NCT02766452

Brief Summary

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
105

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2011

Typical duration for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2011

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2012

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2013

Completed
2.7 years until next milestone

First Submitted

Initial submission to the registry

May 5, 2016

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 9, 2016

Completed
Last Updated

May 9, 2016

Status Verified

May 1, 2016

Enrollment Period

1 year

First QC Date

May 5, 2016

Last Update Submit

May 5, 2016

Conditions

Outcome Measures

Primary Outcomes (1)

  • Parents' participation behaviors

    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 Outcomes (6)

  • Parents' knowledge acquisition

    Post-treatment (In average, between 1 and 7 days following the intervention)

  • Parents' anxiety

    Post-treatment (In average, between 1 and 7 days following the intervention)

  • Children's distress in the recovery room (RR)

    Post-treatment (In average, between 1 and 7 days following the intervention)

  • Children's pain

    Post-treatment (In average, between 1 and 7 days following the intervention)

  • Children's analgesic requirements

    Post-treatment (In average, between 1 and 7 days following the intervention)

  • +1 more secondary outcomes

Study Arms (2)

Pre-operative educational DVD preparation

EXPERIMENTAL

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" DVDBehavioral: Standard pre-operative preparation

Standard pre-operative preparation

PLACEBO COMPARATOR

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

Interventions

Pre-operative educational DVD 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.

Pre-operative educational DVD preparationStandard pre-operative preparation

Eligibility Criteria

Age3 Years - 10 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (6)

  • Tourigny J, Chapados C, Pineault R. Determinants of parental behaviour when children undergo day-care surgery. J Adv Nurs. 2005 Dec;52(5):490-7. doi: 10.1111/j.1365-2648.2005.03617.x.

    PMID: 16268854BACKGROUND
  • Vogelsang J. The Visual Analog Scale: an accurate and sensitive method for self-reporting preoperative anxiety. J Post Anesth Nurs. 1988 Aug;3(4):235-9. No abstract available.

    PMID: 2457102BACKGROUND
  • Tourigny J. [A new instrument to measure distress in the operated child]. Infirm Que. 2000 Nov-Dec;8(2):18-26, 28-9. French.

    PMID: 11885458BACKGROUND
  • Splinter, W. M., Semelhago, L. C., et Chou, S. (1994). The reliability and validity of a modified CHEOPS pain score. Anesthesia and Analgesia, 78, S413.

    BACKGROUND
  • Chartrand, J. (2014). Effet d'un DVD éducatif pré-opératoire sur les connaissances et les conduites des parents en salle de réveil: une étude clinique randomisée (Doctoral dissertation, Université d'Ottawa). Retrieved from http://hdl.handle.net/10393/31231

    RESULT
  • Chartrand J, Tourigny J, MacCormick J. The effect of an educational pre-operative DVD on parents' and children's outcomes after a same-day surgery: a randomized controlled trial. J Adv Nurs. 2017 Mar;73(3):599-611. doi: 10.1111/jan.13161. Epub 2016 Oct 20.

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

May 5, 2016

First Posted

May 9, 2016

Study Start

September 1, 2011

Primary Completion

September 1, 2012

Study Completion

September 1, 2013

Last Updated

May 9, 2016

Record last verified: 2016-05

Data Sharing

IPD Sharing
Will not share