| CTRI Number |
CTRI/2026/01/101957 [Registered on: 23/01/2026] Trial Registered Prospectively |
| Last Modified On: |
22/01/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A short study to see how play activities help reduce pain and improve daily functioning in children after heart surgery.” |
|
Scientific Title of Study
|
Short Term Effect of Play Therapy on Pain and Functional Status in Pediatrics Post Cardiac Surgery -A Randmized Controlled Trial |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Trupti Balasaheb Aher |
| Designation |
MPT |
| Affiliation |
TMVs Lokmanya Tilak college of physiotherapy Kharghar Navi Mumbai |
| Address |
TMVs Lokmanya Tilak college of physiotherapy third floor department of cardiovascular and respiratory physiotherapy tilak maharashtra vidyapeeth j block raghunath vihar sector 14 Kharghar Navi Mumbai
Raigarh
MAHARASHTRA
410210
India |
| Phone |
8452854514 |
| Fax |
|
| Email |
aahertrupti@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Hiranmayee Bagwe PT |
| Designation |
Associate professor |
| Affiliation |
TMVs lokmanya Tilak college of physiotherapy Kharghar Navi Mumbai |
| Address |
TMVs Lokmanya Tilak college of physiotherapy third floor department of cardiovascular and respiratory physiotherapy tilak maharashtra vidyapeeth block raghunath vihar sector 14 Kharghar Navi Mumbai
Raigarh
MAHARASHTRA
410210
India |
| Phone |
9699969313 |
| Fax |
|
| Email |
hiranmayee.bagwe@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Hiranmayee Bagwe PT |
| Designation |
Associate professor |
| Affiliation |
TMVs lokmanya Tilak college of physiotherapy Kharghar Navi Mumbai |
| Address |
TMVs Lokmanya Tilak college of physiotherapy third floor department of cardiovascular and respiratory physiotherapy tilak maharashtra vidyapeeth block raghunath vihar sector 14 Kharghar Navi Mumbai
Raigarh
MAHARASHTRA
410210
India |
| Phone |
9699969313 |
| Fax |
|
| Email |
hiranmayee.bagwe@gmail.com |
|
|
Source of Monetary or Material Support
|
| TMVs lokmanya Tilak college of physiotherapy |
|
|
Primary Sponsor
|
| Name |
TMVs lokmanya Tilak college of hysiotherapy raghunath vihar sector 14 Kharghar Navi Mumbai 410210 |
| Address |
TMVs lokmanya Tilak college of physiotherapy third floor department of cardiovascular and respiratory physiotherapy tilak maharashtra vidyapeeth j block raghunath vihar sector 14 Kharghar Navi Mumbai 410210 |
| Type of Sponsor |
Research institution |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| TMVs lokmanya Tilak college of physiotherapy Kharghar |
TMVs lokmanya Tilak college of physiotherapy third floor department of cardiovascular and respiratory physiotherapy tilak maharashtra vidyapeeth j block raghunath vihar sector 14 Kharghar Navi Mumbai 410210 |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Trupti Balasaheb Aher |
Shri Satya Sai sanjivani hospital Kharghar |
First floor post operative ward Plot No. 2, Sector 38, Kharghar, Navi Mumbai, Maharashtra 410210
Near Jama Masjid Taloja
Raigarh
MAHARASHTRA |
8452854514
aahertrupti@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| TMVs lokmanya Tilak college of physiotherapy institutional ethics committee (academics) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I52||Other heart disorders in diseasesclassified elsewhere, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Conventional Therapy |
Control Group: Conventional Therapy
A structured post-operative physiotherapy protocol will be followed from POD-2 with gradual progression.
POD-2: Passive/active-assisted limb exercises, bedside transfers and ambulation. Pursed-lip and diaphragmatic breathing, chest physiotherapy (percussion and vibration), and sitting with head elevation 60°.
POD-3: Active exercises, continued breathing exercises and chest physiotherapy; sitting out of bed with support.
POD-4: Sitting out of bed and attempting standing; breathing exercises and chest physiotherapy as needed.
POD-5: Active exercises, breathing exercises, assisted walking for 1–2 rounds.
POD-6: Independent walking for 2–3 rounds with continued active and breathing exercises.
POD-7: Continued active and breathing exercises to improve mobility and recovery.
Exercises (2 sets × 10 reps unless stated):
Ankle pumps, heel slides, hip abduction–adduction (supine), dynamic quadriceps (sitting), shoulder flexion, shoulder abduction (up to 90° or as tolerated), elbow flexion–extension, wrist mobility (flexion, extension, radial/ulnar deviation, circles).
Breathing Exercises:
Pursed-lip breathing (2×10 reps, sitting).
Diaphragmatic breathing (1×10 reps, supine/semi-Fowler’s).
Chest Physiotherapy:
Percussion and vibration in supine for 25 minutes, 10–12 repetitions per technique, 2 sets, with intermittent rest after 10 minutes; percussion with cupped hands over a towel and vibration during exhalation. |
| Intervention |
Play therapy |
Experimental Group :- Play Therapy
Group B will be given play therapy in the form of picking up sticks, bubble
blowing, building blocks, pinwheel breathing, and balloon blowing
therapy.
Bubble Breathing:
To begin this activity, the therapist will fill the room with bubbles. Most
children will instinctively try to pop the bubbles as they float down. After
a few moments of free play, the therapist will guide the children to focus
on creating one large bubble. During this part, the therapist will provide
instructions on deep breathing techniques, encouraging the children to take
slow, deep breaths from the abdomen and to exhale gradually and gently.
This activity will be performed in 2 sets of 10–12 repetitions, with 1
session conducted per day for a duration of six days.
Picking Up Sticks:
In this task, either the therapist or the child will hold a bunch of sticks and
will drop them onto a flat surface, such as a table. The objective will be for
the child to carefully remove one stick at a time without causing any
movement in the surrounding sticks. Players will take turns, and a turn will
end when a participant accidentally moves another stick.
This activity will involve 1 set, timed for 10 minutes, and will be carried
out once per day over a period of six days.
Building Blocks:
To initiate this activity, the therapist will present the child with a collection
of building blocks and will give the following instructions: “I am going to
give you some blocks and set a timer for 10 minutes. During this time, you
are to focus on building a tower with the blocks. Try not to be distracted
by anything happening around you, and continue building without
stopping until the timer goes off.”
This activity will be conducted for a duration of 10 minutes per session,with 1 session per day for six consecutive days.
Pinwheel Breathing:
The child will be asked to take a deep breath in and breathe out in such a
way that the pinwheel will rotate for as long as possible.
(10–12 repetitions, 2 sets, 1 session per day for six days.)
Balloon Blowing Therapy:
The patient will sit in a comfortable position. A small balloon attached to
a straw will be given to the child. The child will take a deep breath and will
blow into the straw to inflate the balloon. The process will be repeated 10–
12 times for 2 sets.
(2 sets of 10–12 repetitions, 1 session per day for six days.) |
|
|
Inclusion Criteria
|
| Age From |
5.00 Year(s) |
| Age To |
10.00 Year(s) |
| Gender |
Both |
| Details |
Children between 5-10 years of age who are undergoing cardiac
surgery.(congenital cardiac surgery )
Both male and female.
Written informed consent and assent from parent.
Ability to understand the language used in the assessment tools and
instructions.
5. extubated patients ( POD-2) |
|
| ExclusionCriteria |
| Details |
Presence of other chronic or acute conditions (e.g., primary
neuromuscular disorders, orthopedic issues,) that may independently
affect posture or physical function.
History of additional major surgeries unrelated to cardiac surgery
within the past year.
patients with sternal wound infections, dehiscence, or major
complications preventing participation.
children unable to engage in play therapy |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Post operative pain status
|
Post operative day 2 and post operative day 7
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Functional status score |
Six days |
|
|
Target Sample Size
|
Total Sample Size="70"
Sample Size from India="70"
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 3 |
|
Date of First Enrollment (India)
|
10/02/2026 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
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
|
Methodology Randomized Controlled Trial (RCT). 70 pediatric patients (5-10 yrs) post-cardiac surgery were divided into two groups (n=35 each) via simple random sampling. Group A (Control): Conventional Physiotherapy. Group B (Experimental): Play Therapy + Conventional Physiotherapy. Outcomes Measures Primary Outcomes: Pain (measured by Faces Pain Scale-Revised (FPS-R)) and Functional Status (measured by Functional Status Score (FSS)). Procedure Baseline assessment (Pain/FSS) on Post-Operative Day 2 (POD-2). Interventions (one session/day) were administered for six consecutive days. Reassessment (Pain/FSS) was performed on Post-Operative Day 7 (POD-7). |