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

Background: Early childhood demands for good care, conscious and mindful parenting. The survival through childhood depends on adults who consciously handle the hunger, sickness and socioemotional needs of children. Good care also includes practices of keeping children safe from harm, giving them love, attention, and providing the opportunities to learn. Hospitalization is obviously quite stressful for the child of any age. For years, it has been known that play is an vital element for promoting the normal growth and development of children. Methods: This Randomized Controlled Trial will be implemented through the hospital settings of Acharya Vinoba Bhave Rural Hospital, Wardha and the enrolled children will be followed at home visits at scheduled intervals over a period of one year from enrolment. Children in intervention arm will receive customized Play Therapy sessions during hospital stay and at scheduled home visits. Assessments will be done for child development parameters through a set of tools and difference in development scores will be compared between intervention and control groups. Discussion: Intervention group is expected to show signi�cant improvements in child development scores compared to control group. The customized play therapy programme will be adapted to different paediatric inpatient settings and attempts will be made to develop a dedicated and safe Play Therapy kit for hospitalized children.


Introduction
Background and rationale {6a} Period of early childhood from birth to 6 years of life is a very crucial period.Early childhood demands for good care, conscious and mindful parenting.The survival through childhood depends on adults who consciously handle the hunger, sickness and socioemotional needs of children.Good care also includes practices of keeping children safe from harm, giving them love, attention, and providing the opportunities to learn.Right from birth, children get bonded to special adults and try to learn the important basic skills by copying them.The learnings from these relationships serve as a base for getting the children prepared for life skills (1).It was found that, globally over 200 million children fail to reach their developmental potential in the rst 5 years due to poverty, poor health services, poor nutrition and lack of appropriate psycho social care (2).
Early childhood is a period of rapid development.Play and recreation is naturally an essential part of childhood and is vital to normal development.Through various types of play and recreational activities, children start to learn, try to express themselves, cope with anxiety, develop their skills and master the experiences.Play can also help to facilitate in learning how to adapt and tolerate the healthcare and hospitalization experience.In a sense, play and recreation mimics a therapy of giving children the opportunity for exploring, processing and expressing their healthcare experiences in a safe and protected environment (3).
Hospitalization is obviously quite stressful for the child of any age.Even, the older children need their parents during the period of a serious illness, and cannot tolerate their absence even for a short period.They want their parents to be there when they need them and wish to be loved and missed.Play is very essential part of a child's life and is a key aspect in fostering child's growth and development.Toys serve as the "tools" of play and help to create a more "natural" environment for a child.Selection and use of appropriate toys can help to reduce the traumatic effects of hospitalization and healthcare experiences.
It also aids in the speedy recovery from the illness.Play can be made an integral part of the hospitalized child's care and treatment plan.Play helps to support the child by offering the opportunity for creative expression, coping and diversion.There are a number of studies conducted in various hospitals which provide the evidence that a supervised play program can be an effective way of providing warm and child-friendly atmosphere which can be helpful to promote the child's growth and development.In bigger hospitals and healthcare facilities, a childcare specialist can coordinate the play therapy program provided that a proper play zone, suitable materials and playmates are available.It is evident that, for any child, play is an effective way of learning and play materials, toys and equipment serve as the 'learning tools' (4).
For years, it has been known that play is an vital element for promoting the normal growth and development of children.In many Western countries, play therapy is used to alleviate the stress experienced by paediatric patients and their families during hospitalization (5).Play constitutes an important parameter of a child's normal development.Also, play serves as an important means of communication in childhood.Although, child's ability to play may be in uenced by the child's physical or mental disease.Play can prove to be of special therapeutic value for sick children.It can help to enhance their physical and emotional well-being.It can help to explore the issues related to the child's experiences during hospitalization, can help to reduce the in uence of negative feelings during hospitalization.Play when blended with the treatment plan, can be quite helpful in promoting the child growth, development and life skills.
Healthcare professionals can incorporate play as a part of treatment and care strategy for hospitalized children.The role and value of play is greater in case of children with life-threatening disease, disability and vulnerable situations.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 child's con dence that he can continue his/her normal life even inside the hospital.
With this understanding of play, healthcare professionals can explore the effects of hospitalization and disease on children in addition to enhancing their emotional development.Though the play, children can learn to gain control in different situations.Play can help to change the hospitalization experience into a positive experience.Appropriate activities need to be chosen which will help the children grow, encouraging the caregivers to bring the child's favourite toys to the hospital and get actively involved in the entire procedure.Play facilitates to promote healing, improves coping potential, helps in tackling fears and expressing feelings of the children.Hospitals should take every effort to use play activities for reducing the stress and converting the negative aspects of the hospital experiences into a positive experience (6).

Rationale:
As per Census 2011, India, had a population of 121.1 Cr, among which 16.45 Cr children were in the age group 0-6 years and 37.24 Cr belonged to the age group 0-14 years which constitute around 13.59% and 30.76% of the total population respectively.74% of the children aged 0-6 years reside in rural areas where as the rural population constitutes 69% of the total population of India (7).
In India, rate of hospitalization of children aged 1-6 years is almost doubled due to common ailments like fever and diarrhoea whereas hospitalization due to non-communicable diseases and injuries has also increased to a great extent over last decade(8).The average length of hospital stay ranges between 6-15 days depending on the type of ailments (9).
The role and value of play is greater in case of children with life-threatening disease, disability and vulnerable situations.A number of diseases and conditions require 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 child's con dence that he can continue his/her normal life even inside the hospital.With this understanding of play, healthcare professionals can explore the effects of hospitalization and disease on children in addition to enhancing their emotional development.
Acharya Vinoba Bhave Rural Hospital (AVBRH) in Wardha is a tertiary care hospital of Datta Meghe Institute of Medical Sciences and catering to the healthcare needs of rural population from 5 districts namely Wardha , Nagpur, Chandrapur, Yawatmal and Amaravati.AVBRH is a 1500 bedded healthcare facility with specialized Pediatric Department, dedicated Neonatal Intensive Care Unit and Child Development Centre.This study will be focussed on the development of a locally adapted Play Therapy Programme for the hospitalized children, 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 child to child or healthcare staff.
To develop a structured 'Play Therapy Programme' for the parents and children under-5 years visiting the paediatric inpatient facility of AVBRH.

2.
To enhance knowledge and skills of parents on early child development and improve parent-child interactions.

3.
To improve the Motor, Language, Cognitive and Social-emotional development parameters of under-5 children visiting AVBRH, through play therapy and follow-up at scheduled home visits.
To develop a dedicated Play Therapy Kit specially designed for hospitalized children, with provision of follow-up and assessment mechanisms through online mode.

Trial design {8}
This will be a Randomized Controlled Trial.The Study participants will be randomized in to Intervention and Control groups with 1:1 ratio using Block Randomization.

Methods: Participants, Interventions And Outcomes
Study setting {9} This study will be conducted at Department of Pediatrics in Acharya Vinoba Bhave Rural Hospital, Wardha and nearby villages within 25 KM radius.Wardha is the smallest district in Maharashtra State of India.
Children admitted to Pediatric Ward of AVBRH aged 6 months to 4 years.

2.
Children from villages within 25 Km periphery of AVBRH.

3.
Parents consenting for Participation of Child in Play Therapy Programme.
Seriously sick, Moribund children with life threatening conditions.

2.
Children in Intensive Care treatment.

Who will take informed consent? {26a}
The investigator will take the written informed consent from the parents of the hospitalized children.
Additional consent provisions for collection and use of participant data and biological specimens {26b} NA

Interventions
Explanation for the choice of comparators {6b} All participants consenting for the participation in study will be assigned the Unique ID.Using blocked randomization process (10) with age groups as Blocking variable, participants will be allocated either to intervention or control groups.Age groups will be -1.
All children hospitalized in AVBRH, scheduled to have a stay of minimum 3 days in hospital and their parents signing the informed consent will be enrolled in the study.

Intervention description {11a}
A play therapy manual will be developed with the activities speci ed as per the following domains of child development-

1.
Physical development: It focuses on increasing the skill and performance of the body.It includes control and coordination between nervous system, maturing brain and growing bones and muscles.

2.
Psychosocial development and communication skills: It focuses on incorporating physical and mental health that takes into account knowledge, skills and capacity.It also refers to social connections and support.Psychosocial development in uences an individual in the value systems, beliefs and norms of a particular society or culture.Language and communication skills help the child to express herself through words, gestures, facial expressions as well as her ability to understand others.Good communication and language skills can help in fostering achievements at school and beyond.

3.
Emotional development: It incorporates learning what emotions and feelings are, understanding why and how they happen, recognition of one's own feelings and that of others and the ability to manage those feelings and emotions.

4.
Cognitive development: This refers to the development of thinking and reasoning.Children learn to think in concrete ways such as they learn to combine, separate and sort.It includes abstract thinking and reasoning one's own thoughts and principles .
Duration of the Interventions: 1.
All the children who fall in the age range of 6 months to four years old will receive intervention (along with their parents) every day during their hospital stay for one hour to 2 hours.

2.
The children will receive fortnightly follow-up sessions through home visits (or through Social Media Group meetings if needed) till 12 months from enrolment in the programme.
3. Activities described in the Play Therapy Manual will be followed for the follow-up sessions.
Criteria for Group Sessions at hospital: 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-1.
6 months to 30 months old

Above 30 months old
A particular criterion will be used for each activity.Each activity will be divided into four parts.The rst part will state the purpose of activity such as how will an activity bene t a child and what are the aims and objectives of an activity.The second part state about the materials that are to be used for the activity.
The third part will show the age of children who can participate in that activity.The fourth part will give the instructions as to how a particular activity should be performed.
The intervention delivery details are as below- This will be an 45 min.session and relevant Documents/reading materials / videos will be shared through What's app.
Fortnightly Follow-up sessions till 1 year of child enrolment.

After 1 month of enrolment till 1 year
Through Online Mode-What's app Video Call/ Google Classroom.Home visit will be scheduled as needed.
This will be an 45 min.online session and relevant Documents/reading materials will be shared.
Assessment of Age appropriate Developmental Milestones.
At 1 year of enrolment.
This will be done in ECD Setting of AVBRH or at Home visit to the child's family.
Age appropriate Assessment Tools will be used.Reports will be shared with parents and follow-up instructions and meeting schedules.

Variables:
For all children, changes will be observed in the-

Implementation {16c}
The principal Investigator will generate the allocation sequence, will enroll the participants, and will assign participants to interventions.

Assignment of interventions: Blinding
Who will be blinded {17a} The outcome assessors will be blinded after assignment to interventions.Endline Assessments will be done by a separate team of researchers at home visits.
Procedure for unblinding if needed {17b} NA Data and management

Plans for collection of outcomes
Assessments will be conducted at following time points and tools as detailed below will be used for related assessments: Assessment and Details:

Variables:
For all children, changes will be observed in the- The pre and post intervention data of child development in speci ed domains will be and fed to STATA-14 after appropriate cleaning and compilation.Individual and Child Age-Group wise scores of development will be calculated and tabulated.Mean differences in child development intervention and control groups will be calculated.The Effect Size by Cohen's D will be calculated for each Child Age Group and Signi cance be estimated.

Plans to promote participant retention and complete follow-up {18b}
To promote participant retention and complete follow-up, all enrolled children will receive scheduled home visits at intervals.Also telephonic follow-up will be taken for those missing the home visits.The outcome data will detail on the participants who discontinue or deviate from intervention protocols.

Data management {19}
All data will be collected in Tablet PC based ODK collect app with in-built range check, double entry and value checks.Data will be exported to server after ensuring the correctness data .The data from server can be downloaded as xls le.

Con dentiality {27}
Each participant will be allotted a Unique ID which will be used for analysis and reporting purpose.All data will be anonymous and personal will be to ensure protect con dentiality before, during, and after the trial.
Plans for collection, laboratory evaluation and storage biological specimens for genetic or molecular analysis in this {33}

Statistical methods primary and secondary outcomes {20a}
The pre and post intervention data of child development in speci ed domains will be collected and to STATA-14 after appropriate cleaning and compilation.Individual and Child Age-Group wise scores of development will be calculated and tabulated.Mean differences in child development scores for intervention and control groups will be calculated.The Effect Size by Cohen's D will be calculated for each Child Age Group and will be estimated.

Interim analyses {21b}
NA Methods for additional analyses (e.g.analyses) {20b} Subgroup and adjusted analyses will be done for relevant of developmental scores.
Methods in analysis to handle protocol and any statistical methods to handle missing data {20c} Attempts will be taken to ensure collection of complete data.In cases of missing data in few cases, imputation will be done.
to give access to the full protocol, participant level-data and statistical code {31c} Related Data on protocol, participant level-data and statistical code will be shared through Personalized mails if

Oversight and monitoring
Composition of the coordinating centre and trial steering committee {5d} The principal Investigator will look into data on real time basis will share the data with the concerned statistician quarterly basis.

Composition of the monitoring committee, its role and reporting structure {21a}
As this is PhD thesis, all related data will be managed and monitored by Principal Investigator along with the support from statistical expert.

Adverse event reporting and {22}
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 as per the guidelines from Institutional Ethics Frequency and plans for auditing trial conduct {23} NA Plans important protocol amendments to relevant parties (e.g.trial committees) {25} Important modi cations will be communicated to relevant parties (eg.investigators, trial participants, trial registries through emails and printed Hard copies, as required

Dissemination {31a}
The trial results will be published in Scopus, Pubmed and Web of Science indexed journals which will be accessible to healthcare professionals, the public, and other relevant groups.The participants will be informed the results through personalized visits.Data will be shared personalized mails , if requested.

Impact of Hospitalisation on
Hospitalization plays a signi cant affect in a child's life.Many children who are admitted to hospitals have complex healthcare needs and some of them require highly technical interventions.According to the 2013 statistics by WHO children under the age of ve died from diseases like acute respiratory infections, birth asphyxia, diarrhoea, neonatal sepsis, injuries, congenital anomalies and infant prematurity (12).Children who are hospitalised with the above said diseases tend to have a traumatic experience at hospital such as in the long-run hospitalisation tends to demonstrate negative psychological and behavioural responses (13).the hospitals are focused more physical recovery and mortality than the overall wellbeing of the child and her family (14).
Children tend to perceive hospitals negatively which impact their physical and mental health.In a study that was conducted it was found out that children who were hospitalized felt scared, bored and alone (15).Children experience happiness, sadness, anger and fear in the presence of a doctor and nurse(16).In another study it was found out that there was a reciprocal relationship between anxiety, blood pressure and heart rate (17).It was also found out that when children were asked to draw a person in hospital, the drawings indicated anxiety.They drew pictures of people who were sad and dependent(18).
Furthermore, according to the parents a child's behaviour, function and health before hospitalization and after hospitalization is signi cantly different.
Children suffer from emotional distress three to ve months after hospitalization and surgery and this is most common in the age range of one year to six years.Trauma that children face at the hospital has been termed as Paediatric Trauma Mental Stress which is characterized by avoidance, re-experience of the event, hyper arousal which arises from major illness or medical intervention that causes a threat to child's health and is considered to be intrusive, and alarming medical care.Children tend to internalize their problems and may have symptoms of depression and anxiety which further aggravates their illness (19).There are certain risk factors that are involved when children are hospitalised 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 possibilities of their treatment (20).
Problems Children Face During Hospitalization: The children suffer from various psychological problems at the hospital the following are some of the problems that children face on a daily basis in hospital.

Lack of Identity
The relationship between nurse, parents and children tend to vary.Nurses and children have different perspectives for one another.Children who suffer from acute conditions are not treated in a child-friendly manner but they are considered as beings on whom the goals need to be met.Children when hospitalised nd it hard to maintain their own social identity and work hard to reduce the stigma around them.They tend to become resilient by resisting the way they are dehumanised by the hand of nurses.In a study that was conducted it was found out that the nurses tend to take children as patients on whom treatment needs to be performed and not as humans whose past experiences and history needs to be taken into account.Hospital ward is a place for children in which their voices cannot be heard and even for those children who would raise their voice it was taken to be as a challenge by nurses (21).

Lack of Communication
Studies have found out that there is a lack of communication between the hospital staff and patients which makes the stay at hospital threatening.It was found out that children who were readmitted were perceived by the nurses to be resilient and their families to be more experienced at caretaking hence this misunderstanding increase their chance of readmission.In another study it was found out that during the time of discharge when the nurses do not cascade the information properly the coping mechanism of parents as well as children negates.When it comes to Family Centred Care it was found out that nurses need skill training, managerial support and adequate resources to meet families' needs appropriately.It has been concluded that hidden expectations and unclear suggestions are stressful for the families (22).Nurses who to parents with unconditional positive regard and empathy as well as reinforcing parenthood by praising parents tend to decrease the stress level of parents(23).Nurses play an important role to overcome the stress that parents and children face.

Play for Hospitalised
Children when hospitalised tend to look for activities that can keep them calm.Such as in some instances they look towards their parents so that they can speak to them and they look towards 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 (15).Physical exercise, healing touch, music therapy, therapeutic massage, and health education has decreased the symptoms of cancer (24).Play activities that include art has also affected children's overall health at the hospital.In 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 infant grabs them, or show infants bold colours or play games like peek a boo or mimic what the child is saying can sooth the child(2).
Other activities have also assisted in alleviating the symptoms of anxiety and pain.In a study that was conducted it was found out that children tend to prefer natural landscapes with calming colours over abstract paintings that have bold colours.The natural painting paved way to positive physiological outcomes and it was used for distraction which reduced pain perception (25).Reading also in uences children's wellbeing and when caregivers read books to children when sick, children feel comfortable and emotional a liation with the caregivers grow(26).Videoconferencing with family has also assisted in reducing the stress of children (27).
Surgical procedures can create anxiety in children as well as their parents.In a study that was conducted it was found out that before the children went through surgery the nurses taught the children the procedures and outcome of the surgery and the nurses as well as the children re-demonstrated the in dolls.This reduced their anxiety as well as caregivers' since they observed it as well (17).When children above the age of four were educated about their health they showed lower level of anxiety than children younger than them.When play routine was introduced to hospitalised children lower level of cortisol in their urine was indicated(28).Play activities can help in reducing the organic symptoms in children.The time span spent at the hospital can also be shortened when children participate in activities related to play stimulation.While a child is engaged in play activities it plays an important role in decreasing the stress of parents and children.As the studies suggest play stimulation can play an important role in relieving the symptoms of stress and organic diseases.The hospital staff needs to be trained, play stimulation should take place in the wards and should be given to the parents and their children to release their stress.Before the play stimulation activities should be practiced it is important for the caregivers, therapists, hospital staff and parents to understand what is to be expected in different age domains related to cognitive and psychosocial development.

Scope and Implications:
This Play therapy intervention package for hospitalized children is expected to bring out a evidence based Proof of Concept for the future 'Play Therapy Stimulation Package' for hospitalized children with 'Special Stimulation Kit' which can be later patented and commercialized as a business model for hospitals with Inpatient Child care Units in this region.As this will be a Single Centre study, the Response Rate and Acceptance of intervention by bene ciaries may not be generalizable to different types /levels of inpatient child care facilities.Minimum 3 days hospital stay is expected with initial Play therapy start.Stay less than this duration may not be that much effective to stimulate children and sensitize parents.Also follow-up after discharge may pose some challenges.

7 .
Physical Development (Using Developmental Milestones Checklist-II) a. Improvement in Fine Motor b. Improvement in Gross Motor scores 8. Cognitive Development Scores (Using Developmental Milestones Checklist-II) 9. Language Development Scores(Using Developmental Milestones Checklist-II) 10.Socioemotional Development Scores(Using Pro le of Socio-emotional Development) 11.Home Environment (Using Inventory Assessment ) 12. Parent-child Interactions (Using Observation of Mother Child Interaction Tool) 3. Analysis Plan: AbbreviationsWorld Health Organization ECD: Early Child Development DMC: Developmental Milestones Checklist PSED: Pro le of Socioemotional Development ODK: Online Data Kit OMCI: Observation of Mother-Child Interaction PP Quiz: Positive Parenting Quiz