Parental Presence at Anesthesia Induction

Study Overview
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Brief Summary
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Parental presence during induction for young infants is still debated. There is a paucity of information on the real-world interaction between parents, infant and the anesthesia team. Aim To investigate parents' anxiety, need of information and experiences during induction of their infant, as well as staff communication and experiences, using quantitative and qualitative methods. Methods Randomized controlled trial of parent´s experiences of participating in their infant´s anesthesia induction. Parents will be randomized to being present in the operating room until the infant is asleep due to anesthesia induction (intervention group), or leaving their child to the anesthesia team in the OR holding area (control group).

Detailed Description
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Background Surgery in a paediatric setting involves a considerable amount of stress for children and for their parents. The pros and cons of parental presence during anesthesia induction are debated, especially in infants. In older children, parents play a critical role in paediatric surgery, since children depend on parents for support and guidance in coping. However, many centers will not allow parental presence for young infants and neonates, since attachment relationships develop during the second half of infancy (6 - 12 months of age), and the risk of complications during induction are increased. However, there is a paucity of information on the real-world interaction between parents, infant and the anesthesia team. Therefore, the present study will investigate how parental presence affects the parents´ perioperative anxiety level and experiences in a randomized controlled trial. Anesthesia team communication, attitudes and experiences and the rate of complications during induction and emergence will also be studied. The study hypothesis is that presence at induction reduces the parents' anxiety level. Aim To investigate parents' anxiety, need of information and experiences during induction of their infant, as well as staff communication and experiences, using quantitative and qualitative methods. Methods Design: randomized controlled trial. After informed consent has been obtained from both parents, they are randomized to being present in the operating room until the infant is asleep due to anesthesia induction (intervention group), or leaving their child to the anesthesia team in the Operating Room (OR)holding area (control group). When they arrive at the OR holding area, the parents are asked to fill in the Amsterdam Preoperative Anxiety and Information Scale (APAIS) questionnaire. Electrocardiogram (EKG) electrodes are placed on the infant's chest and connected to an anesthesia monitor. Then the infant is transported to the OR together with the parent if in the intervention group. In the intervention group, the parent is encouraged to stay close to their child and are given ample room on one side of the OR table for this purpose. If appropriate, a peripheral i.v. line is placed. A standard pre-induction time-out is performed, after which the anesthesia induction starts (i.v. thiopental or propofol if a line is in place, mask induction with sevoflurane if not). As soon as the child is asleep (no voluntary movements, eyes closed), the parents are escorted out of the OR, and are asked to fill in the APAIS questionnaire a second time. As in the control group, they are informed that they will be called to the Post Anesthesia Care Unit (PACU) at the end of the procedure. Depending on investigator availability, the parents will be interviewed about their experiences on the day after surgery. In addition, the nurse anesthetist and attending anesthesiologist will be interviewed on the day of surgery. The induction and the emergence will be video recorded and field notes will be taken by a separate investigator taking care not to disturb the procedure. Field notes, video-recordings and interviews will be transcribed and analyzed using phenomenological/hermeneutic methods. Open questions about how the subject experienced the induction will be posed, and follow-up questions to obtain in-depth understanding of the subjects' sentiments and reflections.

Official Title
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Parental Presence at Anesthesia Induction in Infants - a Randomized Controlled Trial

Conditions
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Anesthesia, Parent-Child Relations

Intervention / Treatment
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* Other: Parental presence


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Infant scheduled for general anesthesia parents are available, accompanying their infant Exclusion Criteria: age of infant > 6 months critical illness (supplementary oxygen, inotropic support or ventilator therapy)

Ages Eligible for Study
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Maximum Age: 6 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomized controlled trial
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Parental presence<br>Parents are present and active in the care of their child until general anesthesia has been established in the operating room | Other: Parental presence<br>* The parent is encouraged to stay close to their child and are given ample room on one side of the OR table for this purpose<br>|
| No Intervention: Control<br>Parents leave their infant in the holding area of the operating rooms | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| APAIS Anxiety | Parents fill out the form Amsterdam Preoperative Anxiety and Information Scale. The Anxiety component of the scale har four items and the total score (minimum value 4, max 20) is the primary outcome. High scores indicate worse outcome. | Within 5 minutes of leaving their child to the anesthesia team. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Infant´s heart rate | The changes in heart rate of the infant during the pre-induction period and during induction. | From when EKG monitoring starts in the holding area until child is unresponsive due to general anesthesia - a time fram of up to 15 minutes | 
| Adverse events | Adverse events during induction such as desaturation, bradycardia, hypotension, difficult intubation, difficult i.v. access. | Anesthesia induction (a time frame of up to 10 minutes) | 
| Staff interview data | The staff self-reported experience of parental presence at induction (interview data) | Within 24 hours after the case is finished in the OR | 
| Parental interview data | The parents self-reported experience of leaving their child before surgery (interview data) | Within 48 hours after the case is finished in the OR |