Preoperative AnxietyNCT06612398

Effect of a Preparation Video on Preoperative Anxiety in Children Undergoing Dental Treatment Under GA

A study testing Preoperative preparation video in people with Preoperative Anxiety, run by King Abdullah University Hospital at 1 site in Jordan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The present study investigated the effect of an animated preoperative preparation video in mitigating preoperative anxiety among children receiving comprehensive dental treatment under General Anesthesia (GA). Read more about this study

Who is it for?: Ages 4 to 7 yearsHealthy volunteers can take part
Conditions the study is for: Preoperative Anxiety
What is being tested?: Preoperative preparation video
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 84 participants
Where: 1 siteJordan
Study dates: 1 Feb 2023to 1 Oct 2023
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 4 to 7 years
All sexes
Healthy volunteers accepted
Child

Who may be able to join

Children who are healthy, with American Society of Anesthesiologists (ASA) Grade 1 and 2 status.
Age 4-7 years.
Children undergoing GA for the first time who require comprehensive dental rehabilitation.

Who cannot join

Presence of a systemic disease, as well as mental, cognitive, and intellectual disabilities.
Presence of visual or auditory disability.
Participants who refuse to answer subjective scales due to heightened anxiety levels.
Participants with no access to internet services.
Presence of active severe dental pain and/or facial abscess as it could affect the participant's state anxiety.

Trial locations and contacts

1 site in 1 country.

Jordan1 site

Jordan University of Science and Technology
Irbid

Other trials in Jordan

About this study

Official title: Effect of a Preoperative Preparation Video on Preoperative Anxiety Among Children Undergoing Dental Treatment Under General Anesthesia

Read the detailed description

This randomised controlled trial, conducted at King Abdullah University Hospital (KAUH) over an eight-month period from February to October 2023, focused on children aged four to seven years undergoing comprehensive dental treatment under GA. Participants were randomly assigned to either the control group or the study group. Participants in the control group received the standard care provided upon arrival at the Day Case Unit (DCU) at KAUH, involving only a verbal explanation of the anaesthesia induction process. In contrast, on the night before the surgery, participants in the study group were presented with an animated video illustrating the story of a child's journey through the hospital facilities, including the anaesthesia induction, and the postoperative return home. Additionally, all parents watched the video alongside their children and provided positive comments on its content. The primary outcome assessed was the children's preoperative anxiety measured by modified Yale Preoperative Anxiety Scale (m-YPAS) and Visual Facial Anxiety Scale (VFAS), allowing for an evaluation of the intervention's impact.

Conditions: Preoperative Anxiety
Being tested: Preoperative preparation video

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Preoperative preparation videoBehavioural
An animated video illustrating the story of a child's journey through the hospital facilities, including the anaesthesia induction, and the postoperative return home.

Study groups in NCT06612398
Study group	Role	What they receive
Standard of care	No intervention	Participants received the standard care provided upon arrival and being admitted to the hospital, involving only a verbal explanation of the anaesthesia induction process.
Preoperative preparation video	Experimental	On the night before the surgery, participants were presented with an animated video illustrating the story of a child's journey through the hospital facilities, including the anaesthesia induction, and the postoperative return home. Receives: Behavioral: Preoperative preparation video

What is being measured

The primary outcome is the main question the study is designed to answer.

modified Yale Preoperative Anxiety Scale
Observational anxiety scale, values (23.3-100) with higher scores indicating higher levels of anxiety
Measured: 1 day
Visual Facial Anxiety Scale
Self-report anxiety scale, values (0-10) with higher scores indicating higher levels of anxiety
Measured: 1 day

Secondary outcomes (2)

Face, Legs, Activity, Cry, Consolability scale
Observational pain scale, values (0-10) with higher scores indicating higher levels of pain
Measured: 1 day
Pediatric Anesthesia Emergence Delirium scale
Observational emergence delirium scale, values (0-20) with higher scores indicating higher levels of emergence delirium
Measured: 1 day

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Feb 20231 Oct 2023

First posted25 Sep 2024
Study start1 Feb 2023
Primary completion1 Oct 2023
Study completion1 Oct 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (29)Papers the sponsor has linked to this study.
Other trials for Preoperative 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: Interventional
Phase: Phase N/A
Primary purpose: Supportive care
Allocation: Randomised
Intervention model: Parallel groups
Model description: Randomized controlled trial
Masking: Single blind
Who is masked: Outcomes assessor
Enrolment: 84 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06612398
Sponsor's protocol ID: 72/149/2022
Status last verified: Aug 2024
First submitted: 30 Aug 2024
Last updated: 25 Sep 2024
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Kain ZN, Mayes LC, O'Connor TZ, Cicchetti DV. Preoperative anxiety in children. Predictors and outcomes. Arch Pediatr Adolesc Med. 1996 Dec;150(12):1238-45. doi: 10.1001/archpedi.1996.02170370016002.
PubMed 8953995
Al-Jundi SH, Mahmood AJ. Factors affecting preoperative anxiety in children undergoing general anaesthesia for dental rehabilitation. Eur Arch Paediatr Dent. 2010 Feb;11(1):32-7. doi: 10.1007/BF03262707.
PubMed 20129031
Kain ZN, Mayes LC, Caldwell-Andrews AA, Karas DE, McClain BC. Preoperative anxiety, postoperative pain, and behavioral recovery in young children undergoing surgery. Pediatrics. 2006 Aug;118(2):651-8. doi: 10.1542/peds.2005-2920.
PubMed 16882820
Kim J, Chiesa N, Raazi M, Wright KD. A systematic review of technology-based preoperative preparation interventions for child and parent anxiety. Can J Anaesth. 2019 Aug;66(8):966-986. doi: 10.1007/s12630-019-01387-8. Epub 2019 May 16.
PubMed 31098960
Schwartz BH, Albino JE, Tedesco LA. Effects of psychological preparation on children hospitalized for dental operations. J Pediatr. 1983 Apr;102(4):634-8. doi: 10.1016/s0022-3476(83)80211-x.
PubMed 6834205
Wright KD, Raazi M, Walker KL. Internet-delivered, preoperative, preparation program (I-PPP): Development and examination of effectiveness. J Clin Anesth. 2017 Jun;39:45-52. doi: 10.1016/j.jclinane.2017.03.007. Epub 2017 Mar 27.
PubMed 28494907
Kain ZN, Mayes LC, Cicchetti DV, Bagnall AL, Finley JD, Hofstadter MB. The Yale Preoperative Anxiety Scale: how does it compare with a "gold standard"? Anesth Analg. 1997 Oct;85(4):783-8. doi: 10.1097/00000539-199710000-00012.
PubMed 9322455
Cao X, Yumul R, Elvir Lazo OL, Friedman J, Durra O, Zhang X, White PF. A novel visual facial anxiety scale for assessing preoperative anxiety. PLoS One. 2017 Feb 14;12(2):e0171233. doi: 10.1371/journal.pone.0171233. eCollection 2017.
PubMed 28196099
Crellin DJ, Harrison D, Santamaria N, Babl FE. Systematic review of the Face, Legs, Activity, Cry and Consolability scale for assessing pain in infants and children: is it reliable, valid, and feasible for use? Pain. 2015 Nov;156(11):2132-2151. doi: 10.1097/j.pain.0000000000000305.
PubMed 26207651
Sikich N, Lerman J. Development and psychometric evaluation of the pediatric anesthesia emergence delirium scale. Anesthesiology. 2004 May;100(5):1138-45. doi: 10.1097/00000542-200405000-00015.
PubMed 15114210
Koo TK, Li MY. A Guideline of Selecting and Reporting Intraclass Correlation Coefficients for Reliability Research. J Chiropr Med. 2016 Jun;15(2):155-63. doi: 10.1016/j.jcm.2016.02.012. Epub 2016 Mar 31.
PubMed 27330520
Powell R, Scott NW, Manyande A, Bruce J, Vogele C, Byrne-Davis LM, Unsworth M, Osmer C, Johnston M. Psychological preparation and postoperative outcomes for adults undergoing surgery under general anaesthesia. Cochrane Database Syst Rev. 2016 May 26;2016(5):CD008646. doi: 10.1002/14651858.CD008646.pub2.
PubMed 27228096
Kain ZN, Caldwell-Andrews AA, Mayes LC, Weinberg ME, Wang SM, MacLaren JE, Blount RL. Family-centered preparation for surgery improves perioperative outcomes in children: a randomized controlled trial. Anesthesiology. 2007 Jan;106(1):65-74. doi: 10.1097/00000542-200701000-00013.
PubMed 17197846
Rantala A, Pikkarainen M, Miettunen J, He HG, Polkki T. The effectiveness of web-based mobile health interventions in paediatric outpatient surgery: A systematic review and meta-analysis of randomized controlled trials. J Adv Nurs. 2020 Aug;76(8):1949-1960. doi: 10.1111/jan.14381. Epub 2020 Apr 22.
PubMed 32281673
Demblon MC, Bicknell C, Aufegger L. Systematic review of the development and effectiveness of digital health information interventions, compared with usual care, in supporting patient preparation for paediatric hospital care, and the impact on their health outcomes. Front Health Serv. 2023 Apr 6;3:1103624. doi: 10.3389/frhs.2023.1103624. eCollection 2023.
PubMed 37089454

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Preoperative Anxiety trials

Study at a glance

From the registry record, last updated by the sponsor on 25 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Effect of a Preoperative Preparation Video on Preoperative Anxiety Among Children Undergoing Dental Treatment Under General Anesthesia
ClinicalTrials.gov ID: NCT06612398
Acronym / sponsor ID: 72/149/2022
Conditions: Preoperative Anxiety
Study type: Interventional
Recruitment status: Completed
Enrolment: 84 participants (actual)
Lead sponsor: King Abdullah University HospitalUniversity, hospital or other
Collaborators: Jordan University of Science and Technology
Study start: 1 Feb 2023 (actual)
Primary completion: 1 Oct 2023 (actual)
Study completion: 1 Oct 2023 (actual)
First posted: 25 Sep 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.

Detailed description

Study design

Primary purpose: Supportive care
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (outcomes assessor)
Number of arms: 2
Model description: Randomized controlled trial

Arm	Type	Receives
Standard of care	No intervention	–Participants received the standard care provided upon arrival and being admitted to the hospital, involving only a verbal explanation of the anaesthesia induction process.
Preoperative preparation video	Experimental	Behavioral: Preoperative preparation videoOn the night before the surgery, participants were presented with an animated video illustrating the story of a child's journey through the hospital facilities, including the anaesthesia induction, and the postoperative return home.

Who may qualify

Ages: 4 to 7 years
Sex: All
Healthy volunteers: Accepted
Age groups: Child

Key inclusion criteria (3 listed)

Children who are healthy, with American Society of Anesthesiologists (ASA) Grade 1 and 2 status.
Age 4-7 years.
Children undergoing GA for the first time who require comprehensive dental rehabilitation.

Key exclusion criteria (5 listed)

Presence of a systemic disease, as well as mental, cognitive, and intellectual disabilities.
Presence of visual or auditory disability.
Participants who refuse to answer subjective scales due to heightened anxiety levels.
Participants with no access to internet services.
Presence of active severe dental pain and/or facial abscess as it could affect the participant's state anxiety.

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
Preoperative preparation videoAn animated video illustrating the story of a child's journey through the hospital facilities, including the anaesthesia induction, and the postoperative return home.	Behavioural	Preoperative preparation video

Primary outcome

modified Yale Preoperative Anxiety Scale
Time frame: 1 day
Observational anxiety scale, values (23.3-100) with higher scores indicating higher levels of anxiety
Visual Facial Anxiety Scale
Time frame: 1 day
Self-report anxiety scale, values (0-10) with higher scores indicating higher levels of anxiety

2 secondary outcomes

Face, Legs, Activity, Cry, Consolability scale
Time frame: 1 day
Pediatric Anesthesia Emergence Delirium scale
Time frame: 1 day

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 25 Sep 2024.
Background: PubMed 8953995Kain ZN, Mayes LC, O'Connor TZ, Cicchetti DV. Preoperative anxiety in children. Predictors and outcomes. Arch Pediatr Adolesc Med. 1996 Dec;150(12):1238-45. doi: 10.1001/archpedi.1996.02170370016002.
Background: PubMed 20129031Al-Jundi SH, Mahmood AJ. Factors affecting preoperative anxiety in children undergoing general anaesthesia for dental rehabilitation. Eur Arch Paediatr Dent. 2010 Feb;11(1):32-7. doi: 10.1007/BF03262707.
Background: PubMed 16882820Kain ZN, Mayes LC, Caldwell-Andrews AA, Karas DE, McClain BC. Preoperative anxiety, postoperative pain, and behavioral recovery in young children undergoing surgery. Pediatrics. 2006 Aug;118(2):651-8. doi: 10.1542/peds.2005-2920.
Background: PubMed 31098960Kim J, Chiesa N, Raazi M, Wright KD. A systematic review of technology-based preoperative preparation interventions for child and parent anxiety. Can J Anaesth. 2019 Aug;66(8):966-986. doi: 10.1007/s12630-019-01387-8. Epub 2019 May 16.
Background: PubMed 6834205Schwartz BH, Albino JE, Tedesco LA. Effects of psychological preparation on children hospitalized for dental operations. J Pediatr. 1983 Apr;102(4):634-8. doi: 10.1016/s0022-3476(83)80211-x.
Background: PubMed 28494907Wright KD, Raazi M, Walker KL. Internet-delivered, preoperative, preparation program (I-PPP): Development and examination of effectiveness. J Clin Anesth. 2017 Jun;39:45-52. doi: 10.1016/j.jclinane.2017.03.007. Epub 2017 Mar 27.
Background: PubMed 9322455Kain ZN, Mayes LC, Cicchetti DV, Bagnall AL, Finley JD, Hofstadter MB. The Yale Preoperative Anxiety Scale: how does it compare with a "gold standard"? Anesth Analg. 1997 Oct;85(4):783-8. doi: 10.1097/00000539-199710000-00012.
Background: PubMed 28196099Cao X, Yumul R, Elvir Lazo OL, Friedman J, Durra O, Zhang X, White PF. A novel visual facial anxiety scale for assessing preoperative anxiety. PLoS One. 2017 Feb 14;12(2):e0171233. doi: 10.1371/journal.pone.0171233. eCollection 2017.
Background: PubMed 26207651Crellin DJ, Harrison D, Santamaria N, Babl FE. Systematic review of the Face, Legs, Activity, Cry and Consolability scale for assessing pain in infants and children: is it reliable, valid, and feasible for use? Pain. 2015 Nov;156(11):2132-2151. doi: 10.1097/j.pain.0000000000000305.
Background: PubMed 15114210Sikich N, Lerman J. Development and psychometric evaluation of the pediatric anesthesia emergence delirium scale. Anesthesiology. 2004 May;100(5):1138-45. doi: 10.1097/00000542-200405000-00015.
Background: PubMed 27330520Koo TK, Li MY. A Guideline of Selecting and Reporting Intraclass Correlation Coefficients for Reliability Research. J Chiropr Med. 2016 Jun;15(2):155-63. doi: 10.1016/j.jcm.2016.02.012. Epub 2016 Mar 31.
Background: PubMed 27228096Powell R, Scott NW, Manyande A, Bruce J, Vogele C, Byrne-Davis LM, Unsworth M, Osmer C, Johnston M. Psychological preparation and postoperative outcomes for adults undergoing surgery under general anaesthesia. Cochrane Database Syst Rev. 2016 May 26;2016(5):CD008646. doi: 10.1002/14651858.CD008646.pub2.
Individual participant dataSharing planned: No

Related trials for Preoperative Anxiety

Recruiting
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Not yet recruitingPhase 4
Effect of Midazolam Given at Induction on Recall of Propofol Injection Pain
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RecruitingObservational study
Preoperative Anxiety and One-year Patient-reported Outcomes in Orthopedic Surgery Patients Receiving Enhanced Recovery After Surgery or Conventional Care
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Not yet recruiting
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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.

Mawia Bataineh, Doctor study chair

Jordan University of Science and Technology

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Preoperative preparation video in people with Preoperative Anxiety, run by King Abdullah University Hospital at 1 site in Jordan.

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 5 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 25 Sep 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 Jordan. 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: 1 day). The study lists 2 primary outcomes in all. 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 NCT06612398, which also lists 29 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 25 Sep 2024.