Perioperative NursingNCT02766452
Effects of Preparing Parents To Participate In Their Child's Care In The Recovery Room
A study testing "You and your child in the recovery room" DVD and Standard pre-operative preparation in people with Perioperative Nursing, run by University of Ottawa.
Trial 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). Read more about this study
- Who is it for?
- Ages 3 to 10 yearsHealthy volunteers can take part
- Conditions the study is for
- Perioperative Nursing
- What is being tested?
- "You and your child in the recovery room" DVD and Standard pre-operative preparation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 105 participants
- Where
- No sites listed yet
- Study dates
- Sep 2011to Sep 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 10 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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
Who cannot join
- 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.
About this study
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
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.
Read the 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.
- Conditions
- Perioperative Nursing
- Being tested
- "You and your child in the recovery room" DVD, Standard pre-operative preparation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
"You and your child in the recovery room" DVDBehavioural
Standard pre-operative preparationBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: "You and your child in the recovery room" DVD; Behavioral: 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. Receives: Behavioral: Standard pre-operative preparation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Post-treatment (In average, between 1 and 7 days following the intervention)
Secondary outcomes (6)
Parents' knowledge acquisition
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.
Measured: Post-treatment (In average, between 1 and 7 days following the intervention)
Parents' anxiety
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)
Measured: Post-treatment (In average, between 1 and 7 days following the intervention)
Children's distress in the recovery room (RR)
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)
Measured: Post-treatment (In average, between 1 and 7 days following the intervention)
Children's pain
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)
Measured: Post-treatment (In average, between 1 and 7 days following the intervention)
Children's analgesic requirements
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)
Measured: Post-treatment (In average, between 1 and 7 days following the intervention)
Children's length of recovery
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.
Measured: Post-treatment (In average, between 1 and 7 days following the intervention)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2016 (estimated)
- Study startSep 2011
- Primary completionSep 2012
- Study completionSep 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Perioperative NursingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 105 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Ottawa
- Sponsor type
- University, hospital or other
- Collaborators
- Children's Hospital of Eastern Ontario
- Responsible party
- Principal investigator, Julie Chartrand, University of Ottawa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02766452
- Sponsor's protocol ID
- 11/55X
- Status last verified
- May 2016
- First submitted
- 5 May 2016
- Last updated
- 9 May 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
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.
PubMed 16268854Vogelsang 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.
PubMed 2457102Tourigny J. [A new instrument to measure distress in the operated child]. Infirm Que. 2000 Nov-Dec;8(2):18-26, 28-9. French.
PubMed 11885458Splinter, 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.
PubMed 27681601
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02766452
- Acronym / sponsor ID
- 11/55X
- Conditions
- Perioperative Nursing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 105 participants (actual)
- Lead sponsor
- University of OttawaUniversity, hospital or other
- Collaborators
- Children's Hospital of Eastern Ontario
- Study start
- Sep 2011
- Primary completion
- Sep 2012 (actual)
- Study completion
- Sep 2013 (actual)
- First posted
- 9 May 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pre-operative educational DVD preparation | Experimental | Behavioral: "You and your child in the recovery room" DVD, Behavioral: Standard pre-operative preparationAfter 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. |
| Standard pre-operative preparation | Placebo comparator | Behavioral: Standard pre-operative preparationAfter their PAC appointment, parents in the control groups took the hospital's 20 minute surgical virtual tour in the hospital's family library. |
Who may qualify
- Ages
- 3 to 10 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| "You and your child in the recovery room" DVD | Behavioural | Pre-operative educational DVD preparation |
| Standard pre-operative preparationAttendance 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. | Behavioural | Pre-operative educational DVD preparation, Standard pre-operative preparation |
Primary outcome
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).
6 secondary outcomes
Parents' knowledge acquisition
Time frame: 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)
Children's distress in the recovery room (RR)
Time frame: 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)
Children's analgesic requirements
Time frame: 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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2016.
- Background: PubMed 16268854Tourigny 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.
- Background: PubMed 2457102Vogelsang 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.
- Background: PubMed 11885458Tourigny J. [A new instrument to measure distress in the operated child]. Infirm Que. 2000 Nov-Dec;8(2):18-26, 28-9. French.
- BackgroundSplinter, W. M., Semelhago, L. C., et Chou, S. (1994). The reliability and validity of a modified CHEOPS pain score. Anesthesia and Analgesia, 78, S413.
- Results publicationChartrand, 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
- Derived from this study: PubMed 27681601Chartrand 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing "You and your child in the recovery room" DVD and Standard pre-operative preparation in people with Perioperative Nursing, run by University of Ottawa.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 May 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Parents' participation behaviors (time frame: Post-treatment (In average, between 1 and 7 days following the intervention)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02766452, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 May 2016.