Preoperative AnxietyNCT06054282
A Mobile Application for Child-focused Perioperative Education
A study testing "Ready for Tonsillectomy" educational mobile application in people with Preoperative Anxiety, run by Children's Healthcare of Atlanta at 1 site in United States.
Trial summary
The investigators developed a child-friendly mobile application to support accessible, interactive patient/caregiver education about pediatric tonsillectomy. This randomized controlled trial aims to evaluate whether the intervention reduces preoperative anxiety, improves patients' confidence and positive coping… Read more about this study
- Who is it for?
- Ages 5 to 13 yearsHealthy volunteers can take part
- Conditions the study is for
- Preoperative Anxiety
- What is being tested?
- "Ready for Tonsillectomy" educational mobile application
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 360 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Feb 2024to Jun 2024
- 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 5 to 13 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Pediatric patients ages 5-13 years (inclusive) scheduled for a tonsillectomy, along with their caregivers.
Who cannot join
- Patients/caregivers who do not speak English and/or Spanish, do not have a mobile device, or are unable to give consent and assent.
Trial locations and contacts
1 site in 1 country.
Kara K Prickett, MD, FACS contact
United States1 site, 1 recruiting
- Recruiting
Children's Healthcare of Atlanta
Atlanta, Georgia, 30322
Kara K Prickett, MD, FACS
Holly Cordray, BS
About this study
Official title: A Mobile Application for Child-focused Perioperative Education: A Randomized Controlled Trial
The investigators developed a child-friendly mobile application to support accessible, interactive patient/caregiver education about pediatric tonsillectomy. This randomized controlled trial aims to evaluate whether the intervention reduces preoperative anxiety, improves patients' confidence and positive coping, improves caregivers' satisfaction and self-efficacy, and reduces call volumes from caregivers to the clinic after surgery compared to current standard care.
Read the detailed description
This is a prospective, questionnaire-based randomized controlled trial to evaluate a child-focused patient education intervention. The investigators developed a child-friendly mobile application to support accessible, interactive patient/caregiver education about pediatric tonsillectomy. Families in the intervention group will be invited to use the "Ready for Tonsillectomy" mobile application on their own mobile devices as they prepare for surgery and during recovery. The trial will compare preoperative anxiety and other patient-centered outcomes between families who use the mobile application (intervention) and families who receive current standard care materials without additional education (control). Primary and secondary endpoints include:
- Patients' preoperative anxiety (primary endpoint)
- Patient-reported confidence in knowing what to expect
- Patient-reported attitudes toward the procedure
- Patient-reported coping strategies
- Postoperative pain in the post-anesthesia care unit
- Caregivers' preoperative anxiety
- Caregivers' satisfaction with educational materials
- Caregivers' self-efficacy in managing their child's postoperative pain.
- Caregiver-initiated phone call volumes to the clinic within 2 weeks after surgery
- Mobile application use/interactions based on integrated user analytics
The target sample size is based on a power analysis using the primary outcome measure, which is validated for ages 7-13 years; the investigators will recruit a total of approximately 180 patients ages 7-13 years along with their caregivers (i.e., 180 caregivers for this cohort). A secondary cohort of patients ages 5-6 years will be enrolled simultaneously until the investigators reach the target sample size for the primary cohort (maximum 180 additional patients in the younger cohort, plus their caregivers). Participants will give informed verbal consent/assent at least 2 weeks before surgery. At this time, the family will be randomly assigned to either the intervention or control arm. Families in the intervention arm will download the mobile application on their smartphone or tablet; they will be able to access the application as frequently as desired in the weeks leading up to surgery and afterward. All participants will complete questionnaires while waiting in their private preoperative rooms on the day of surgery.
- Conditions
- Preoperative Anxiety
- Being tested
- "Ready for Tonsillectomy" educational mobile application
- Keywords
- patient education, tonsillectomy, pediatrics, otolaryngology, preoperative anxiety, perioperative care
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
"Ready for Tonsillectomy" educational mobile applicationBehavioural
The "Ready for Tonsillectomy" mobile application provides child-focused, procedure-specific education developed with feedback from patients, caregivers, and pediatric otolaryngologists. The application guides patients and their families through each aspect of the surgical experience, including reasons for tonsillectomy, how to prepare for surgery, anesthesia, and postoperative recovery. Diverse characters focus on the child's perspective in the treatment process, showing what happens at each step. Written at an early elementary reading level (available in English or Spanish), the text is integrated with graphics and animations. The application aims to promote active learning and equip patients with positive expectations and coping strategies as they approach surgery. It also prepares caregivers to navigate their child's surgery and optimize recovery. Notifications provide key information and reminders for caregivers to promote adherence and address common questions.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Patients and caregivers will use the "Ready for Tonsillectomy" mobile application on their mobile devices as they prepare for and recover from surgery, in addition to standard care. Individual families will receive a phone call for enrollment/verbal informed consent at least 2 weeks before the scheduled surgery, likely around the time of the clinic visit when surgery is scheduled. Participants assigned to the intervention arm will download the mobile application at this time. They will be able to access the application as often as desired in the weeks leading up to surgery and afterward. Receives: Behavioral: "Ready for Tonsillectomy" educational mobile application |
| Control | No intervention | Families will receive standard care (standard educational handouts and preoperative consults). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Children's Perioperative Multidimensional Anxiety Scale (CPMAS)
The Children's Perioperative Multidimensional Anxiety Scale (CPMAS) is a patient-reported, 5-item visual analog scale validated for patients 7-13 years of age. The scale has demonstrated good internal consistency and test-retest reliability, and it is more feasible to implement than an observer-rated metric. Scores range from 0-500; higher scores indicate greater anxiety (worse outcomes).
Measured: Preoperative period, day of surgery
Secondary outcomes (7)
Children's Fear Scale (CFS)
Patients 5-6 years of age will complete the Children's Fear Scale (CFS), which is validated for this age cohort, in lieu of the CPMAS. CFS scores range from 0-4; higher scores indicate greater fear (worse outcomes).
Measured: Preoperative period, day of surgery
Patients' confidence and coping
Patients will report their confidence in knowing what to expect and their attitudes toward the procedure on a Likert scale. Scores range from 1-5; higher scores indicate more positive views (better outcomes). In an open-ended text field, patients will also be asked to report any coping strategies that they are using or might use if they felt worried about the procedure. These responses will be coded according to a content analysis system based on pediatric coping literature.
Measured: Preoperative period, day of surgery
Face, Legs, Activity, Cry, Consolability (FLACC) scale
In light of potential benefits of Enhanced Recovery After Surgery protocols, the investigators will collect Face, Legs, Activity, Cry, Consolability (FLACC) scale scores as a measure of postoperative pain. Postoperative nurses standardly record this measure in the post-anesthesia care unit. Scores range from 0-10; higher scores indicate greater pain (worse outcomes).
Measured: Postoperative recovery, day of surgery
State-trait Anxiety Inventory (STAI)
Caregivers will report their own preoperative anxiety using a validated 6-item short form of the State-trait Anxiety Inventory (STAI). This is a well-established measure of state anxiety widely used in clinical research. Sum scores range from 6-24; higher scores indicate greater anxiety (worse outcomes).
Measured: Preoperative period, day of surgery
Caregivers' satisfaction and self-efficacy
On a Likert scale, caregivers will report their satisfaction with the educational materials they received as well as their self-efficacy in managing their child's postoperative pain. Scores range from 1-5; higher scores indicate more positive views (better outcomes).
Measured: Preoperative period, day of surgery
Caregiver-initiated postoperative call volumes
Caregiver-initiated phone encounters within 2 weeks after surgery will be reviewed in the medical record to determine if the intervention reduced caregivers' need to call the clinic with postoperative questions.
Measured: Up to 2 weeks after surgery
User analytics
Within the intervention group, integrated user analytics software will track participants' use of different pages of the application (Pendo.io, Inc.). The investigators will use this data to evaluate the fidelity of the intervention, correlate patient outcomes with the extent of intervention use, and inform possible revisions to improve engagement for future users.
Measured: Throughout the study period (beginning with time of download)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2023
- Study start19 Feb 2024
- Primary completionJun 2024 (estimated)
- Study completionJun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 360 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Children's Healthcare of Atlanta
- Sponsor type
- University, hospital or other
- Collaborators
- Georgia Clinical & Translational Science Alliance
- Responsible party
- Sponsor
- Investigators
- Kara K Prickett, MD, FACS, Principal investigator, Children's Healthcare of Atlanta; Emory University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06054282
- Sponsor's protocol ID
- STUDY00001807
- Status last verified
- Feb 2024
- First submitted
- 19 Sep 2023
- Last updated
- 22 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Deidentified data may be made available at the principal investigator's discretion.
Publications
Cordray H, Patel C, Prickett KK. Reducing Children's Preoperative Fear with an Educational Pop-up Book: A Randomized Controlled Trial. Otolaryngol Head Neck Surg. 2022 Aug;167(2):366-374. doi: 10.1177/01945998211053197. Epub 2021 Oct 26.
PubMed 34699270Chow CH, Van Lieshout RJ, Buckley N, Schmidt LA. Children's Perioperative Multidimensional Anxiety Scale (CPMAS): Development and validation. Psychol Assess. 2016 Sep;28(9):1101-9. doi: 10.1037/pas0000318.
PubMed 27537004McMurtry CM, Noel M, Chambers CT, McGrath PJ. Children's fear during procedural pain: preliminary investigation of the Children's Fear Scale. Health Psychol. 2011 Nov;30(6):780-8. doi: 10.1037/a0024817. Epub 2011 Aug 1.
PubMed 21806301Merkel SI, Voepel-Lewis T, Shayevitz JR, Malviya S. The FLACC: a behavioral scale for scoring postoperative pain in young children. Pediatr Nurs. 1997 May-Jun;23(3):293-7.
PubMed 9220806Marteau TM, Bekker H. The development of a six-item short-form of the state scale of the Spielberger State-Trait Anxiety Inventory (STAI). Br J Clin Psychol. 1992 Sep;31(3):301-6. doi: 10.1111/j.2044-8260.1992.tb00997.x.
PubMed 1393159Cordray H, Wright EA, Patel C, Raol N, Prickett KK. A Mobile Application for Child-Focused Tonsillectomy Education: Development and User-Testing. Laryngoscope. 2024 May;134(5):2455-2463. doi: 10.1002/lary.31198. Epub 2023 Nov 20.
PubMed 37983833
Study at a glance
From the registry record, last updated by the sponsor on 22 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Mobile Application for Child-focused Perioperative Education: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06054282
- Acronym / sponsor ID
- STUDY00001807
- Conditions
- Preoperative Anxiety
- Keywords
- patient education, tonsillectomy, pediatrics, otolaryngology, preoperative anxiety, perioperative care
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 360 participants (estimated)
- Lead sponsor
- Children's Healthcare of AtlantaUniversity, hospital or other
- Collaborators
- Georgia Clinical & Translational Science Alliance
- Study start
- 19 Feb 2024 (actual)
- Primary completion
- Jun 2024 (estimated)
- Study completion
- Jun 2024 (estimated)
- First posted
- 26 Sep 2023 (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 investigators developed a child-friendly mobile application to support accessible, interactive patient/caregiver education about pediatric tonsillectomy. This randomized controlled trial aims to evaluate whether the intervention reduces preoperative anxiety, improves patients' confidence and positive coping, improves caregivers' satisfaction and self-efficacy, and reduces call volumes from caregivers to the clinic after surgery compared to current standard care.
Detailed description
This is a prospective, questionnaire-based randomized controlled trial to evaluate a child-focused patient education intervention. The investigators developed a child-friendly mobile application to support accessible, interactive patient/caregiver education about pediatric tonsillectomy. Families in the intervention group will be invited to use the "Ready for Tonsillectomy" mobile application on their own mobile devices as they prepare for surgery and during recovery. The trial will compare preoperative anxiety and other patient-centered outcomes between families who use the mobile application (intervention) and families who receive current standard care materials without additional education (control). Primary and secondary endpoints include:
- Patients' preoperative anxiety (primary endpoint)
- Patient-reported confidence in knowing what to expect
- Patient-reported attitudes toward the procedure
- Patient-reported coping strategies
- Postoperative pain in the post-anesthesia care unit
- Caregivers' preoperative anxiety
- Caregivers' satisfaction with educational materials
- Caregivers' self-efficacy in managing their child's postoperative pain.
- Caregiver-initiated phone call volumes to the clinic within 2 weeks after surgery
- Mobile application use/interactions based on integrated user analytics
The target sample size is based on a power analysis using the primary outcome measure, which is validated for ages 7-13 years; the investigators will recruit a total of approximately 180 patients ages 7-13 years along with their caregivers (i.e., 180 caregivers for this cohort). A secondary cohort of patients ages 5-6 years will be enrolled simultaneously until the investigators reach the target sample size for the primary cohort (maximum 180 additional patients in the younger cohort, plus their caregivers). Participants will give informed verbal consent/assent at least 2 weeks before surgery. At this time, the family will be randomly assigned to either the intervention or control arm. Families in the intervention arm will download the mobile application on their smartphone or tablet; they will be able to access the application as frequently as desired in the weeks leading up to surgery and afterward. All participants will complete questionnaires while waiting in their private preoperative rooms on the day of surgery.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: "Ready for Tonsillectomy" educational mobile applicationPatients and caregivers will use the "Ready for Tonsillectomy" mobile application on their mobile devices as they prepare for and recover from surgery, in addition to standard care. Individual families will receive a phone call for enrollment/verbal informed consent at least 2 weeks before the scheduled surgery, likely around the time of the clinic visit when surgery is scheduled. Participants assigned to the intervention arm will download the mobile application at this time. They will be able to access the application as often as desired in the weeks leading up to surgery and afterward. |
| Control | No intervention | –Families will receive standard care (standard educational handouts and preoperative consults). |
Who may qualify
- Ages
- 5 to 13 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Pediatric patients ages 5-13 years (inclusive) scheduled for a tonsillectomy, along with their caregivers.
Key exclusion criteria (1 listed)
- Patients/caregivers who do not speak English and/or Spanish, do not have a mobile device, or are unable to give consent and assent.
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 |
|---|---|---|
| "Ready for Tonsillectomy" educational mobile applicationThe "Ready for Tonsillectomy" mobile application provides child-focused, procedure-specific education developed with feedback from patients, caregivers, and pediatric otolaryngologists. The application guides patients and their families through each aspect of the surgical experience, including reasons for tonsillectomy, how to prepare for surgery, anesthesia, and postoperative recovery. Diverse characters focus on the child's perspective in the treatment process, showing what happens at each step. Written at an early elementary reading level (available in English or Spanish), the text is integrated with graphics and animations. The application aims to promote active learning and equip patients with positive expectations and coping strategies as they approach surgery. It also prepares caregivers to navigate their child's surgery and optimize recovery. Notifications provide key information and reminders for caregivers to promote adherence and address common questions. | Behavioural | Intervention |
Primary outcome
Children's Perioperative Multidimensional Anxiety Scale (CPMAS)
Time frame: Preoperative period, day of surgery
The Children's Perioperative Multidimensional Anxiety Scale (CPMAS) is a patient-reported, 5-item visual analog scale validated for patients 7-13 years of age. The scale has demonstrated good internal consistency and test-retest reliability, and it is more feasible to implement than an observer-rated metric. Scores range from 0-500; higher scores indicate greater anxiety (worse outcomes).
7 secondary outcomes
Children's Fear Scale (CFS)
Time frame: Preoperative period, day of surgery
Patients' confidence and coping
Time frame: Preoperative period, day of surgery
Face, Legs, Activity, Cry, Consolability (FLACC) scale
Time frame: Postoperative recovery, day of surgery
State-trait Anxiety Inventory (STAI)
Time frame: Preoperative period, day of surgery
Caregivers' satisfaction and self-efficacy
Time frame: Preoperative period, day of surgery
Caregiver-initiated postoperative call volumes
Time frame: Up to 2 weeks after surgery
User analytics
Time frame: Throughout the study period (beginning with time of download)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Feb 2024.
- Background: PubMed 34699270Cordray H, Patel C, Prickett KK. Reducing Children's Preoperative Fear with an Educational Pop-up Book: A Randomized Controlled Trial. Otolaryngol Head Neck Surg. 2022 Aug;167(2):366-374. doi: 10.1177/01945998211053197. Epub 2021 Oct 26.
- Background: PubMed 27537004Chow CH, Van Lieshout RJ, Buckley N, Schmidt LA. Children's Perioperative Multidimensional Anxiety Scale (CPMAS): Development and validation. Psychol Assess. 2016 Sep;28(9):1101-9. doi: 10.1037/pas0000318.
- Background: PubMed 21806301McMurtry CM, Noel M, Chambers CT, McGrath PJ. Children's fear during procedural pain: preliminary investigation of the Children's Fear Scale. Health Psychol. 2011 Nov;30(6):780-8. doi: 10.1037/a0024817. Epub 2011 Aug 1.
- Background: PubMed 9220806Merkel SI, Voepel-Lewis T, Shayevitz JR, Malviya S. The FLACC: a behavioral scale for scoring postoperative pain in young children. Pediatr Nurs. 1997 May-Jun;23(3):293-7.
- Background: PubMed 1393159Marteau TM, Bekker H. The development of a six-item short-form of the state scale of the Spielberger State-Trait Anxiety Inventory (STAI). Br J Clin Psychol. 1992 Sep;31(3):301-6. doi: 10.1111/j.2044-8260.1992.tb00997.x.
- Background: PubMed 37983833Cordray H, Wright EA, Patel C, Raol N, Prickett KK. A Mobile Application for Child-Focused Tonsillectomy Education: Development and User-Testing. Laryngoscope. 2024 May;134(5):2455-2463. doi: 10.1002/lary.31198. Epub 2023 Nov 20.
- Individual participant dataSharing planned: No. Deidentified data may be made available at the principal investigator's discretion.
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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.
Kara K Prickett, MD, FACS contact
Kara K Prickett, MD, FACS principal investigator
Children's Healthcare of Atlanta; Emory University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing "Ready for Tonsillectomy" educational mobile application in people with Preoperative Anxiety, run by Children's Healthcare of Atlanta 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 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: status not confirmed, as of the sponsor's last update on 22 Feb 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 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hari Vendantam (404-785-0141, hari.vendantam@choa.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Children's Perioperative Multidimensional Anxiety Scale (CPMAS) (time frame: Preoperative period, day of surgery). 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 NCT06054282, which also lists 6 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 22 Feb 2024.