Children Who Underwent Minor SurgeryNCT03314220
The Effectiveness of Preoperative Preparation for Improving Perioperative Outcomes in Children and Caregivers
A study testing preoperative preparation in people with Children Who Underwent Minor Surgery, run by Chiayi Christian Hospital.
Trial summary
This study aimed to accomplish the following objectives: 1. Develop a family-centered preoperative preparation program. 2. Evaluate the effectiveness of this program in terms of children's preoperative emotional behaviors, postoperative behavior, and posthospital behavior and caregivers' anxiety. Read more about this study
- Who is it for?
- Ages 3 to 12 years
- Conditions the study is for
- Children Who Underwent Minor Surgery
- What is being tested?
- preoperative preparation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- No sites listed yet
- Study dates
- 15 May 2014to 15 May 2016
- 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 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- aged 3-12 years, received general anesthesia, and admitted for elective outpatient ear, nose and throat, orthopedic, ophthalmology or general surgery.
Who cannot join
- Children with severe development delay or chronic illness were excluded. Caregivers were excluded if they could not accompany their child to the hospital on the day of the surgery.
About this study
This study aimed to accomplish the following objectives:
- Develop a family-centered preoperative preparation program.
- Evaluate the effectiveness of this program in terms of children's preoperative emotional behaviors, postoperative behavior, and posthospital behavior and caregivers' anxiety.
- Conditions
- Children Who Underwent Minor Surgery
- Being tested
- preoperative preparation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
preoperative preparationBehavioural
Participants in the experimental group received standard care plus our newly developed, multicomponent family-centered preoperative preparation program. This program included the following: (1) a tour of the preoperative area and recovery room; (2) a 4-min cartoon video entitled 'I am not afraid of surgery,' which was tailored to the child; this video included 29 scenes that depicted a boy's surgical journey with a particular emphasis on strategies for addressing postoperative pain; and (3) familiarization with medical equipment such as name badges, disposable hair caps, anesthetic masks, EKG leads, and pulse oximeters, which were placed on a doll, to help children understand the surgical instruments and promote better cooperation at the time of anesthesia induction.
| Study group | Role | What they receive |
|---|---|---|
| standard care plus preoperative preparation | Experimental | experimental group received standard care plus preoperative preparation, which included a tour, a cartoon video depicting a boy's surgical journey and familiarization with medical equipment. Receives: Behavioral: preoperative preparation |
| standard care | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Children's Emotional Behaviors: The Children's Emotional Manifestation Scale
to assess children's emotional behaviors during stressful medical situations
Measured: before the operative day
Children's Emotional Behaviors: The Children's Emotional Manifestation Scale
to assess children's emotional behaviors during stressful medical situations
Measured: the morning in the day of surgery
Children's Emotional Behaviors: The Children's Emotional Manifestation Scale
to assess children's emotional behaviors during stressful medical situations
Measured: at 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 posted19 Oct 2017
- Study start15 May 2014
- Primary completion15 May 2016
- Study completion15 May 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Children Who Underwent Minor SurgeryStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chiayi Christian Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03314220
- Sponsor's protocol ID
- 103013
- Status last verified
- Oct 2017
- First submitted
- 2 Oct 2017
- Last updated
- 19 Oct 2017
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness of Preoperative Preparation for Improving Perioperative Outcomes in Children and Caregivers
- ClinicalTrials.gov ID
- NCT03314220
- Acronym / sponsor ID
- 103013
- Conditions
- Children Who Underwent Minor Surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- Chiayi Christian HospitalUniversity, hospital or other
- Study start
- 15 May 2014 (actual)
- Primary completion
- 15 May 2016 (actual)
- Study completion
- 15 May 2016 (actual)
- First posted
- 19 Oct 2017 (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.
This study aimed to accomplish the following objectives:
- Develop a family-centered preoperative preparation program.
- Evaluate the effectiveness of this program in terms of children's preoperative emotional behaviors, postoperative behavior, and posthospital behavior and caregivers' anxiety.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| standard care plus preoperative preparation | Experimental | Behavioral: preoperative preparationexperimental group received standard care plus preoperative preparation, which included a tour, a cartoon video depicting a boy's surgical journey and familiarization with medical equipment. |
| standard care | No intervention | – |
Who may qualify
- Ages
- 3 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- aged 3-12 years, received general anesthesia, and admitted for elective outpatient ear, nose and throat, orthopedic, ophthalmology or general surgery.
Key exclusion criteria (1 listed)
- Children with severe development delay or chronic illness were excluded. Caregivers were excluded if they could not accompany their child to the hospital on the day of the surgery.
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 preparationParticipants in the experimental group received standard care plus our newly developed, multicomponent family-centered preoperative preparation program. This program included the following: (1) a tour of the preoperative area and recovery room; (2) a 4-min cartoon video entitled 'I am not afraid of surgery,' which was tailored to the child; this video included 29 scenes that depicted a boy's surgical journey with a particular emphasis on strategies for addressing postoperative pain; and (3) familiarization with medical equipment such as name badges, disposable hair caps, anesthetic masks, EKG leads, and pulse oximeters, which were placed on a doll, to help children understand the surgical instruments and promote better cooperation at the time of anesthesia induction. | Behavioural | standard care plus preoperative preparation |
Primary outcome
Children's Emotional Behaviors: The Children's Emotional Manifestation Scale
Time frame: before the operative day
to assess children's emotional behaviors during stressful medical situations
Children's Emotional Behaviors: The Children's Emotional Manifestation Scale
Time frame: the morning in the day of surgery
to assess children's emotional behaviors during stressful medical situations
Children's Emotional Behaviors: The Children's Emotional Manifestation Scale
Time frame: at induction of anesthesia
to assess children's emotional behaviors during stressful medical situations
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 19 Oct 2017.
- Individual participant dataSharing planned: No
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.
Questions about this trial
What is this clinical trial studying?
A study testing preoperative preparation in people with Children Who Underwent Minor Surgery, run by Chiayi Christian Hospital.
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 1 inclusion and 1 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 19 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.
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?
Children's Emotional Behaviors: The Children's Emotional Manifestation Scale (time frame: before the operative day). The study lists 3 primary outcomes in all. 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 19 Oct 2017.