Introducción

Congenital talipes equinovarus (CTEV) is a common malformation in children with an incidence of 1 case per 800 live births, 90% of which are born in low- and middle-income countries.1,2 Based on World Bank population data, birth rates, and a talipes equinovarus incidence rate of 1.24 per 1 000 people, it is estimated that 909 people are born with this condition in Colombia every year.2 CTEV may present as an equinus, varus, adductus, or cavus deformity and may occur as an isolated case, be idiopathic, be associated with syndromes, or be secondary to progressive diseases.3

The Ponseti method (PM) is used to treat CTEV due to the low cost of its implementation and the favorable outcomes demonstrated in deformity correction in the short, medium and long term.4 The first stage of the PM, which takes place once a week, entails manipulation of the foot with a detailed and careful technique and the placement of a closed long-leg cast in order to gradually correct the deformity. Then, a percutaneous Achilles tendon tenotomy is performed, and once the deformity is corrected, an abduction brace is used to prevent CTEV recurrence.5 When CTEV is not treated or the treatment is inadequate, the patient may suffer severe functional disability, as well as a significant psychosocial impact.6

Despite the effective outcomes achieved with the PM,7 during the procedure the child may show discomfort and/or distress through crying, muscle tension and/or body movements making the procedure an unpleasant experience for both the child and the caregiver, further causing stress for them and the healthcare professionals treating the child. This can also generate uncertainty, potentially compromising the willingness and attitude of patients and their caregivers during the intervention, as well as adherence to treatment. Therefore, improving the emotional state and disposition of children and their families while implementing the PM is paramount.8

In this context, it has been considered that using non-pharmacological techniques (NPT), which have been used in the care of the pediatric population during minor,9 dental10 and preoperative procedures that usually generate discomfort, fear or anguish, is pertinent to improve the patient’s emotional state. These techniques have been effective, as they have provided a peaceful environment for the patient, better conditions for the execution of painful procedures, and reduced intervention times.9

Since 2001, a tertiary and quaternary healthcare service provider in Bogotá, Colombia, has implemented the Programa de Terapia Lúdica y Psicopedagogía (Play Therapy and Psychopedagogy Program), which aims to reduce the level of stress in children during hospitalization through strategies based on pedagogy, play, integral development of the child, and NPTs. In 2017, this service provider was certified as a Ponseti clinic by the Sociedad Colombiana de Traumatología y Ortopedia and the Ponseti International Association (PIA), thereby becoming a medical center with institutional recognition for the outpatient care of patients diagnosed with CTEV, with exclusive facilities, specific and scheduled care times, qualified and certified personnel in the PM, as well as the capacity to develop research work.

Since 2019, the Programa de Terapia Lúdica y Psicopedagogia and the Ponseti Clinic began to work together to implement NPTs. However, its results and impact have not been reported. For this reason, the objectives of this research were to describe the outcomes of NPT implementation during standard PM treatment sessions of patients with CTEV, the level of patient and family satisfaction with the care received, and the quality of care, as well as to evaluate possible factors associated with the success of NPT implementation.

Methodology

Study type

Descriptive observational cohort study.

Population and sample

The study population included patients under 18 years of age with a de novo diagnosis or relapsed CTEV, with or without previous treatment, who were treated using the PM and NPTs at a Ponseti clinic in Bogotá (Colombia) for two months between February and November 2021 (N=22). Patients who did not follow the treatment were excluded (n=1), so the sample consisted of 21 participants.

Implementation of non-pharmacological techniques to support the patient’s emotional state during standard care

At the Ponseti clinic where the study was conducted, patients with CTEV are treated by a pediatric orthopedic specialist with certified training in the PM. It should be noted that, at this institution, the standard of care for congenital talipes equinovarus patients involves the use of NPTs. At the first consultation, patients are offered the possibility of taking part in the Programa de Terapia Lúdica y Psicopedagogia and, if caregivers agree, a psychopedagogy specialist implements the NPTs during the PM sessions. The NPTs used in this program were developed or adapted from the literature11-14 and are standardized and adjusted for age and psychomotor development, with variations only in the items or strategies used for sensory stimulation.

Cognitive techniques stimulate the visual and auditory senses. In patients under twelve months of age, items or strategies such as visual tracking cards, bubbles, toy microphones with flashing lights, soft rhythm rattles, instrumental music for babies, sentence verbalization (soothing and affectionate), among others, are used. In older pediatric patients, items or strategies such as rotating night light projectors, books or tablets with interactive applications, children’s music or music of the patient’s preference, sentence verbalization, among others, are considered. It should be stressed that the psychopedagogy specialist manipulates the material or item at the child’s eye level and, in some cases, the child can also manipulate and interact with the item.

Regarding behavioral techniques, the senses of taste, touch, and smell are stimulated. In patients younger than twelve months, items or strategies such as 5% dextrose solution (sweet solution), relaxing massages, sensory books, and toys such as rattles are used. With older pediatric patients, rubber dolls are employed, as well as simple mazes and inflatable water mattresses. Although the mother’s smell in a handkerchief is usually used for olfactory stimulation in children under three months of age and essential oils in patients older than three months, in the present study this sense was not stimulated in the participants due to difficulties in using these elements in the office.

NPTs are implemented while providing healthcare services in the presence of caregivers. If the caregiver is identified as a potential source of stress or anxiety for the child, they are required to move out of the patient’s visual field. Items that come into direct contact with the patient are disinfected at the end of the consultation and those used to stimulate the sense of taste are disposed of in a biosecure manner after their use, in accordance with institutional guidelines.

NPTs were implemented under two schemes. For the first NPT scheme, techniques directed to hearing, touch and taste were implemented in children under six months of age, while the techniques for older children were directed to touch and sight. If these techniques failed, the second NPT scheme was implemented at all ages, which included techniques targeting sight and smell. If these new techniques also failed, caregivers were involved in the process. NPT failure was defined as the presence of emotional dysregulation, uncontrolled crying or physical movements that prevented the use of the PM. At the end of each session, the healthcare team recorded the number of NPT schemes used with the patient, the success or failure of the implemented scheme, the senses stimulated in each of the schemes, the items or strategies used in the implementation of the NPTs, the type of office (exclusive Ponseti Clinic office, shared office, or minor procedure room), the care by a nursing assistant assigned to the Ponseti Clinic, the care by a nursing assistant with certification in the PM, and the caregiver in charge of the session.

Health care outcomes

The outcomes assessed included the level of patient and family satisfaction with the care received and the quality of health care, which were measured as an additional process of standard patient care at the end of each session by means of close-ended questions, using standardized formats in Microsoft Excel. First, caregivers were asked about their level of satisfaction with the treatment session, which was measured with the question “How satisfied are you with today’s session?” (response options: high, medium, low); on the other hand, patients’ satisfaction was measured based on the level of calmness reported by the psychopedagogy specialist, which was used as a proxy variable, through the question “In general, how calm was the child during today’s session?” (very calm, fairly calm, neutral, uneasy, very uneasy).

Secondly, the quality of health care was evaluated in terms of the time it took to remove the cast and place the new cast, as well as the simplicity of the procedure for each of the members of the healthcare team (physician, nursing assistant, and psychopedagogy specialist), which was measured by asking the question “How easy did you find today’s session? “(extremely difficult, very difficult, neither easy nor difficult, very easy, extremely easy), and based on the simplicity of the procedure for the patient as measured by the number of times the child cried, using the occurrence of a period of tranquility or calmness as a reference for the count.

Sociodemographic and clinical data

The patients’ clinical and sociodemographic characterization information was extracted from the hospital psychoeducation program database by one researcher, and then another researcher verified that the collected data were correct. With respect to the sociodemographic variables, the following data were recorded: sex, age, place of residence, travel time from the home to the Ponseti clinic per trip, type of family (nuclear family [parents and siblings], extended family [grandparents, aunts, uncles, and other relatives] or single-parent family), main caregiver at home, occupation of the main caregiver, and level of schooling of the main caregiver. Regarding clinical variables, the following data were collected: relevant medical history, timely or late initiation of treatment with the PM, history of treatment with the PM, and number of treatment sessions with the PM and NPTs used.

Statistical analysis

Data are described using dispersion measures (medians and interquartile ranges [IQR]) for quantitative variables based on their normality (Shapiro-Wilk test), and absolute frequencies and percentages for categorical variables. Moreover, the exploratory association between succeeding in the first or second NPT scheme and the categorical variables was determined using the chi-square test (χ2) and a statistical significance value ≥0.05 for hypothesis testing. All analyses were done in the STATA 15 software.

Ethical considerations

This study was approved by the Ethics Committee of the Fundación Universitaria Sanitas de Colombia through CEIFUS 1851-21 of September 9, 2021. The caregivers, on behalf of the patients, signed the informed consent, and verbal and written assent was requested from children aged 7 years and older, as this was established as a sufficient age to understand what their participation in the study entailed, in accordance with the international ethical guidelines for health-related research involving human subjects of the Council for International Organizations of Medical Sciences (CIOMS)15 and the Declaration of Helsinki.16

This research followed the ethical principles for conducting biomedical studies involving human subjects established in the Declaration of Helsinki;16 the scientific, technical and administrative standards for health research set out in Resolution 8430 of 1993,17 issued by the Colombian Ministry of Health; as well as the ethical guidelines of the CIOMS.15 During data collection, analysis and publication of results, patient privacy and confidentiality were preserved.

Results

Of the 21 patients included in this study, 66.67% (n=14) were male. The median age was 4.5 months (IQR=2-6 months; range: 2-48 months) and only one child had a relevant medical history, specifically, a diagnosis of arthrogryposis multiplex congenita. Regarding the initiation of treatment with the PM, 95.24% (n=20) of the cases were considered clinically timely and the remaining 4.76% were considered late (n=1); in addition, 71.43% (n=15) had no history of treatment with the PM. On the other hand, 80.95% of the patients resided in the city of Bogotá (n=17) and the median travel time from home to the Ponseti clinic was 60 minutes each way (IQR=40-120 minutes; range: 20-180 minutes). 61.90% (n=13) of the participants lived with their nuclear family, 23.81% (n=5) with their extended family, and 9.52% (n=2) in a single-parent family. In 80.95% (n=17) of the cases, the main caregiver at home was the mother, and 57.14% (n=12) and 23.81% (n=5) of the main caregivers had a formal job as an employee or was self-employed, respectively (Table 1).

In total, 122 PM sessions using NPTs were performed, with a median of 5 consultations per patient (IQR=5-7 sessions; range=3-13 sessions), in which the mother was the primary caregiver in 86.07% (n=105). Of the sessions, 54.92% were performed in an exclusive office. Furthermore, an exclusive nursing assistant from the Ponseti Clinic and one with PM training cared for the patient in 91.80% (n=112) and 90.16% (n=110) of the sessions, respectively. The complete description of the characteristics is presented in Table 1.

Table 1. Description of patient and caregiver characteristics (n=21).

Variable	% (n)
Sex
Female	33.33 (7)
Male	66.67 (14)
Patient’s age in months (median [interquartile range; minimum-maximum range])	4.5 (2-6;2-48)
Place of residence
Bogotá	80.95 (17)
Chía	4.76 (1)
Cúcuta	4.76 (1)
Tunja	4.76 (1)
Valledupar	4.76 (1)
Travel time from home to the Ponseti Clinic in minutes (median [interquartile range; minimum-maximum range])	60 (40-120; 20-180)
Family type
Nuclear family	61.90 (13)
Extended family	23.81 (5)
Single-parent family	9.52 (2)
No data	4.76 (1)
Primary caregiver of the patient at home
Mother	80.95 (17)
Father	9.52 (2)
Grandparents	9.52 (2)
Primary caregiver’s level of education
Graduate	9.52 (2)
Undergraduate	28.57 (6)
Technical	19.05 (4)
High School	28.57 (6)
Elementary	14.29 (3)
Primary caregiver’s occupation
Employee	57.14 (12)
Self-employed	23.81 (5)
Unemployed	19.05 (4)
Primary caregiver during PM and NPT treatment sessions
Mother	86.07 (105)
Father	12.30 (15)
Parent’s siblings	1.64 (2)
Type of office in which the patient was treated
Shared office or minor procedures room	45.08 (55)
Exclusive office or not shared with other specialties	54.92 (67)
Care by an exclusive assistant nurse of the Ponseti clinic
Yes	91.80 (112)
No	8.20 (10)
Care by an assistant nurse trained in the PM
Yes	9.84 (12)
No	90.16 (110)

PM: Ponseti method; NPT: non-pharmacological techniques.

Source: Own elaboration.

Concerning the outcome of NPT implementation, it was evident that the first scheme was successful in 66.67% (n=14) of the patients and 79.51% (n=97) of the treatment sessions. With this scheme, techniques aimed at stimulating a single sense in 13.93% (n=17) of the consultations, mainly the auditory sense (6.50%; n=8). Likewise, two senses were stimulated with NPTs in 74.59% (n=91) of the sessions, and three senses in 11.48% (n=14) of the sessions, the most frequent combinations being taste and hearing and taste, touch, and hearing, respectively. The elements and strategies used for the implementation of the NPT schemes are described in Table 2.

On the other hand, the second NPT scheme was applied in 33.33% (n=7) of the patients and in 20.49% (n=25) of the consultations, with failure being evident in 2 patients (28.57%) and 9 sessions (36%). Moreover, the second scheme was used in all sessions in 2 of the 7 patients. In general, the second scheme was aimed at stimulating the auditory (15.38%; n=4) and touch (84.62%; n=21) senses (Table 2).

Table 2. Implementation of non-pharmacological techniques to improve the emotional state of the patients included in the study (n=21).

Variable	% (n)
First NPT scheme (n=21 patients; n=122 consultations)
Success (number of consultations)	79.51 (97)
Failure (number of consultations)	20.49 (25)
Success (number of patients)	66.67 (14)
Failure (number of patients)	33.33 (7)
Number of senses stimulated in the first NPT scheme
1	13.93 (17)
2	74.59 (91)
3	11.48 (14)
Second NPT scheme (n=7 patients; n=25 consultations)
Success (number of consultations)	36 (9)
Failure (number of consultations)	64 (16)
Success (number of patients)	71.43 (5)
Failure (number of patients)	28.57 (2)
Elements or strategies used in the implementation of NPTs
Sense of hearing	Children’s music, rattle, and mother’s song
Sense of taste	Sweet solution
Sense of touch	Massage
Sense of sight	Bubbles, children’s books, magic board, and labyrinth
Caregiver satisfaction
High	86.07 (105)
Medium	13.93 (17)
Child satisfaction
Very quiet	41.80 (51)
Fairly quiet	18.03 (22)
Neutral	1.64 (2)
Unsettled	19.67(24)
Very uneasy	18.03 (22)
No data	0.82 (1)
Simplicity of the procedure for the physician
Extremely easy	68.85 (84)
Very easy	18.03 (22)
Neither easy nor difficult	6.56 (8)
Very difficult	5.74 (7)
No data	0.82 (1)
Simplicity of the procedure for the assistant nurse
Extremely easy	67.21 (82)
Very easy	21.31 (26)
Neither easy nor difficult	5.74 (7)
Very difficult	4.92 (6)
No data	0.82 (1)
Simplicity of the procedure for the educational psychologist
Extremely easy	58.20 (71)
Very easy	27.87 (34)
Neither easy nor difficult	2.46 (3)
Very difficult	10.66 (13)
No data	0.82 (1)

NPT: non-pharmacological techniques to improve the patient’s emotional state.

Source: Own elaboration.

Finally, sex, history of treatment with the PM, and the caregiver’s level of satisfaction with the care received during treatment were identified as possible factors associated with NPT success. In addition, the perceived simplicity of the procedure reported by each of the healthcare team members, the number of senses stimulated, and the sense stimulated were associated with the success of the first NPT scheme, but this association was not observed in the case of the second scheme (Table 3).

Table 3. Association between variables and success in the implementation of non-pharmacological techniques schemes to improve the emotional state of patients.

Variable	First non-pharmacological techniques scheme	Second non-pharmacological techniques scheme
Sex	χ2=7.0656, p=0.008	χ2=21.0938, p=0.000
History of treatment with the PM	χ2=4.0389, p=0.044	χ2=5.4687, p=0.019
Number of senses stimulated	χ2=11.9360, p=0.003	χ2=3.5858, p=0.058
Stimulated sense	χ2=27.4363, p=0.001	χ2=0.2501, p=0.617
Level of caregiver satisfaction	χ2=55.6368, p=0.000	χ2=4.8900, p=0.027
Simplicity of the procedure as reported by the healthcare team	- Physician: χ2=57.1486, p=0.000 - Nursing assistant: χ2=47.7032, p=0.000 - Educational psychologist: χ2=63.2051, p=0.000	- Physician: χ2=6.5021, p=0.165 - Nursing assistant: χ2=6.5642, p=0.161 - Educational psychologist: χ2=7.5053, p=0.111

Note: Statistically significant results are highlighted in bold.

PM: Ponseti method; NPT: nonpharmacological techniques to improve the patient’s emotional state; χ2: chi-square test; p: statistical significance value.

Source: Own elaboration.

Regarding children’s satisfaction, 59.83% (n=73) were calm during the procedure, 37.7% (n=46) felt uneasy, and 1.64% (n=2) had a neutral mood. In turn, 86.07% (n=105) and 13.93% (n=17) of caregivers reported having a high and medium level of satisfaction with the consultation, respectively. Also, a significant association was found between caregiver satisfaction and the child’s degree of comfort during the consultation (x2= 30.9151; p= 0.000). It is also important to mention that, although the research protocol proposed by the authors considered the measurement of patient satisfaction, it was not possible to evaluate this variable because all the participants in the cohort were under 5 years of age.

In relation to quality of care, the median cast removal time was 12 minutes (IQR=10-15 minutes; range: 7-60 minutes), while the median new cast placement time was 36.5 minutes (IQR=30-50 minutes; range:10-60 minutes). The simplicity of the procedure was reported as “extremely easy” or “very easy” by the physician in 86.89% (n=106) of the consultations, by the nursing assistant in 88.52% (n=108), and by the psychopedagogy specialist in 86.07% (n=105). In contrast, cases considered “very difficult” were reported more frequently by the psychopedagogy specialist (10.66%) than by the physician (5.74%) and the nursing assistant (4.92%). Regarding the simplicity of the procedure for the patient, the median frequency of crying was 3.5 times (IQR= 1-6.5; range: 1-11) per visit.

Discussion

The present study describes the potential impact of implementing various NPTs adjusted for psychomotor development, age, and the particular needs of the child within the healthcare setting of treatment with the PM in patients with CTEV. In this regard, it was identified that the implemented NPTs improve the emotional state of patients, make it easier to implement the Ponseti method, and improve the experience of parents, children and the healthcare team involved ( physician, nursing assistant, and psychopedagogy specialist). This generates higher levels of satisfaction with the treatment sessions and guarantees and increases the quality of healthcare, which has been reported to be favorable in the care of vulnerable pediatric patients.18

The implementation of NPTs contributes to the humanization of health care for patients with CTEV treated with the PM and their relatives, given that it has been reported that these families have specific needs related to health care, such as education about this condition and its treatment.19 Thus, the implementation of NPTs aims to identify, respect and integrate the psychosocial needs and psychomotor development of patients, providing pleasant experiences during the sessions. In this sense, these techniques represent an important part of comprehensive and quality health care, since they generate well-being for those involved.20

The implementation of NPTs by a psychopedagogy specialist, the adaptation of the Ponseti clinic facilities into an environment favorable for the implementation of the PM and the NPTs, and having personnel focused on providing a comfortable environment for the patient, allow for an easy manipulation of the foot and casting of the extremities, thus enabling the maintenance of proper foot position to correct the deformity. Moreover, NPTs provide reassurance to the caregiver and the patient, thus contributing to improved levels of adherence to treatment, optimization of care times during sessions and, consequently, of the PM treatment. Thus, the systematic, organized and planned incorporation of NPTs into Ponseti clinics can contribute to the implementation of CTEV treatment using the PM and the achievement of the expected results, making these techniques a key tool for health professionals in the context of these specialized centers.

Although the implementation of NPTs requires trained personnel, such as a psychologist or a psychopedagogy specialist, this could decrease the costs related to the treatment of CTEV (e.g., the number of casts used per patient or consultation time), increase the chances of being treated, and reduce the indirect costs borne by caregivers for transportation to the clinic and the psychoemotional toll that comes with long and/or unsuccessful treatment; however, studies are needed to confirm these hypotheses.

At the time of writing this article and according to the evidence search, there is no study reporting a similar experience in another Ponseti Clinic. In addition, while medical treatment with the PM can be given without NPTs, these techniques are a way to promote, strengthen and direct pediatric health care toward the paradigm of person-centered care.21 In view of the foregoing, institutional commitment is necessary, as it allows for the provision of adequate facilities and exclusive and permanently available personnel for the care of patients with CTEV.

The methodological limitations of this study include the failure to calculate sample size, which would allow determining the effectiveness of NPTs in pediatric patients with CTEV during treatment using the PM. For this reason, the present research is an exploratory approach that was carried out to contribute to knowledge and future research. This implies that extrapolation and generalization of results is limited and, therefore, should be done with caution. Another limitation is that the study was conducted during the COVID-19 pandemic and biosecurity measures were adopted to reduce the spread of the virus, affecting the conditions of standard health care in the institution. Finally, it should be noted that the implementation of activities as part of the NPTs may vary slightly in the attitudinal component since the way in which they are carried out depends on the operator (e.g., reading a book may be more expressive and/or dynamic in some sessions than in others).

This study is the first article identified by the authors in the literature that reports the use of NPT protocols that take into account the psychomotor development of children and that were applied in pediatric patients with CTEV during their treatment using the PM, contributing to the knowledge and identification of future research opportunities.

Conclusion

The use of NPTs during PM sessions for children with CTEV improves the child’s psychoemotional state by reducing discomfort, distress, fear and/or stress during the consultation, thus facilitating the performance of PM procedures, while increasing the level of satisfaction of the caregiver and the healthcare team with the treatment sessions. The implementation of NPTs requires trained personnel, institutional commitment, and availability of materials and spaces for patient care, as provided by the Ponseti clinics.

Conflicts of interest

None stated by the authors.

Funding

None stated by the authors.

Acknowledgments

None stated by the authors.

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