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CTRI Number  CTRI/2024/12/078502 [Registered on: 24/12/2024] Trial Registered Prospectively
Last Modified On: 20/06/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Study to compare between colouring and watching videos to decrease anxiety before surgery among children. 
Scientific Title of Study   Colouring Activity Versus Video Distraction Technique To Alleviate Preoperative Paediatric Patient Anxiety: A Randomised Control 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 Abhishek Nagarajappa 
Designation  Associate Professor  
Affiliation  AIIMS New Delhi 
Address  Room no.5, 4th floor Porto Cabin Adjacent To Dialysis Unit, Department of Anaesthesiology, Pain Medicine and Critical Care AIIMS,Ansari Nagar

South
DELHI
110029
India 
Phone  8587970180  
Fax    
Email  rhinome@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Abhishek Nagarajappa 
Designation  Associate Professor 
Affiliation  AIIMS NEW DELHI 
Address  Department of Anaesthesiology, Pain Medicine and Critical Care AIIMS, Ansari Nagar

South
DELHI
110029
India 
Phone  8587970180  
Fax    
Email  rhinome@gmail.com  
 
Details of Contact Person
Public Query  
Name  Abhishek Nagarajappa 
Designation  Associate Professor 
Affiliation  AIIMS NEW DELHI 
Address  Department of Anaesthesiology, Pain Medicine and Critical Care AIIMS, Ansari Nagar

South
DELHI
110029
India 
Phone  8587970180  
Fax    
Email  rhinome@gmail.com  
 
Source of Monetary or Material Support  
Department of Anaesthesiology, Pain Medicine and Critical Care AIIMS New Delhi,Ansari Nagar Delhi 110029 India  
 
Primary Sponsor  
Name  Abhishek Nagarajappa 
Address  Room no.5, 4th floor Porto Cabin Adjacent To Dialysis Unit, Department of Anaesthesiology, Pain Medicine and Critical Care AIIMS New Delhi,Ansari Nagar Delhi 110029 India  
Type of Sponsor  Other [Self] 
 
Details of Secondary Sponsor  
Name  Address 
Department of Anaesthesiology Pain Medicine and Critical Care  AIIMS,Ansari Nagar New Delhi 110029 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Abhishek Nagarajappa   AIIMS NEW DELHI  Paediatrics OT, MCH Block 2nd Floor, OT no 13 to 15 AIIMS New Delhi, Ansari Nagar, New Delhi - 110029
South
DELHI 		 8587970180

rhinome@gmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institute Ethics Committee AIIMS, New Delhi  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 
Intervention  Colouring Activity   In this group, the coloring activity will be incorporated into the Child Information Sheet (CIS). To help the child acclimate to the procedures in the operating theater, the drawings will feature a mix of operating theater scenarios, medical equipment, as well as a few blank pages for the child to express their imagination through drawing. The colouring activity will be provided on the morning of surgery in the preoperative room and can continue until the child is transferred to the operating table. One hour before the surgery [T1], the child’s anxiety score will be noted using mYPAS-SF score. The child will be shifted to the OT with their coloring template on the trolley, the anxiety scores [T2] will again be noted in the trolley. Induction of General Anesthesia (GA) will be done on the trolley itself, with the help of a face mask and inhalational agents while the child is engaged with his activity book. Anxiety score will be assessed for the third time during this time [T3].  
Comparator Agent  Video Distraction   In this group, the child will be shifted to the preoperative room one hour prior to the surgery, and the anxiety score will be assessed using mYPAS-SF score [T1]. Twenty minutes before being transferred to the operating theatre (OT), the child will be allowed to view videos of their choice on a tablet or mobile phone in the preoperative room until the induction of anesthesia using a face mask. The child will then be transferred to OT on a trolley, and their anxiety scores [T2] will be recorded during this transport. Induction of GA will be done on the trolley, using face mask and inhalational agents, while the child continues to watch videos. The anxiety score will be evaluated for the third time during this process [T3]. 
 
Inclusion Criteria  
Age From  5.00 Year(s)
Age To  12.00 Year(s)
Gender  Both 
Details  1. 5 to 12 years
2. ASA PS: I, II 
 
ExclusionCriteria 
Details  Mentally subnormal, low visual acuity, profound sensory mutual hearing loss, parent’s or guardian’s refusal, child’s refusal, and conditions affecting hand grip 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded 
Primary Outcome  
Outcome  TimePoints 
To compare preoperative anxiety levels between two groups using the modified Yale Preoperative Anxiety
Scale- Short Form (mYPAS-SF) between two-time
points
T(1) in the waiting area, before the activity is given
T(3) during mask induction 		 Baseline, 1 hour 
 
Secondary Outcome  
Outcome  TimePoints 
Difference in mYPAS - SF scale before
intervention t (1) vs t(2) & t(4)
T1 - In the waiting area, before the activity is given
T2- During the transport of patients in a
trolley
T4- Postoperative period

Mask acceptance score

Induction Compliance Checklist

Patient satisfaction (Neville score) 		 baseline, 45 minutes, 3 hours 
 
Target Sample Size   Total Sample Size="216"
Sample Size from India="216" 
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 4 
Date of First Enrollment (India)   05/01/2025 
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="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
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  
Preoperative anxiety affects >75% of paediatric patients, manifesting as fear and distress,
particularly during induction of General Anaesthesia (GA)1
. This anxiety can lead to increased
postoperative pain, emergence delirium, increased analgesic requirements and negative
postoperative behavioural changes such as sleep disturbance, separation anxiety, eating
problems and new-onset enuresis 2,3 Anxiety has long-term adverse effects which may lead to
separation anxiety disorders and healthcare avoidance in the future. Research shows a clear
effect of artistic interventions on self-report4 measures of decrease in stress, anxiety, and mood.
Anaesthesiologists have employed a variety of pharmacological and non-pharmacological
strategies to alleviate anxiety in paediatric patients. Pharmacological interventions include
medications such as midazolam 5, clonidine 6 and dexmedetomidine7. On the other hand, non-
pharmacological approaches encompass therapeutic play8,9
, music therapy10
, clown
intervention11, 12
, hypnosis13
, storytelling14
, head play15
, engaging children in video games 16
,
and interactive activities with play dough17
. Additionally, strategies like pre-operative
information video18
, and web-based tailored intervention19 have been explored. More
innovative techniques, such as smartphones20 and Virtual Reality (VR) tours21 of the operating
theatre, along with video distraction22 methods, have also been studied for their effectiveness
in reducing anxiety in young patients during medical procedures.
Research shows that non-pharmacological methods are superior to pharmacological methods
to alleviate paediatric patient anxiety, and they can be used without the fear of causing any side
effects23
. Midazolam is associated with delayed onset of action associated with adverse effects
such as agitation, restlessness and extended duration of hospitalisation among patients24
. Pre-
operative education empowers children to approach surgery with positive expectations and also
improve the caregiver’s perception of the experience25
.
Colouring activity helps lower anxiety in children through several mechanisms26
. i)
mindfulness and focus: Engaging in colouring allows children to utilise all their senses,
promoting presence in the moment. ii) Structured Creativity: Working with pre-drawn
templates offers a clear structure, which can be less overwhelming than colouring on a blank
page. iii) Relaxation Response: The repetitive nature of colouring provides a calming rhythm
akin to meditation, which aids relaxation and lowers cortisol levels. iv) Emotional Expression:
Colouring enables children to visually express their emotions, facilitating communication
about their feelings and promoting emotional release. These factors make colouring a valuable
tool for managing anxiety in paediatric populations.
Hypothesis: Engaging in colouring activities provides a superior anxiolytic effect in children
due to its soothing properties, prolonged calming effects, and the sense of achievement it
fosters. Additionally, it allows children to express their emotions creatively in a non-verbal
manner, potentially enhancing their emotional well-being. We planned this study to evaluate
the effect of using colouring activities in the Child information sheet in the preoperative period
on decreasing the preoperative anxiety in children in OT

Reference
(1) Getahun AB, Endalew NS, Mersha AT, Admass BA. Magnitude and Factors Associated
with Preoperative Anxiety Among Pediatric Patients: Cross-Sectional Study. Pediatric
Health Med Ther. 2020 Dec 16;11:485-494. doi: 10.2147/PHMT.S288077. PMID:
33364873; PMCID: PMC7751437
(2) Fortier MA, Del Rosario AM, Martin SR, Kain ZN. Perioperative anxiety in children.
Paediatr Anaesth. 2010 Apr;20(4):318–22.
(3) Kain ZN, Mayes LC, Caldwell-Andrews AA, Karas DE, McClain BC. Preoperative
anxiety, postoperative pain and behavioural recovery in young children undergoing
surgery. Pediatrics. 2006;118:651–8.
(4) Beesdo K, Knappe S, Pine DS. Anxiety and anxiety disorders in children and adolescents:
developmental issues and implications for DSM-V. Psychiatr Clin North Am. 2009
Sep;32(3):483–524.
(5) Sulimani, Rami & Albabtain, Aoday & Althobaiti, Talal & Altowygry, Saleh & Alshehri,
Ayman & Almuzaini, Tariq & Alrowaili, Mohammed & Althubaity, Naif & Alrashah,
Mohammed & Alharthi, Abdulrahman & Alrubayyi, Saad. (2024). Clinical implications of
midazolam in preoperative anxiety and sedation: a review. International Journal Of
Community Medicine And Public Health. 10.18203/2394-6040.ijcmph20243011.
(6) Verdecchia N, Nelson R, White S, Cladis F. Pre-Admission Oral Clonidine to Reduce
Severe Pre-Operative Anxiety in Pediatric Patients with Behavioral Disorders: A Case
Series. Children (Basel). 2024;11(3):264. Published 2024 Feb 20.
doi:10.3390/children11030264.
(7) Mountain, Brian & Smithson, Linda & Cramolini, Mark & Wyatt, Tami & Newman, Mike.
(2011). Dexmedetomidine as a pediatric anesthetic premedication to reduce anxiety and to
deter emergence delirium. AANA journal. 79. 219-
(8) Li HC, Lopez V, Lee TLI. Effects of preoperative therapeutic play on outcomes of school-
age children undergoing day surgery. Res Nurs Health. 2007 Jun;30(3):320–32.
(9) Therapeutic play intervention on children’s perioperative anxiety, negative emotional
manifestation and postoperative pain: a randomized controlled trial. J Adv Nurs. (2015) 71
(5):1032–43. doi: 10.1111/jan.12608
(10) Yu H, Liu Y, Li S, Ma X. Effects of music on anxiety and pain in children with cerebral
palsy receiving acupuncture: a randomized controlled trial. Int J Nurs Stud. 2009
Nov;46(11):1423–30.
(11) Golan G, Tighe P, Dobija N, Perel A, Keidan I. Clowns for the prevention of
preoperative anxiety in children: a randomized controlled trial. Paediatr Anaesth. (2009)
19(3):262–6. doi: 10.1111/j.1460-9592.2008.02903
(12) Heilbrunn BR, Wittern RE, Lee JB, Pham PK, Hamilton AH, Nager AL. Reducing
anxiety in the pediatric emergency department: a comparative trial. J Emerg Med. (2014)
47(6):623–31. doi: 10.1016/j.jemermed.2014.06.052
(13) Huet A, Lucas-Polomeni MM, Robert JC, Sixou JL, Wodey E. Hypnosis and dental
anesthesia in children: a prospective controlled study. Int J Clin Exp Hypn.
2011;59(4):424–40.
(14) Tunney AM, Boore J. The effectiveness of a storybook in lessening anxiety in children
undergoing tonsillectom y and adenoidectomy in Northern Ireland. Issues Compr Pediatr
Nurs. (2013) 36(4):319–35. doi: 10.3109/01460862.2013.834398.
(15)Lim E, Fabila T, Sze Ying T, Tan J. Headplay personal cinema system facilitates
intravenous cannulation in children: a randomized controlled trial. Int J Pediatr. (2013)
2013:849469. doi: 10.1155/2013/849469.
(16)Gao X-L, Liu Y, Tian S, Zhang D-Q, Wu Q-P. Effect of interesting games on relief of
preoperative anxiety in preschool children. Int J Nurs Sci. (2014) 1 (1):89–92. doi:
10.1016/j.ijnss.2014.02.002.
(17)Bumin Aydın G, Yüksel S, Ergil J, Polat R, Akelma FK, Ekici M, et al. The effect of
play distraction on anxiety before premedication administration: a randomized trial. J Clin
Anesth. (2017) 36:27–31. doi: 10.1016/j.jclinane.2016.0404
(18)Batuman A, Gulec E, Turktan M, Gunes Y, Ozcengiz D. Preoperative informational
video reduces preoperative anxiety and postoperative negative behavioral changes in
children. Minerva Anestesiol. (2016) 82(5):534–42.
(19)Fortier MA, Bunzli E, Walthall J, Olshansky E, Saadat H, Santistevan R, et al. Web-
based tailored intervention for preparation of parents and children for outpatient surgery
(webtips): formative evaluation and randomized controlled trial. Anesth Analg. (2015)
120(4):915–22. doi: 10.1213/ane.0000000000000632
(20) Cumino DO, Vieira JE, Lima LC, Stievano LP, Silva RAP, Mathias LAST.
Smartphone-based behavioural intervention alleviates children’s anxiety during
anaesthesia induction: A randomised controlled trial. Eur J Anaesthesiol. 2017
Mar;34(3):169–75.
(21) Ryu  JH, Oh AY, Yoo HJ, Kim JH, Park JW, Han SH. The effect of an immersive virtual
reality tour of the operating theater on emergence delirium in children undergoing general
anesthesia: a randomized controlled trial. Paediatr Anaesth. (2019) 29(1):98–105. doi:
10.1111/pan.13535.
(22)Bandyopadhyay S, Kaur M, Sinha R, Muthiah T, Ayub A, Subramaniam R. Effect of
video distraction on preoperative anxiety scores in pediatric patients undergoing general
anesthesia in ophthalmic daycare procedures: A randomized controlled trial. J Anaesthesiol
Clin Pharmacol. 2024;40(1):133–9.
(23)Mustafa MS, Shafique MA, Zaidi SDEZ, Qamber A, Rangwala BS, Ahmed A, et al.
Preoperative anxiety management in pediatric patients: a systemic review and meta-
analysis of randomized controlled trials on the efficacy of distraction techniques. Front
Pediatr. 2024;12:1353508.
(24) Hu AM, Zhong XX, Li Z, Zhang ZJ, Li HP. Comparative Effectiveness of Midazolam,
Propofol, and Dexmedetomidine in Patients with or at Risk for Acute Respiratory Distress
Syndrome: A Propensity Score-Matched Cohort Study. Front Pharmacol. 2021;12:614465
Published 2021 Mar 23. doi:10.3389/fphar.2021.614465
(25) Cordray H, Patel C, Prickett KK. Reducing Children’s Preoperative Fear with an
Educational Pop-up Book: A Randomized Controlled Trial. Otolaryngol Head Neck Surg.
2022 Aug;167(2):366–74.
(26) Unyoked. Art therapy for anxiety: benefits, activities and prompts. Available from:
https://unyoked.co/wellness/art-therapy-for-anxiety. Child Mind Institute. Understanding
anxiety in children and teens. 2018.


 
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