The Impact of Meditation on Anxiety and Post-Operative Pain in Pediatric Patients Undergoing Urological Surgery

NCT06858267 | Not Yet Recruiting

• 1 other identifier: 2254633
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

1. 1.The aim of this study is to assess anxiety in pediatric patients preoperatively, perioperatively, and postoperatively and whether meditation reduces anxiety in the days before, during, and after the surgery.
2. 2.The second aim of this study is to see if longitudinal meditation is associated with decreased postoperative pain by examining whether the group prescribed meditation has reduced pain medication intake, measured by the frequency of liquid analgesic medicine intake.

Conditions

Pediatric Kidney Disease

Keywords

The Impact of Meditation on Anxiety and Post-Operative Pain in Pediatric Patients Undergoing Urological Surgery

Outcome Measures

Primary Outcomes (1)

• Preoperative Meditation may decrease preoperative anxiety among the patient and their guardians. And to see if longitudinal meditation is associated with decreased postoperative pain by examining frequency of liquid analgesic medicine intake.

  Number of participants with meditation as assessed to change pain label from baseline in pain score on the scale at 1-week postoperative condition. The final questionnaire survey will be done 1 week postoperatively to assess how much pain the patient is still in after the quantity of analgesic usage logged throughout the week.

  Active participation in the study will last for about one month, this includes three weeks pre-operatively and one week post-operatively. Total duration of the project is approximately two years.

Study Arms (2)

30 study subjects with meditation

EXPERIMENTAL

The meditation regimen will be linked in a Qualtrics that is delivered to them via email daily. The patient and their parents will open the link, enter their assigned number, and follow the guided meditation embedded in the Qualtrics. This will track how many times and for how long the patients are following the regimen. The first PeSSKi (Perceived Stress Scale for Kids) questionnaire survey will be asked and sent via email after the appointment surgery is scheduled to assess anxiety. The second PeSSKi questionnaire survey will be over email at the halfway point to the surgery to see impact of meditation and anxiety levels at this point. The third questionnaire survey will be done immediately before the day of surgery in person to assess how anxious the patient is. The final questionnaire survey will be done 1 week postoperatively to assess the pain label of the patient is still in after the quantity of analgesic usage logged throughout the week.

Behavioral: PeSSKi questionnaire survey; Behavioral: Meditation Video

30 study subjects without meditation

PLACEBO COMPARATOR

The control group will only receive the questionnaire without meditation. The first PeSSKi questionnaire survey will be asked and sent via email after the appointment where the surgery is scheduled to assess anxiety. The second PeSSKi questionnaire survey will be over email at the halfway point to the surgery to see the anxiety levels are at this point. The third questionnaire survey will be done immediately before the day of the surgery in person to assess how anxious the patient is. The final questionnaire survey will be done 1 week postoperatively to assess how much pain the patient is still in after the quantity of analgesic usage logged throughout the week. The questionnaire has eleven questions on a five-point scale ranging from "Not at all" to "A lot". The questionnaire link is given bellow: https://augusta.qualtrics.com/jfe/form/SV\_2b2DZ9x16jY9IzQ (PeSSKi questionnaire) The control group will receive just the PeSSKi questionnaire.

Behavioral: PeSSKi questionnaire survey

Interventions

PeSSKi questionnaire survey BEHAVIORAL

The control group will only receive the questionnaire without meditation. The PeSSKi questionnaire survey will be receive in 4 time point, First questionnaire will sent via email after the appointment for the surgery is scheduled. The second PeSSKi questionnaire survey will share via email at halfway point to the surgery. The third questionnaire survey will be done immediately before the day of surgery in person to assess how anxious the patient is. The final questionnaire survey will be done 1 week postoperatively to assess how much pain the patient is still in after the quantity of analgesic usage logged throughout the week.

30 study subjects with meditation; 30 study subjects without meditation

Meditation Video BEHAVIORAL

The experimental group pediatric patients selected for this study and their parents will be receiving meditation and PeSSKi (Perceived Stress Scale for Kids) questionnaire. The ideal meditation schedule will be 3-5 meditations per week for 5 minutes beginning 3 weeks before surgery. This will provide a dose-response relationship of meditation to anxiety and postoperative pain for data analysis. The Patient and their parents will open the link, enter their assigned number, and follow the guided meditation embedded in the Qualtrics. This will track how many times and for how long the patients are following the regimen. The questionnaire has eleven questions on a five-point scale ranging from "Not at all" to "A lot". An example of the meditation video questionnaire is linked here: https://augusta.qualtrics.com/jfe/form/SV\_3DeFFKdJVupMJQq (experimental group) https://augusta.qualtrics.com/jfe/form/SV\_2b2DZ9x16jY9IzQ (PeSSKi questionnaire)

30 study subjects with meditation

Eligibility Criteria

• Age: 6 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Age 6-18
• Pediatric urology patients at Children's Healthcare of Georgia in Augusta, GA; scheduled for any urological surgery
• Otherwise, healthy patients
• Must record any medical history and medications
• Must record prior attempts of meditation therapy
• Children must provide assent

You may not qualify if:

• History of any prior surgeries
• History of anxiety or anxiety-related disorders
• Diagnosis of developmental delay

Sponsors & Collaborators

• Augusta University: lead

Study Sites (1)

Augusta University

Augusta, Georgia, 30912, United States

Location

Related Links

• Experimental Group\_ Meditation Video
• PeSSKi (Perceived Stress Scale for Kids) questionnaire for Experimental and control group

Central Study Contacts

Bradley Morganstern, MD

CONTACT

706-721-0982; BMORGANSTERN@augusta.edu

Masuma Anwar, Pharmacy

CONTACT

706-721-9680; maanwar@augusta.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: Pediatric patients between the ages of 6 to 18 who will be undergoing urological surgery will be selected for this study along with their parents. Recruitment will begin in the clinic after surgery is scheduled. The patients will be also sign an informed consent form and assent. Patients and parents will be divided into two groups receiving meditation and not receiving meditation. The ideal meditation schedule will be 3-5 meditations per week for 5 minutes beginning 3 weeks before surgery. This will provide a dose-response relationship of meditation to anxiety and postoperative pain for data analysis. For randomization, the patients and their parents will be assigned a number, surveyed at 4-time points, and given a meditation regimen to see how anxiety is affected. The meditation regimen will be linked in a Qualtrics. The control group will only receive the questionnaire without meditation. The survey has eleven questions on a five-point scale ranging from "Not at all" to "A lot"

Study Record Dates

• First Submitted: February 24, 2025
• First Posted: March 5, 2025
• Study Start: March 1, 2025
• Primary Completion (Estimated): December 30, 2027
• Study Completion (Estimated): December 30, 2028
• Last Updated: March 7, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)