A study to observe the effect of pre-recorded lullaby in a childs own mothers voice on radiotherapy procedures which are under sedation.
Not Applicable
Recruiting
- Conditions
- Health Condition 1: C768- Malignant neoplasm of other specified ill-defined sites
- Registration Number
- CTRI/2024/01/061077
- Lead Sponsor
- Mahamana Pandit Madan Mohan Malaviya Cancer Centre and Homi Bhabha Cancer Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
Inclusion Criteria: Pediatric patients of both the sex less than three years of age undergoing radiotherapy.
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.
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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;To observe the total dose requirement (per kg body weight) of general anesthetics (midazolam and ketamine) per episode of radiotherapy.Timepoint: During radiotherapy