An Innovative Tailored Intervention for Improving Children's Postoperative Recovery (WebTIPS) (NCT03730259) | Clinical Trial Compass
CompletedNot Applicable
An Innovative Tailored Intervention for Improving Children's Postoperative Recovery (WebTIPS)
United States1,274 participantsStarted 2019-04-12
Plain-language summary
The goal of this randomized trial is to examine the effectiveness of a tailored Internet-based Preparation Program (WebTIPS) in reducing anxiety and improving the recovery process in children undergoing surgery. Two hospitals and all parent-child dyads will be randomized to either a Web-based Tailored Intervention Preparation for Surgery (WebTIPS) Group or to a Web-based Information (WebINFO) Group, the attention control group. The WebTIPS group will receive the newly developed intervention with short message service (SMS), while the WebINFO Group will only receive an internet and mobile platform with information on the management of preoperative anxiety and perioperative pain. The aims of this study are to:
Primary aim:
Quality of Clinical Care:
Determine whether and to what extent WebTIPS is more effective than an attention control intervention in reducing preoperative anxiety among children ages 1-12 years old undergoing anesthesia and outpatient surgery.
Secondary aims:
Quality of Clinical Care:
1. Examine the impact of WebTIPS on Post-Anesthesia care unit based postoperative clinical recovery parameters, such as pain and emergence delirium.
2. Examine the impact of WebTIPS on home-based postoperative clinical recovery parameters such as pain, new onset behavioral changes and return to normal daily activity over 2 weeks.
3. Determine if the use of WebTIPS reduces parental preoperative anxiety.
Experience of Care:
Examine the effects of WebTIPS on parental satisfaction with the overall experience of the surgical episode.
Who can participate
Age range
1 Year – 12 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
Children:
* Children scheduled to undergo anesthesia and outpatient surgery.
* Children whose health status is American Society of Anesthesiologists (ASA) physical status I-III will be recruited for this study.
* Only children who are in the normal range of development will be recruited for this study
Parents:
* Parents of children who are enrolled in the study.
Healthcare Providers:
* Anesthesia care providers in the two study hospitals
* Nurses who provide preoperative nursing care to children who are about to undergo surgery in the two study hospitals
Exclusion Criteria:
Children:
* Patients with health status defined by ASA status IV-V
* Children who are not in the normal range of development and who are visually impaired will be excluded from this study.
* Children with visual impairment.
Parents:
* Parents who refuse to be part of the study and whose children are not eligible for the study.
* Parents who are visually impaired.
Healthcare Providers:
* Anesthesiologists who refuse to be part of the study
* Nurses who refuse to be part of the study
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Assess Children's Domains of Behavior Indicating Anxiety [Activity, Emotional Expressivity, State of Arousal, Vocalization and Use of Parents]
Timeframe: Day of surgery (Holding Area, Separation, Entrance to operating room, and placement of the anesthesia mask)