AnxietyNCT05257304
EFFECTS OF REPEATED GENERAL ANAESTHESIA ON THE LEVEL OF PRE-PROCEDURE ANXIETY IN CHILDREN UNDERGOING RADIOTHERAPY.
An observational study of Anxiety, run by Aga Khan University Hospital, Pakistan at 1 site in Pakistan.
Trial summary
Observation of pre-precedure anxiety in pre-operative suite in children from age 2-12yrs, undergoing radiotherapy under general anesthesia. Read more about this study
- Who is it for?
- Ages 2 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Anxiety
- How many people
- 40 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Aug 2021to 1 Aug 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: ASA I and II patients aged 2-12 years who are undergoing radiotherapy under general anesthesia
Who may be able to join
- Child of either gender
- 2-12 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
Who cannot join
- Procedure to be done under sedation alone
- Children with developmental delay
- Children coming with other relatives apart from parents.
Trial locations and contacts
1 site in 1 country.
Pakistan1 site, 1 recruiting
- Recruiting
Aga Khan University Hospital
Karachi, Sindh, 75350
Sufiyan Nasir, MBBS, 03362812522, sufiyan.nasir@aku.edu
About this study
Observation of pre-precedure anxiety in pre-operative suite in children from age 2-12yrs, undergoing radiotherapy under general anesthesia.
Read the 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
- Medical subject headings
- Anxiety Disorders
What is being measured
The primary outcome is the main question the study is designed to answer.
Anxiety score
Pre operative anxiety score would be assessed
Measured: First 3 radiotherapy cycles
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2022
- Study start1 Aug 2021
- Primary completion1 Aug 2023 (estimated)
- Study completion1 Aug 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnxietyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Aga Khan University Hospital, Pakistan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sufiyan Nasir, Aga Khan University Hospital, Pakistan
- Investigators
- Sufiyan Nasir, MBBS, Principal investigator, Aga Khan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05257304
- Sponsor's protocol ID
- AgaKhanUH(SN)
- Status last verified
- Feb 2022
- First submitted
- 17 Feb 2022
- Last updated
- 25 Feb 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EFFECTS OF REPEATED GENERAL ANAESTHESIA ON THE LEVEL OF PRE-PROCEDURE ANXIETY IN CHILDREN UNDERGOING RADIOTHERAPY.
- ClinicalTrials.gov ID
- NCT05257304
- Acronym / sponsor ID
- AgaKhanUH(SN)
- Conditions
- Anxiety
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Aga Khan University Hospital, PakistanUniversity, hospital or other
- Study start
- 1 Aug 2021 (actual)
- Primary completion
- 1 Aug 2023 (estimated)
- Study completion
- 1 Aug 2023 (estimated)
- First posted
- 25 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 2 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- ASA I and II patients aged 2-12 years who are undergoing radiotherapy under general anesthesia
Key inclusion criteria (5 listed)
- Child of either gender
- 2-12 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
Key exclusion criteria (3 listed)
- Procedure to be done under sedation alone
- Children with developmental delay
- Children coming with other relatives apart from parents.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Anxiety score
Time frame: First 3 radiotherapy cycles
Pre operative anxiety score would be assessed
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Feb 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sufiyan Nasir, MBBS principal investigator
Aga Khan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Anxiety, run by Aga Khan University Hospital, Pakistan at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sufiyan Nasir, MBBS (03362812522 ext. 2898, sufiyan.nasir@aku.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Anxiety score (time frame: First 3 radiotherapy cycles). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Feb 2022.