Effects of Preparing Parents To Participate In Their Child's Care In The Recovery Room

May 5, 2016 updated by: Julie Chartrand, University of Ottawa

The Effects of a Preoperative Educational DVD on Parents' Participation in Their Child's Care in the Recovery Room at the Time of a Same-day Surgery: A Randomized Controlled Trial

The objectives of this study were to evaluate the effect of a preoperative educational DVD on parents' knowledge acquisition, participation and anxiety related to their child's care in the recovery room (RR). It also aimed at evaluating the DVD in terms of children's postoperative distress, pain, analgesic requirements and length of recovery.

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

Following the development of a validated preoperative educational Digital Versatile Disc (DVD) for parents, a randomized clinical trial, with a pre-test-post-test control group, was conducted on 123 French or English speaking parent-child dyads whose child was aged from 3 to 10 years and underwent an ear-nose-throat (ENT) or dental same day surgery at a Canadian pediatric hospital. The parents in the control group received the standard preoperative preparation (verbal and written information about hospital procedures and the hospital's surgical virtual tour). The parents in the experimental group viewed the DVD and received the standard preoperative preparation. Parents and children were videotaped in the recovery room; parental participation and children's distress were measured using observational scales. A validated multiple choice questionnaire was used to measure parents' knowledge acquisition, whereas a visual analogue scale allowed parents to report their anxiety level prior to, during and after their stay in the recovery room. A chart review was conducted to collect data on children's postoperative pain, analgesic requirements and length of recovery. In order to assess the effect of the DVD on parents and their child, T-test, chi-square analyses and repeated measures ANOVAs were conducted among 105 dyads.

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.
Interventional

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.
105

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

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

3 years to 10 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Parents speaking, reading and communicating to their child in english or french
  • Parents who consented to participating in the study
  • Parents who had a child aged 3 to 10 years who underwent a day surgery of the ENT type (an adenoidectomy or an amygdalectomy or a combination of both) or of the dental type (a dental exam under general anesthesia or an extraction or a dental repair under general anesthesia) were part of the sampling

Exclusion Criteria:

  • The parents and the children who did not fit the eligibility criterias were excluded from the study.
  • The parents who completed the consent form and questionnaires before the day of the surgery and who did the pre-surgical preparation, but who did not accompany the child in the recovery room were not part of the study.
  • Also excluded, children who presented post-anesthetic complications (ex.: respiratory distress, hemorrhage, severe emotional distress, etc.).
  • Children presenting surgical complications (ex.: cardio-respiratory distress and hemorrhage) were also excluded from the study.

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

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
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.
Experimental: Pre-operative educational DVD preparation
After their pre-assessment clinic (PAC) appointment, parents in the intervention group took the hospital's 20 minute surgical virtual tour in the hospital's family library. Parents in the intervention group also watched the 12 minute DVD entitled, "You and Your Child in the RR". This pre-operative educational tool was developed and tested in a previous study (Chartrand 2014). It was designed to enable parents to gain knowledge about the equipment and procedures related to the RR, and about nurses' and parents' roles in supporting their child in the RR. The DVD also focused on potential reactions of children waking up after a general anesthesia and strategies parents can use to support their child in the RR. The DVD included images of RR equipment and positive nurse-family and parent-child interactions.
Behavioral: "You and your child in the recovery room" DVD
Behavioral: Standard pre-operative preparation
Attendance to the Pre-anesthetic assessment clinic to meet with registered practical nurse and anesthesiologist (physical assessment and medical history). Completion of the Surgery Virtual Tour.
Placebo Comparator: Standard pre-operative preparation
After their PAC appointment, parents in the control groups took the hospital's 20 minute surgical virtual tour in the hospital's family library.
Behavioral: Standard pre-operative preparation
Attendance to the Pre-anesthetic assessment clinic to meet with registered practical nurse and anesthesiologist (physical assessment and medical history). Completion of the Surgery Virtual Tour.

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
Parents' participation behaviors
Time Frame: Post-treatment (In average, between 1 and 7 days following the intervention)
Video recordings were taken of parents and children during the child's stay in the recovery room, every 3 minutes for 15 seconds at a time. A maximum of six segments were randomly selected to capture a range of parental participation behaviors throughout their stay in the RR. Thus, the maximum duration of the recordings was 1 ½ minutes per parent (six observation periods x 15 seconds). Parents' participation behaviors were measured using an observational checklist, the Inventaire des conduites parentales (ICP) (Parental Behaviours Inventory), which includes different behaviors parents may have during a child's same-day surgery (Tourigny et al., 2005). The ICP is composed of 13 indicators divided into three categories; verbal information (i.e. providing information to child and answering child's questions), cognitive strategies (i.e. applying positive reinforcement and implementing coping strategies) and attitudes (i.e. showing the child affection and being close to the child).
Post-treatment (In average, between 1 and 7 days following the intervention)

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
Measure Description
Time Frame
Parents' knowledge acquisition
Time Frame: Post-treatment (In average, between 1 and 7 days following the intervention)
A multiple choice questionnaire was designed and validated for this study, then used to measure parents' knowledge. Parents' answers were tabulated to get a total score for each parent and for each test (test 1: Pre-intervention and test 2: Post-intervention). The maximum score for each test was 10. Parents' knowledge acquisition was measured by calculating the difference between parents' scores on test 1 and test 2.
Post-treatment (In average, between 1 and 7 days following the intervention)
Parents' anxiety
Time Frame: Post-treatment (In average, between 1 and 7 days following the intervention)
Defined by parents' self-reporting of their anxiety at three time points: 1) immediately before entering the RR; 2) 5 minutes after entering the RR; and 3) 5 minutes after leaving the RR with their child. Parents' anxiety was measured using the Visual Analogue Scale for Anxiety (VAS-A) (Vogelsang 1988)
Post-treatment (In average, between 1 and 7 days following the intervention)
Children's distress in the recovery room (RR)
Time Frame: Post-treatment (In average, between 1 and 7 days following the intervention)
Defined as facial, verbal, and affective manifestations, and motor indicators of emotional distress related to anxiety, anger, fear and pain. Parent-child dyads were digitally video-recorded in the RR. The video segments randomly selected to measure parents' participation behaviours in the RR were also used to measure children's distress behaviours. Children's distress behaviours were measured with the Échelle descriptive du comportement de l'enfant opéré (EDCEO) (Observation scale to assess the behaviour of children undergoing surgery) (Tourigny 2000)
Post-treatment (In average, between 1 and 7 days following the intervention)
Children's pain
Time Frame: Post-treatment (In average, between 1 and 7 days following the intervention)
Post-operative pain was assessed in the RR and the daycare surgery (DCS) unit and documented by nurses using the Modified Children's Hospital of Eastern Ontario Pain Score (mCHEOPS) (Splinter et al. 1994)
Post-treatment (In average, between 1 and 7 days following the intervention)
Children's analgesic requirements
Time Frame: Post-treatment (In average, between 1 and 7 days following the intervention)

Post-operative analgesics required by children in the RR and in the DCS unit included opioid analgesics (e.g. Fentanyl and Morphine) and non-opioids (e.g.

Acetaminophen)
Post-treatment (In average, between 1 and 7 days following the intervention)
Children's length of recovery
Time Frame: Post-treatment (In average, between 1 and 7 days following the intervention)
Time (in minutes) elapsed between the arrival of the children in the RR and their departure from the DCS unit. The time at which children were discharged from the DCS unit was determined based on the achievement of specific criteria regarding level of activity and consciousness, vital signs, blood perfusion, pain and wound assessment and feeding.
Post-treatment (In average, between 1 and 7 days following the intervention)

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.
University of Ottawa

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Children's Hospital of Eastern Ontario

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

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.
September 1, 2011

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.
September 1, 2012

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.
September 1, 2013

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 5, 2016

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.
May 5, 2016

First Posted (Estimate)

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.
May 9, 2016

Study Record Updates

Last Update Posted (Estimate)

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.
May 9, 2016

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.
May 5, 2016

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.
May 1, 2016

More Information

Terms related to this study

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.
  • 11/55X

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

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