Abstract
Introduction
Sensory processing is crucial to adaptive behavioural responses in occupational therapy. Nevertheless, information on sensory processing in adults is limited. The Adult Sensory Processing Scale (ASPS) measures behavioural responses indicative of sensory processing in different sensory systems. The study aimed to examine the cultural adaptation, reliability and validity of the ASPS-Turkish (ASPS-T).
Methods
The ASPS-T was administered to 405 individuals, who were aged 18 to 64 (38.5 ± 11.4) years. The cross-cultural adaptation and translation procedures were conducted following Beaton’s guidelines. Internal consistency was examined by Cronbach’s alpha. Criterion-related validity of the ASPS was determined by the Adolescent/Adult Sensory Profile using Construct validity and was examined by confirmatory factor analysis using AMOS.
Results
The study included 405 participants (271 female and 134 male). Exploratory factor analysis with varimax rotation determined 11 factors with 55.15% total variance. In confirmatory factor analysis (CFA), model fit indices showed an acceptable fit. The reliability of the scale was 0.834, and test–retest reliability changed from 0.94 to 0.99, illustrating high internal consistency and excellent reliability of the scale.
Conclusions
The ASPS-T is reliable and valid for analysing sensory processing patterns of adults in the Turkish population.
Introduction
People are exposed to sensory stimuli every minute of the day. The sensory integration process is an organization of the sensory stimuli received from the inside of the body or the environment, so as to organise sensory information and give the appropriate behavioural responses (Dunn, 2001; Pollock, 2009; Miller et al., 2007). Peoples’ nervous systems have personal differences in sensory processing processes (Dunn, 2001). While most people seem to have typical sensory processing abilities, more intense sensory processing patterns are seen in 15% of the population. For example, some may show increased sensitivity or decreased sensitivity to sensory stimuli (Ben-Avi et al., 2012; Miller et al., 2007; Smith Roley et al., 2007). The differences in the sensory integration process can result in difficulties in creating adaptive responses in adults (Engel-Yeger and Shochat, 2012). Different patterns of sensory processing have been associated with different problems in adults, including sleep quality, anxiety state, somatisation, distress, morale, difficulties in social interactions, family, work and therapeutic relationships, which can directly affect daily life (Ben-Avi et al., 2012; Engel-Yeger and Shochat, 2012; Redfern et al., 2009; Syu and Lin, 2018).
The responses to sensory stimuli are expressed as over-responsiveness, under-responsiveness and sensory seeking by Ayres’ original sensory integration theory (Ayres, 1972; Ayres and Robbins, 2005; Miller et al., 2007). Current studies demonstrate the effects of over-responsiveness on functional abilities, behaviours, emotions, sleep quality and mental health. This shows that adults who react excessively to environmental stimuli experience daily life differently from other adults. Individuals can feel overwhelmed by sensory bombardment; therefore, they may need to escape from their environment to ‘be recharged’. This condition could result in an increased tendency to develop stress, anxiety and depression symptoms (Abernethy, 2010; Bar-Shalita et al., 2020; Benham, 2006; Engel-Yeger and Shochat, 2012; Kinnealey and Fuiek, 1999; Kinnealey et al., 1995, 2011), whereas people with sensory sensitivity can be as healthy as those who are not sensitive when in low-stress conditions. It is therefore important to determine the sensory sensitivity of adults (Ayres, 1972; Benham, 2006).
Sensory integration therapy is used commonly with children in Turkey and across the world. Furthermore, sensory integration process practices and research are ongoing for adults. Various instruments have different perspectives to evaluate sensory processing, such as the Adolescent/Adult Sensory Profile (AASP), the Sensory Over-Responsivity, Sensory Perception Quotient (SPQ), and the Highly Sensitive Person (Brown et al., 2001; Dunn and Brown, 2002; Schoen et al., 2008; Tavassoli et al., 2014). The use of diverse clinical evaluation tools such as ASPS-T may help to understand adults’ sensory processes and improve new intervention strategies that address the needs of the relevant occupations. In contrast, culturally adapted, reliable and valid assessment tools are needed and can be used in many languages and cultures, and are critical to gaining knowledge and understanding (Kimberlin and Winterstein, 2008). Few standards have been defined for the translation and cultural adaptation of instruments, and the multi-step approach is considered the best practice in achieving cultural and semantic equivalence of the adapted version. The cross-cultural adaptation process includes both translation and cultural adaptation so that it is necessary to use existing tools effectively in other cultural and linguistic settings (Tuthill et al., 2014). Therefore, it is important to reduce the risk of bias when an instrument is used in a different language, setting and time (Herdman et al., 1998). The aim of this study was a cross-cultural adaptation of the ASPS into Turkish (ASPS-T) and to determine its psychometric features including validity, reliability, factor structure and internal consistency in adults.
Instrument
The Adult Sensory Processing Scale (ASPS) as a self-report instrument was developed to assess identifying patterns of sensory responsiveness linked to distinct sensory systems in adults.
The ASPS is consistent with the original sensory integration theory of Ayres, which emphasises different processing models according to different sensory systems (Brown et al., 2001). The ASPS is designed to measure different behavioural response patterns (over-responding, under- responding and sensory seeking) of specific sensory systems (tactile, proprioceptive, vestibular, auditory and visual) that indicate sensory processing challenges. According to ASPS, over-responsiveness is a tendency towards increased sensitivity, or an aversion in response to ordinary sensory input that would not bother most people. For example, if a visually over-responsive individual goes out without sunglasses, they will feel uncomfortable. Under-responsiveness is a tendency towards a decreased sensitivity, or a lack of awareness of sensory input that most people would notice. For instance, the individual with an ‘under-responding to auditory’ may tend to listen to music louder than other people. Sensory seeking is a tendency to initiate behaviours that produce sensations with greater intensity or frequency than is typical for most people. A person with a sensory seeking to proprioception may prefer activities such as rock climbing or boxing or to be overly active in comparison to others. Sensory responsiveness models related to different sensory systems in adults have been defined by over-responsiveness, under-responsiveness and sensory seeking patterns similar to those in children. A total of 11 factors and 48 items are defined, and the number of questions for each factor is different. All items are rated on a 5-point Likert scale with Never = 1, Rarely = 2, Sometimes = 3, Often = 4 and Always = 5. In the ASPS, the behavioural pattern range is defined as a typical range with possible difficulties and definite difficulties for each factor and low scores reflects the typical range. The Typical Range and Definite Difficulties for each factor are defined as follows: <15.77 and >21.01 for factor 1, <20.05 and >25.61 for factor 2, <15.53 and >20.73 for factor 3, <10.04 and >13.63 for factor 4, <11.80 and >15.33 for factor 5, < 9.03 and > 12.02 for factor 6, < 17.28 and > 20.38 for factor 7, < 5.58 and > 7.62 for factor 8, < 7.33 and > 9.66 for factor 9, < 7.56 and > 10.27 for factor 10, and < 7.48 and > 10.08 for factor 11 (Blanche et al., 2014).
Methods
Participants
This study was conducted in the Faculty of Health Sciences at Uskudar University between April 2019 and March 2020. A total of 405 adults took part in this study on a voluntary basis. Participants comprise the student community, faculty members, other employees and their families and other voluntary individuals who are included in the study with brochures placed in the collective use area. The adequacy of the sample size was measured with the Kaiser–Meyer–Olkin (KMO) test. Fifty-five of the 405 participants were randomly selected to be re-interviewed, and they completed the questionnaire once more. The study included criteria such as being aged 18–64 years, able to read and write, and healthy. Participants were excluded who had a diagnosis of any disorders that prevented them from completing the survey, such as cancer or cognitive problems. Participants comprised university students, faculty employees, other employees and their families. Each participant was invited to take part in the study using a face-to-face interview. After receiving both written and oral information about the project, all the participants who voluntarily took part provided a signed consent form. A total of 460 individuals were called to participate in the study and 55 individuals were rejected. Among the individuals invited to the study, 21 were excluded because they refused to participate in the study, 29 did not meet the age criteria, 2 because of having a diagnosis of dementia and 3 were cancer survivors.
Data collection
Participants completed the socio-demographic form, the ASPS-T, and the AASP in the study. The socio-demographic form contained items regarding age, gender, general health status and other health interventions.
The concurrent validity of the ASPS was demonstrated using the AASP as an external criterion (Chang et al., 2016). Therefore ASPS-T’s external validity was examined with the AASP. The AASP was developed and built on Dunn’s sensory processing model and is suitable for those aged 11 years and over (Dunn and Brown, 2002). It comprises 60 items and is used to evaluate individuals’ sensory processing skills in daily life. Each item is related to responses to sensory input through six sensory factors that refer to everyday activities, including taste and smell, movement, vision, touch, processing, auditory processing, as well as activity levels. Responses of the participants’ sensory stimuli are evaluated in four quadrants: low registration, sensory sensitivity, sensory avoiding and sensory seeking. Low registration refers to behaviours such as missing stimuli or taking longer to respond to them than other people. Sensory sensitivity is defined as being easily distracted from stimuli, feeling discomfort with sensation, and responding more than normal to stimuli, but not actively limiting exposure to uncomfortable sensations. Sensation avoiding is defined as actively limiting exposure to sensations and avoiding distracting situations, whilst sensory seeking refers to the tendency to create additional stimuli or look for an environment that provides sensory stimuli (Dunn, 1997). The responses record on a Likert scale as almost always, often, sometimes, rarely and almost never, and the scores of the related items are added to supply the score for each quadrant. The tests to settle the validity and reliability of the AASP were completed by Ucgul et al. (Üçgül et al., 2017).
Procedure
The current study comprises three parts: cross-cultural adaptation, piloting and examination of psychometric properties of the ASPS-T. The researcher contacted the developers of the original ASPS and received written permission from the authors to translate it into Turkish. Our study was conducted by the Helsinki Declaration and Uskudar University. The Clinical Research Ethical Board approved the study (Approval Number: 61351342-193). The questionnaires were filled out once and included a 5-minute break.
Phase 1: The cross-cultural adaptation process
Translating the Turkish version of ASPS and the cross-cultural adaptation procedure was carried out under the guidance of Beaton et al. (Beaton et al., 2000). The translation from English to Turkish was performed by two therapists whose mother tongue is Turkish, but who are also fluent in English. Each of the translations was reviewed by three therapists to synthesise them. After consensus of the final version, it was back-translated by two native English-speaking translators. An expert committee meeting was held with the team of authors, an occupational therapist and linguists to consider the final version of the ASPS-T. The final version was compared with the original version to reveal any inconsistencies; no discrepancies were observed. During the translation phase, minimal adjustments were made to address linguistics.
Phase 2: Piloting process
A pre-assessment was made with a pilot study to explore ASPS-Turkish’s cultural harmony. The translated questionnaire was completed by 20 participants to identify any items that were not coherent. Four participants stated they could not understand the meaning of avoid-kaçınmak, so therapists suggested yaşamamak, and this was accepted by participants. Three participants could not respond to the first item on factor 10 because they had not travelled by boat or transportation before, so we added the phrase ‘all types of vehicles’ to the sentence. All the authors met to compare the ASPS-T with the original version and assess its suitability after minimal changes and concluded the current correction did not cause any loss in the meaning of the word. After the changes, pilot study participants evaluated the intelligibility of the scale with a 1 to 5 Likert scale and confirmed the clearness unanimously. Therefore, the final version of the ASPS-T, which has minor changes, was the best representation of the original, and each item was found to be suitable for Turkish patients. The pilot study participants were not included in the sample. After cultural equivalence had been achieved, 405 healthy individuals aged 18 and over were asked to complete the ASPS questionnaire.
Phase 3: Data analysis and psychometric properties
IBM SPSS Statistics 26.0 was used for the statistical analysis. CFA was examined with IBM AMOS software. The dataset was divided into two randomized parts (60%, n = 244–40%, n = 161) with SPSS – select cases function. The first dataset (n = 244) was used to analyse factor loads by Exploratory Factor Analysis (EFA). The second part of the dataset was used for Confirmatory Factor Analysis (CFA). Gorsuch suggested that sample size for explanatory factor analysis would be 5 participants for each item and at least 100 participants in total; and Kline suggested sample size should be between 100 and 200 for confirmatory factor analysis (Gorsuch, 1988; Kline, 2013). Both datasets covered the minimum requirements for both EFA and CFA in this study.
The Shapiro–Wilk test was used to evaluate the distribution of the collected data (normal = p>0.05) (Razali and Wah, 2011). The ceiling effect was causing measurement inaccuracy and was checked for all factors and the total score (Taylor, 2010). Descriptive analysis was used to describe participants’ demographic data and questionnaire results. Numerical values were represented as mean and standard deviation, and categorical data were represented as frequencies. Exploratory factor analysis and confirmatory factor analysis (EFA and CFA) were used to measure the construct validity of the instrument. In the EFA, principal component analysis with Varimax rotation, the KMO test, Barlett’s test of sphericity, anti-image correlation and total variance explained were used. Model fit indices were used to determine the best suitable analysis to model the dataset and theoretical model in CFA. Reliability was determined using internal consistency and test–retest reliability. Internal consistency was evaluated by Cronbach’s alpha internal consistency coefficient for each factor. Cronbach’s alpha coefficient reliability increases as it approaches 1 and decreases as it approaches 0. The scales’ Cronbach’s alpha values were interpreted as (<0.40) not reliable, (0.40–0.60) low reliability, (0.60–0.80) moderate reliability and (>0.80) high reliability (Alpar, 2013). Test–retest reliability was assessed by comparing responses for the first and second administrations of the ASPS-T using the intra-class correlation coefficient (ICC) (Koo and Li, 2016). ICC rates were accepted as poor (<0.40), moderate (0.40–0.60), good (0.60–0.75) and excellent (0.75–1.00) (Alpar, 2013). Test–retest reliability, a week after the first application of the ASPS, was evaluated by re-interviewing 55 people who were randomly selected and who completed the questionnaire.
Results
Demographic characteristics of respondents.
According to the results of the ceiling effect analysis, there were no statistically significant ceiling effects for all factors and total scale value (p < 0.05). This finding was per the fact that all factor means were not close to their maximum or minimum values. Thus, the nature of factor means distributions also supported the results of the ceiling calculation.
The sensory system response of participants.
Explanatory factor analysis
Factor structure and weight of each item in the scale.
Extraction method: Principal component analysis. Rotation method: Varimax with Kaiser normalization rotation converged in 11 iterations.
Confirmatory factor analysis
Items of factors, min–max, mean scores, reliability, and the test–retest reliability of the ASPS.
Correlation results between ASPS total and AASP factors.
AASP: adolescent/adult sensory profile.
Discussion
Although sensory integration was based on Ayres, there is still a need for further knowledge concerning this core concept in occupational therapy (Ayres, 1964). The literature has shown that healthy individuals experienced different sensory responsiveness under daily living conditions. In this study, most of the participants have had specific sensory system responses different from the ‘normal range’. This study aimed to translate the ASPS into Turkish and to determine the validity and reliability of the ASPS in a Turkish population using psychometric methods. The mean duration of patients completing the ASPS-T was 13 minutes. Psychometric analysis indicated that the ASPS-T is a valid and reliable scale for evaluating the responsiveness within specific sensory systems in the Turkish population aged 18–64 years.
The cross-cultural adaptation of the ASPS was uncomplicated, and the instrument translators, back translators and pilot study participants’ feedback shaped the final version of the ASPS-T. According to the feedback received in phase 1 and 2, minor adjustments to the translated questionnaire were sufficient. After the adjustments, the participants could understand the questionnaire items, which were perceived to reflect the concept of sensory processing. The cultural adaptation process in phase 2 was explained in the introduction. The instrument translation included a change of language and context; therefore, translation can generate confusion in how the instrument is able to measure what it is supposed to measure (Mokkink et al., 2010). After the translation and adaptation process, this study has shown that the measurement properties of the ASPS-T reflect those of the original. The questions in the ASPS included daily personal experiences to facilitate the participants’ comprehension of the questionnaire. The ASPS’s sensory patterns are defined according to Ayres’ original sensory integration theory. It measures the reported different response patterns to inputs from auditory, visual, tactile, vestibular and proprioceptive systems that are sensitive to individual differences in the adult population, for instance, investigations of reactions of visual over-responsive behaviours through questions, such as ‘I carry sunglass with me wherever go’ or ‘I tend to look for the shade or stay in the shade if I am outside’. Therefore, it is crucial as it reveals relationships, between recognisable sensory processing patterns of adults and indicators of well-being, such as daily activity preferences and quality of life (Blanche et al., 2014). This study has indicated that the Turkish of ASPS is crucial that includes specific sensory responses that could support a more inclusive perspective when planning intervention.
The factor loading of the ASPS was analysed across the ASPS-T. According to the results, the factor loading of items factor load similarly to the original ASPS (Blanche et al., 2014). According to Tabachnick and Fidell (2013), the factor load of items should be a minimum of 0.32 (Tabachnick and Fidell, 2013). The ASPS-T minimum factor load was .351(item 45) and the original ASPS was .325 (item 37). Both are acceptable loads.
The scales’ Cronbach’s alpha values should be >0.40 to be accepted as reliable (Alpar, 2013). The lowest Cronbach’s alpha level of ASPS-T was found in factor 9 (0.258) and factor 10 (0.506), respectively. Factor 9’s Cronbach’s alpha value was not reliable but when looked at the ‘Cronbach’s alpha if item deleted’, it was seen that factor 9 did not decrease the total α value of the ASPS-T. So, factor 9 was considered appropriate within the scale. In addition, it was 0.56 on the original scale and had low reliability. Factor 9 has been criticised for containing few items or showing poor internal consistency in the original ASPS (Blanche et al., 2014). Thus, we considered the Cronbach’s alpha value for factor 9 in both surveys and we recommend improving this factor on the original scale. While factor 10’s Cronbach’s alpha value was above the 0.60 level, factor 11’s value was below 0.60 in the original ASPS. However, a contrary situation was observed in the ASPS-T (Blanche et al., 2014). Although these factors indicated poor internal consistency, they are crucial to the specificity of sensory responses within particular sensory systems, so that they could be used in large sample sizes. Split half-analysis using the Spearman–Brown coefficient was used to determine the test–retest reliability. Excellent test–retest reliability was found for each factor of the scale. After all the adjustments were made, the ASPS-T had high reliability, and the internal consistency and test–retest reliability are comparable to those of the English version.
We predicted a 4-factor structure analysis for our database and showed a good model fit so that the CFA results of the present study provided additional evidence for the construct adequate validity of the ASPS-Turkish. These findings are consistent with those of the study carried out by Blanche (Blanche et al., 2014). Thus, the ASPS-T is an applicable tool to figure out the relationship between occupational choices and diverse modes of processing within specific sensory systems. We conducted a correlation analysis between ASPS-T and AASP sub-parameters to analyse the convergent validity of the scale. Dunn’s model established a relationship between sensory sensitivity and sensory avoidance because of low thresholds for sensory information. The same explanation was appropriate to low registration and sensory seeking as both include high thresholds for sensory information (Dunn, 2001). The AASP Turkish and Israeli version correlation results have similarly shown a positive correlation between low registration and sensory sensitivity and sensory avoidance. In addition, the results demonstrated the correlation between sensory avoidance and sensory sensitivity (Engel-Yeger, 2012; Üçgül et al., 2017). Our study indicated similar results, ASPS-over-responsiveness detected a low to moderate positive significant correlation between AASP sensory sensitivity, sensory avoiding and low registration. Our analyses confirmed Dunn’s model with indicated low to moderate correlations between ASPS and AASP sub-parameter scores. This result showed us that closely the ASPS is related to other variables and other measures of the same construct.
ASPS is a questionnaire that assesses different behavioural response patterns of specific sensory systems and sensory processing challenges. Our study showed that the ASPS-T is valid and reliable in the Turkish sample.
In the literature, it is asserted that sensory responses in healthy individuals are related to various factors such as age, gender, geographic area, culture, belief, education level and employment status. In the evaluations made according to age ranges in different cultures, and including the original AASP study, it was highlighted that reference values specific to each age group should be established (Brown and Dunn, 2002; Gándara-Gafo et al., 2019; Al-Momani et al., 2020; Almomani et al., 2014). Engel-Yeger found that a relatively high percentage of Israeli participants in the three age groups were in the performance ranges ‘more or less than most people’ in the different AASP quadrants; however, in general, quadrant mean scores and standard deviations of the evaluated population have been reported to have achieved results consistent with the AASP guideline (Engel-Yeger, 2012). The Chinese conducted an AASP study with 96 healthy people and 33 people living with dementia, all aged 65 years and above. When the averages of the four sensory processing quadrants of the healthy participants were compared with the AASP guideline, the registration, sensitivity, and avoidance quadrants were found to be ‘similar to most people’, whereas the sensation-seeking score was ‘less than most people’ (Chung, 2006). On the other hand, Gándara-Gafo et al. indicated that the quadrant reference values for the Hispanic population were different from the values in the original study and from other populations, such as Israel and China, and emphasised the importance of determining reference values according to cultures (Gándara-Gafo et al., 2019). Similarly, Almomani et al. detected that the sensory processing skills of the Arabic participants were different from those of the people from the European population in the Arabic version of the AASP study. They advised to compare sensory processing skills between different cultures and to examine the effect of different factors such as socioeconomic status and demographics in future studies (Almomani et al., 2014). Al-Momani et al. have compared the cut-off scores between the Arabic and the English versions of AASP. The results showed the cut-off scores were larger in the ‘less’ categories and higher in the ‘more than’ categories in the Arabic version. Arabic people’s different sensory stimuli responses have been associated with religion, cultural habits and the plain physical features in cities (Al-Momani et al., 2020). When the AASP Turkish sensory quadrant scores were compared to the original study reference values, Üçgül et al. found that almost half of the healthy participants differed from ‘like most people’ as demonstrated in the sensory seeking (45%), sensory sensitivity (50%) and sensory avoidance (49%) quadrant scores (Üçgül et al., 2017). There was no detailed analysis for AASP sensory quadrants in our study, but when the outcomes were compared with the reference values determined in the original ASPS study, the Turkish sample indicated difficulties in auditory, tactile, proprioceptive (seeker), auditory (seeking) and tactile (clothing) senses, which were out of the typical range. It was determined that the sensory responses were outside the normal range of more than 50% of the participants in 5 out of 11 factors. These responses included over-responsive to auditory (54.82%), tactile (58.03%), tactile-clothing (72.35%), proprioceptive seeker-under (59.26%), and under-responsive to auditory seeking (70.87%). We consider the difference in results may have been affected by factors such as culture, habits, working status, gender, or age, but the analysis made in the study is not sufficient to make inferences on this issue. In future studies, we suggest that the factors affecting the sensory responses of Turkish people should be investigated in detail and that reference values in Turkey should be defined. In addition, both results indicate the presence of sensory processing problems that may affect the daily lives of adults. Considering that our sample group consists of healthy adults, we think that occupational therapists working with adults should consider using sensory processing processes in their evaluations. In addition, we recommend a detailed study of the sensory processing processes of adults, the factors affecting this, and their effects on daily living.
Methodological strengths and limitations
The current study had several limitations. First, the AASP and the ASPS contain approximately 100 items in total, and we observed that the participants found it difficult to remain focused. Moreover, it might be appropriate to define a standard time frame between the two surveys in questionnaires with so many items for future studies. Second, sensory processing abilities can vary among genders, different ages, healthy individuals or certain diseases such as schizophrenia, depression and anxiety. This study was not conducted with people who had been diagnosed with sensory processing disorders. However, this study did not any consider specific health conditions, so our sampling was not appropriate for the generalisation of our findings. Future studies could focus on specific groups such as schizophrenia, different ages and gender. Thus, we recommend conducting studies to define specific health conditions at the item distribution of the scale, factor loading and validity of the subscales. In this study, most of the participants’ specific sensory system responses were different from the ‘normal range’, and so we considered that tools that evaluate the sensory system in adults should be spread, researched and encouraged in this area. The current form of ASPS-Turkish can contribute to the understanding of sensory processing in adults.
Conclusion
In this study, ASPS was translated and adapted to Turkish. In summary, the results demonstrated that the ASPS-T is a valid and reliable instrument for assessing the different behavioural response patterns in specific sensory systems among adults. The current form of ASPS-Turkish can contribute to the understanding of sensory processing in adults with healthy or specific health conditions.
Footnotes
Acknowledgments
Thanks to all participants.
Patient and Public Statement
Not included at any stage of the research.
Research ethics
This study was conducted in ethical approval, which was obtained by the Uskudar University Ethical Commission of Clinical Research with the confirmation number 61351342-2019-193.
P & P Statement
Not included at any stage of the research.
Informed Consent
This study’s process was carried out by ethical standards of the Responsible Committee on Human Experimentation (institutional and national) and per the Declaration of Helsinki, as revised in 2000. All patients were informed about the study, and informed consent was obtained.
Declaration of conflicting interests
The author(s) declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article.
Funding
The author(s) received no financial support for the research, authorship, and/or publication of this article.
Contributorship
ZBA and SŞ researched literature, developed and designed concept, obtained ethical approval, and collected and processed data. ZBA and OA were involved in data analysis and interpretation. All authors reviewed and edited the manuscript and approved the final version of the manuscript.
ClinicalTrials.gov Identifier
NCT04713839.
Data availability
The datasets generated during and/or analysed during the current study are available from the corresponding author on reasonable request.
