Effectiveness of Play Therapy Programme in Promoting Early Child Development (ECD) of under-5 Children visiting Tertiary Care Hospital in Rural Settings: Study Protocol of  a Randomized Controlled Trial.

Impact of hospitalisation on children

Hospitalization plays a significant effect in a child’s life. Many children admitted to hospitals have complex healthcare needs, and some require highly technical interventions. According to the 2013 statistics by World Health Organization (WHO), children under the age of five died from diseases like acute respiratory infections, birth asphyxia, diarrhoea, neonatal sepsis, injuries, congenital anomalies, and infant prematurity.⁷ Children hospitalized with the above diseases tend to have a traumatic experience at a hospital, such as in the long-run hospitalization tends to demonstrate negative psychological and behavioural response.⁸ Usually, the hospitals are focused more on physical recovery and mortality than the overall well-being of the child and her family.⁹ Children tend to perceive hospitals negatively, which impacts their physical and mental health. A study found that hospitalized children felt scared, bored, and alone.¹⁰ Children experience happiness, sadness, anger, and fear in the presence of a doctor and nurse.¹¹ In another study, it was found that there was a reciprocal relationship between anxiety, blood pressure, and heart rate.¹² It was also found that when children were asked to draw a person in a hospital, the drawings indicated anxiety. They drew pictures of people who were sad and dependent.¹³

Furthermore, according to the parents, a child’s behaviour, function, and health before hospitalization and after hospitalization are significantly different. Children suffer from emotional distress three to five months after hospitalization and surgery, which is most common in the age range of one year to six years. Trauma that children face at the hospital has been termed Paediatric Trauma Mental Stress which is characterized by avoidance, re-experience of the event, and hyperarousal which arises from a major illness or medical Intervention that causes a threat to a child’s health and is considered to be intrusive, painful and alarming medical care. Children tend to internalize their problems and may have symptoms of depression and anxiety which further aggravates their illness.¹⁴ Certain risk factors are involved when children are hospitalized or undergo surgery. Some risk factors may be attributed to their age range, temperament, baseline anxiety, past medical encounters, and parents’ Level of anxiety. Children tend to suffer from anxiety while hospitalized due to uncertain treatment possibilities.¹⁵

Play stimulation for hospitalised children

Children, when hospitalized, tend to look for activities that can keep them calm. In some instances, they look toward their parents so that they can speak to them and look toward other children with whom they can play instead of getting bored. Some children found the hospital as a place where they can explore, learn and make new friends.¹⁰ Physical exercise, healing touch, music therapy, therapeutic massage, and health education have decreased cancer symptoms.¹⁶ Play activities that include art have also affected children’s overall health at the hospital. In the case of infants if their parents talk to them, massage them, make eye contact, sing to them or put objects at a closer distance and the infant grabs them, shows infants bold colours, or plays games like peek-a-boo or mimicking what the child is saying can soothe the child.²

Other activities have also assisted in alleviating the symptoms of anxiety and pain. A study found that children prefer natural landscapes with calming colours over abstract paintings with bold colours. The realistic painting paved the way for positive physiological outcomes and was used for distraction, reducing pain perception.¹⁷ Reading also influences children’s well-being, and when caregivers read books to children when they are sick, children feel comfortable, and their emotional affiliation with the caregivers grows.¹⁸ Videoconferencing with the family has also assisted in reducing the stress of children.¹⁹ Surgical procedures can create anxiety in children as well as their parents. A study found that before the children went through surgery, the nurses taught them the procedures and outcome of the surgery. The nurses, as well as the children, re-demonstrated the procedure in dolls. Since they observed it, this reduced their anxiety and caregivers.¹⁷ When children above the age of four were educated about their health, they showed lower levels of anxiety than children younger than them. When play routine was introduced to hospitalized children, a lower cortisol level in their urine was indicated.²⁰ Play activities can help in reducing the organic symptoms in children. The time spent at the hospital can also be shortened when children participate in activities related to play stimulation.

Rationale

As per the census of 2011, India had a population of 1211 million, among which 164.5 million children were in the age group of 0-6 years, and 372.4 million belonged to the age group of 0-14 years, which constituted around 13.59% and 30.76% of the total population, respectively. 74% of the children aged 0-6 years reside in rural areas, whereas the rural population constitutes 69% of the total population of India.⁷ In India, the hospitalization rate of children aged 1-6 years is almost doubled due to common ailments like fever and diarrhoea. In contrast, hospitalization due to non-communicable diseases and injuries has also increased greatly over the last decade.⁸ The average length of hospital stays ranged between 6-15 days, depending on the type of ailment.⁹

The role and value of play are greater in the case of children with life-threatening diseases, disabilities, and vulnerable situations. Several diseases and conditions require the Hospitalization of children for weeks to a month. Play therapy during hospitalization can help to restore the child’s ability to play which was discontinued due to hospital admission. It can help to manage a child’s confidence that he can continue his/her normal life inside the hospital. With this understanding of play, healthcare professionals can explore the effects of Hospitalization and disease on children and enhance their emotional development.

Acharya Vinoba Bhave Rural Hospital (A.V.B.R.H.) in Wardha is a tertiary care hospital of Datta Meghe Institute of Medical Sciences and catering to the healthcare needs of the rural population from five districts Wardha, Nagpur, Chandrapur, Yawatmal, and Amaravati. A.V.B.R.H. is a 1,500 bedded healthcare facility with a specialized Paediatric Department, dedicated Neonatal Intensive Care Unit, and Child Development Centre. This study will focus on developing a locally adapted Play Therapy Programme for hospitalized children, the sensitization of parents regarding child development, and developing a safe, harmless, and sterilizable Play Kit for hospitalized children to minimize the risk of transmission of infection from children to children or healthcare staff. An earlier preprint version of this article can be found on Research Square.²¹

Objectives

Primary objectives:

Secondary objectives:

Trial design

This will be a randomized controlled exploratory trial. The study participants will be randomized into Intervention and Control groups with a 1:1 ratio using block randomization.

Study setting

This study will be conducted at the Department of Paediatrics in Acharya Vinoba Bhave Rural Hospital, Wardha, and nearby villages within a 25 K.M. radius. Wardha is the smallest district in the Maharashtra State of India.

Eligibility criteria

Inclusion criteria:

Exclusion criteria:

The Investigator will take written informed consent from the parents of the hospitalized children. The comparator (control) group will include children from the adjoining paediatric ward on another floor and admitted during the period when interventions will not be implemented. Children from this group will receive all required treatment and nursing care except the Play therapy sessions. This will help to avoid any contamination. Baseline assessments and socio-demographic information of these children will be collected at enrolment. Follow-up home visits will be done at monthly home visits. Assessments will be done at six months and 12 months from the date of enrolment. If successful, the children from control group will receive play therapy after the trial is over.

The children and their parents signing the informed consent will be enrolled in the study. All enrolled children hospitalized in A.V.B.R.H., scheduled to stay for a minimum of three days in the hospital, will be assigned a Unique ID. Children will be allocated to intervention or control groups using a block randomization process^22,23 with age groups as the blocking variable. Intervention group will receive the play therapy sessions along with the required treatment and nursing care during hospitalization stay. Sociodemographic profile and baseline assessments will be done. Play therapy sessions will be conducted at the dedicated play area in hospital. Also, these children from the intervention area will receive the play sessions at scheduled monthly home visits. Figure 1 shows the anticipated Consort Flow Diagram of study participants.

Figure 1. Consort flow diagram.

The play therapy manual has been developed by the Principal Investigator with the activities specified as per the domains of child development including physical development, language and communication skills, socio-emotional development, and cognitive development. A couple of parents and children were involved and their inputs were included in the development and piloting of the Play Therapy Manual. The Play Activity manual²⁴ is available in the extended data.

The Principal Investigator will train the team of Research Assistants on the intervention package. The trained and certified Research Assistants will deliver the intervention in hospital setting and then at home visits as per the schedule drafted by Principal Investigator.

Duration of the interventions

Criteria for group sessions at the hospital

The hands of parents and their children will be washed before the activities start to avoid infectious contamination. Children will be divided into two groups as below:

The intervention delivery details are as below:

On first day of hospitalization, parents and children will be interacted at Paediatrics ward. Randomization will be done and the parents in intervention arm will be sensitized about Play Therapy Programme. Written informed consents of parents will be taken from those who consent for participation and will be enrolled in the programme and e-learning platform/Whatsapp group.

On second day of hospitalization, a session will be conducted at designated play area in hospital. The session will emphasize on importance of early child development, its implications; diet, nutrition and healthcare of children. This session will be followed by play interaction session on cognitive and language development.

On third day of hospitalization, a play session on motor developmental activities will be conducted. This will be followed by session on socioemotional development and activities to promote it. Relevant Documents and reading materials in local language will be shared with parents during these sessions. The enrolled children will participate in play sessions and activities till the child is hospitalized.

After discharge from the hospital, parents and children will be contacted through monthly home visits personally and if needed, through online mode (Whatapp video call/Google classroom) at monthly intervals. The home visits will be scheduled for the assessment of Home Environment and Parent-Child Interactions. The monthly sessions will be continued till one year from the date of enrolment of child in the programme. Appropriate medical and nursing care will be provided during the hospital stay. If needed, referral services will be provided during follow-up at-home visits. If Children and parents insist on discontinuing play therapy, the sessions will be discontinued for those children.

After one-year of enrollment, assessments of age-appropriate developmental milestones of children will be done either in the hospital ECD Centre or through personalized home visit to the enrolled family. Age-appropriate assessment tools will be used. Reports will be shared with parents, and follow-up instructions and meeting schedules will be shared. Figure 2 shows the schedule of enrolment, interventions, and assessments.

Figure 2. The schedule of enrolment, interventions, and assessments.

The participants from control group will not receive any messages on any aspects of intervention, neither they will be interacted directly by intervention team throughout the study period. The control group participants will be contacted by the assessors for the baseline and endline assessments only.

There is no anticipated harm from the trial participation. The study participants will be provided with the printed copies of Play Therapy Manuals after completion of trial. The children with below average development scores will receive additional ECD services at hospital ECD centre and will receive follow-up till next one year through home visits.

Outcomes

Primary outcomes:

Secondary outcomes:

Figure 2 details the schedule of enrolment, interventions, and assessments.

Sample size

With reference to the study conducted by Gaidhane et al., ^25,26 the expected difference in child development outcomes between the intervention and control groups is 0.5 SD, considering a dropout rate of 10%, level of significance = 5%, and power = 80%. The formula for calculating sample size for two independent means is:

n = Minimum sample size required in each group,

d = Expected mean difference between two groups = 0.5

δ = standard deviation = 1.69 (As per Previous Study)

Zα: value of type I error at 5% significance level =1.96

Zβ: value of type II error at 80 % Power (1-β) = 0.84

Based on the above formula, the calculations are as follows:

Thus, the sample size required per group is 180. Hence total sample size required is 360. A sample size of 360 subjects, 180 in each arm, is sufficient to detect a difference of 0.5 between groups in developmental scores, assuming a standard deviation of 1.69 using a two-tailed t-test of difference between means with 80% power and a 5% level of significance. For assessing the changes in parenting knowledge and skills, parents of all children in intervention group (180) will be assessed.

Recruitment

Parents of children reporting to A.V.B.R.H. in the first three months (January-March 2023) will be enrolled in the trial. All participants consenting to participate in the study will be assigned the Unique ID. Using a blocked randomization process with age groups as the Blocking variable, participants will be allocated to intervention or control groups. Age groups will be:

All children hospitalized in A.V.B.R.H., scheduled to stay for a minimum of three days in the hospital, and their parents signed the informed consent will be enrolled in the study.

Assignment of interventions: allocation

All participants consenting to participate in the study will be assigned the Unique ID. Sequence generation will be done using computer generated random numbers. Using a block randomization process^10,11 with age groups as the blocking variable, participants will be allocated either to intervention or control groups.

Sequentially numbered, opaque, sealed envelopes will be used for implementing the allocation sequence.

The Principal Investigator will generate the allocation sequence, trained assistants will enroll the participants, and assign participants to intervention and control groups. The Principal Investigator will train the Research Assistants for intervention, and assessors for baseline-endline assessments, supervise the data collection process and monitor the trial implementation process. We will ensure that all adults associated with the trial have the appropriate permissions and training and criminal records check to work with children. The outcome assessors and data analysts will be blinded.

Data collection and management

Data will be collected in pre-tested Open Data Kit (O.D.K.) based app with inbuilt checks for data quality, identifying duplicate entries. The data received on dedicated server of Research Cell of Datta Meghe Institute of Medical Sciences will be imported and checked on real time basis. The data will be encrypted for sensitive information and will be handled by the assigned team including Information Technology Coordinator and statistician. The datasets will be shared and made reusable according to FAIR data principles.

Assessments will be conducted using the tools as detailed below:

The research assistants will be trained on the use of all these tools and inter-rater, intra-rater scoring exercises will be conducted during training. To promote participant retention and complete follow-up, all enrolled children in the intervention group will receive scheduled home visits at monthly intervals. The children in the control group will be followed up telephonically at monthly intervals. Also, telephonic follow-up will be taken for those missing home visits in intervention group. The outcome data will detail the participants who discontinue or deviate from intervention protocols.

Data management

All data will be collected in tablet P.C. based O.D.K. collect app with an in-built range check, double entry, and value checks. Data will be exported to the server after ensuring the correctness of the data entered. The data from the server can be downloaded as an excel file. Each participant will be allotted a Unique ID which will be used for analysis and reporting purposes. All data will be anonymous and personal information will be maintained to protect confidentiality before, during, and after the trial.

Statistical methods

After appropriate cleaning and compilation, the pre- and post-intervention child development data in specified domains will be collected and fed to STATA-14 by the assigned statistician. Individual and child age-group wise scores of developments will be calculated and tabulated. Mean differences in child development scores for intervention and control groups and pre-post intervention will be calculated. The effect size by Cohen’s-D will be calculated for each child age group, and significance of differences in effect size will be estimated. Also, qualitative subgroup and adjusted analyses, Difference in difference analysis for motor, language, cognitive and socio-emotional development scores will be done. Attempts will be undertaken to ensure the collection of complete data. In cases of missing data, families will be contacted through home visits and missing data will be collected. If any case/family could not be tracked, iterative algorithm or multiple imputation technique will be used to handle the missing data. The datasets analysed during the current study, statistical code and full protocol will be made available by publishing on open data repository Zenodo.

Oversight and monitoring

Composition of the coordinating center and trial steering committee

The Trial Steering Committee (TSC) consist of the following:

The Principal Investigator is responsible for all aspects of local organisation including identifying potential recruits and taking consent. The PhD Supervisor, Head of Public Health Department, Director Research and Development, and Head of Paediatrics department will be supervising the trial. Trial Steering Committee (TSC) will meet over the course of the trial to oversee conduct and progress in monthly meeting.

Composition of the data monitoring committee, its role, and reporting structure

The data monitoring committee (DMC) consists of Research-in-charge of the institute and Research-in-charge and Data Manager of the department. All related data will be managed and monitored by Principal Investigator, along with support from a statistical expert as per the guidance of Data Monitoring Committee. Since this is a play therapy intervention, hardly any adverse events and other unintended effects of trial interventions or trial conduct are expected. If encountered, those will be reported per the guidelines from the Institutional Ethics Committee. Project Management Group will review the trial conduct in monthly meetings. The Trial Steering Group and the independent Data Monitoring and Ethics Committee will review the conduct and progress of trial in quarterly meetings. Important protocol modifications will be communicated to relevant parties (e.g., investigators, Regional Ethics Committee/Institutional Review Boards, trial participants, and trial registries through emails and printed hard copies, as required).

Dissemination plans

The project results and data will be published on Stepping Stones Project website of our Institute.³⁴ The trial results will be published in Scopus, Pubmed, and Web of Science-indexed specialty journals on early child development and have access to healthcare professionals, the public, and other relevant groups. The participants will be informed of the results through personalized visits and provided the information brochures.

Trial status

This trial was registered prospectively with Clinical Trial Registry of India (CTRI).³⁵ Recruitment of Participants started from Jan 2023. Expected date of trial completion is 30^th May 2024.