A Mobile Application for Child-focused Perioperative Education

Preoperative Anxiety Clinical Trial

Official title:

A Mobile Application for Child-focused Perioperative Education: A Randomized Controlled Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06054282
• Other study ID #: STUDY00001807
• Status: Recruiting
• Phase: N/A
• Start date: February 19, 2024
• Est. completion date: June 2024

Study information

• Verified date: February 2024
• Source: Children's Healthcare of Atlanta
• Contact: Hari Vendantam
• Phone: 404-785-0141
• Email: hari.vendantam[@]choa.org
• Is FDA regulated: No
• Study type: Interventional

Clinical 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, improves caregivers' satisfaction and self-efficacy, and reduces call volumes from caregivers to the clinic after surgery compared to current standard care.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 360
• Est. completion date: June 2024
• Est. primary completion date: June 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 5 Years to 13 Years

Eligibility

Inclusion Criteria:

• Pediatric patients ages 5-13 years (inclusive) scheduled for a tonsillectomy, along with their caregivers.

Exclusion Criteria:

• Patients/caregivers who do not speak English and/or Spanish, do not have a mobile device, or are unable to give consent and assent.

Related Conditions & MeSH terms

• Preoperative Anxiety

Intervention

Behavioral:
• "Ready for Tonsillectomy" educational mobile application
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.

Locations

Country	Name	City	State
United States	Children's Healthcare of Atlanta	Atlanta	Georgia

Sponsors (2)

Lead Sponsor	Collaborator
Children's Healthcare of Atlanta	Georgia Clinical & Translational Science Alliance AppHatchery

Country where clinical trial is conducted

United States, 

References & Publications (6)

Chow 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. — View Citation

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. — View Citation

Cordray H, Wright EA, Patel C, Raol N, Prickett KK. A Mobile Application for Child-Focused Tonsillectomy Education: Development and User-Testing. Laryngoscope. 2023 Nov 20. doi: 10.1002/lary.31198. Online ahead of print. — View Citation

Marteau 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. Erratum In: Br J Clin Psychol. 2020 Jun;59(2):276. — View Citation

McMurtry 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. — View Citation

Merkel 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	Preoperative period, day of surgery
Secondary	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).	Preoperative period, day of surgery
Secondary	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.	Preoperative period, day of surgery
Secondary	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).	Postoperative recovery, day of surgery
Secondary	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).	Preoperative period, day of surgery
Secondary	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).	Preoperative period, day of surgery
Secondary	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.	Up to 2 weeks after surgery
Secondary	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.	Throughout the study period (beginning with time of download)