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

Augusta University

Status: Not yet enrolling

Conditions: Pediatric Kidney Disease

Treatments: Behavioral: Meditation Video; Behavioral: PeSSKi questionnaire survey

Study type: Interventional

Funder types: Other

Identifiers

NCT06858267

2254633

Details and patient eligibility

About

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.

Full description

Up to 70% of pediatric patients experience preoperative and perioperative anxiety. The anxiety level of their parents or guardians also affects the anxiety levels of pediatric patients themselves. Anxiety levels often peak during the time of anesthesia induction, suggesting the unfamiliar physical environment plays a role in increasing anxiety levels. Pediatric anxiety often manifests in various ways such as strong emotions, physical noncompliance, and regression. Pre-operative anxiety has been shown to increase the risk of cardiovascular events during the operation, increase difficulty gaining access to intubation, and increase anesthetic requirements. The effects of pre-operative anxiety do not end once the operation is complete. Rather, there have been suggestions that preoperative anxiety has a positive association with postoperative pain and prolonged hospital stay. Thirteen percent of pediatric surgical patients have postoperative pain that interferes with their daily activities or sleep patterns. In addition, 25-63% of pediatric patients who undergo urological surgeries experience moderate to severe pain on postoperative day 1 and the pain decreases but persists for 2 days on average. Therefore, it is worthwhile to explore noninvasive and adaptable methods to decrease preoperative anxiety among the patient and their guardians'.

Mindfulness is turning one's awareness of past and future events inward to focus on the present time. The practice provides an opportunity for people to reflect on their current internal conditions in a space and time that is not pressured, which can improve their ability to healthily and effectively respond to those conditions. One such study proposed that trait mindfulness and perceived anxiety have an inverse relationship. While another showed those with higher levels of trait mindfulness have increased resistance to stress and psychological flexibility. By embracing the entire spectrum of emotions one may encounter in the present or about a future event, people may be able to feel relief instead of increased anxiety or worry.

Enrollment: 60 estimated patients

Sex: All

Ages: 6 to 18 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 2 patient groups, including a placebo group

30 study subjects with meditation

Experimental group

Description:

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.

Treatment:

Behavioral: PeSSKi questionnaire survey

Behavioral: Meditation Video

30 study subjects without meditation

Placebo Comparator group

Description:

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.

Treatment:

Behavioral: PeSSKi questionnaire survey