How Un-random is the Randomization

Morankar, Rahul; Tewari, Nitesh; Goel, Shubhi

doi:10.5005/jp-journals-10077-3074

Cited by 3 publications

(3 citation statements)

References 6 publications

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“…The eligible participants were categorized into 5 strata according to the age of the child undergoing surgery (2, 3, 4, 5, and 6 y) and then randomized into each group at a 1:1 ratio. We used stratified simple randomization to keep the groups as similar as possible [ 46 ]. The researcher prepared 2 envelopes in advance, with one for children aged 2 years and the other for children up to the age of 6 years.…”

Section: Methodsmentioning

confidence: 99%

“…We reversed the latter scores (4 became 1, 3 became 2, 2 became 3, and 1 became 4) so that, when evaluating the total score, a higher score represented a higher level of anxiety. The total score on the S-Anxiety scale ranges from mild (20)(21)(22)(23)(24)(25)(26)(27)(28)(29)(30)(31)(32)(33)(34)(35)(36)(37)(38)(39) and moderate (40)(41)(42)(43)(44)(45)(46)(47)(48)(49)(50)(51)(52)(53)(54)(55)(56)(57)(58)(59) anxiety to intense anxiety (60-80) [49]. The internal consistency of the pretranslated version of the questionnaire used in this study (Mind Garden) has been assessed.…”

Section: Stai (Parents)mentioning

confidence: 99%

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Effectiveness of a Mobile App Intervention for Preparing Preschool Children and Parents for Day Surgery: Randomized Controlled Trial

Kerimaa,

Hakala,

Haapea

et al. 2023

J Med Internet Res

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Background Day surgery allows families to return home quickly. Only a few approaches to preparing for day surgery have demonstrated how digital solutions can support families and children. Objective This study aims to evaluate the effectiveness of a mobile app intervention on preschool children’s fear and pain and parents’ anxiety and stress in preparing children for day surgery. Methods This study was conducted at the Pediatric Day Surgical Department of a university hospital in Finland between 2018 and 2020. Parents of children (aged 2-6 y) who were in a queue for elective day surgery were randomized into the intervention group (IG; n=36) and control group (CG; n=34). The CG received routine preparations, whereas the IG was prepared using a mobile app. Parents’ and children’s outcomes were measured using validated scales at 4 different points: at home (T1 and T4) and at the hospital (T2 and T3) before and after surgery. Group differences were analyzed using statistical methods suitable for the material. Results Before surgery, parents in both groups experienced mild anxiety, which decreased after surgery. Parental anxiety did not differ between groups preoperatively (P=.78) or postoperatively (P=.63). Both groups had less anxiety at home after surgery compared with before. The IG showed a significant decrease (P=.003); the CG also improved (P=.002). Preoperatively at home, most parents in both groups experienced no stress or mild stress (P=.61). Preoperatively at the hospital, parents in both groups experienced mild stress; however, parents in the IG experienced more stress during this phase (P=.02). Parents in the IG experienced significantly less stress postoperatively than those in the CG (P=.05). Both groups showed decreased stress levels from before to after surgery (IG: P=.003; CG: P=.004) within each group. There were no significant differences in children’s pain levels between the groups and measurement points. This was observed before surgery at home (P=.25), before surgery at the hospital (P=.98), and after surgery at the hospital (P=.72). Children’s fear decreased more in the IG (P=.006) than in the CG (P=.44) comparing the phases before and after surgery at home. Fear did not differ between the IG and CG preoperatively at home (P=.20) or at the hospital (P=.59) or postoperatively at the hospital (P=.62) or at home (P=.81). Conclusions The mobile app intervention did not reduce anxiety or pain. However, it was observed that parents in the IG experienced substantially heightened stress levels before surgery at the hospital, which decreased significantly after surgery at home. In addition, fear levels in children in the IG decreased over time, whereas no significant change was observed in the CG. These results are important for developing health care service chains and providing families with innovative and customer-oriented preparation methods. Trial Registration ClinicalTrials.gov NCT03774303; https://classic.clinicaltrials.gov/ct2/show/NCT03774303

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Section: Methodsmentioning

confidence: 99%

Section: Stai (Parents)mentioning

confidence: 99%

Effectiveness of a Mobile App Intervention for Preparing Preschool Children and Parents for Day Surgery: Randomized Controlled Trial

Kerimaa,

Hakala,

Haapea

et al. 2023

J Med Internet Res

View full text Add to dashboard Cite

show abstract

“…The eligible participants were divided into five age groups (2, 3, 4, 5, and 6 years) and then randomly assigned to each group with a 1:1 ratio using stratified simple randomization [25]. The researcher prepared two envelopes beforehand; one for 2-year-olds and the other for children up to six years old.…”

Section: Participants Randomizationmentioning

confidence: 99%

A Mobile Application Can Be Used as an Alternative to the Traditional Preparation Method for Parents in Pediatric Day Surgery: A Randomized Controlled Trial

Kerimaa,

Haapea,

Hakala

et al. 2024

Communications in Computer and Information Science

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Background: Digital preparation programs for day surgery are now available through smartphones; however, research on the effectiveness of digital interventions among parents is lacking.Aim: This study aimed to assess the effectiveness of a mobile application intervention in preparing parents for pediatric day surgery and to describe the correlations between parents’ anxiety, stress, and satisfaction.Methods: A total of 70 parents of preschool children who were scheduled for elective day surgery were randomly divided into two groups: the intervention group (IG; n = 36) and the control group (CG; n = 34). The study took place in the pediatric day surgical department of a university hospital in Finland. The IG used a mobile application, while the CG used routine methods. Parents’ anxiety, stress and satisfaction were measured using validated instruments.Results: There was no significant difference in parental anxiety levels between the two groups, both before and after the surgery. After the surgery, both groups of parents reported feeling less anxious while at home. Pre-surgery, most parents experienced no/mild stress at home. However, post-surgery, intervention group parents reported significantly less stress at home than control group parents. The mean VAS score for parents’ satisfaction in both groups was high: 8.8 for the intervention group (SD 1.9) and 8.6 for the control group (SD 0.9). These mean scores did not significantly differ. Anxiety, stress, and satisfaction showed a significant correlation in most cases at both T1 and T4.Conclusions: A mobile application can serve as an alternative to the traditional method of preparing parents for pediatric day surgery.

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Effectiveness of a Mobile App Intervention for Preparing Preschool Children and Parents for Day Surgery: Randomized Controlled Trial (Preprint)

Kerimaa,

Hakala,

Haapea

et al. 2023

Preprint

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BACKGROUND Day surgery allows families to return home quickly. Only a few approaches to preparing for day surgery have demonstrated how digital solutions can support families and children. OBJECTIVE This study aims to evaluate the effectiveness of a mobile app intervention on preschool children’s fear and pain and parents’ anxiety and stress in preparing children for day surgery. METHODS This study was conducted at the Pediatric Day Surgical Department of a university hospital in Finland between 2018 and 2020. Parents of children (aged 2-6 y) who were in a queue for elective day surgery were randomized into the intervention group (IG; n=36) and control group (CG; n=34). The CG received routine preparations, whereas the IG was prepared using a mobile app. Parents’ and children’s outcomes were measured using validated scales at 4 different points: at home (T1 and T4) and at the hospital (T2 and T3) before and after surgery. Group differences were analyzed using statistical methods suitable for the material. RESULTS Before surgery, parents in both groups experienced mild anxiety, which decreased after surgery. Parental anxiety did not differ between groups preoperatively (P=.78) or postoperatively (P=.63). Both groups had less anxiety at home after surgery compared with before. The IG showed a significant decrease (P=.003); the CG also improved (P=.002). Preoperatively at home, most parents in both groups experienced no stress or mild stress (P=.61). Preoperatively at the hospital, parents in both groups experienced mild stress; however, parents in the IG experienced more stress during this phase (P=.02). Parents in the IG experienced significantly less stress postoperatively than those in the CG (P=.05). Both groups showed decreased stress levels from before to after surgery (IG: P=.003; CG: P=.004) within each group. There were no significant differences in children’s pain levels between the groups and measurement points. This was observed before surgery at home (P=.25), before surgery at the hospital (P=.98), and after surgery at the hospital (P=.72). Children’s fear decreased more in the IG (P=.006) than in the CG (P=.44) comparing the phases before and after surgery at home. Fear did not differ between the IG and CG preoperatively at home (P=.20) or at the hospital (P=.59) or postoperatively at the hospital (P=.62) or at home (P=.81). CONCLUSIONS The mobile app intervention did not reduce anxiety or pain. However, it was observed that parents in the IG experienced substantially heightened stress levels before surgery at the hospital, which decreased significantly after surgery at home. In addition, fear levels in children in the IG decreased over time, whereas no significant change was observed in the CG. These results are important for developing health care service chains and providing families with innovative and customer-oriented preparation methods. CLINICALTRIAL ClinicalTrials.gov NCT03774303; https://classic.clinicaltrials.gov/ct2/show/NCT03774303

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How Un-random is the Randomization

Cited by 3 publications

References 6 publications

Effectiveness of a Mobile App Intervention for Preparing Preschool Children and Parents for Day Surgery: Randomized Controlled Trial

Effectiveness of a Mobile App Intervention for Preparing Preschool Children and Parents for Day Surgery: Randomized Controlled Trial

A Mobile Application Can Be Used as an Alternative to the Traditional Preparation Method for Parents in Pediatric Day Surgery: A Randomized Controlled Trial

Effectiveness of a Mobile App Intervention for Preparing Preschool Children and Parents for Day Surgery: Randomized Controlled Trial (Preprint)

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