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

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

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

Observational

Enrollment (Actual)

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

      • 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

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
Intervention / Treatment
paediatric 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

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

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.

Investigators

  • 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)

July 1, 2014

Primary Completion (ACTUAL)

December 1, 2015

Study Completion (ACTUAL)

December 1, 2015

Study Registration Dates

First Submitted

May 31, 2018

First Submitted That Met QC Criteria

July 22, 2018

First Posted (ACTUAL)

July 31, 2018

Study Record Updates

Last Update Posted (ACTUAL)

August 6, 2018

Last Update Submitted That Met QC Criteria

August 2, 2018

Last Verified

August 1, 2018

More Information

Terms related to this study

Other Study ID 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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