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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age6-18
SponsorAugusta University

About this trial

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. 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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

History of any prior surgeries

History of anxiety or anxiety-related disorders

Diagnosis of developmental delay

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

  • 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)

Treatment groups

60 Participants
are divided into 2 treatment groups
Group A: 30 study subjects with meditationExperimental treatment 2 interventions
Group B: 30 study subjects without meditationPlacebo comparator 1 intervention

Trial outcomes

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.

Time frame
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.

Secondary outcomes

Other outcomes

Sponsors and contacts

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