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

NCT ID: NCT02766452

Last Updated: 2016-05-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

105 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-09-30

Study Completion Date

2013-09-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Perioperative Nursing

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Caregivers Investigators Outcome Assessors

Study Groups

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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.

Group Type EXPERIMENTAL

"You and your child in the recovery room" DVD

Intervention Type BEHAVIORAL

Standard pre-operative preparation

Intervention Type BEHAVIORAL

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.

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.

Group Type PLACEBO_COMPARATOR

Standard pre-operative preparation

Intervention Type BEHAVIORAL

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.

Interventions

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"You and your child in the recovery room" DVD

Intervention Type 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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.
Minimum Eligible Age

3 Years

Maximum Eligible Age

10 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Children's Hospital of Eastern Ontario

OTHER

Sponsor Role collaborator

University of Ottawa

OTHER

Sponsor Role lead

Responsible Party

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Julie Chartrand

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

References

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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.

Reference Type BACKGROUND
PMID: 16268854 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 2457102 (View on PubMed)

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

Reference Type BACKGROUND
PMID: 11885458 (View on PubMed)

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.

Reference Type 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

Reference Type 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.

Reference Type DERIVED
PMID: 27681601 (View on PubMed)

Other Identifiers

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11/55X

Identifier Type: -

Identifier Source: org_study_id

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