Clinical trial NCT02766452: Effects of Preparing Parents To Participate In Their Child's Care In The Recovery Room
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Perioperative Nursing
Lead sponsor: University of Ottawa
Sponsor class: OTHER
Collaborators: name: Children's Hospital of Eastern Ontario
First posted: 2016-05-09
Enrollment: 105
Sex: ALL
Minimum age (years): 3
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Parents' participation behaviors
timeFrame: Post-treatment (In average, between 1 and 7 days following the intervention)
Secondary outcomes:
measure: Parents' knowledge acquisition
timeFrame: Post-treatment (In average, between 1 and 7 days following the intervention)
measure: Parents' anxiety
timeFrame: Post-treatment (In average, between 1 and 7 days following the intervention)
measure: Children's distress in the recovery room (RR)
timeFrame: Post-treatment (In average, between 1 and 7 days following the intervention)
measure: Children's pain
timeFrame: Post-treatment (In average, between 1 and 7 days following the intervention)
measure: Children's analgesic requirements
timeFrame: Post-treatment (In average, between 1 and 7 days following the intervention)
measure: Children's length of recovery
timeFrame: Post-treatment (In average, between 1 and 7 days following the intervention)
Other outcomes:
Locations:
Study officials:
References:
citation: 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.
citation: 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.
citation: Tourigny J. [A new instrument to measure distress in the operated child]. Infirm Que. 2000 Nov-Dec;8(2):18-26, 28-9. French.
citation: 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.
citation: 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
citation: 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.