FastingNCT03606564
Parents Perception and Compliance With Pre Operative Fasting Instructions in Paediatric Patients
An observational study of Fasting, run by Post Graduate Institute of Medical Education and Research, Chandigarh at 1 site in India.
Trial summary
This study evaluates the perception and compliance with the fasting instructions given to parents of children undergoing surgery. A questionnaire was provided to the parents indicating fasting time requested and actual time of fasting. Read more about this study
- Who is it for?
- Ages 1 year to 12 years
- Conditions the study is for
- Fasting
- What is being tested?
- study of fasting time among pediatric patients undergoing day care surgery
- How many people
- 1,050 participants
- Where
- 1 siteIndia
- Study dates
- Jul 2014to Dec 2015
- 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 1 year to 12 years
- All sexes
- No healthy volunteers
- Child
Study population: Consecutive children aged 1 to 12 years of ASA I and II category, scheduled to undergo elective day care surgery under general anaesthesia, were included in this prospective study
Who may be able to join
- Children aged 1 to 12 years
- ASA I and II category
- Elective day care surgery
- General anaesthesia planned
Who cannot join
- Parent's refusal to participate.
- Children with complex nutritional requirements eg. feeding via gastrostomy tube
- Parents who cannot read or understand English, Hindi or Punjabi
Trial locations and contacts
1 site in 1 country.
India1 site
Post Graduate Institute of Medical Education and Research,
Chandigarh, 160012
About this study
Official title: Parent's Perception and Compliance With Pre-operative Fasting Instructions in Paediatric Patients Undergoing Day Care Surgery
This study evaluates the perception and compliance with the fasting instructions given to parents of children undergoing surgery. A questionnaire was provided to the parents indicating fasting time requested and actual time of fasting.
Read the detailed description
American Society of Anesthesiologists (ASA) have recommended fasting guidelines of 8 hours of solids, 6 hours for formula milk, 4 hours for breast milk and 2 hours of clear liquids, for preoperative patients undergoing elective surgery. Parents of Children undergoing surgery are instructed to adhere to these guidelines. Parents might not be compliant with these instructions. They may fast their children less than or more than the recommended time.
Main aim of this study is to find out the incidence of non compliance with the fasting instructions and try to find the reasons for such non compliance.
- Conditions
- Fasting
- Being tested
- study of fasting time among pediatric patients undergoing day care surgery
- Keywords
- compliance, fasting guidelines
- Medical subject headings
- Fasting, Patient Compliance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
study of fasting time among pediatric patients undergoing day care surgeryOther
parents of children undergoing day care surgery were given a questionnaire to be filled containing questions regarding time of fasting that was instructed and
| Study group | Role | What they receive |
|---|---|---|
| paediatric patients undergoing day care surgery | Not described Receives: Other: study of fasting time among pediatric patients undergoing day care surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Median duration of fasting
Median time of pre operative fasting as advised by anaesthesiologist/surgeon/nurse in the Pre Anaesthesia Clinic was compared with the Median duration of fasting of the patient just before surgery.
Measured: 1.5 years
Percentage of parents who followed the preoperative fasting instructions
Percentage of parents who adhered to advised fasting time was compared with percentage of parents who fasted their children more than or less than what was advised.
Measured: 1.5 years
Secondary outcomes (8)
Percentage of parents who attended Pre Anaesthesia Clinic
Measured: 1.5 years
Percentage of parents who could recall fasting instructions that were provided in Pre Anaesthesia Clinic
Measured: 1.5 years
Percentage of parents who could tell if they were provided separate fasting instructions for solids and liquid foods
Measured: 1.5 years
Percentage of parents who could recall if fasting instructions were verbal or written orders
Measured: 1.5 years
Percentage of parents who received fasting instructions from anyone other than the anaesthetist
Measured: 1.5 years
Percentage of parents who understood the actual reason to fast before surgery
Measured: 1.5 years
Percentage of patients who were not adequately fasted.
Measured: 1.5 years
Percentage of parents who complained about fasting time being too long for their children
Measured: 1.5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2018
- Study startJul 2014
- Primary completionDec 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FastingStudies 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
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 1,050 participants (actual)
Sponsor and investigators
- Lead sponsor
- Post Graduate Institute of Medical Education and Research, Chandigarh
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, KARAN SINGLA, Post Graduate Institute of Medical Education and Research, Chandigarh
- Investigators
- indu bala, MD, Principal investigator, PGIMER, chandigarh, india
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03606564
- Sponsor's protocol ID
- 9605/PG-2Trg/2013/13402
- Status last verified
- Aug 2018
- First submitted
- 31 May 2018
- Last updated
- 6 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Parent's Perception and Compliance With Pre-operative Fasting Instructions in Paediatric Patients Undergoing Day Care Surgery
- ClinicalTrials.gov ID
- NCT03606564
- Acronym / sponsor ID
- 9605/PG-2Trg/2013/13402
- Conditions
- Fasting
- Keywords
- compliance, fasting guidelines
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,050 participants (actual)
- Lead sponsor
- Post Graduate Institute of Medical Education and Research, ChandigarhUniversity, hospital or other
- Study start
- Jul 2014 (actual)
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 31 Jul 2018 (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.
This study evaluates the perception and compliance with the fasting instructions given to parents of children undergoing surgery. A questionnaire was provided to the parents indicating fasting time requested and actual time of fasting.
Detailed description
American Society of Anesthesiologists (ASA) have recommended fasting guidelines of 8 hours of solids, 6 hours for formula milk, 4 hours for breast milk and 2 hours of clear liquids, for preoperative patients undergoing elective surgery. Parents of Children undergoing surgery are instructed to adhere to these guidelines. Parents might not be compliant with these instructions. They may fast their children less than or more than the recommended time.
Main aim of this study is to find out the incidence of non compliance with the fasting instructions and try to find the reasons for such non compliance.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| paediatric patients undergoing day care surgery | – | Other: study of fasting time among pediatric patients undergoing day care surgery |
Who may qualify
- Ages
- 1 year to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Consecutive children aged 1 to 12 years of ASA I and II category, scheduled to undergo elective day care surgery under general anaesthesia, were included in this prospective study
Key inclusion criteria (4 listed)
- Children aged 1 to 12 years
- ASA I and II category
- Elective day care surgery
- General anaesthesia planned
Key exclusion criteria (3 listed)
- Parent's refusal to participate.
- Children with complex nutritional requirements eg. feeding via gastrostomy tube
- Parents who cannot read or understand English, Hindi or Punjabi
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| study of fasting time among pediatric patients undergoing day care surgeryparents of children undergoing day care surgery were given a questionnaire to be filled containing questions regarding time of fasting that was instructed and | Other | paediatric patients undergoing day care surgery |
Primary outcome
Median duration of fasting
Time frame: 1.5 years
Median time of pre operative fasting as advised by anaesthesiologist/surgeon/nurse in the Pre Anaesthesia Clinic was compared with the Median duration of fasting of the patient just before surgery.
Percentage of parents who followed the preoperative fasting instructions
Time frame: 1.5 years
Percentage of parents who adhered to advised fasting time was compared with percentage of parents who fasted their children more than or less than what was advised.
8 secondary outcomes
Percentage of parents who attended Pre Anaesthesia Clinic
Time frame: 1.5 years
Percentage of parents who could recall fasting instructions that were provided in Pre Anaesthesia Clinic
Time frame: 1.5 years
Percentage of parents who could tell if they were provided separate fasting instructions for solids and liquid foods
Time frame: 1.5 years
Percentage of parents who could recall if fasting instructions were verbal or written orders
Time frame: 1.5 years
Percentage of parents who received fasting instructions from anyone other than the anaesthetist
Time frame: 1.5 years
Percentage of parents who understood the actual reason to fast before surgery
Time frame: 1.5 years
Percentage of patients who were not adequately fasted.
Time frame: 1.5 years
Percentage of parents who complained about fasting time being too long for their children
Time frame: 1.5 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2018.
- Individual participant dataSharing planned: No
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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.
indu bala, MD principal investigator
PGIMER, chandigarh, india
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 Fasting, run by Post Graduate Institute of Medical Education and Research, Chandigarh at 1 site in India.
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 4 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: finished, as of the sponsor's last update on 6 Aug 2018. 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 India. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Median duration of fasting (time frame: 1.5 years). The study lists 2 primary outcomes in all. 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 6 Aug 2018.