Comparison of Anxiety Levels in Children During Induction of Anaesthesia with and without Parental Presence: A Randomised Controlled Trial

By Ghulam Fatima, Syed Muhammad Nadeem Naqvi, Shabbir Hussain, Ali Asgher, Sarosh Ul Hassan, Nazish Kanwal

Affiliations

1. Department of Anaesthesia and Paediatric Surgery, Liaquat National Hospital and Medical College, Karachi, Pakistan

doi: 10.29271/jcpsp.2025.07.54

ABSTRACT
Objective: To evaluate the effect of parental presence on the anxiety levels of children during anaesthesia induction.
Study Design: Randomised controlled trial (RCT).
Place and Duration of the Study: Department of Anaesthesia and Paediatric Surgery, Liaquat National Hospital and Medical College, Karachi, Pakistan, from January to June, 2024.
Methodology: Paediatric patients (aged between 4-12 years) admitted for minor surgery (duration <1 hour) were enrolled in the study after gaining voluntary informed consent from their parents. The patients were randomised into the control group and the test group, i.e. parental presence during induction of anaesthesia (PPIA). The anxiety levels of the children were measured via a pre-established questionnaire, i.e. modified Yale preoperative anxiety scale (mYPAS). The anxiety levels between the two groups were compared using the Mann-Whitney U test, while the association of the presence/absence of anxiety with demographics was done via Chi-square or Fisher’s exact test, as appropriate.
Results: A total of 70 participants (35 in each group) were enrolled in the study with a female predominance. The median anxiety level was significantly lower in the PPIA group in comparison to the control group (56.7 vs. 75.0; p-value = 0.001), but demographics did not impact the anxiety scores in the present study.
Conclusion: This RCT shows that the presence of parents during anaesthesia induction helps reduce anxiety in children. The results prove that PPIA is a promising non-pharmacological intervention, and leads to improved perioperative outcomes. More research in other populations and contexts is justified.

Key Words: Minor surgery, Children, Induction of anaesthesia, Anxiety, Parents.

INTRODUCTION

Anxiety is an inevitable biological response to complying with and resisting unpleasant situations.¹ Caumo and Ferreira reported anxiety levels between 11 to 80% in surgical candidates.² Before surgery, all patients typically experience some level of fear, but children are more likely to experience this; therefore, they should receive extra care.³ Approximately five million children in the US undergo surgery each year, and between 50 and 70% of them suffer from severe anxiety.⁴
 

 A variety of factors influence children's anxiety prior to surgery which include physical injury that may result in pain, discomfort, or even death, separation from parents and forming relations with strangers (doctors and nurses), fear of the unknown, not having an inkling about the acceptable norms, and lastly, loss of control over one's self.⁵ As the perspective of a child is quite different from that of an adult, these factors might have an influence on them.

Children who exhibit negative preoperative behaviours, such as avoiding eye contact, incessant chattering or complete refusal to hold a conversation, abnormal clinginess with their parents, shouting, and weeping, need to be physically restrained while anaesthesia is being induced.² Preoperative anxiety causes overstimulation of the sympathetic, para-sympathetic, and endocrine systems, which might result in tachycardia, hypertension, and cardiac dysfunction, eventually leading to arrhythmias.

Reducing each patient's anxiety to a normal level should be the goal.⁶ Pharmacological interventions include premedication with benzodiazepines (e.g., midazolam) to reduce children's anxiety, while non-pharmacological interventions include the use of toys, movies, hospital tours, photographs, parental presence during anaesthesia induction, and more.⁷

Parental presence at anaesthesia induction (PPIA) is the interaction that takes place in the induction room during the course of anaesthesia induction between the child, parent, anaesthesiologist, and perioperative nurses.⁸ Given that, most children under the age of 12 years are immature both in psychological and intellectual terms to handle the psychological trauma associated with preoperative anxieties, and the strong protective instinct of the parents, leading to both the child and their parents being stressed about being separated from each other for medical procedures.⁹ PPIA has been promoted because of its simplicity, non-invasive nature, and feasibility to adopt. It also lessens the trauma of parent separation, improves parental satisfaction, and decreases the need for preoperative agent regimens while increasing their cooperation.⁸ Yet, critics have pointed out problems such as the child's anxiety, the parents' erratic behaviour in the event of an emergency (such as a challenging intubation), the effect on the trainee anaesthesiologist (loss of confidence), and the disruption of the operating room (OR) routine caused by the participation of the parents.¹⁰ In many nations, institutions permit the transfer of a non-sedated child and his parent to the induction room in order to alleviate the child's preoperative discomfort, in accordance with the family-centred care paradigm and thus enhance the patient  experience.¹¹

Children whose parents helped with every part of their care were less depressed and made more contributions than children whose parents did not help. It was demonstrated in the study by Talabi et al. that in the presence of a parent during the induction of anaesthesia, the quality of anaesthesia induction was  improved.¹²

The present study aimed to determine the impact of parental presence/absence on the anxiety levels of the children undergoing  anaesthesia  induction.

METHODOLOGY

The study received approval from the Institutional Review Board (Approval No: 0945-2023-ERC). Following the approval, the study was carefully explained to the participants/parents, and voluntary informed consent was taken. In case of inability to read, the consent was read to the participant, followed by attainment of the consent in the presence of an impartial witness (independent of the principal investigator). Paediatric patients of both genders, aged between 4 and 12 years with the American Society of Anesthesiologists (ASA) I or II undergoing surgical procedures were enrolled in the study on the day of their elective or daycare surgery. This single-centre, randomised, placebo-controlled trial was conducted in the operation theatre (OT) of the Department of Anaesthesia and Paediatric Surgery, Liaquat National Hospital and Medical College, Karachi, Pakistan, from January to June, 2024. The trial is registered on ClinicalTrials.gov (NCT06709443).

Patients who either refused themselves or the refusal was given by the attendants, those undergoing emergency surgery, suffering from renal insufficiency, and were either less than four years or older than 12 years were excluded from the study.

The determination of the sample size was based on the findings of a previous study by Sadeghi et al., who reported that children with a parental presence had a mean ± standard deviation (SD) anxiety level of 35.5 ± 16.6 compared to 59.8 ± 22.0 in those without the presence of any parent.¹³ With an alpha of 0.05 and power (1-β) of 0.80, the sample size was calculated to be 22 patients (11 in each group). However, to raise the robustness of the results, the sample size was increased to 70, i.e. 35 patients in each group.

Participants were chosen and assigned to either the PPIA or the control group using a randomisation block method. A set of envelopes was prepared, out of which one was picked by a resident trainee and opened by another resident trainee. The envelope that allowed the presence of the parent was labelled as PPIA, while the other that did not allow was the control group. Both groups were assigned equal number of participants. Patients in the control group were not accompanied by any of the parents, and patients in the PPIA group had the presence of a parent in the OT until they left following the loss of consciousness of the child after the induction of anaesthesia.

The induction was done using oxygen and the inhalational agent sevoflurane. The duration of induction depended on the age as well as the cooperation of the individual. The anxiety levels were evaluated using the modified Yale preoperative anxiety scale (mYPAS). The scale assessed 22 expressions under five different categories, which included activity, vocalisation, use of parents, state of arousal, and emotional expressivity.¹⁴ The threshold of the mYPAS score that was used to determine that a child was anxious was >40. A proforma was filled out by the principal investigator.

The SPSS version 26.0 was used for the statistical analysis. The Shapiro-Wilk test was employed to assess the normality of the data. Quantitative variables, such as age and anxiety scores, were summarised using median ± interquartile range (IQR) values, while categorical variables, including gender, comorbidities, and procedures performed, were presented using frequencies and percentages. The association of the demographics with the presence or absence of anxiety as per the mYPAS questionnaire (anxious: >40; non-anxious: ≤40) was assessed using the Chi-square/Fisher’s exact tests, as appropriate. The comparison of the anxiety score between the two groups was evaluated using the independent t-test or Mann-Whitney U test, as appropriate. A p-value of 0.05 or less was considered statistically significant.

RESULTS

As per the inclusion criteria, a total of 70 participants were enrolled in the study and randomised into two study groups, and each group comprised of 35 patients. The gender distribution between the study groups revealed a female predominance.

Table I: Relationship of demographics with anxiety levels between the study groups.

Study groups	Frequencies	PPIA (n = 35)		Control (n = 35)		p-values
		Anxious∞ (n = 31)	Non-anxious∞ (n = 4)	Anxious∞ (n = 34)	Non-anxious∞ (n = 1)
Gender						0.377£
Male		10 (32.3)	2 (50.0)	16 (47.1)	1 (100)
Female		21 (67.7)	2 (50.0)	18 (52.9)	0
Age						0.064£
<6 years	22	7 (22.6)	0	14 (41.2)	1 (100)
≥6 years	48	24 (77.4)	4 (100)	20 (58.8)	0
	PPIA		Control
Anxiety score, median (IQR)	56.7 (51.7-66.7)		75.0 (63.3-81.7)			<0.001¥
∞mYPAS: ≤40 Non-anxious; >40 Anxious; ¥ Mann-Whitney U test; £ Fisher’s exact test.

Figure 1: Frequency of comorbidities in two study groups.

Figure 2: Frequency of procedures performed in both study groups.

The median (IQR) age of the study participants was 7.0 (5.0-9.0) years. Of these, 22 (31.4%) were less than 6 years, while the remaining were ≥6 years. In terms of presence of comorbids, the majority of the participants had none in both of the groups [PPIA = 32 (91.4%); controls = 31 (88.6%)], followed by asthma [PPIA = 3 (8.6%); controls = 2 (5.8%)] (Figure 1). The most frequent surgical indication in the current study was hernia repair for both the groups [PPIA = 7 (20.0%); controls = 9 (25.7%)], followed by cystoscopy [PPIA = 4 (11.4%); controls = 6 (17.1%)] (Figure 2). The anxiety score between the two groups was reported to be significantly lower in the PPIA group as compared to the control group (p-value <0.001), but association of the demographics (age and gender) based on the presence/absence of anxiety revealed no statistical difference between the two study groups (Table I).
 

DISCUSSION

The findings of the present study on PPIA and the effect of its presence on paediatric patients' anxiety levels are consistent with a number of recent studies in the field. However, some contrasts with the published literature were also observed.

The study population in the present study had a female dominance, which was an interesting finding and contrasted with a 2023 study by Huda et al. that showed a more male- dominant population in their PPIA research.¹⁵ Future studies are needed to investigate whether gender may have an impact on PPIA, both in terms of effectiveness and in terms of anxiety reduction.

The surgical indications reported in the current study are similar to those reported by Morini et al. in a systematic review, where hernia repair was the most common indication in children.¹⁶ This finding of hernia repair to be a common paediatric surgical procedure supported the hypothesis that the sample of the present study was representative of typical paediatric surgical populations.

The PPIA group reported a significant reduction in the anxiety scores compared to the control group in the current study. This was consistent with a 2025 systematic review and Bayesian network meta-analysis by Li et al., which showed that PPIA lowered the preoperative anxiety in children.¹⁷ The authors analysed 34 RCTs and found that PPIA has a positive effect on children's anxiety during anaesthesia induction. The finding of the current study also corresponded with a 2016 RCT of Sadeghi et al. who reported that PPIA reduced preoperative anxiety in children undergoing elective surgery in an effective manner.¹³

Nevertheless, the results from the present study lacked significant differences in anxiety levels with respect to age and gender, as demonstrated in some previous studies. Ozdogan et al.¹⁸ and Erhaze et al.¹⁹ found that younger children (<6 years) had greater anxiety reduction with PPIA than older children in their studies. Challa et al.²⁰ and Talabi et al.¹² found that a child’s age, parental anxiety, and previous hospitalisation experiences affected the effectiveness of PPIA in decreasing anxiety. A 2019 meta-analysis by Vagnoli et al. indicated that PPIA was more effective at reducing the anxiety in younger children in comparison to older children.²¹ In the current study, it might be suggested that PPIA may be equally effective across different age groups. However, there is a need for further research to evaluate the role of age on the effectiveness of PPIA.

The present study was consistent with current trends in paediatric anaesthesia research, which focuses on PPIA as an intervention to reduce preoperative anxiety. In a 2025 review of paediatric preoperative anxiety, Achule et al. stressed the need for non-pharmacological interventions, such as PPIA, as an alternative to pharmacological interventions.²² The authors noted that such interventions were cost-effective, and the side effects that could occur with pharmacological approaches were avoided. However, researchers have also investigated alternative approaches as well. Aplanalp et al. conducted a systematic review, which showed that the tablet-based distraction techniques were as effective as PPIA in curtailing the children’s preoperative anxiety.²³ This suggests that the addition of PPIA with other non-pharmacological interventions will provide greater benefits.

Several important limitations were present during this investigation. The findings may be restricted to other healthcare environments due to the single-site study design. The sample size was sufficient to detect the primary outcome but not necessarily enough to detect differences across subgroups. The research was entirely focused on short-term anxiety during anaesthesia induction and did not consider any long-term outcomes or postoperative effects. Furthermore, parental anxiety was not assessed, which may have affected child anxiety. Therefore, the results likely do not apply to more complex clinical situations, and the study population was restricted to ASA I-II patients undergoing minor surgical procedures. In addition, all personnel could not be blinded. Finally, cultural factors were not explicitly examined as influences on parent-child dynamics and anxiety.

The results of this study support the growing body of evidence for PPIA as a useful non-pharmacological intervention for reducing preoperative anxiety in children. Future research could investigate the possibility of synergy between the use of PPIA and other anxiety-reducing techniques, for example, distraction techniques or virtual reality interventions. It may also be useful to investigate the long-term effects of PPIA on children's overall surgical experience and postoperative outcomes in order to identify opportunities to improve paediatric perioperative care.

CONCLUSION

The results of the present study largely agree with the literature on the efficacy of PPIA in the reduction of anxiety in children undergoing induction of anaesthesia. The reduction of anxiety scores in the PPIA group was similar to many of the previous studies. The anxiety levels did not vary with age and gender in the present study. In aligning this study with current paediatric anaesthesia research trends, the focus on PPIA as a non-pharmacological intervention reflects a method away from pharmacological interventions and a step towards a patient-centred, low-risk approach to managing preoperative anxiety in children.

ETHICAL  APPROVAL:
The study was approved by the Institutional Review Board of Liaquat National Hospital and Medical College, Karachi, Pakistan. The authors confirm that all the administrative and ethical approval were obtained prior to initiating the research work.

PATIENTS’  CONSENT:
The study was carefully explained to the participants/ parents, and voluntary informed consent was taken.

COMPETING  INTEREST:
The authors declared no conflict of interest.

AUTHORS’  CONTRIBUTION:
GF: Conceptualised the study.
SMNN: Designed the study product.
SH: Performed literature search.
AA: Critically reviewed and revised the initial manuscript draft.
SUH: Collected the data, analysed the data, and wrote the results.
NK: Collected data.
All authors approved the final version of the manuscript to be published.

REFERENCES

1. Fraley B. Preoperative anxiety and education in the adolescent population. Beckley, West Virginia: Mountain State University; 2007. Available from: httpss://www.proquest.com/ openview/11e49db29aa532e98064a2b50b468735/1?pq- origsite=gscholar&cbl=18750.
2. Caumo W, Ferreira MBC. Perioperative anxiety: Psychobiology and effects in postoperative recovery. Pain Clinic 2013; 15(2):87-101. doi: 10.1163/156856903321579217.
3. Mahmoud E. Impact of medical trauma on pediatric patients: A focus on pain and fear management. J Nurs Rep Clin Pract 2025; 13(1):17-32. doi: 10.5409/wjcp.v5.i2.143.
4. Garcia De Avila MA, Prata RA, Jacob F, Nobrega FMO, De Barros GR, Sugiura BMG. Educational intervention through a comic book for preoperative anxiety in children, adolescents, and their parents: A randomised clinical trial. J Pediatr Nurs 2022; 67:e208-14. doi: 10.1016/j.pedn.2022. 07.010.
5. Ibanga A, Ibanga H. Psychological Issues in Paediatric Surgery. In: Emmanuel A, Stephen W, Kokila L, Benedict C, Dan P, Eds. Pediatric surgery: A comprehensive text for Africa. 1: GHO Pub; 2012. p. 800.
6. Mizobata VN, Teixeira TRF, Crepalde PAF, Minharro MCO, Garcia de Avila MA. Effectiveness of a perioperative pediatric nursing intervention with a Brazilian educational comic book: A quasi-experimental study. Creat Nurs 2025; 31(2):201-8. doi: 10.1177/10784535251319439.
7. Ozdemir C, Duzgun MV, Karazeybek E, Dalgic AI. The effect of a video-assisted operating room promotion program on the anxiety levels of parents and their children: A randomised controlled trial protocol. J Pediatr Nurs 2022; 67:e150-5. doi: 10.1016/j.pedn.2022.08.006.
8. Shih MC, Elvis PR, Nguyen SA, Brennan E, Clemmens CS. Parental presence at induction of anesthesia to reduce anxiety: A systematic research and meta-analysis. J Perianesth Nurs 2023; 38(1):12-20. doi: 10.1016/j.jopan. 2022.03.006.
9. Turgoose DP, Kerr S, De Coppi P, Blackburn S, Wilkinson S, Rooney N, et al. Prevalence of traumatic psychological stress reactions in children and parents following paediatric surgery: A systematic review and meta-analysis. BMJ Paediatr Open 2021; 5(1):e001147. doi: 10.1136/bmjpo- 2021-001147.
10. Kain ZN, Mayes LC, Wang SM, Caramico LA, Krivutza DM, Hofstadter MB. Parental presence and a sedative premedicant for children undergoing surgery: A hierarchical study. Anesthesiology 2000; 92(4):939-46. doi: 10.1097/000 00542-200004000-00010.
11. Chorney JM, Kain ZN. Family-Centred pediatric perioperative care. Anesthesiology 2010; 112(3):751-5. doi: 10.1097/ALN.0b013e3181cb5ade.
12. Talabi AO, Sowande OA, Mosaku KS, Owojuyigbe AM, Amosu LO, Adejuyigbe O. Effect of parental presence on anxiety during induction of anaesthesia in children undergoing elective day case surgery. Ann Pediatr Surg 2021; 17(37). doi: 10.1186/s43159-021-00106-7.
13. Sadeghi A, Tabari AK, Mahdavi A, Salarian S, Razavi SS. Impact of parental presence during induction of anesthesia on anxiety level among pediatric patients and their parents: A randomised clinical trial. Neuropsychiatr Dis Treat 2017; 12:3237-41. doi: 10.2147/NDT.S119208.
14. Kain ZN, Mayes LC, Cicchetti DV, Bagnall AL, Finley JD, Hofstadter MB. The Yale Preoperative Anxiety Scale: How does it compare with a "gold standard"? Anesth Analg 1997; 85(4):783-8. doi: 10.1097/00000539-199710000-00012.
15. Huda AU, Arif A, Asim Z. Incidence of preoperative anxiety and associated features in children undergoing general anesthesia for a surgery in Middle East population. Anesth Pain Intensive Care 2023; 27(5):575-8. doi: 10.35975/apic. v27i5.2314.
16. Morini F, Dreuning KMA, Janssen Lok MJH, Wester T, Derikx JPM, Friedmacher F, et al. Surgical management of pediatric inguinal hernia: A systematic review and guideline from the European Pediatric Surgeons' Association Evidence and Guideline Committee. Eur J Pediatr Surg 2022; 32(3): 219-32. doi: 10.1055/s-0040-1721420.
17. Li Y, Peng S, Xia X, Yin L, Liao L. Nonpharmacological interventions for decreasing anxiety during anesthesia induction in children: A systematic review and Bayesian network meta-analysis. BMC Anesthesiol 2025; 25(1):226. doi: 10.1186/s12871-025-03077-z.
18. Ozdogan HK, Cetinalp S, Kuran G, Tugal O, Tahiroglu M, Herdem UE, et al. The effects of maternal presence during anesthesia induction on salivary cortisol levels in children undergoing tonsillectomy and/or adenoidectomy. J Clin Anesth 2017; 39:64-6. doi: 10.1016/j.jclinane.2017.03.001.
19. Erhaze EK, Dowling M, Devane D. Parental presence at anaesthesia induction: A systematic review. Int J Nurs Pract 2016; 22(4):397-407. doi: 10.1111/ijn.12449.
20. Challa C, Geng-Ramos G, Gray L, Orshan T, Thackeray L, Gupta P. Anxiety in children: A review on how to address it in the perioperative setting post-pandemic. Paediatr Anaesth 2023; 33(6):422-6. doi: 10.1111/pan.14656.
21. Vagnoli L, Bettini A, Amore E, De Masi S, Messeri A. Relaxation-guided imagery reduces perioperative anxiety and pain in children: A randomised study. Eur J Pediatr 2019; 178(6): 913-21. doi: 10.1007/s00431-019-03376-x.
22. Achule A, Gedeno K, Aweke Z. Management of preoperative anxiety with non-pharmacological methods in pediatric patients in resource-limited settings: A literature review. Ann Med Surg (Lond) 2025; 87(2):780-90. doi: 10.1097/ MS9.0000000000002912.
23. Aplanalp CJ, Hansen R, Otto A, Sukpraprut-Braaten S, Baker H, Aldridge T, et al. A systematic review of tablet-based interactive distraction as a preoperative anxiolytic in pediatric patients undergoing same-day procedures. Cureus 2024; 16(5):e60274. doi: 10.7759/cureus.60274.