Effect of Parental Presence on Anxiety of Children During Induction of Anesthesia
PPIA
Impact of Parental Presence on the Mean Anxiety Level of Children During Anesthesia Induction - A Randomized Controlled Trial
2 other identifiers
observational
75
1 country
1
Brief Summary
Anxiety is when children feel scared, worried, or nervous before or during anesthesia induction. This can happen because they don't know what's happening, are scared of the hospital or medical equipment, or are worried about being separated from their parents. When parents are present, they can:
- Provide emotional support and reassurance
- Distract the child from scary things
- Help the child feel more calm and safe This can help reduce the child's anxiety levels. When parents are not present, children may feel:
- More scared and anxious
- Alone and unsupported
- More worried about what's happening This can increase the child's anxiety levels. we can prepare children and parents beforehand about what will happen
- Allow parents to be present during anesthesia induction
- Use distraction techniques like toys or videos
- Use gentle and calm anesthesia induction techniques By doing these things, we can help reduce anxiety in children and make the experience less scary for them.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Jan 2024
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 10, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
June 10, 2024
CompletedFirst Submitted
Initial submission to the registry
November 25, 2024
CompletedFirst Posted
Study publicly available on registry
November 29, 2024
CompletedDecember 10, 2024
December 1, 2024
5 months
November 25, 2024
December 5, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Anxiety
Modified yale preoperative anxiety scale (myPAS) assess activity, vocaliztion and Emotional expressivity andstate of apparent arousal. score 4 to 18 4 means no anxiety and 18 means highly anxious
minimum 2 to 3 minutes during Induction of anesthesia
Study Arms (2)
PPIA: children anesthetized in the presence of parents
PPIA: Children induced during the presence parents to assess the level of anxiety while aneshetizing.
Control group
Control Group: children induced without the parental presence to assess level of anxiety during anesthitizing.
Eligibility Criteria
A group of patients selected from a surgical day care units and wards who presented for minor elective surgical procedures.
You may qualify if:
- Pediatric patients
- aged 5-10 years
- minor surgery
- duration \<1 hour
- ASA 1 and ASA 2 patients
You may not qualify if:
- Patients and attendant refusal
- Emergency surgeris
- Renal insuffciency
- Age less than 5 and more than 10 years
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Liaquat National Hospital and Medical College
Karachi, Sindh, Pakistan
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ghulam Fatima Dr Ghulam Fatima
Liaquat National Hospital and Medical College
Study Design
- Study Type
- observational
- Observational Model
- OTHER
- Time Perspective
- PROSPECTIVE
- Target Duration
- 35 Days
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
November 25, 2024
First Posted
November 29, 2024
Study Start
January 1, 2024
Primary Completion
June 10, 2024
Study Completion
June 10, 2024
Last Updated
December 10, 2024
Record last verified: 2024-12
Data Sharing
- IPD Sharing
- Will not share
1. \*Patient confidentiality\*: Sharing IPD could compromise patient confidentiality and anonymity, potentially harming participants or their families. 2. \*Sponsor's intellectual property\*: Clinical trial sponsors may consider IPD as their intellectual property, and sharing it could compromise their commercial interests. 3. \*Competitive advantage\*: Sharing IPD could provide competitors with valuable insights, potentially eroding the sponsor's competitive advantage. Data quality and validation\*: IPD may require additional validation and quality control checks before sharing, which can be time-consuming and resource-intensive. 4. \*Methodological limitations\*: Sharing IPD without proper context and methodology information may lead to misinterpretation or misuse of the data. 5. Informed consent\*: Participants may not have provided informed consent for their data to be shared, which could raise ethical concerns.