Effect of digital imitation on Pain Fear and Anxiety among paediatric patients undergoing cancer injections into the spine

Effect of virtual reality headset device on pain, fear and anxiety in Paediatric Cancer Patients during Lumbar Punctures (LP) at a Tertiary Care Centre in Mumbai. Open label RCT

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2025/07/091715

Enrollment

160

Registered

2025-07-25

Start date

Unknown

Completion date

Unknown

Last updated

2025-08-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: C910- Acute lymphoblastic leukemia [ALL]

Interventions

Intervention1: Effect of Virtual Reality Headset device on Pain Fear and Anxiety in Pediatric Cancer Patients during Lumbar Punctures LP at a Tertiary Care Centre in Mumbai. Open label RCT.: The s

Eligibility

Inclusion criteria

Inclusion criteria: 1. Patients with Leukemia in the age group of 7-15 years undergoing L.P. for chemotherapy. 2. Who is cognitively appropriate when assessed by a pediatrician and psychologist as appropriate to use VR, with consent from parents or guardians. 3. Caregivers and children who can understand English/Hindi/Marathi.

Exclusion criteria

Exclusion criteria: 1. Active nausea or vomiting 2. Developmental delay: Children who cannot verbalize. 3. Children who cannot tolerate applying a VR headset device during the procedure. 4. History of seizures.

Design outcomes

Primary

Measure	Time frame
To evaluate the effectiveness of VR as a distraction technique in reducing pain during paediatric lumbar punctures.by using Wong baker pain scaleTimepoint: pain is assessed consistently across all participants. Pain levels will be measured at four time points using the Wong-Baker FACES WBS Pain Rating Scale in both the VR intervention group and the standard care group. The assessment time points are as follows T1 at 5 minutes before the procedure T2at Immediately 5 minutes post lumbar puncture LP T3 at 15 minutes after the LP T4 at 30 minutes after the LP	—

Measure

Time frame

To evaluate the effectiveness of VR as a distraction technique in reducing pain during paediatric lumbar punctures.by using Wong baker pain scaleTimepoint: pain is assessed consistently across all participants. Pain levels will be measured at four time points using the Wong-Baker FACES WBS Pain Rating Scale in both the VR intervention group and the standard care group. The assessment time points are as follows T1 at 5 minutes before the procedure T2at Immediately 5 minutes post lumbar puncture LP T3 at 15 minutes after the LP T4 at 30 minutes after the LP

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Secondary

Measure	Time frame
To compare the pain, fear and anxiety levels experienced during LP of pediatric patients receiving VR intervention versus those receiving standard care.by using the Children Fear Scale and Children Anxiety Meter-Scale in children from the age group of 7to15 years with leukaemia undergoing LP.Timepoint: to compare the effect of fear and Anxiety levels of children at the baseline before and 10 minutes after lumbar puncture for intrathecal chemotherapy using the children fear scale and children anxiety meter scale	—

Measure

Time frame

To compare the pain, fear and anxiety levels experienced during LP of pediatric patients receiving VR intervention versus those receiving standard care.by using the Children Fear Scale and Children Anxiety Meter-Scale in children from the age group of 7to15 years with leukaemia undergoing LP.Timepoint: to compare the effect of fear and Anxiety levels of children at the baseline before and 10 minutes after lumbar puncture for intrathecal chemotherapy using the children fear scale and children anxiety meter scale

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Countries

India

Contacts

Public Contactmiss Vaishali Raut

Tata Memorial hospital Mumbai

manisha.19pawar@gmail.com7738059723

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026