Parents Perception and Compliance With Pre Operative Fasting Instructions in Paediatric Patients

August 2, 2018 updated by: KARAN SINGLA, Postgraduate Institute of Medical Education and Research, Chandigarh

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
1050

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • India
      • Chandigarh, India, 160012
        • Post Graduate Institute of Medical Education and Research,

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

1 year to 12 years (CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

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

Description

Inclusion Criteria:

  • Children aged 1 to 12 years
  • ASA I and II category
  • Elective day care surgery
  • General anaesthesia planned

Exclusion Criteria

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
paediatric patients undergoing day care surgery
Other: study of fasting time among pediatric patients undergoing day care surgery
parents of children undergoing day care surgery were given a questionnaire to be filled containing questions regarding time of fasting that was instructed and

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
1.5 years
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.
1.5 years

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Percentage of parents who attended Pre Anaesthesia Clinic
Time Frame: 1.5 years
1.5 years
Percentage of parents who could recall fasting instructions that were provided in Pre Anaesthesia Clinic
Time Frame: 1.5 years
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
1.5 years
Percentage of parents who could recall if fasting instructions were verbal or written orders
Time Frame: 1.5 years
1.5 years
Percentage of parents who received fasting instructions from anyone other than the anaesthetist
Time Frame: 1.5 years
1.5 years
Percentage of parents who understood the actual reason to fast before surgery
Time Frame: 1.5 years
1.5 years
Percentage of patients who were not adequately fasted.
Time Frame: 1.5 years
1.5 years
Percentage of parents who complained about fasting time being too long for their children
Time Frame: 1.5 years
1.5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Postgraduate Institute of Medical Education and Research, Chandigarh

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: indu bala, MD, PGIMER, Chandigarh, India

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 1, 2014

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2015

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2015

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 31, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 22, 2018

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 31, 2018

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 6, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 2, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2018

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 9605/PG-2Trg/2013/13402

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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