Ignite Creation Date:
2025-12-24 @ 9:22 PM
Ignite Modification Date:
2025-12-24 @ 9:22 PM
Study NCT ID:
NCT05257304
Status:
UNKNOWN
Last Update Posted:
2022-02-25
First Post:
2022-02-17
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
EFFECTS OF REPEATED GENERAL ANAESTHESIA ON THE LEVEL OF PRE-PROCEDURE ANXIETY IN CHILDREN UNDERGOING RADIOTHERAPY.
Sponsor:
Aga Khan University Hospital, Pakistan
Organization:
Study Overview
Official Title:
EFFECTS OF REPEATED GENERAL ANAESTHESIA ON THE LEVEL OF PRE-PROCEDURE ANXIETY IN CHILDREN UNDERGOING RADIOTHERAPY.
Status:
UNKNOWN
Status Verified Date:
2022-02
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Observation of pre-precedure anxiety in pre-operative suite in children from age 2-12yrs, undergoing radiotherapy under general anesthesia.
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.
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: