NCT05257304

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Aug 2021

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2021

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

February 17, 2022

Completed
8 days until next milestone

First Posted

Study publicly available on registry

February 25, 2022

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2023

Completed
Last Updated

February 25, 2022

Status Verified

February 1, 2022

Enrollment Period

2 years

First QC Date

February 17, 2022

Last Update Submit

February 17, 2022

Conditions

Anxiety

Outcome Measures

Primary Outcomes (1)

  • Anxiety score

    Pre operative anxiety score would be assessed

    First 3 radiotherapy cycles

Eligibility Criteria

Age2 Years - 12 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

ASA I and II patients aged 2-12 years who are undergoing radiotherapy under general anesthesia

You may qualify if:

  • Child of either gender
  • years of age
  • ASA status (1,2 and stable 3)
  • Pre-school, school and non-school going
  • Scheduled for a radiotherapy procedure under general anesthesia for at least 3 cycles under GA

You may not qualify if:

  • Procedure to be done under sedation alone
  • Children with developmental delay
  • Children coming with other relatives apart from parents.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Aga Khan University Hospital

Karachi, Sindh, 75350, Pakistan

RECRUITING

MeSH Terms

Conditions

Anxiety Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Study Officials

  • Sufiyan Nasir, MBBS

    Aga Khan University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Sufiyan Nasir, MBBS

CONTACT

03362812522sufiyan.nasir@aku.edu

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Resident

Study Record Dates

First Submitted

February 17, 2022

First Posted

February 25, 2022

Study Start

August 1, 2021

Primary Completion

August 1, 2023

Study Completion

August 1, 2023

Last Updated

February 25, 2022

Record last verified: 2022-02

Locations

PA(1)