, 2]. CL/P childrens, since of the birth, should been multiprofessional team follow-up. General health, aesthetic, nutrition, speech, audition and oral health problems, also psychosocial impacts, are the reasons for the health monitoring [3–5].

The CL/P children birth cause family impacts. Parents expectations is shattered and a specific routine for a CL/P children care its begin [3, 6]. Qualitative researchs show CL/P children parents after birth experienced feelings like distress, fear, mourning and guilt. These are harmful to mental health and that can persist throughout early childhood and into adulthood [7–9].

In the literature, there are few quantitative results that evaluated anxiety, depression and/or stress symptoms in NSCL/P children parents. Therefore, there are publications [10–17] with divergent results which may be caused by inconsistencies regarding the methods used and multiple non-standard instruments to assess these symptoms [10]. Furthermore, most of the studies [3–6, 11–13, 18–20] that evaluate CL/P children parents psychosocial impacts aren’t directed at the anxiety, depression and stress symptoms, but focusing on variables such as social support, quality of life, pre-surgical parental stress or resilience in have a CL/P children.

COVID-19 pandemic delayed care of NSCL/P patients, mainly due the cancel of elective surgeries [21]. Peru [22], United States [23], United Kingdom [24] and Brazil [25] carried out studies showed that there were significant changes in the protocols used, delay in surgical repairs, increased time for care, maintenance of aesthetic and functional problems and reduction in the number of rehabilitation procedures. Changes in CL/P children's care during the pandemic caused signs and symptoms in their parents' mental health [26, 27]. Moreover, provoked fear by COVID can be potential trigger of harm to the psychological health of the population, also a predictor in the adoption of preventive methods of contagion [28].

Thus, association between COVID-19’ fear and psychological impacts symptoms of NSCL/P childrens parents and caregivers are still not well understood. No studies were identified in Brazil and Latin America that evaluated the presence of anxiety, depression and stress symptoms in NSCL/P childrens parents. In addition, to date, there aren’t studies that applied the Fear of COVID-19 Scale (FC-19S) in parents and caregivers of NSCL/P childrens. Thus, the aim of this study was to assess the levels of anxiety, depression, stress and fear of COVID-19 in NSCL/P childrens parents and caregivers.

Study design and context

Quantitative, cross-sectional, case-control study was carried out. Due to the transpandemic period, non-probabilistic convenience sampling was chosen.

Study Participants

Case group was composed by parents and/or caregivers of NSCL/P childrens. Children were assisted by the Craniofacial Anomalies Rehabilitation Center, Dental School, Edson Antônio Vellano University (Minas Gerais state, Brazil). Eligibility criteria were: be a responsible caregiver of the NSCL/P children. Control group consisted of parents and/or caregivers of childrens without the CL/P presence, systemic alterations or any syndromic alteration. Control group was recruited at the Pediatric Dentistry Clinic of the same institution. In both groups, individuals under the age of 18 and over 60 was excluded.

Data Collection

Studied variables were measured by three questionnaires: sociodemographic profile, Depression, Anxiety and Stress Scale (DASS-21) and Fear of COVID-19 Scale (FC-19S). Data were collected between October 2021 and November 2022 by previously trained researchers.

Sociodemographic variables were: Sex, age, child's age, marital status, kinship to the child, monthly income and schooling.

DASS-21 [29] was used to measure and classify anxiety, depression and stress symptoms. Composition of the instrument is 21 questions. Values for the answer was in the Likert scale with the scores 0 to 3 (totally disagree to totally agree). From 21 questions, the 2, 4, 7, 9. 15. 19 and 20 questions was to anxiety construct. The depression construct was meassured by the questions 3, 5, 10, 13, 16, 17 e 21. Stress is assessed in the 1, 6, 8, 11, 12, 14 and 18 questions. Total score calculing must be by the pontuation sum of the seven items of each subscale, later multiplied by two.

Sum is interpreted: 1) normal: 0–7, 0–9 and 0–14, for anxiety, depression and stress, respectively; 2) mild: 8–9, 10–13 and 15–18, for anxiety, depression and stress, respectively; 3) moderate: 10–14, 14–20 and 19–25, for anxiety, depression and stress, respectively; 4) severe: 15–19, 21–27 and 26–33, for anxiety, depression and stress, respectively; 5) extremely severe: scores above 20, 28 and 34, for anxiety, depression and stress, respectively.

FC-19S is a validated instrument that presents psychometric properties robust and reliable for general population application [28, 30]. Questionnaire has seven likert-type answers questions (1 – strongly disagree to 5 – strongly agree). The composite score ranged from 7 to 35, with a higher score indicating greater fear of COVID-19. Regarding the classification of levels: mild (7 to 19 points); moderate (20 to 26 points) and severe (over 27 points) [31].

Data analysis

Obtained data were entered into the Excel Microsoft 2013 software and exported to the IBM Statistical Package for the Social Sciences (SPSS) 22.0® version to statistical analysis. Descriptive analyzes of absolute (n) and relative (%) frequency were performed for categorical variables. Mean and standard deviation (SD) analyzes were performed for continuous numeric variables. Bivariate analysis were performed using Pearson's chi-square test at two different times witch different dependent variables. Odds Ratio (OR) and Confidence Interval (CI_95%) also were calculed witch Pearson's chi-square test.

In the first moment, group (case/control) was selected as dependent variables. Sociodemographic variables was selected as independent variables. A multivariate binary logistic regression model using the forced-entry method was performed to test prediction symptoms between groups. In the forced-entry method all predictors variables was included in the same block with no hierarchy between them. Hosmer and Lemeshow test was used to test goodness of fit and accuracy of model (indicated by p > 0.05). Anxiety, depression and stress classifications were dichotomized (normal to moderate/severe to extremely severe) for bivariate analysis witch sociodemographic variables. In all analysis 5% was accepted as significance level (p ≤ 0.05).

Ethical Aspects

The study was approved by the Ethics and Research Committee (# 49246121.6.0000.5143). All participants signed an Informed Consent Form.

The final study sample consisted of 210 parents and caregivers, 80 (38.1%) from the case group and 130 (61.9%) from the control group. It was observed that the participants were predominantly female (90.0%), lived with a partner (65.2%) and studied at least high school (35.2%). Monthly income was 371.27 US$ (SD: 290.92 US$). Most caregivers were mothers (80.5%), fathers (8.6%) and other relatives (grandparents, uncles, stepfather or stepmother; 11.0%). Sociodemographic characteristics associations witch studied groups are in Table 1.

Table 1

–Bivariate analysis between groups (case/control) witch sample sociodemographic characteristics (n = 210), 2021–2022.
	Control	Case
Variable	N (%)	N (%)	OR (_95%CI)	P-value*
Sex
Male	9 (6.9)	12 (15.0)	1	0.058
Female	121 (93.1)	68 (85.0)	0.42 (0.16–1.05)
Age***	35.6 (9.5)	35.4 (8.7)	-	0.838
Marital status
No partner	52 (40.0)	21 (26.2)	1	0.042*
With partner	78 (60.0)	59 (73.8)	1.87 (1.01–3.44)
Years of study
Up to 8 years	68 (52.3)	41 (51.2)	1	0.882
More than 8 years	62 (47.7)	39 (48.8)	1.04 (0.59–1.82)
Monthly income
Up to minimum salary	64 (50.8)	25 (32.9)	1	0.045*
One to two salaries	34 (27.0)	27 (35.5)	1.57 (1.01–2.43)
More than two salaries	28 (22.2)	24 (31.6)	1.64 (1.05–2.56)
Kinship with the child
Other caregivers	20 (15.4)	3 (3.8)	1	0.009*
Father/Mother	110 (84.6)	77 (96.2)	4.66 (1.34–16.25)
Child’ age***	7.5 (2.2)	5.4 (5.7)	-	< 0.001**
* Pearson's chi-square test significant statistical association (p ≤ 0.05). Student t test significant statistical association. * In these variables, values were described witch mean and standard deviation values.

Anxiety, depression, stress and fear of COVID-19 levels are shown in Table 2. It is seen that even though there are no associations with anxiety, depression and stress levels, between the groups, case group had higher OR for severe form these symptoms. Being a caregiver for a child without NSCL/P was likely to have more fear of COVID-19.

Table 2

– Bivariate analysis by binary logistic regression between groups witch psychological characteristics (n = 210), 2021–2022.
	Control	Case
Variable	N (%)	N (%)	OR (_95%CI)	P-value*
Anxiety levels
Normal	65 (50.0)	44 (55.0)	1
Mild	2 (1.5)	3 (3.8)	2.21 (0.35–13.80)	0.394
Moderate	23 (17.7)	14 (17.5)	0.89 (0.41–1.93)	0.785
Severe	9 (6.9)	7 (8.8)	1.14 (0.39–3.31)	0.797
Extremely severe	31 (23.8)	12 (15.0)	0.57 (0.26–1.23)	0.154
Depression levels
Normal	62 (47.7)	40 (50.0)	1
Mild	14 (10.8)	6 (7.5)	0.66 (0.23–1.87)	0.438
Moderate	14 (10.8)	7 (8.8)	0.77 (0.28–2.08)	0.614
Severe	11 (8.5)	10 (12.5)	1.40 (0.54–3.62)	0.476
Extremely severe	29 (22.3)	17 (21.2)	0.90 (0.44–1.86)	0.793
Stress levels
Normal	61 (46.9)	33 (41.2)	1
Mild	8 (6.2)	11 (13.8)	2.54 (0.93–6.93)	0.068
Moderate	19 (14.6)	4 (5.0)	0.38 (0.11–1.23)	0.110
Severe	13 (10.0)	14 (17.5)	1.99 (0.83–4.73)	0.119
Extremely severe	29 (22.3)	18 (22.5)	1.14 (0.55–2.36)	0.710
Fear of COVID-19
Mild	73 (56.2)	57 (71.2)	1
Moderate to severe	57 (43.8)	23 (28.7)	0.51 (0.28–0.93)	0.029*
*Significant statistical association through binary logistic regression (p ≤ 0.05).

Table 3 shows the prediction results by binary logistic regression of the symptoms evaluated in NSCL/P children parents. Hosmer and Lemeshow test result showed well-fitted model (p = 0.662). Negative correlation is seen for development extremely severe anxiety and moderate fear of COVID-19. Positive correlation is seen for development mild and severe stress.

Table 3

– Predictive factors, through binary logistic regression, of psychological symptoms in children with non-syndromic oral clefts parents (n = 210), 2021–2022.
Variables	β	OR	_95%CI	P-value
Extremely severe anxiety	-1.602	0.20	0.20–0.49	0.027*
Mild stress	1.410	4.09	1.28–13.06	0.017*
Moderate fear of COVID-19	-1.047	0.35	0.14–0.83	0.018*
Only variables that presents statistical significance (≤ 0.05) were included. *Statistical significance (p ≤ 0.05).

Among the population studied associations were observed between: being female and anxiety and depression severe symptoms, being a parent/caregiver of children average aged seven years with depression symptoms, and being very fear of COVID-19 with all symptoms DASS-21 measured (Table 4).

Table 4

– Association between severe and extremely severe psychological symptoms and characteristics of sample (n = 210), 2021–2022.
	Anxiety	OR (_95%CI)	P-value*	Depression	OR (_95%CI)	P-value*	Stress	OR (_95%CI)	P-value*
Variables
Group
Control	40 (67.8)	1		40 (59.7)	1		42 (56.8)	1
Case	19 (32.2)	0.70 (0.37–1.32)	0.272	27 (40.3)	1.14 (0.63–2.07)	0.653	32 (43.2)	1.39 (0.78–2.49)	0.257
Sex
Male	01 (1.7)	1		02 (3.0)	1		04 (5.4)	1
Female	58 (98.3)	8.85 (1.16–6.75)	0.012*	65 (97.0)	4.98 (1.12–2.20)	0.020*	70 (94.6)	2.50 (0.80–7.27)	0.102
Age***	35.3 (8.6)	(-2.46–3.14)^a	0.811	36,2 (9.9)	(-1.73–3.66)^a	0.482	34,8 (8.6)	(-1.57–3.69)^a	0.427
Marital status
No partner	23 (39.0)	1.29 (0.69–2.40)	0.422	29 (43.3)	1.71 (0.94–3.12)	0.076	25 (33.8)	1
With partner	36 (61.0)	1		38 (56.7)	1		49 (66.2)	1.06 (0.58–1.94)	0.826
Years of study
Up to 8 years	36 (61.0)	1.67 (0.90–3.08)	0.099	38 (56.7)	1.32 (0.74–2.38)	0.339	41 (55.4)	1.24 (0.70–2.19)	0.454
More than 8 years	23 (39.0)	1		29 (43.3)	1		33 (44.6)	1
Monthly income
Up to minimum salary	25 (44.6)	1.30 (0.58–2.87)	0.514	29 (44.6)	1.19 (0.56–2.51)	0.644	32 (43.8)	1.06 (0.51–2.17)	0.872
One to two salaries	19 (33.9)	1.50 (0.64–3.50)	0.339	21 (32.3)	1.29 (0.58–2.88)	0.526	23 (31.5)	1.14 (0.52–2.47)	0.733
More than two salaries	12 (21.4)	1		15 (23.1)	1		18 (24.7)	1
Kinship with the child
Other caregivers	05 (8.5)	1		07 (10.4)	1		05 (6.8)	1
Father/Mother	54 (91.5)	1.46 (0.51–4.13)	0.472	60 (89.6)	1.08 (0.42–2.76)	0.873	69 (93.2)	2.10 (0.74–5.92)	0.151
Child’ age***	7.38 (3.97)	(-2.10–0.36)^a	0.166	7,58 (4.16)	(0.03–2.40)^a	0.044**	6,83 (3.92)	(-1.29–1.04)^a	0.835
Fear of COVID-19
Mild	27 (45.8)	1		35 (52.2)	1		41 (55.4)	1.34 (0.61–2.91)	0.461
Moderate	10 (16.9)	1.15 (0.50–2.63)	0.730	10 (14.9)	0.82 (0.36–1.84)	0.635	11 (14.9)	1
Severe	22 (37.3)	5.59 (2.56–12.22)	0.00****	22 (32.8)	3.98 (1.85–8.53)	0.00****	22 (29.7)	4.26 (1.65–11.01)	0.002*
* Pearson's chi-square test significant statistical association (p ≤ 0.05). Student t test significant statistical association. * In these variables, values were described witch mean and standard deviation values. **** Pearson's chi-square test significant statistical association (p < 0.001). ^aDifference between means confidence interval.

In the present study, no statistical differences were identified between anxiety, depression and stress levels between parents and caregivers of NSCL/P children and healthy children. However, the results discussion with those literature findings must be analyzed with caution.

Three studies [14–16] that used DASS-21 to measured psychological symptoms in NSCL/P children parents were founded. An Indian study [14], carried out with 50 NSCL/P children parents observed a positive association between the parents' stress and depression symptoms and the child's behavioral problems.

A second study, conducted in Belgium having 90 NSCL/P children parents parents [15] which, in addition to measuring psychological symptoms, also applied instruments to compare self-esteem and concerns about their social behavior. In the results, anxiety, depression and stress scores were normal, having no differences with other studies analyzed in the discussion. Moreover, higher anxiety scores only, were statistically associated with older parental age. Older parental age had association with depression and cleft postnatal diagnosis.

In Kumar et al. [16] study, there is a similarity in the methodology applied with our study, mainly due comparative group presence. Parents of CL/P adolescence (10 to 17 years) obtained a statistically significant association with higher levels of symptoms in the three dimensions measured by the DASS-21 (p < 0.001). Furthermore, there was a prevalence of severe and extremely severe depressive symptoms of 22.9% and 20%, respectively, in the group of CL/P children parents, while in the group of healthy children parents the prevalence was 1% and 2% for the same symptom ratings. Regarding anxiety in CL/P children parents group, extremely severe classification was 50% of prevalence, while in the control group the prevalence was 6.1%. As for the stress, severe symptoms were 21.4% in case group, and 1% in control.

As in the present study, two studies [17, 32] don’t showed association between anxiety and depression in the investigated groups. However, findings on the subject are diverse. There are publications in which parents of healthy children's scored more than NSCL/P caregivers [12, 33, 34], as well, contrary results [10, 13, 16, 35]. However, most of studies, symptoms levels were measured used different instruments.

Self-perceived parental stress is a constantly evaluated variable in studies with parents and caregivers of NSCL/P children [5, 6, 9, 10–13, 19, 33, 36]. Jeong et al. [33] showed that parents who had lower scores on the Beck's Anxiety and Depression Inventories had more stress. Furthermore, a reduction in the stress levels in NSCL/P children' parents with the passing of childhood is noted [6, 36]. Also, it's seen a correlation of these symptoms in the childs behavior [6, 33, 36].

Only two studies that measured psychological impacts in parents of NSCL/P childrens in Brazil was identified [11, 37]. First study was a cohort [11] that aimed analyzed parental stress in NSCL/P child parents before and after surgical procedures. This study found that stress levels used to progressively reduce after the intervention. Carvalho et al. [37] evaluated parents and caregivers emotions through of authors elaborate questionnaire. This one not showing anxiety, depression and/or stress symptoms, but feelings as fear, despair, sad and "shok" as more prevalent after cleft diagnosis.

Our study was the first to applied FC-19S in NSCL/P children parents. It was found that being a parent/caregiver was a protective factor in relation to parents/caregivers of healthy children. This finding remains apparently unexplained. However, it should be noted that some CL/P patients, in the pandemic, were assisted by teleorientation. This could be information that contributed to the fact that those NSCL/P children caregivers didn't feel impact generated by the pandemic more intensely and thus demonstrating less fear than the control group. Studies also evaluated fear of COVID-19 in healthy children parents [38, 39]. However, didn't used FC-19S [38] and another aimed fear and breastfeeding effectiveness associate [39]. This contribute to the importance verifying to fear od COVID-19 as an aggravating in family cycle mental health [38, 39].

Regarding groups features differences, NSCL/P children parents, compared to the control group, have higher OR in have a partner and have higher monthly income. There aren’t no results in the literature that explain this finding. However, it is necessary to point out that in Brazil, the treatment of CL/P is paid by the Unified Health Public System (SUS in Portuguese) [40]. Therefore regardless of the family members socioeconomic level, all patients with CL/P are treated in the same Specialized Centers.

Similar to the others studies [41–48] be female showed associations to anxiety and depression symptoms. Publications that infer that women have a higher OR in anxiety and depression symptoms development are based on many factors, mainly as physiological issues [43, 45, 48] and social demands [42, 43, 46, 47]. In addition, women historically seek more health services [44, 46] where surveys are carried out. Furthermore in COVID-19 pandemic had an increase in domestic violence case number [41], variable contributing the risk of mental disorders symptoms development.

Children's age (mean of 7.5 years) was associated with their parents' depression symptoms. This result differs from an Indian study [16] which parents of NSCL/P children over ten years old had greater scores in DASS-21 all dimension compared to parents of clinically healthy children and CL/P younger children. However, in a study carried out with caregivers of children [49], it was identified that mothers of younger children, regardless of the presence of disabilities or anomalies in their children, commonly present some anxiety, depression and stress levels.

Anxiety, depression and stress symptoms had strong association with severe fear of COVID-19. Thus, its able to infer that greater mental problems individuals are more afraid of COVID-19. Even though it is a relatively new scale, there are some studies [50–57] that used in conjunction FC-19S with the DASS-21. And also founded associations between fear of COVID-19 and higher scores of these symptoms [50–52, 54, 56, 57]. Furthermore there was strong correlation between instruments [51, 54, 57]. However, it should be noted that such association measures may changed over time. Because some studies emphasize that datas collection were carried out in the initial pandemic period or at virus infection waves peak [50–53, 55]. These factors may interfere in fear of COVID-19 scores witch has a psychological symptoms predilection. A differential of our study is that data collection was carried out over a year, thus, the participants experienced different pandemic phases, reducing possible bias regarding the high levels of fear of COVID-19.

There are some limitations that should be listed. As this is a convenience sampling study, the findings may be underreported, since the COVID-19 pandemic situation has led to changes in the health habits of individuals with greater mental health problems. Other limitation is due cross-sectional design of study which cannot measure the causality of parenting with the measured symptoms development.

Doesn't observed differences between anxiety, depression and stress levels in control group compared NSCL/P children parents and caregivers. However, severe symptoms predilection was found in parents of oral cleft children. Additionally, NSCL/P children parents and caregivers were less fear of COVID-19. Anxiety, depression and stress symptoms were associated to female, responsables by seven years old age children and severe fear of COVID-19. In the final multivariate binary logistic regression model, lower OR of extremely severe anxiety, higher OR of mild stress and lower OR of fear of COVID-19 remained associated with NSCL/P children parents.

Author Contribution

Trezena S: study design, data analysis and interpretation, writing up the first draft of the paper, and approval of the final manuscript. Oliveira FES: data analysis and interpretation, writing up the first draft of the paper, and approval of the final manuscript. Marques CE: selection of participants, collection, tabulation of data and approval of the final manuscript. Marques NCT: study design, selection of participants, collection, tabulation of data and approval of the final manuscript. Martelli DRB: study design, review and approval of the final manuscript. Martelli Júnior H: study design, writing up the first draft of the paper, and approval of the final manuscript.

Ethics Approval and Consent to Participate: All procedures performed in the present study were in accordance with the ethical standards of the institutional research committee and with the Declaration of Helsinki for research involving humans. All study participants signed a written consent form. The present study has the approval of the Unimontes’ Ethics and Research Committee (# 49246121.6.0000.5143).

Funding: No funding was obtained for this study.

Conflict of Interests: The authors declare no competing interests.

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Anxiety, depression, stress and fear of COVID-19 in non-syndromic oral cleft children' parents and caregivers

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