AnxietyPPIANCT06709443
Effect of Parental Presence on Anxiety of Children During Induction of Anesthesia
An observational study of Anxiety and Preoperative Anxiety, run by Liaquat National Hospital & Medical College at 1 site in Pakistan.
Trial 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. Read more about this study
- Who is it for?
- Ages 5 to 10 years
- Conditions the study is for
- Anxiety, Preoperative Anxiety
- How many people
- 75 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Jan 2024to 10 Jun 2024
- How long will I take part?
- 35 Days
- Phase
- Observational
- 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 5 to 10 years
- All sexes
- No healthy volunteers
- Child
Study population: A group of patients selected from a surgical day care units and wards who presented for minor elective surgical procedures.
Who may be able to join
- Pediatric patients
- aged 5-10 years
- minor surgery
- duration <1 hour
- ASA 1 and ASA 2 patients
Who cannot join
- Patients and attendant refusal
- Emergency surgeris
- Renal insuffciency
- Age less than 5 and more than 10 years
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Impact of Parental Presence on the Mean Anxiety Level of Children During Anesthesia Induction - A Randomized Controlled Trial
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:
Read more
- 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.
Read the detailed description
Induction of pediatric anesthesia represents a highly stressful event for children, often resulting in preoperative anxiety that can impair the child's perioperative experience and result in adverse postoperative outcomes. It has been proposed that parental presence during induction of anesthesia Preoperative anxiety is linked to postoperative maladaptive behaviors, such as pain following surgery, insomnia, conflicts between the child and his parent, separation anxiety, increased urinary frequency during the night, reduced appetite, lack of interest, agitation, and alienation.may be a non-pharmacologic intervention to reduce children's anxiety. In patients with extreme anxiety, unfavorable postoperative behaviors after anesthesia induction are likely to result in long-term issues, which adversely affect the process of recovery, and also develop a feeling of inadequate care. Parental presence at anesthesia induction is the interaction that takes place in the induction room during the course of anesthesia induction between the child, parent, anesthesiologist, and perioperative nurses.
- Conditions
- Anxiety, Preoperative Anxiety
- Keywords
- Pre-operative anxiety,, Minor surgery,, parental presence during induction of anesthesia, modified Yale Preoperative Anxiety Scale
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: minimum 2 to 3 minutes during Induction of anesthesia
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2024
- Study start1 Jan 2024
- Primary completion10 Jun 2024
- Study completion10 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnxietyStudies 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 75 participants (actual)
- Target duration
- 35 Days
Sponsor and investigators
- Lead sponsor
- Liaquat National Hospital & Medical College
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ghulam Fatima, Liaquat National Hospital & Medical College
- Investigators
- Ghulam Fatima Dr Ghulam Fatima, Principal investigator, Liaquat National Hospital and Medical College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06709443
- Sponsor's protocol ID
- LNHMC karachi
- Other IDs
- Dr ghulam fatima
- Acronym
- PPIA
- Status last verified
- Dec 2024
- First submitted
- 25 Nov 2024
- Last updated
- 10 Dec 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Parental Presence on the Mean Anxiety Level of Children During Anesthesia Induction - A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06709443
- Acronym / sponsor ID
- PPIA / LNHMC karachi
- Conditions
- Anxiety, Preoperative Anxiety
- Keywords
- Pre-operative anxiety,, Minor surgery,, parental presence during induction of anesthesia, modified Yale Preoperative Anxiety Scale
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- Liaquat National Hospital & Medical CollegeUniversity, hospital or other
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- 10 Jun 2024 (actual)
- Study completion
- 10 Jun 2024 (actual)
- First posted
- 29 Nov 2024 (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.
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.
Detailed description
Induction of pediatric anesthesia represents a highly stressful event for children, often resulting in preoperative anxiety that can impair the child's perioperative experience and result in adverse postoperative outcomes. It has been proposed that parental presence during induction of anesthesia Preoperative anxiety is linked to postoperative maladaptive behaviors, such as pain following surgery, insomnia, conflicts between the child and his parent, separation anxiety, increased urinary frequency during the night, reduced appetite, lack of interest, agitation, and alienation.may be a non-pharmacologic intervention to reduce children's anxiety. In patients with extreme anxiety, unfavorable postoperative behaviors after anesthesia induction are likely to result in long-term issues, which adversely affect the process of recovery, and also develop a feeling of inadequate care. Parental presence at anesthesia induction is the interaction that takes place in the induction room during the course of anesthesia induction between the child, parent, anesthesiologist, and perioperative nurses.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Target follow-up
- 35 Days
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 5 to 10 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- A group of patients selected from a surgical day care units and wards who presented for minor elective surgical procedures.
Key inclusion criteria (5 listed)
- Pediatric patients
- aged 5-10 years
- minor surgery
- duration <1 hour
- ASA 1 and ASA 2 patients
Key exclusion criteria (4 listed)
- Patients and attendant refusal
- Emergency surgeris
- Renal insuffciency
- Age less than 5 and more than 10 years
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Anxiety
Time frame: minimum 2 to 3 minutes during Induction of anesthesia
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
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 10 Dec 2024.
- Fraley B. Preoperative anxiety and education in the adolescent population. Beckley, West Virginia: Mountain State University; 2007. 2. Caumo W, Ferreira MBC. Perioperative anxiety: psychobiology and effects in postoperative recovery. The Pain Clinic. 201Link provided by the sponsor.
- Individual participant dataSharing planned: No. 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.
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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.
Ghulam Fatima Dr Ghulam Fatima principal investigator
Liaquat National Hospital and Medical College
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Anxiety and Preoperative Anxiety, run by Liaquat National Hospital & Medical College at 1 site in Pakistan.
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 5 inclusion and 4 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 10 Dec 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 Pakistan. 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?
Anxiety (time frame: minimum 2 to 3 minutes during Induction of anesthesia). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 10 Dec 2024.