Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05469412
Other study ID # 2022-7684-21894
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date March 20, 2023
Est. completion date April 1, 2024

Study information

Verified date April 2024
Source Aga Khan University
Contact Muhammad Asghar Ali, FCPS
Phone +9234862897
Email asghar.ashraf@aku.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 84
Est. completion date April 1, 2024
Est. primary completion date March 25, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 2 Years to 12 Years
Eligibility Inclusion Criteria: 1. Children aged between 2 and 12 years old 2. ASA I and II 3. Informed consent signed by parents or legal guardians Exclusion Criteria: 1. Previous exposure to surgery 2. Contraindication to midazolam 3. Patients with developmental delay 4. Patients with significant visual/hearing problems

Study Design


Related Conditions & MeSH terms


Intervention

Device:
iPad®
Use of Technology.
Drug:
Midazolam
Standard management combined with pharmacological intervention (oral midazolam 0.5 mg/kg) administered at least 30 min before surgery (maximum 20mg).

Locations

Country Name City State
Pakistan Aga Khan University Hospital Karachi Sindh

Sponsors (1)

Lead Sponsor Collaborator
Aga Khan University

Country where clinical trial is conducted

Pakistan, 

References & Publications (3)

Agbayani 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. — View Citation

Cheng 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. — View Citation

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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.
Day 1
See also
  Status Clinical Trial Phase
Completed NCT04027933 - Standard Patient Simulation in Nursing Students' Approach Toward Patients With Bipolar Disorder N/A
Recruiting NCT05378581 - Use of Virtual Reality Mask During Blood and Skin Allergic Tests in 7 to 13 Children N/A
Not yet recruiting NCT05614687 - Art as Healing: A Community-informed Art-based Programme (CiAbP) for Reintegrating Ex-offenders Into Society in Nigeria N/A
Completed NCT05828264 - The Effect of "Quantum-Touch" on Pain, Fear, and Anxiety of the Children N/A
Completed NCT04755998 - Evaluating the Effect of the Use of Virtual Reality Headset in School Vaccinations N/A
Completed NCT04299555 - Assessment of Fears of Patients Standing at the Operating Block
Active, not recruiting NCT03993509 - Effect of rTMS on Anxiety N/A
Completed NCT06011668 - EFFECT OF DISTRACTION METHODS ON PAIN AND ANXIETY DURING INTRAMUSCULAR INJECTION IN CHILDREN N/A
Completed NCT05930015 - Effects of Music Combined With Sports Games on Alleviating Psychological Stress, Anxiety and Mental Energy Among Adolescents During COVID-19 Pandemic in Lanzhou Gansu Province China N/A
Recruiting NCT06004115 - Processes and Circuitry Underlying Threat Sensitivity as a Treatment Target for Co-morbid Anxiety and Depression Phase 4
Recruiting NCT06257186 - Investigating the Effect of Art Therapy on Women With Fear of Childbirth During Pregnancy: A Mixed Method Study N/A
Recruiting NCT03821779 - Prefrontal Oscillations in Social Anxiety Disorder (POSAD) N/A
Recruiting NCT06436079 - Evaluation of the Effectiveness of a Nursing Intervention Program in Reducing Anxiety in Users Who Perform Scheduled Sessions in the Hyperbaric Chamber N/A
Completed NCT06336811 - Virtual Reality Distraction During Phlebotomy in Children N/A
Recruiting NCT05548699 - Precision Mental Health in Diabetes - Subtypes of Mental Health, Trajectories, and Patterns With Glycaemic Control
Recruiting NCT04406181 - Psychological Well-being of Patients Awaiting for Cardiac Surgery During the COVID-19 Pandemic N/A
Completed NCT04821960 - Memory and Fear Study (Fear of Memory Loss Study) N/A
Completed NCT06415188 - The Effect of Therapeutic Play on Pain, Fear, Anxiety and Physiological Parameters and Parents' Satisfaction N/A
Completed NCT04631172 - Covid-19 Anxiety and Phobia Levels of the Parents
Active, not recruiting NCT04385732 - Melanoma Surveillance Photography (MSP) to Improve Early Detection of Melanoma in Ultra-high and High Risk Patients N/A