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

Anxiety Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05257304
• Other study ID #: AgaKhanUH(SN)
• Status: Recruiting
• Start date: August 1, 2021
• Est. completion date: August 1, 2023

Study information

• Verified date: February 2022
• Source: Aga Khan University Hospital, Pakistan
• Contact: Sufiyan Nasir, MBBS
• Phone: 03362812522
• Email: sufiyan.nasir[@]aku.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: August 1, 2023
• Est. primary completion date: August 1, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 2 Years to 12 Years

Eligibility

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.

Related Conditions & MeSH terms

• Anxiety
• Anxiety Disorders

Locations

Country	Name	City	State
Pakistan	Aga Khan University Hospital	Karachi	Sindh

Sponsors (1)

Lead Sponsor	Collaborator
Aga Khan University Hospital, Pakistan

Country where clinical trial is conducted

Pakistan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Anxiety score	Pre operative anxiety score would be assessed	First 3 radiotherapy cycles