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A study to observe the effect of pre-recorded lullaby in a childs own mothers voice on radiotherapy procedures which are under sedation.

The Effect of Pre-recorded Lullaby in a Childs Own Mothers Voice on Radiotherapy Procedure under Sedation : An Observational Study - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2024/01/061077
Enrollment
192
Registered
2024-01-02
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: C768- Malignant neoplasm of other specified ill-defined sites

Interventions

Intervention1: NIL: Playing prerecorded lullaby in patients own mothers voice along with routine sedatives for anxiolysis and immobilization during radiotherapy is already an existing practice in our

Sponsors

Mahamana Pandit Madan Mohan Malaviya Cancer Centre and Homi Bhabha Cancer Hospital
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Inclusion Criteria: Pediatric patients of both the sex less than three years of age undergoing radiotherapy.

Exclusion criteria

Exclusion criteria: Exclusion Criteria: Patients with a history of severe cognitive impairments or hearing impairments that could affect their response to the lullaby will be excluded. Patients unfit for radiotherapy under sedation (eg. Inadequate NBM hours, Acute lower respiratory tract infection, fever) will be excluded. Patients with prolonged fasting period (more than 8 hours) will be excluded.

Design outcomes

Primary

MeasureTime frame
To determine the number of episodes of intra-procedure spontaneous movements under sedation, interfering with radiotherapy treatment (observed on telemetry CCTV monitor).Timepoint: During the procedure of radiotherapy

Secondary

MeasureTime frame
To observe the total dose requirement (per kg body weight) of general anesthetics (midazolam and ketamine) per episode of radiotherapy.Timepoint: During radiotherapy;To observe immediate post procedure sedation status as per AVPU scale after each episode of radiotherapyTimepoint: Immediate post radiotherapy;To observe recovery time for each patient after completion of radiotherapyTimepoint: after completion of radiotherapy at recovery room

Countries

India

Contacts

Public ContactDr Uddalak Chattopadhyay

Mahamana Pandit Madan Mohan Malaviya Cancer Centre and Homi Bhabha Cancer Hospital Varanasi

uddalak@mpmmcc.tmc.gov.in8617279293

Outcome results

None listed

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