Study design
This study adopted retrospective cohort methodology. The retrospective cohort design allowed assessment of the efficacy and safety of infants’ soft palate manipulation as Saudi traditional therapy to treat infant colic and poor feeding. As mothers are the primary caregivers in Saudi Arabia, they were the main target to be surveyed in this study. Given that this is the first study to explore Autheem therapy safety, urban settings were included only at this stage. To match school readiness as a gain for participation, a development assessment at the age of 36 months was offered. Pre-structured survey was carried to understand motives and influencing factors of seeking Autheem therapy.
Participant recruitment
Mothers were recruited from six General Pediatrics Clinics under cluster two of the Saudi Ministry of Health Primary Care Program in Riyadh, Saudi Arabia. Children were recruited to participate in this study when they presented for three-year well child visits. Mothers provided their consent before participation and were asked to complete a questionnaire that covered their demographic details, their perspective on “Autheem” therapy, and the safety measures offered upon Autheem therapy. This structured survey was built based on expert opinions, clinical observation and suggestions from two experienced Saudi pediatricians. It was tested by a pilot study on random participants for clarity and length. The survey was supplemented by a translated to Arabic and a validated tool to assess child development among both cases and control cohorts. Children who were born prematurely, diagnosed with metabolic/genetic disorders, had a history of birth asphyxia, had a history of brain injury, or had oropharyngeal abnormalities such as cleft palate were excluded from the study to minimize any confounding factors. The two groups, exposed and controls, were matched 1;1 for age, gender, baseline health, and term status of pregnancies. The match allowed balanced groups and aimed to minimize confounding as only healthy and full term children were included in both groups.
Attitude, efficacy, and safety
The study aimed to evaluate mothers’ perceptions and satisfaction regarding Autheem therapy and their primary source of information in the first stage. Additionally, the study examined whether there were any unfavorable outcomes resulting from the therapy and whether any precautions were taken to ensure its safety. Acute adverse outcomes like hospitalization, viral infections, fractures, injuries, and lethargy were explored. Impact on development was sought out as a long-term adverse outcome of Autheem therapy. Furthermore, the influence of traditional healers on vaccine hesitancy and accessing cautery therapy were evaluated. The questionnaire was tested through a pilot study and is available in English format in the supplementary data.
Child development assessment
To investigate the relationship between Autheem therapy and developmental milestones, a 36-month developmental assessment using a validated Arabic version of “Ages and Stages” tool was administered to both cases and healthy controls. Ages and Stages is a reliable and validated tool in Arabic and has showed good reliability and cultural sensitivity in previous [7].
Sample size
Sample size was determined after consulting with two Saudi pediatric experts with more than 10 years of experience and extensive research background along with using an online sample size calculator (OpenEpi) to achieve a Power of 80% with 95% Confidence Interval, a minimum sample size of 38 participants per each cohort was designed to allow a statistically significant findings while avoiding type I and type II errors. Likewise, both cohorts were matched per age, gender, health status and gestational age at birth to minimize confounding and statistical errors.
Statistics
Initially, data were logged into an Excel sheet. Then, a consulting biostatistician aided in calculating the risk ratio, odds ratio, and means using SPSS software Version 28. Utilizing z-test, a correlation between mothers’ characteristics, Autheem therapy, and developmental delays were tested using multiple logistic regression analysis.
Ethics
Prior to data collection, this study was reviewed and obtained IRB approval from King Fahad Medical City, Riyadh, Saudi Arabia. Before surveying any mother, informed consent was discussed, and mothers were reminded of the lack of impact of participation on their clinical care. Then, a consent was obtained from patients’ parents or legal guardians prior to answering survey about children’s development and Autheem exposure. Mothers were allowed to stop or withdraw participation any time before data analysis. Cultural sensitivity and non-judgmental care was provided during data collection.
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