NCT06709443

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
75

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2024

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2024

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 10, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 10, 2024

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

November 25, 2024

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 29, 2024

Completed
Last Updated

December 10, 2024

Status Verified

December 1, 2024

Enrollment Period

5 months

First QC Date

November 25, 2024

Last Update Submit

December 5, 2024

Conditions

Keywords

Pre-operative anxiety,Minor surgery,parental presence during induction of anesthesiamodified Yale Preoperative Anxiety Scale

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

Age5 Years - 10 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodProbability Sample
Study Population

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

Location

Related Links

MeSH Terms

Conditions

Anxiety Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Study Officials

  • Ghulam Fatima Dr Ghulam Fatima

    Liaquat National Hospital and Medical College

    PRINCIPAL INVESTIGATOR

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.

Locations