- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02766452
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
Completed
Conditions
Intervention / Treatment
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
Interventional
Enrollment (Actual)
105
Phase
- 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
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 |
Intervention / Treatment |
---|---|
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.
|
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.
|
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
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
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
Collaborators
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
- 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.
- 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.
- Tourigny J. [A new instrument to measure distress in the operated child]. Infirm Que. 2000 Nov-Dec;8(2):18-26, 28-9. French.
- 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.
- 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
- 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 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
September 1, 2011
Primary Completion (Actual)
September 1, 2012
Study Completion (Actual)
September 1, 2013
Study Registration Dates
First Submitted
May 5, 2016
First Submitted That Met QC Criteria
May 5, 2016
First Posted (Estimate)
May 9, 2016
Study Record Updates
Last Update Posted (Estimate)
May 9, 2016
Last Update Submitted That Met QC Criteria
May 5, 2016
Last Verified
May 1, 2016
More Information
Terms related to this study
Other Study ID Numbers
- 11/55X
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.
Clinical Trials on Perioperative Nursing
-
University of Sao PauloUniversidade Estadual de LondrinaUnknownThirst | Perioperative NursingBrazil
-
Tarsus UniversityMustafa Kemal University; Mersin University; Necmettin Erbakan UniversityRecruitingPerioperative Care | Healthy Individuals | Oxygen Saturation | Nursing | Gel NailTurkey
-
Tarsus UniversityMustafa Kemal University; Mersin University; Necmettin Erbakan UniversityRecruitingPerioperative Care | Healthy Individuals | Oxygen Saturation | Nursing | Shellac Nail PolishTurkey
-
Gazi UniversityCompletedNursing Caries | Cholelithiases | Perioperative Complication | Bowel IleusTurkey
-
Marmara UniversityNot yet recruitingNursing Education | Nursing Students | Nursing ModelTurkey
-
Kırıkkale UniversityCompletedEducation | Nursing Care | Student Nursing | Medical-surgical NursingTurkey
-
Kafkas UniversityNot yet recruiting
-
Bilecik Seyh Edebali UniversitesiCompletedEducation, Nursing | Students, NursingTurkey
-
Saglik Bilimleri Universitesi Gulhane Tip FakultesiEastern Mediterranean UniversityCompletedPain, Postoperative | Nursing Caries | Perioperative ComplicationTurkey
-
Duzce UniversityCompletedNursing Students | Nursing Education ResearchTurkey
Clinical Trials on "You and your child in the recovery room" DVD
-
University of North CarolinaRTI InternationalCompletedProstatic NeoplasmsUnited States
-
Memorial Sloan Kettering Cancer CenterNational Cancer Institute (NCI); Indiana UniversityCompletedMetastatic Breast CancerUnited States
-
University Hospital, Strasbourg, FranceUnknownPost-operative Vomiting Incidence | Pediatric Day Case SurgeryFrance
-
Universidade Estadual de LondrinaCompleted
-
Brandon HathornBaylor Heart and Vascular Institute Cardiovascular Research Review CommitteeCompletedCoronary Artery Disease | Valve Disease, Heart
-
West China HospitalCompletedLiver TransplantationChina
-
Centre Hospitalier Universitaire de NīmesCompleted
-
Pusan National University Yangsan HospitalCompletedExtubation in the OR After LDLTKorea, Republic of
-
University GhentUniversity of TorontoRecruitingQuality Improvement | Patient Safety | Endovascular ProceduresBelgium
-
American Board of Internal MedicineThe Josiah Macy, Jr. FoundationCompleted