Tonsillar HypertrophyNCT03677453
Interactive Perioperative Teaching Platform (IPTP)
A study testing Interactive Perioperative Teaching Platform in people with Tonsillar Hypertrophy and Adenoid Hypertrophy, run by Vidya Raman at 1 site in United States.
Trial summary
The proposed study will assess whether an interactive perioperative teaching platform (IPTP) provided to families of patients undergoing ambulatory pediatric surgery will reduce families' anxiety, and improve satisfaction and understanding, relative to current practice. Read more about this study
- Who is it for?
- Ages Up to 18 years
- Conditions the study is for
- Tonsillar Hypertrophy, Adenoid Hypertrophy, Cryptorchidism
- What is being tested?
- Interactive Perioperative Teaching Platform
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 151 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Oct 2018to 30 Nov 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 Up to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Children aged 0-18 years
- Undergoing adenotonsillectomy or orchiopexy, hydrocele or hypospadias repair
- Only patients booked for ambulatory surgery in the main operating room (OR)
Who cannot join
- Patients will be excluded if they have previously undergone surgery or require a translator
Trial locations and contacts
1 site in 1 country.
United States1 site
Nationwide Children's Hospital
Columbus, Ohio, 43205
About this study
The proposed study will assess whether an interactive perioperative teaching platform (IPTP) provided to families of patients undergoing ambulatory pediatric surgery will reduce families' anxiety, and improve satisfaction and understanding, relative to current practice. The IPTP will educate patient families on the continuum of their child's surgical experience, from arriving at the hospital through registration, the operating room (OR), and the hospital floor. An active video format will be used to provide instructions for navigating the hospital; describe induction of anesthesia and the surgical procedure; and provide post-surgery and post-discharge instructions for pain management. A comparison cohort of patients undergoing surgery without access to the IPTP will be recruited to assess the benefits of the IPTP for improving metrics of family satisfaction, preoperative anxiety, and postoperative understanding of discharge instructions.
- Being tested
- Interactive Perioperative Teaching Platform
- Medical subject headings
- Cryptorchidism, Hypospadias, Testicular Hydrocele
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Interactive Perioperative Teaching PlatformOther
Also called IPTP
An active video format will be used to provide instructions for navigating the hospital; describe induction of anesthesia and the surgical procedure; and provide post-surgery and post-discharge instructions for pain management.
| Study group | Role | What they receive |
|---|---|---|
| IPTP | Active comparator | Patients will have access to the web-based interactive teaching tool. Receives: Other: Interactive Perioperative Teaching Platform |
| Non-IPTP | No intervention | Patients will not have access to the web-based interactive teaching tool. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient family satisfaction
Family satisfaction will be assessed by a member of the research team using an adaptation of the English version of the Leiden Perioperative Patient Satisfaction questionnaire (LPPSq) recommended for research on satisfaction with surgeries involving anesthesia. The English version assesses 4 domains of satisfaction: information provision, professional competence, patient-staff relationship, and service with a total of 24 questions on these topics. It is scored on a 1-5 Likert scale (from completely dissatisfied to completely satisfied).
Measured: Immediately prior to discharge
Secondary outcomes (1)
Anxiety level
Anxiety will be measured using the short-form State-Trait Anxiety Inventory 10 with scores ranging from 6-24 (least to most anxious).
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2018
- Study start10 Oct 2018
- Primary completion30 Nov 2020
- Study completion30 Nov 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tonsillar HypertrophyStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 151 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vidya Raman
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Vidya Raman, Nationwide Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03677453
- Sponsor's protocol ID
- IRB17-01340
- Status last verified
- Feb 2021
- First submitted
- 17 Sep 2018
- Last updated
- 3 Feb 2021
- Results posted
- No
- Data monitoring committee
- 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 3 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Interactive Perioperative Teaching Platform (IPTP)
- ClinicalTrials.gov ID
- NCT03677453
- Acronym / sponsor ID
- IRB17-01340
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 151 participants (actual)
- Lead sponsor
- Vidya RamanUniversity, hospital or other
- Study start
- 10 Oct 2018 (actual)
- Primary completion
- 30 Nov 2020 (actual)
- Study completion
- 30 Nov 2020 (actual)
- First posted
- 19 Sep 2018 (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 proposed study will assess whether an interactive perioperative teaching platform (IPTP) provided to families of patients undergoing ambulatory pediatric surgery will reduce families' anxiety, and improve satisfaction and understanding, relative to current practice. The IPTP will educate patient families on the continuum of their child's surgical experience, from arriving at the hospital through registration, the operating room (OR), and the hospital floor. An active video format will be used to provide instructions for navigating the hospital; describe induction of anesthesia and the surgical procedure; and provide post-surgery and post-discharge instructions for pain management. A comparison cohort of patients undergoing surgery without access to the IPTP will be recruited to assess the benefits of the IPTP for improving metrics of family satisfaction, preoperative anxiety, and postoperative understanding of discharge instructions.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| IPTP | Active comparator | Other: Interactive Perioperative Teaching PlatformPatients will have access to the web-based interactive teaching tool. |
| Non-IPTP | No intervention | –Patients will not have access to the web-based interactive teaching tool. |
Who may qualify
- Ages
- Up to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Children aged 0-18 years
- Undergoing adenotonsillectomy or orchiopexy, hydrocele or hypospadias repair
- Only patients booked for ambulatory surgery in the main operating room (OR)
Key exclusion criteria (1 listed)
- Patients will be excluded if they have previously undergone surgery or require a translator
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 |
|---|---|---|
| Interactive Perioperative Teaching PlatformAlso: IPTPAn active video format will be used to provide instructions for navigating the hospital; describe induction of anesthesia and the surgical procedure; and provide post-surgery and post-discharge instructions for pain management. | Other | IPTP |
Primary outcome
Patient family satisfaction
Time frame: Immediately prior to discharge
Family satisfaction will be assessed by a member of the research team using an adaptation of the English version of the Leiden Perioperative Patient Satisfaction questionnaire (LPPSq) recommended for research on satisfaction with surgeries involving anesthesia. The English version assesses 4 domains of satisfaction: information provision, professional competence, patient-staff relationship, and service with a total of 24 questions on these topics. It is scored on a 1-5 Likert scale (from completely dissatisfied to completely satisfied).
1 secondary outcome
Anxiety level
Time frame: Baseline
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 3 Feb 2021.
- 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 Interactive Perioperative Teaching Platform in people with Tonsillar Hypertrophy and Adenoid Hypertrophy, run by Vidya Raman at 1 site in United States.
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 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 3 Feb 2021. 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 United States. 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?
Patient family satisfaction (time frame: Immediately prior to discharge). 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 3 Feb 2021.