Anxiety and FearNCT05469412
Comparison of Pharmacological and Non-Pharmacological Interventions For Alleviating Preoperative Anxiety In Children
A study testing iPad® and Midazolam in people with Anxiety and Fear, run by Aga Khan University at 1 site in Pakistan.
Trial summary
The purpose of this study is to find out any beneficial effects of electronic devices over preoperative pharmacological intervention in the preoperative period. Read more about this study
- Who is it for?
- Ages 2 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Anxiety and Fear
- What is being tested?
- iPad® and Midazolam
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 84 participants
- Where
- 1 sitePakistan
- Study dates
- 20 Mar 2023to 1 Apr 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 2 to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Children aged between 2 and 12 years old
- ASA I and II
- Informed consent signed by parents or legal guardians
Who cannot join
- Previous exposure to surgery
- Contraindication to midazolam
- Patients with developmental delay
- Patients with significant visual/hearing problems
Trial locations and contacts
1 site in 1 country.
About this study
Official title: To Compare Pharmacological and Non-Pharmacological Interventions (Use of Technology) For Alleviating Preoperative Anxiety In Children Undergoing General Anesthesia In A Tertiary Care Hospital Of Pakistan: A Randomized Controlled Trial.
The purpose of this study is to find out any beneficial effects of electronic devices over preoperative pharmacological intervention in the preoperative period.
Read the detailed description
Preparation for surgery with the induction of general anesthesia can be a stressful experience for a child. Preoperative anxiety can prolong induction of anesthesia and postoperative recovery, as well as increasing the risk of postoperative delirium, pain, and analgesic use.
Pharmacological interventions are associated with increased cost to the hospital, potential surgical delay while waiting for the medication to take effect, and delayed discharge from the recovery room. Non-pharmacological modalities comprise education, behavioral techniques, parental presence at induction of anesthesia, and using technology including cellular phones and tablets/iPad, with each category including an array of effective strategies for reducing anxiety.
- Conditions
- Anxiety and Fear
- Being tested
- iPad®, Midazolam
- Keywords
- Preoperative Anxiety
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
iPad®Device
Also called Tablet
Use of Technology.
MidazolamDrug
Standard management combined with pharmacological intervention (oral midazolam 0.5 mg/kg) administered at least 30 min before surgery (maximum 20mg).
| Study group | Role | What they receive |
|---|---|---|
| Interventional group | Experimental | Standard management combined with distraction by using technology (Tablets/iPads). Receives: Device: iPad® |
| Control group | Active comparator | Standard management combined with pharmacological intervention (oral midazolam 0.5 mg/kg) administered at least 30 min before surgery (maximum 20mg). Receives: Drug: Midazolam |
What is being measured
The primary outcome is the main question the study is designed to answer.
modified Yale Preoperative Anxiety Scale
The instrument contains 27 items in 5 categories that indicate preoperative anxiety in children: activity, emotional expressivity, state of arousal, vocalization, and use of parents.
Scores range from 23.33 to 100, with higher values indicating higher anxiety.
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2022
- Study start20 Mar 2023
- Primary completion25 Mar 2024
- Study completion1 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Anxiety and FearStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 84 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aga Khan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Muhammad Asghar Ali, Aga Khan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05469412
- Sponsor's protocol ID
- 2022-7684-21894
- Status last verified
- Jun 2024
- First submitted
- 13 Jun 2022
- Last updated
- 26 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Manyande A, Cyna AM, Yip P, Chooi C, Middleton P. Non-pharmacological interventions for assisting the induction of anaesthesia in children. Cochrane Database Syst Rev. 2015 Jul 14;2015(7):CD006447. doi: 10.1002/14651858.CD006447.pub3.
PubMed 26171895Agbayani CG, Fortier MA, Kain ZN. Non-pharmacological methods of reducing perioperative anxiety in children. BJA Educ. 2020 Dec;20(12):424-430. doi: 10.1016/j.bjae.2020.08.003. Epub 2020 Oct 21. No abstract available.
PubMed 33456927Cheng X, Chen Z, Zhang L, Xu P, Qin F, Jiao X, Wang Y, Lin M, Zeng L, Huang L, Yu D. Efficacy and Safety of Midazolam Oral Solution for Sedative Hypnosis and Anti-anxiety in Children: A Systematic Review and Meta-Analysis. Front Pharmacol. 2020 Mar 18;11:225. doi: 10.3389/fphar.2020.00225. eCollection 2020.
PubMed 32256348
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- To Compare Pharmacological and Non-Pharmacological Interventions (Use of Technology) For Alleviating Preoperative Anxiety In Children Undergoing General Anesthesia In A Tertiary Care Hospital Of Pakistan: A Randomized Controlled Trial.
- ClinicalTrials.gov ID
- NCT05469412
- Acronym / sponsor ID
- 2022-7684-21894
- Conditions
- Anxiety and Fear
- Keywords
- Preoperative Anxiety
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 84 participants (actual)
- Lead sponsor
- Aga Khan UniversityUniversity, hospital or other
- Study start
- 20 Mar 2023 (actual)
- Primary completion
- 25 Mar 2024 (actual)
- Study completion
- 1 Apr 2024 (actual)
- First posted
- 21 Jul 2022 (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.
The purpose of this study is to find out any beneficial effects of electronic devices over preoperative pharmacological intervention in the preoperative period.
Detailed description
Preparation for surgery with the induction of general anesthesia can be a stressful experience for a child. Preoperative anxiety can prolong induction of anesthesia and postoperative recovery, as well as increasing the risk of postoperative delirium, pain, and analgesic use.
Pharmacological interventions are associated with increased cost to the hospital, potential surgical delay while waiting for the medication to take effect, and delayed discharge from the recovery room. Non-pharmacological modalities comprise education, behavioral techniques, parental presence at induction of anesthesia, and using technology including cellular phones and tablets/iPad, with each category including an array of effective strategies for reducing anxiety.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Interventional group | Experimental | Device: iPad®Standard management combined with distraction by using technology (Tablets/iPads). |
| Control group | Active comparator | Drug: MidazolamStandard management combined with pharmacological intervention (oral midazolam 0.5 mg/kg) administered at least 30 min before surgery (maximum 20mg). |
Who may qualify
- Ages
- 2 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Children aged between 2 and 12 years old
- ASA I and II
- Informed consent signed by parents or legal guardians
Key exclusion criteria (4 listed)
- Previous exposure to surgery
- Contraindication to midazolam
- Patients with developmental delay
- Patients with significant visual/hearing problems
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 |
|---|---|---|
| iPad®Also: TabletUse of Technology. | Device | Interventional group |
| MidazolamStandard management combined with pharmacological intervention (oral midazolam 0.5 mg/kg) administered at least 30 min before surgery (maximum 20mg). | Drug | Control group |
Primary outcome
modified Yale Preoperative Anxiety Scale
Time frame: Day 1
The instrument contains 27 items in 5 categories that indicate preoperative anxiety in children: activity, emotional expressivity, state of arousal, vocalization, and use of parents. Scores range from 23.33 to 100, with higher values indicating higher anxiety.
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 26 Jun 2024.
- Background: PubMed 26171895Manyande A, Cyna AM, Yip P, Chooi C, Middleton P. Non-pharmacological interventions for assisting the induction of anaesthesia in children. Cochrane Database Syst Rev. 2015 Jul 14;2015(7):CD006447. doi: 10.1002/14651858.CD006447.pub3.
- Background: PubMed 33456927Agbayani CG, Fortier MA, Kain ZN. Non-pharmacological methods of reducing perioperative anxiety in children. BJA Educ. 2020 Dec;20(12):424-430. doi: 10.1016/j.bjae.2020.08.003. Epub 2020 Oct 21. No abstract available.
- Background: PubMed 32256348Cheng X, Chen Z, Zhang L, Xu P, Qin F, Jiao X, Wang Y, Lin M, Zeng L, Huang L, Yu D. Efficacy and Safety of Midazolam Oral Solution for Sedative Hypnosis and Anti-anxiety in Children: A Systematic Review and Meta-Analysis. Front Pharmacol. 2020 Mar 18;11:225. doi: 10.3389/fphar.2020.00225. eCollection 2020.
- 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 iPad® and Midazolam in people with Anxiety and Fear, run by Aga Khan University 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 3 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 26 Jun 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?
modified Yale Preoperative Anxiety Scale (time frame: Day 1). 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 NCT05469412, which also lists 3 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 26 Jun 2024.