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CTRI Number  CTRI/2025/06/088257 [Registered on: 04/06/2025] Trial Registered Prospectively
Last Modified On: 07/05/2025
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Physiotherapy (Not Including YOGA) 
Study Design  Single Arm Study 
Public Title of Study   Therapeutic play and its effects on fear and anxiety in children following surgery. 
Scientific Title of Study   The Effect of therapeutic play on fear and anxiety levels in children post-surgery: An experimental study 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Arya Hemant Patil 
Designation  PG Student 
Affiliation  Pravara Institute of Medical Sciences 
Address  504, Department of Paediatric Physiotherapy, Dr. APJ Abdul Kalam College of Physiotherapy, Pravara Institute of Medical Sciences, Loni – 413736, Maharashtra

Ahmadnagar
MAHARASHTRA
413736
India 
Phone  09404531752  
Fax    
Email  aryapatil1106@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Tejas Borkar PT 
Designation  Associate Professor 
Affiliation  Pravara Institute of Medical Sciences 
Address  504, Department of Paediatric Physiotherapy, Dr. APJ Abdul Kalam College of Physiotherapy, Pravara Institute of Medical Sciences, Loni – 413736, Maharashtra

Ahmadnagar
MAHARASHTRA
413736
India 
Phone  09371271752  
Fax    
Email  tejasborkar57@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Tejas Borkar PT 
Designation  Associate Professor 
Affiliation  Pravara Institute of Medical Sciences 
Address  504, Department of Paediatric Physiotherapy, Dr. APJ Abdul Kalam College of Physiotherapy, Pravara Institute of Medical Sciences, Loni – 413736, Maharashtra

Ahmadnagar
MAHARASHTRA
413736
India 
Phone  09371271752  
Fax    
Email  tejasborkar57@gmail.com  
 
Source of Monetary or Material Support  
NIL 
 
Primary Sponsor  
Name  Dr. APJ Abdul Kalam College of Physiotherapy, PIMS, Loni 
Address  Dr. APJ Abdul Kalam College of Physiotherapy, Pravara Institute of Medical Sciences, Loni – 413736, Maharashtra  
Type of Sponsor  Private medical college 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Arya Hemant Patil  Dr. A. P. J. Abdul Kalam College of Physiotherapy  504 Pediatric Physiotherapy Department, Pravara Institute of Medical Sciences, Dr. A. P. J. Abdul Kalam College of Physiotherapy, Loni, 413736
Ahmadnagar
MAHARASHTRA 
9404531752

aryapatil1106@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional ethical committee, Dr. APJAK COPT  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: O||Medical and Surgical,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Not Applicable  Not Applicable 
Intervention  Therapeutic Play  Day 1: Initial Play - Going through every step of the medical procedure using different toys and equipment. Day 2: Medical Play - Various real and/or toy medical equipment like stethoscope, syringe without needles, bandages, medical cup, gloves, mask, and nurse’s cap during children’s hospitalization will be used. Day 3: Medical Play - Getting children involved in different kinds of expressive play activities like painting, singing, sand play, puppets and encourage them to share or express their feelings. Day 4: Distraction Play - Interesting sensory toys to distract children’s attention from medical procedure done. Day 5: Distraction Play - Interesting games like blowing bubbles, music, relaxation techniques will be given to the children. Day 6: Developmental Play - Involving children in appropriate play activities like board games. Day 7: Developmental Play - Involving children in appropriate play activities like story books, arts and crafts.  
 
Inclusion Criteria  
Age From  6.00 Year(s)
Age To  18.00 Year(s)
Gender  Both 
Details  1. Children post-surgery.
2. At least 6 years of age.
3. Voluntary participation in the therapeutic play.
4. Participant whose parents are willing to give written informed consent.
 
 
ExclusionCriteria 
Details  1. Children with Pre-diagnosed psychological conditions.
2. Children with identified cognitive and learning difficulties.
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
1. The hospital fears rating scale (HFRS).
2. Screen for child anxiety related disorders (SACRED). 
Day 0 and Day 7 
 
Secondary Outcome  
Outcome  TimePoints 
NIL
 
NIL 
 
Target Sample Size   Total Sample Size="42"
Sample Size from India="42" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   Phase 2 
Date of First Enrollment (India)   11/06/2025 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

INTRODUCTION

Hospitalization can be a threatening and stressful experience for children [1]. Because of unfamiliar with the environment and medical procedures and unaware of the reasons for hospitalization, it can result in children’s anger, uncertainty, anxiety, and feelings of helplessness [2, 3]. Anxiety is the most commonly reported of these negative responses, and high levels of anxiety can be harmful to children’s physiological and psychological health. Excessive anxiety also impedes children’s efficacy in coping with medical treatment, and increases their uncooperative behaviour and negative emotions towards healthcare professionals [1, 3, 4].

Play has long been regarded as a vital element in the normal growth and development of children [5, 6], and is widely used in many Western countries to alleviate the stress experienced by paediatric patients and their families during hospitalization [7]. Through play, children are given the opportunity to develop mastery of self and the environment and to enhance their understanding of the world [8].

Previous studies have reported that play is an effective method of reducing anxiety, fear, and negative emotions among hospitalized children, contributing to their recovery through physical and emotional comforting, and enabling children to express their feelings and knowledge about their illness while facilitating communication between children and health workers, which is considered important for holistic and high-quality care (9)

Play activities are used in routine care for hospitalized children as a form of preparation for surgical or invasive procedures and also during painful or unpleasant procedures. Play is an effective way of making hospitalization less difficult for children, reducing their pain and anxiety. Play also facilitates harmony and communication between children and health workers. The play has an important role in reducing the negative effects of children’s hospitalization (9).

Wolfer and Visintainer [10] conducted an influential study to examine the stress responses and adjustment to hospitalization of paediatric surgical patients. The result showed that children who received psychological preparation, including hospital play interventions, in contrast to those who did not, reported fewer upset behaviour and post-hospital adjustment problems, but more co-operation with the hospital.

Hospitalized children experience more anxiety and fear due less communication with medical teams, medical equipment, visiting restrictions, not being able to leave their rooms or go to the playroom. Children may also wonder as to the reason for experiencing these conditions and possibly conclude that they are undergoing punishment. Therefore, play is important for reducing anxiety and fear in children. Hence this stud aimed to understand the effect of therapeutic play on fear and anxiety levels in children post-surgery.

 

 

NEED FOR THE STUDY:

It is well known that hospitalization is highly stressful for children and can have adverse effects on their health. Previous studies have indicated that a lack of control over the hospital setting and medical procedures is a major source of stress, which may cause substantial fear and anxiety for hospitalized children. There is evidence that individuals with adequate self-control over a potential threat would encourage a positive coping strategy, consequently improve their psychological health. A hospital play intervention is necessary to help children maintain control through familiarization and rehearsal over the hospital setting and medical procedures.

We also believe that through participating in hospital play activities children would enhance their interpersonal skills and social and creative abilities. Children will not only have fun, but will also be encouraged to desensitize fearful and anxious situations and to instil greater self-control over the new situation that they are involved in. It will also help to improve the interaction of children with healthcare workers.

 

RESEARCH QUESTION

What is the effect of therapeutic play on fear and anxiety levels in children post-surgery?

AIM AND OBJECTIVES

AIM:

To investigate the effect of therapeutic play on fear and anxiety levels in children post-surgery.

OBJECTIVES:

1.     To determine the fear levels of the children using the hospital fears rating scale (HFRS).

2.     To find out the anxiety levels of the children with the help of screen for child anxiety related disorders (SACRED).

3.     To assess the change in the fear and anxiety levels of children when engaging in therapeutic play with various medical equipment’s, plushies and toys.

 

Hypotheses

Null Hypothesis (H0):

Therapeutic play has no effect on fear and anxiety levels in children post-surgery.

Alternative Hypothesis (H1):  

Therapeutic play has a significant effect on fear and anxiety levels in children post-surgery.

  

MATERIAL AND METHODOLOGY

Study Setting:  Pediatric Physiotherapy IPD, Dr. A.P.J Abdul Kalam college of physiotherapy, Loni.

 Study Type: Experimental study.

Study Population: children post-surgery

Study Duration: 6 months

Sampling Method: Simple Random Sampling

Sample size: 42

Calculated with Openepi software.

OUTCOME MEASURES

Outcome measures used for this study will be as follows,

1.     The hospital fears rating scale (HFRS) (r = 0.75)

2.      Screen for child anxiety related disorders (SACRED) (r = 0.89)

 

 

 


ELIGIBLITY CRITERIA:

Inclusion criteria:

Ø  Children post-surgery.

Ø  At least 6 years of age.

Ø  Voluntary participation in the therapeutic play.

Ø  Participant whose parents are willing to give written informed consent.

Exclusion criteria:

Ø  Children with Pre-diagnosed psychological conditions.

Ø  Children with identified cognitive and learning difficulties.



 

PROCEDURE

Protocol is prepared and ethical clearance will be obtained from the IEC.

The Participants will be selected based on the eligibility criteria.

Informed consent will be obtained from the caregivers of the participants and demographic data will be recorded.

Prior assessment of the participants will be done.

Participants will be administered with the Play therapy intervention for 30 mins per session for 7 days (a week).

The fear levels will be measured using the hospital fears rating scale (HFRS), while the anxiety levels will be measured using the Screen for child anxiety related disorders (SACRED).

Statistical analysis will be done and result will be calculated.


PROTOCOL:

Play Therapy Intervention:

Day 1: Initial Play - Going through every step of the medical procedure using different toys and equipment.

Day 2: Medical Play - Various real and/or toy medical equipment like stethoscope, syringe without needles, bandages, medical cup, gloves, mask, and nurse’s cap during children’s hospitalization will be used.

Day 3: Medical Play - Getting children involved in different kinds of expressive play activities like painting, singing, sand play, puppets and encourage them to share or express their feelings.

Day 4: Distraction Play - Interesting sensory toys to distract children’s attention from medical procedure done.

Day 5: Distraction Play - Interesting games like blowing bubbles, music, relaxation techniques will be given to the children.

Day 6: Developmental Play - Involving children in appropriate play activities like board games.

Day 7: Developmental Play - Involving children in appropriate play activities like story books, arts and crafts.

 

 REFERENCES

 

1.     Francischinelli AGB, Almeida FA, Fernandes DMSO. Routine use of therapeutic play in the care of hospitalized children: nurses’ perceptions. Acta Paulista de Enfermagem. 2012;25:18–23.

2.     Fernandes SC, Arriaga P. The effects of clown intervention on worries and emotional responses in children undergoing surgery. J Health Psychol. 2010;15:405–15.

3.     Li HCW, Lopez V, Lee TLI. Effects of preoperative therapeutic play onmoutcomes of school-age children undergoing day surgery. Res Nurs Health. 2007;30:320–32.

4.     Lohaus A, Klein-Hessling J, Ball J, Wild M. The prediction of health-related in behavior in elementary school. J Health Psychol. 2004;9:375–9

5.     Erikson E. Childhood and society. 2nd ed. New York: W. W. Norton & Company; 1963.

6.     Piaget J. The origins of intelligence in children. New York: Norton; 1963.

7.     LeVieux-Anglin L, Sawyer EH. Incorporating play interventions into nursing care. Pediatr Nurs. 1993;19:459–63.

8.     Norris AE, Aroian KJ, Warren S, Wirth J. Interactive performance and focus groups with adolescents: The power of play. Res Nurs Health. 2012;35:671–9.

9.     Buyuk ET, Erdeniz EH, Uzsen H, Odabasoglu E, Koyun M. The Effect of Play Activities for COVID-19 Positive and MIS-C Pediatric Patients on the Anxiety and Fear of Children and Their Parents. Paediatria Croatica. 2021 Oct 1;65(4).

Wolfer JA, Visintainer MA. Pediatric surgical patients’ and parents’ stress responses and adjustments. Nurs Res. 1975;24:244–55. 
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