Relaxation Therapy in Pediatric Oncology

Not Applicable

Withdrawn

• Conditions: Pediatric Cancer
• Interventions: Behavioral: Guided Meditation

• Registration Number: NCT04719416
• Lead Sponsor: Geisinger Clinic

Brief 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.

Study Timeline

• Study First Submitted: 2021-01-15
• Study First Submitted QC: 2021-01-20
• Study First Posted: 2021-01-22
• Status Verified: 2022-09
• Study Start: 2022-09
• Last Update Submitted: 2022-09-08
• Last Update Posted: 2022-09-13
• Primary Completion: 2023-06
• Study Completion: 2023-07

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

• Current patient at Geisinger Foss Clinic - oncology department with a diagnosis of cancer for more than 2 months prior to the study start

Exclusion Criteria

• Current use of any psychiatric medications including those for anxiety, depression or mood disorders
• Non-English speaking
• Patients receiving palliative care
• Patients with Langerhans' cell histiocytosis, benign teratomas and craniopharyngioma as they do not clearly constitute malignancy
• Patients with a history of cognitive developmental delay

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Active Treatment with Relaxation	Guided Meditation	This subgroup comprises of patients who are currently receiving active treatment for their cancer diagnosis. They will be completing the pre-recorded relaxation audio therapy twice weekly prior to falling asleep.
Remission with Relaxation	Guided Meditation	This subgroup comprises of patients who are currently in remission for their cancer diagnosis. They will be completing the pre-recorded relaxation audio therapy twice weekly prior to falling asleep.

Primary Outcome Measures

Name	Time	Method
Improved anxiety level	Measurement will be assessed through study completion, an average of 1 year	Anxiety level will be measured through a series of monthly surveys asking patients to rate how often they experience worry over their diagnosis, school, have difficulty paying attention, feel angry, sad or alone as never, rarely, sometimes or often.

Secondary Outcome Measures

Name	Time	Method
Change in levels of pain	Measurement will be assessed through study completion, an average of 1 year	Levels of pain will be assessed through monthly surveys asking the patient to rate their overall pain level over the past month as 1-10 with 10 being a lot of pain.
Improved sleep habits	Measurement will be assessed through study completion, an average of 1 year	Sleep habits will be measured through a series of monthly surveys asking patients to rate how often they experience difficulty falling asleep, staying asleep and if they feel more tired than usual as yes or no.

Trial Locations

Locations (1)

Geisinger Medical Center; 🇺🇸 Danville, Pennsylvania, United States