EFFECTS OF REPEATED GENERAL ANAESTHESIA ON THE LEVEL OF PRE-PROCEDURE ANXIETY IN CHILDREN UNDERGOING RADIOTHERAPY.

Sponsor
Aga Khan University Hospital, Pakistan (Other)
Overall Status
Recruiting
CT.gov ID
NCT05257304
Collaborator
(none)
40
1
24
1.7

Study Details

Study Description

Brief Summary

Observation of pre-precedure anxiety in pre-operative suite in children from age 2-12yrs, undergoing radiotherapy under general anesthesia.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    Radiotherapy procedures are used to damage or destroy growing cancer cells.(1) This strategic use of ionized radiation is being practiced since the early 20th century and is very effective in destroying diseased cancer cells while sparing the healthy ones.(2) These procedures require patients to stay absolutely still, hence requiring general anesthesia in case of children compared to the adults. The treatment also requires multiple cycles of radiotherapy for which children have to undergo general anaesthesia multiple times.(3) Multiple anaesthetics for the same child may lead to preoperative anxiety, increased autonomic fluctuations, increased demand for anaesthetics and nausea/vomiting.(4-5) Pre-operative anxiety not only causes physical but also emotional and psychological trauma.(6) Such patients, subjected to anxiety, may face fear and potential hesitance in visiting the pre-anesthesia clinics for evaluation, induction and problems in pre-operative and recovery span.(7-8)It is therefore important to gauge the extent of this anxiety and to see whether it increases or decreases with subsequent cycles of treatment .Unless this is identified it will be difficult to put appropriate treatments in place.

    Though previous studies are available on pre-operative anxiety in children but there has been little research about level of a child's anxiety under going repeated general anesthesia, especially during radiotherapy sessions. We were unable to identify any study on the subject in our literature search, a gap that needs research.

    Several scales are available to evaluate anxiety in children(9), mYPAS scale is a standard It is also important to measure the anxiety levels of the parents accompanying the child, since this may have an effect on behavior.

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    40 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    EFFECTS OF REPEATED GENERAL ANAESTHESIA ON THE LEVEL OF PRE-PROCEDURE ANXIETY IN CHILDREN UNDERGOING RADIOTHERAPY.
    Actual Study Start Date :
    Aug 1, 2021
    Anticipated Primary Completion Date :
    Aug 1, 2023
    Anticipated Study Completion Date :
    Aug 1, 2023

    Outcome Measures

    Primary Outcome Measures

    1. Anxiety score [First 3 radiotherapy cycles]

      Pre operative anxiety score would be assessed

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    2 Years to 12 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:
    1. Child of either gender

    2. 2-12 years of age

    3. ASA status (1,2 and stable 3)

    4. Pre-school, school and non-school going

    5. Scheduled for a radiotherapy procedure under general anesthesia for at least 3 cycles under GA

    Exclusion Criteria:
    1. Procedure to be done under sedation alone

    2. Children with developmental delay

    3. Children coming with other relatives apart from parents.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Aga Khan University Hospital Karachi Sindh Pakistan 75350

    Sponsors and Collaborators

    • Aga Khan University Hospital, Pakistan

    Investigators

    • Principal Investigator: Sufiyan Nasir, MBBS, Aga Khan University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Sufiyan Nasir, Resident, Aga Khan University Hospital, Pakistan
    ClinicalTrials.gov Identifier:
    NCT05257304
    Other Study ID Numbers:
    • AgaKhanUH(SN)
    First Posted:
    Feb 25, 2022
    Last Update Posted:
    Feb 25, 2022
    Last Verified:
    Feb 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Feb 25, 2022