The Impact of Child Life Intervention on Psychological Status and Quality of Life in Children With Cleft Lip and Palate

Abstract

Objective:

This study aims to investigate the effectiveness of Child Life Intervention on social anxiety and oral health-related quality of life in children with cleft lip and palate.

Methods:

In a single-blind, parallel-group randomized controlled trial, 104 children with cleft lip and palate were randomly assigned to either an intervention group (receiving Child Life Intervention) or a control group (receiving usual care).

Results:

All participants completed the study. Children in the intervention group showed significantly lower scores on both the social anxiety scale and the oral health-related quality of life scale compared with the control group, with statistically significant differences (P<0.05).

Conclusion:

The application of Child Life Intervention demonstrated a significant positive effect in children with cleft lip and palate, leading to notable improvements in social anxiety and oral health-related quality of life.

Cleft lip and palate (CLP) are the most common congenital craniofacial malformation. Its clinical manifestations primarily include dental arch irregularities and speech dysfunction, while oronasal communication increases the risk of complications such as otitis media and upper respiratory tract infections.¹ China has a notably high prevalence of CLP, with a reported incidence of 1.82%.²

At the time of this writing, surgical repair remains the primary treatment for CLP. However, children with CLP are at a substantially heightened risk for social anxiety due to their visible facial differences and speech impairments, which are continuously highlighted in daily social interactions.^3–5 These characteristics subject them to prolonged psychological stress from external attention and evaluation, manifesting as intense fear of negative judgment and active avoidance of social situations.⁶ Such negative emotional responses can severely compromise treatment adherence and pose long-term threats to psychological well-being and social integration.^7,8

Beyond psychological functioning, CLP significantly impacts oral health-related quality of life. Oral health-related quality of life encompasses an individual’s comfort when eating, sleeping, and engaging in social interaction, as well as their self-esteem and satisfaction with oral health.^9,10 For children with CLP, factors such as dental anomalies, speech difficulties, and prolonged treatment regimens can substantially impair their oral health-related quality of life, affecting daily activities, emotional well-being, and social functioning.^11,12 Despite its recognized importance as a patient-centered outcome, oral health-related quality of life has received limited attention in psychosocial interventions for this population.

Play, as a developmentally appropriate activity, effectively helps children feel more comfortable and secure when confronting unfamiliar medical situations.^13,14 Accumulating evidence suggests that play-based approaches play a crucial role in helping children with CLP overcome fear, manage frustration, and alleviate pain.¹⁵ Child Life Intervention is an evidence-based, developmentally supportive approach that utilizes various modalities, including sensory expression and therapeutic play, to reduce anxiety levels in both children and families, improve health care experiences, and enhance quality of life.¹⁶

As one of the first conditions to pioneer multidisciplinary sequential treatment internationally, CLP is characterized by an extended treatment trajectory, involvement of multiple specialties, and variable outcomes. These features predispose affected children to social anxiety and difficulties adapting to normal social life.¹⁷ Conventional nursing approaches often prove monotonous and lack engagement, rendering them insufficient for addressing these complex psychosocial and quality of life challenges. While health care teams in China have begun implementing Child Life service models for hospitalized children with conditions such as leukemia and iron-deficiency anemia,¹⁸ research specifically examining systematic Child Life Intervention for children with CLP, particularly its effects on both social anxiety and oral health-related quality of life, remains limited.

Therefore, this study aims to implement a structured Child Life Intervention protocol for children with CLP and evaluate its effects on social anxiety and oral health-related quality of life, thereby providing empirical evidence to inform clinical nursing practice for this population.

METHODS

Study Design

A prospective, parallel, single-blinded pilot RCT was implemented, spanning the period from November 2024 to June 2025, in adherence to the CONSORT statement.¹⁹

Participants and Setting

Children with CLP who met the following criteria were invited to participate in this study: (1) aged between 6 and 14 years; (2) able to understand and communicate in Chinese. The exclusion criteria were as follows: (1) concurrent diagnosis of immune-related diseases, congenital disorders, or other severe illnesses; (2) presence of intellectual disability, language communication disorders, or cognitive dysfunction; (3) lack of care from a first-degree relative; (4) poor cooperation or noncompliance during the study process.

The primary outcome measure of this study was the postintervention score on the Social Anxiety Scale. On the basis of previous relevant research, the score in the control group was 7.72±4.49, and that in the intervention group was 5.11±2.74. With a 2-sided α of 0.05 and a power of 0.90, the sample size was calculated using the following formula based on the means of the 2 groups. After accounting for a 15% loss to follow-up, a total of 104 participants were finally included in this study, meeting the sample size requirement.

$$n=\frac{{(Z_{1-\alpha /2}+Z_{1-\beta })}^2\times ({\sigma }_1^2+{\sigma }_2^2)}{{\delta }^2}$$

where n is the sample size per group; $Z_{1-\alpha /2}$ and $Z_{1-\beta }$ need to be obtained from the Z-table, σ ₁ is SD of the first group, σ ₂ is SD of the second group, and δ is clinically meaningful difference between the 2 groups.

Group Allocation Procedure and Blinding Implementation

Allocation concealment was implemented using the sequentially numbered opaque sealed envelopes (SNOSE) method. Envelopes were uniformly prepared by an independent research assistant who was not involved in participant recruitment, intervention delivery, or outcome assessment, and each envelope contained a card indicating the group assignment. Once a child met all inclusion criteria and provided informed consent, the on-site research nurse opened the next envelope in numerical sequence to assign the participant to a group. This procedure ensured that neither the researchers nor the participants could predict group assignment before enrollment, effectively controlling for selection bias.

Following group allocation, children in the control group received standard routine care during their hospital stay, including preoperative health education, postoperative wound care, pain management, and discharge instructions. No additional Child Life Intervention activities were provided to the control group throughout the entire study period. Children in the intervention group received structured Child Life Intervention in addition to routine care, and the detailed intervention protocol is shown in Figure 1.

FIGURE 1.

Themes and contents of the intervention.

This study adopted a single-blind design, where both outcome assessors and data analysts were blinded to group assignment. Research assistants responsible for distributing and collecting the SASC and COHIP questionnaires at baseline, discharge, and the 3-month postoperative follow-up were unaware of the participants’ group allocation throughout the study. All study data were entered into a password-protected database by an independent statistician, who also remained blinded to group assignment during the initial data analysis phase.

Measures

Demographic and clinical characteristics questionnaire: A general information questionnaire designed by the researchers was used to collect demographic and clinical characteristics, including sex, age, and disease type.

Chinese Version of SASC

The Chinese version of the Social Anxiety Scale for Children (SASC) was used for assessment (Supplementary Table 1, Supplemental Digital Content 1, http://links.lww.com/SCS/J832). This instrument, developed by La Greca et al,²⁰ contains 10 items rated on a 3-point scale (0=never, 1=sometimes, 2=always), with higher total scores indicating greater levels of social anxiety. According to the Chinese urban norm, a total score of ≥8 points suggests the potential presence of anxiety disorder. The scale has demonstrated acceptable internal consistency (Cronbach α=0.79).²⁰

Child Oral Health Impact Profile

The scale consists of 34 items, of which 28 assess the negative impacts of oral health and 6 assess the positive impacts, covering 5 dimensions: oral symptoms (10 items), functional limitations (6 items), socio-emotional well-being (8 items), school environment (4 items), and self-image (6 items) (Supplementary Table 2, Supplemental Digital Content 1, http://links.lww.com/SCS/J832). It is completed by the child’s caregiver based on the child’s recent oral health status. Each item is scored on a 5-point Likert scale, with total scores ranging from 0 to 136. Higher scores indicate lower oral health-related quality of life in the assessed child. The scale demonstrates good internal consistency (Cronbach α=0.92).²¹

Data Collection

The questionnaires were administered by the researchers in a centralized manner. After explaining the purpose, content, and significance of the survey to the children’s parents or guardians and obtaining their informed consent, the baseline assessments were conducted as follows: the SASC and the Child Oral Health Impact Profile (COHIP) were completed electronically upon admission. Postintervention assessments included the SASC administered electronically at discharge, and the COHIP completed electronically at the 3-month follow-up.

Data Analysis

SPSS version 26.0 (IBM Corp., Armonk, NY) was used for data analysis. Descriptive statistics were applied to summarize participants’ demographic and clinical characteristics. Continuous variables are expressed as mean (SD), and categorical variables as frequency (percentage). Differences between the intervention and control groups were compared using the χ² test and t test, with statistical significance set at P<0.05.

Ethical Considerations

This study was approved by the Institutional Ethics Committee of the affiliated hospital (Approval No. WYKQ2023028). Written informed consent was obtained from all participants and their parents before their involvement in the study. In addition, participants and their parents were informed about the confidentiality of their data and their right to withdraw from the study at any time without penalty.

RESULTS

General Data of Patients

The intervention group consisted of 52 children with a mean age of 10.54 years (SD=2.36), including 30 boys (57.7%) and 22 girls (42.3%). The control group included 52 children with a mean age of 10.48 years (SD=2.59), comprising 26 boys (50%) and 26 girls (50%). Supplementary Table 3, Supplemental Digital Content 1, http://links.lww.com/SCS/J832 presents the general information of both groups. No statistically significant differences were observed between the 2 groups (P>0.05), indicating comparability at baseline.

The Impact of Child Life Intervention on Social Anxiety and Oral Health-Related Quality of Life

Supplementary Table 4, Supplemental Digital Content 1, http://links.lww.com/SCS/J832 presents the statistical data on social anxiety scores for both groups before and after the intervention. Before the intervention, no significant difference was observed in SASC scores between the 2 groups (P>0.05). Following the intervention, SASC scores decreased significantly in both groups compared with baseline levels, with the intervention group demonstrating significantly lower scores than the control group (P<0.05).

Supplementary Table 5, Supplemental Digital Content 1, http://links.lww.com/SCS/J832 shows that before intervention, no significant differences were found between the 2 groups across all domains (P>0.05). After intervention, both groups showed lower scores than before, with the intervention group scoring significantly lower than the control group (P<0.05).

DISCUSSION

Social anxiety refers to intense feelings of worry, tension, or fear during interpersonal interactions, often accompanied by avoidant behaviors. For children with CLP, who present with facial deformities and speech impairments, social anxiety is particularly pronounced and complex.³ As daily communication is unavoidable, the distinctiveness of their appearance and speech is continuously highlighted in social situations, subjecting these children to prolonged psychological stress from external attention and evaluation. Moreover, children with CLP often struggle to develop an independent self-concept, rendering their self-perception more susceptible to direct influence from feedback received at school, at home, and within society.⁴ Consequently, they frequently exhibit pronounced protective behaviors in interpersonal interactions, such as avoiding eye contact, significantly reducing verbal expression or responding only with brief utterances, and even relying on gestures as a substitute for speech.²² Therefore, alongside clinical biomedical treatment, implementing nursing interventions tailored to their psychosocial needs is of paramount importance.

Conventional nursing approaches, characterized by monotonous routines and limited interactive elements, often prove insufficient in effectively alleviating children’s fear and anxiety. In contrast, Child Life Intervention, as a developmental psychological intervention, demonstrates unique value.²³ By utilizing carefully designed games and sensory expression activities, this intervention constructs a safe and supportive environment for children, thereby enhancing their adaptation to and sense of control over medical situations. It helps children learn to cope with stress in a practical context, actively reducing anxiety and fear, and safeguarding their psychological well-being.²⁴ Play activities themselves offer irreplaceable benefits for hospitalized children. Illness and treatment often restrict their normal play and social interactions, yet play serves as a core pathway for children to express emotions, learn coping mechanisms, and develop social skills.²⁵ Hence, introducing diverse forms of play into the medical environment is crucial. A single form of play can easily lead to boredom; therefore, this project integrates multiple types, including role-playing, group activities, music, and picture books, allowing children to select age-appropriate games. This diversity not only enhances the appeal of play but also contributes to boosting children’s self-confidence, social enjoyment, and interpersonal skills, thereby indirectly alleviating their social anxiety. Furthermore, incorporating health education into games effectively stimulates children’s interest and initiative in rehabilitation training. This intrinsic motivation can translate into better postoperative cooperation and recovery outcomes, ultimately promoting an improved oral health-related quality of life. The results of this study demonstrate that Child Life Intervention can effectively alleviate social anxiety symptoms and significantly improve oral health-related quality of life in children with CLP, a finding that is highly consistent with studies on play-based and expressive arts nonpharmacological interventions in other pediatric populations with chronic diseases. A music therapy study for pediatric cancer patients by Wong et al²⁶ reported an overall goal achievement rate of 89.2%, with 88.9% of goals in the body functions domain focusing on emotional regulation and morale enhancement, which significantly improved the mental health of children across all age groups through a safe and nonthreatening medium for emotional expression. Meanwhile, the clown intervention study by Lopes-Junior et al²⁷ found that a single 30-minute interaction reduced the total psychological stress score of children by 38.9% within 4 hours, with significant improvements observed in all stress subdomains, which is highly consistent with the comprehensive alleviation trend of social anxiety symptoms in children in our study. The 3 interventions share core underlying mechanisms: all adopt developmentally appropriate, child-centered activity formats, reduce perceived threat in medical settings and enhance the sense of autonomy and control by constructing a safe and supportive environment, break through the expressive limitations of traditional verbal therapy, enable children to express emotions and build self-confidence through nonverbal or semiverbal actions, and ultimately achieve dual improvements in psychological status and social functioning.

This research has several notable strengths. To the best of our knowledge, it is the first to investigate the significance of applying Child Life Intervention in children with CLP. Building upon Western experiences, we adapted the Child Life Intervention to align with China’s cultural background and medical environment by incorporating traditional Chinese cultural symbols, emphasizing family involvement, and employing age-appropriate communication styles.

Nonetheless, it is important to acknowledge several limitations that should be considered. First, the sample selection and intervention were conducted within a single hospital, which, to some extent, limits the generalizability of the intervention to other, less developed regions. Second, the study population was confined to children with CLP aged between 6 and 14 years; research involving younger children remains limited. Finally, the study period was relatively short. Due to constraints in funding and conditions, it did not cover the entire treatment cycle for children with CLP.

CONCLUSIONS

Child Life Intervention significantly alleviated social anxiety and improved oral health-related quality of life in children with CLP. By providing a structured, play-based approach tailored to developmental needs, the intervention enhanced children’s coping abilities and reduced social avoidance behaviors. These findings suggest that incorporating Child Life Intervention into routine cleft care offers meaningful psychosocial benefits and supports better oral health outcomes.

Supplementary Material

scs-37-02800-s001.docx ^{(27.6KB, docx)}