AnesthesiaPPAINCT05787717
Parental Presence at Anesthesia Induction
A study testing Parental presence in people with Anesthesia and Parent-Child Relations, run by Uppsala University Hospital at 1 site in Sweden.
Trial 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. Read more about this study
- Who is it for?
- Ages Up to 6 months
- Conditions the study is for
- Anesthesia, Parent-Child Relations
- What is being tested?
- Parental presence
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteSweden
- Study dates
- 29 Mar 2023to 8 May 2024
- 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 Up to 6 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Infant scheduled for general anesthesia
- parents are available, accompanying their infant
Who cannot join
- age of infant > 6 months
- critical illness (supplementary oxygen, inotropic support or ventilator therapy)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Parental Presence at Anesthesia Induction in Infants - a Randomized Controlled Trial
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).
Read the detailed description
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.
- Conditions
- Anesthesia, Parent-Child Relations
- Being tested
- Parental presence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Parental presenceOther
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
| Study group | Role | What they receive |
|---|---|---|
| Parental presence | Experimental | Parents are present and active in the care of their child until general anesthesia has been established in the operating room Receives: Other: Parental presence |
| Control | No intervention | Parents leave their infant in the holding area of the operating rooms |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Within 5 minutes of leaving their child to the anesthesia team.
Secondary outcomes (4)
Infant´s heart rate
The changes in heart rate of the infant during the pre-induction period and during induction.
Measured: 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.
Measured: 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)
Measured: 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)
Measured: Within 48 hours after the case is finished in the OR
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2023
- Study start29 Mar 2023
- Primary completion8 May 2024
- Study completion8 May 2024
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 AnesthesiaStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized controlled trial
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Uppsala University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Peter Frykholm, Uppsala University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05787717
- Sponsor's protocol ID
- PPAI1
- Acronym
- PPAI
- Status last verified
- May 2024
- First submitted
- 23 Feb 2023
- Last updated
- 14 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 19228156Landier 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.
PubMed 28456425Landolt 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.
PubMed 9928646Piira 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.
PubMed 15715702Malik F, Marwaha R. Developmental Stages of Social Emotional Development in Children. 2022 Sep 18. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2026 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK534819/
PubMed 30521240Habre 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.
PubMed 28363725
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Parental Presence at Anesthesia Induction in Infants - a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05787717
- Acronym / sponsor ID
- PPAI / PPAI1
- Conditions
- Anesthesia, Parent-Child Relations
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Uppsala University HospitalUniversity, hospital or other
- Study start
- 29 Mar 2023 (actual)
- Primary completion
- 8 May 2024 (actual)
- Study completion
- 8 May 2024 (actual)
- First posted
- 28 Mar 2023 (actual)
- 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.
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
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| Parental presence | Experimental | Other: Parental presenceParents are present and active in the care of their child until general anesthesia has been established in the operating room |
| Control | No intervention | –Parents leave their infant in the holding area of the operating rooms |
Who may qualify
- Ages
- Up to 6 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Infant scheduled for general anesthesia
- parents are available, accompanying their infant
Key exclusion criteria (2 listed)
- age of infant > 6 months
- critical illness (supplementary oxygen, inotropic support or ventilator therapy)
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 |
|---|---|---|
| Parental presenceThe parent is encouraged to stay close to their child and are given ample room on one side of the OR table for this purpose | Other | Parental presence |
Primary outcome
APAIS Anxiety
Time frame: Within 5 minutes of leaving their child to the anesthesia team.
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.
4 secondary outcomes
Infant´s heart rate
Time frame: 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
Time frame: Anesthesia induction (a time frame of up to 10 minutes)
Staff interview data
Time frame: Within 24 hours after the case is finished in the OR
Parental interview data
Time frame: Within 48 hours after the case is finished in the OR
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 14 May 2024.
- Background: PubMed 19228156Scrimin 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.
- Background: PubMed 28456425Landier 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.
- Background: PubMed 9928646Landolt 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.
- Background: PubMed 15715702Piira 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.
- Background: PubMed 30521240Malik F, Marwaha R. Developmental Stages of Social Emotional Development in Children. 2022 Sep 18. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2026 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK534819/
- Background: PubMed 28363725Habre 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.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Parental presence in people with Anesthesia and Parent-Child Relations, run by Uppsala University Hospital at 1 site in Sweden.
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 2 inclusion and 2 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 14 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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?
APAIS Anxiety (time frame: Within 5 minutes of leaving their child to the anesthesia team.). 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 NCT05787717, 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 14 May 2024.