BehaviorNCT04039269
Long Term Memory Preoperative Preparation Reduce Post Operative Behavioral Change
A study testing Preoperative video information in people with Behavior and Agitation, run by Prince of Songkla University at 1 site in Thailand.
Trial summary
The study is designed to test the hypothesis that long term memory created by preoperative video information can reduce the incidence of post operative behavioral changes. Read more about this study
- Who is it for?
- Ages 3 to 14 years
- What is being tested?
- Preoperative video information
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 192 participants
- Where
- 1 siteThailand
- Study dates
- Dec 2013to May 2020
- 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 3 to 14 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- outpatient elective surgery
- aged between 3-14 years
- ASA physical status I-II
Who cannot join
- mental retardation
- patient's telephone contact not available
- emergency case
- having ICU admission plan postoperative
Trial locations and contacts
1 site in 1 country.
Thailand1 site, 1 recruiting
- Recruiting
Faculty of Medicine, Prince of Songkla University
Hat Yai, Changwat Songkhla, 90110
Thavat Chanchayanon, MD, +6674451650, Chanchanon@yahoo.com
Orarat Karnjanawanichkul, MD
About this study
Official title: Could Long Term Memory Created by Preoperative Video Information Reduce Post Operative Behavioral Change?
The study is designed to test the hypothesis that long term memory created by preoperative video information can reduce the incidence of post operative behavioral changes.
Read the detailed description
Emergence agitation (EA) and Post operative behavioral change (PHC) are unpleasant experiences occurred in children after general anesthesia (GA). Previous study reported that the patient who had marked EA tended to have new-onset of postoperative maladaptive behavioral changes.Both pharmacologic and non pharmacologic interventions such as preoperative video information, hand held video games were used to reduce preoperative anxiety, EA and Post operative behavioral changes. In term of memory creation, short term memory (STM) was created. Later that the formation of memory trace requires time, and that this trace remains fragile until the long term memory formation process has been completed. In this study, the investigators hypothetize that long term memory created by preoperative video information can reduce the incidence of post operative behavioral changes.
- Being tested
- Preoperative video information
- Keywords
- Post operative Behavioral Changes, Pediatric, Long term memory, video
- Medical subject headings
- Behavior, Psychomotor Agitation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Preoperative video informationOther
| Study group | Role | What they receive |
|---|---|---|
| Multiple (watch > 3 times) | Active comparator | Preoperative video information Receives: Other: Preoperative video information |
| single (watch 1 time) | Active comparator | Preoperative video information Receives: Other: Preoperative video information |
| conventional (do not watch) | No intervention | Do not watch video |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidences of post operative behavioral changes
Use PHBQ (post operative behavioral questionnaire) Postive for postoperative behavioral change: 10% change from baseline sum score
Measured: up to3 months post operative period
Secondary outcomes (3)
Incidences of Emergence agitation
PAED scale, PAED scale > 10 will be classified as positive for emergence agitation
Measured: evaluate PAED scale in the first 5 minutes after patient arrive PACU
Parental's anxiety level at induction
STATE trait anxiety test:
10% change from baseline sum score will be classify as significant change
Measured: Evaluate 15 minutes before start anesthesia induction
Child's anxiety level at induction
mYpas scale: 10% change from baseline sum score will be classify as significant change
Measured: mYpas will be evaluated immediately after the patient arrives into the operating room
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2019
- Study startDec 2013
- Primary completionMay 2020 (estimated)
- Study completionMay 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BehaviorStudies 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
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 192 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Prince of Songkla University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ngamjit Pattaravit, Prince of Songkla University
- Investigators
- Ngamjit Pattaravit, MD, Principal investigator, Prince of Songkla University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04039269
- Sponsor's protocol ID
- PSUEA2
- Status last verified
- Jul 2019
- First submitted
- 8 Jan 2014
- Last updated
- 31 Jul 2019
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Could Long Term Memory Created by Preoperative Video Information Reduce Post Operative Behavioral Change?
- ClinicalTrials.gov ID
- NCT04039269
- Acronym / sponsor ID
- PSUEA2
- Keywords
- Post operative Behavioral Changes, Pediatric, Long term memory, video
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 192 participants (estimated)
- Lead sponsor
- Prince of Songkla UniversityUniversity, hospital or other
- Study start
- Dec 2013 (actual)
- Primary completion
- May 2020 (estimated)
- Study completion
- May 2020 (estimated)
- First posted
- 31 Jul 2019 (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 study is designed to test the hypothesis that long term memory created by preoperative video information can reduce the incidence of post operative behavioral changes.
Detailed description
Emergence agitation (EA) and Post operative behavioral change (PHC) are unpleasant experiences occurred in children after general anesthesia (GA). Previous study reported that the patient who had marked EA tended to have new-onset of postoperative maladaptive behavioral changes.Both pharmacologic and non pharmacologic interventions such as preoperative video information, hand held video games were used to reduce preoperative anxiety, EA and Post operative behavioral changes. In term of memory creation, short term memory (STM) was created. Later that the formation of memory trace requires time, and that this trace remains fragile until the long term memory formation process has been completed. In this study, the investigators hypothetize that long term memory created by preoperative video information can reduce the incidence of post operative behavioral changes.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Multiple (watch > 3 times) | Active comparator | Other: Preoperative video informationPreoperative video information |
| single (watch 1 time) | Active comparator | Other: Preoperative video informationPreoperative video information |
| conventional (do not watch) | No intervention | –Do not watch video |
Who may qualify
- Ages
- 3 to 14 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- outpatient elective surgery
- aged between 3-14 years
- ASA physical status I-II
Key exclusion criteria (4 listed)
- mental retardation
- patient's telephone contact not available
- emergency case
- having ICU admission plan postoperative
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 video information | Other | Multiple (watch > 3 times), single (watch 1 time) |
Primary outcome
Incidences of post operative behavioral changes
Time frame: up to3 months post operative period
Use PHBQ (post operative behavioral questionnaire) Postive for postoperative behavioral change: 10% change from baseline sum score
3 secondary outcomes
Incidences of Emergence agitation
Time frame: evaluate PAED scale in the first 5 minutes after patient arrive PACU
Parental's anxiety level at induction
Time frame: Evaluate 15 minutes before start anesthesia induction
Child's anxiety level at induction
Time frame: mYpas will be evaluated immediately after the patient arrives into the operating room
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2019.
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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.
Ngamjit Pattaravit, MD principal investigator
Prince of Songkla University
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 video information in people with Behavior and Agitation, run by Prince of Songkla University at 1 site in Thailand.
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: status not confirmed, as of the sponsor's last update on 31 Jul 2019. 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 Thailand. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ngamjit Pattaravit, MD (+66897001350, ngamjitp@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidences of post operative behavioral changes (time frame: up to3 months post operative period). 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 31 Jul 2019.