Clinical Trials Directory

Trials / Withdrawn

WithdrawnNCT04719416

Relaxation Therapy in Pediatric Oncology

Effects of Guided Meditation on Patient Outlook and Symptom Management in Pediatric Oncology Patients

Status
Withdrawn
Phase
N/A
Study type
Interventional
Enrollment
0 (actual)
Sponsor
Geisinger Clinic · Academic / Other
Sex
All
Age
6 Years – 20 Years
Healthy volunteers
Not accepted

Summary

This study will look at the use of relaxation therapy in children with cancer. The study will compared patients who are current receiving treatment for their cancer and those who are currently in remission. Patients will be asked to listen to a short audio recording twice a week prior to going to bed which will walk patients through a mediation session. Surveys will be distributed through parental emails on the first of each month for each child to complete for the duration of 12 months. It is anticipated that the use of relaxation therapy will help to improve anxiety and pain levels in this population.

Detailed description

Rationale: The utilization of complementary therapies in the management of cancer have not been extensively studied in the pediatric population. Patients in active treatment and even those in remission may experience higher levels of anxiety and medical complications compared to their counterparts. Complementary therapies such as meditation have been found to improve symptoms and decrease anxiety and pain levels in adult oncology patients. Objective: The goal of this study is to determine the impact of relaxation breathing with body scan techniques through the utilization of media clips on pediatric oncology patients' complications, hospitalizations, anxiety levels and outlook on diagnosis and treatment management. Methods: A randomized non-blind control trial will be conducted in order to compare a control to a therapy intervention group. The therapy will consist of a video clip approximately 5 minutes in length. The clip will walk the patient through mindfulness in breathing along with muscle relaxation of each muscle group. This therapy is to be completed three times a week prior to falling asleep. Prior to initiation of therapy a baseline questionnaire will be completed. Following initiation, a follow up survey will be distributed on a monthly basis to assess for symptom severity, number of hospitalizations and patient outlook. Population: The study population includes patients seen at Janet Weis Children's Hospital's pediatric oncology clinic. Patients must be in the age range of 6-20 years old for the entire year of the study in order to qualify. Exclusion criteria includes patients who are actively receiving drug therapy for anxiety or depression or receiving palliative care. Patients who pass away within the year of study will be excluded. Time Frame: Following recruitment, each patient will be enrolled for the total of a one-year time frame. Expected Outcomes: The investigators project that the patients utilizing guided meditation will experience decreased levels of anxiety, pain and complications compared to those of the control group.

Conditions

Interventions

TypeNameDescription
BEHAVIORALGuided MeditationApproximately 10 minute recording of guided meditation focuses on muscle relaxation.

Timeline

Start date
2022-09-01
Primary completion
2023-06-01
Completion
2023-07-01
First posted
2021-01-22
Last updated
2022-09-13

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT04719416. Inclusion in this directory is not an endorsement.