Parental Presence at Anesthesia Induction

NCT05787717 | Completed

• 1 other identifier: PPAI1
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Anesthesia; Parent-Child Relations

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Infant´s heart rate

  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

  Anesthesia induction (a time frame of up to 10 minutes)

• Staff interview data

  Within 24 hours after the case is finished in the OR

• Parental interview data

  Within 48 hours after the case is finished in the OR

Study Arms (2)

Parental presence

EXPERIMENTAL

Parents are present and active in the care of their child until general anesthesia has been established in the operating room

Other: Parental presence

Control

NO INTERVENTION

Parents leave their infant in the holding area of the operating rooms

Interventions

Parental presence OTHER

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

Parental presence

Eligibility Criteria

• Age: Up to 6 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Infant scheduled for general anesthesia
• parents are available, accompanying their infant

You may not qualify if:

• age of infant \> 6 months
• critical illness (supplementary oxygen, inotropic support or ventilator therapy)

Sponsors & Collaborators

• Uppsala University Hospital: lead

Study Sites (1)

Uppsala University Hospital

Uppsala, Uppsala County, 75185, Sweden

Location

Related Publications (6)

• Scrimin S, Haynes M, Altoe G, Bornstein MH, Axia G. Anxiety and stress in mothers and fathers in the 24 h after their child's surgery. Child Care Health Dev. 2009 Mar;35(2):227-33. doi: 10.1111/j.1365-2214.2008.00920.x.

  PMID: 19228156 BACKGROUND

• Landier M, Villemagne T, Le Touze A, Braik K, Meignan P, Cook AR, Morel B, Lardy H, Binet A. The position of a written document in preoperative information for pediatric surgery: A randomized controlled trial on parental anxiety, knowledge, and satisfaction. J Pediatr Surg. 2018 Mar;53(3):375-380. doi: 10.1016/j.jpedsurg.2017.04.009. Epub 2017 Apr 21.

  PMID: 28456425 BACKGROUND

• Landolt MA, Boehler U, Schwager C, Schallberger U, Nuessli R. Post-traumatic stress disorder in paediatric patients and their parents: an exploratory study. J Paediatr Child Health. 1998 Dec;34(6):539-43. doi: 10.1046/j.1440-1754.1998.00303.x.

  PMID: 9928646 BACKGROUND

• Piira T, Sugiura T, Champion GD, Donnelly N, Cole AS. The role of parental presence in the context of children's medical procedures: a systematic review. Child Care Health Dev. 2005 Mar;31(2):233-43. doi: 10.1111/j.1365-2214.2004.00466.x.

  PMID: 15715702 BACKGROUND

• Malik F, Marwaha R. Developmental Stages of Social Emotional Development in Children. 2022 Sep 18. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2025 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK534819/

  PMID: 30521240 BACKGROUND

• Habre W, Disma N, Virag K, Becke K, Hansen TG, Johr M, Leva B, Morton NS, Vermeulen PM, Zielinska M, Boda K, Veyckemans F; APRICOT Group of the European Society of Anaesthesiology Clinical Trial Network. Incidence of severe critical events in paediatric anaesthesia (APRICOT): a prospective multicentre observational study in 261 hospitals in Europe. Lancet Respir Med. 2017 May;5(5):412-425. doi: 10.1016/S2213-2600(17)30116-9. Epub 2017 Mar 28.

  PMID: 28363725 BACKGROUND

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Randomized controlled trial

Study Record Dates

• First Submitted: February 23, 2023
• First Posted: March 28, 2023
• Study Start: March 29, 2023
• Primary Completion: May 8, 2024
• Study Completion: May 8, 2024
• Last Updated: May 14, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)