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

NCT ID: NCT05257304

Last Updated: 2022-02-25

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 40 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-08-01
• Study Completion Date: 2023-08-01

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.

Conditions

Anxiety

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Eligibility Criteria

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.

• Minimum Eligible Age: 2 Years
• Maximum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Aga Khan University Hospital, Pakistan

OTHER

Sponsor Role: lead

Responsible Party

Sufiyan Nasir

Resident

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Sufiyan Nasir, MBBS

Role: PRINCIPAL_INVESTIGATOR

Aga Khan University

Locations

Aga Khan University Hospital

Karachi, Sindh, Pakistan

Site Status: RECRUITING

Countries

Pakistan

Central Contacts

Sufiyan Nasir, MBBS

Role: CONTACT

sufiyan.nasir@aku.edu

03362812522 ext. 2898

Facility Contacts

Sufiyan Nasir, MBBS

Role: primary

sufiyan.nasir@aku.edu

03362812522

Other Identifiers

AgaKhanUH(SN)

Identifier Type: -

Identifier Source: org_study_id