Technology-Assisted Yoga and Exercise on Neuropathy and Pain in Children With Leukemia (yogaCIPN)

Technology-Assisted Yoga and Exercise on Chemotherapy-Induced Peripheral Neuropathy and Pain in Children With Leukemia

The study was planned to examine the effects of technology-supported yoga and exercise on chemotherapy-induced peripheral neuropathy and pain in children aged 5-18 years with leukemia.

Study Overview

• Status: Completed
• Conditions: Pain; Leukemia; Excercise; Neuropathy;Peripheral; Children With Cancer; Yoga Therapy
• Intervention / Treatment: Behavioral: yoga and exercise

Detailed Description

The research will be carried out in Marmara University Istanbul Pendik Training and Research Hospital Pediatric Hematology and Oncology Service, and Dokuz Eylul University Pediatric Hematology and Oncology Service. It was planned to include all patients who were selected by the block randomization method, and who met the sampling criteria, in the study. Yoga will be given to the intervention group online. The control group will not be interfered with. Follow-up will be made using data collection tools after taking the study, 3 months later, and 6 months later.

Before starting yoga, "How are you feeling today?" will be asked to child. The yoga session will be individualized according to how the child feels. The content of the yoga sessions will progress in the form of warm-up exercises - breathing work - yoga postures (asana) - meditation - and progressive muscle relaxation exercises. Yoga sessions will be scheduled for 30 minutes. Yoga sessions and progressive muscle relaxation exercises will be held online once a week for eight weeks, then every two weeks for four months.

All yoga sessions will pay attention to the following items:

• Yoga sessions will be stretched according to the child's energy level and comfort.
• If the child expresses that he or she is not feeling well, that yoga session can only consist of breathing exercises and cooling poses.
• The child will be encouraged to express that he/she feels tired when he/she is tired.
• He will be told to move slowly to ensure safety when entering and exiting balance poses.
• The child will be asked what part of his/her body he/she feels while in the pose and where the tension occurs. This will ensure that the child remains safe in the pose.
• If a member of the family wishes to participate while the child is doing yoga, their participation will be supported.
• Movements will be continued by protecting the area with the catheter so that any catheter in the child's body is not bent, twisted, or dislodged.
• Back bending poses with high intensity will not be done.

• Study Type: Interventional
• Enrollment (Actual): 27
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • İzmir, Turkey, 35100
    • Gülçin Özalp Gerçeker

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Age range of the child is between 6-18,
• Diagnosed with acute lymphoblastic leukemia,
• Induction (Steroid and Vincristine) treatment,
• Being on an inpatient or outpatient treatment,
• Newly diagnosed or on induction therapy for less than one month,
• child agreeing to participate in the study voluntarily,
• Parent agreeing to participate in the study voluntarily,
• No relapse,
• Obtaining the consent form from the child and the parent,
• The child does not have a physical or psychological deficit,
• The child's yoga and exercise have an electronic device and internet to participate in the intervention.

Exclusion Criteria:

• The patient's relapse or terminal period,
• The child and family are not willing to participate in the study,
• The child has a cognitive, physical, and psychological deficits,
• The child's illiteracy.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Yoga and exercise group; Before starting yoga, "How are you feeling today?" will be asked to child. The yoga session will be individualized according to how the child feels. The content of the yoga sessions will progress in the form of warm-up exercises - breathing work - yoga postures (asana) - meditation - and progressive muscle relaxation exercises. Yoga sessions will be scheduled for 30 minutes. Yoga sessions and progressive muscle relaxation exercises will be held online once a week for eight weeks, then every two weeks for four months.	Behavioral: yoga and exercise; Technology-Assisted Yoga and Exercise Intervention during 6 months
No Intervention: control group; no yoga or excersize intervention.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pediatric Modified Total Neuropathy Scale and Total Neuropathy Score-Pediatric Vincristine (TNS-PV) for peripheral neuropathy	Pediatric Modified Total Neuropathy Scale and Total Neuropathy Score-Pediatric Vincristine (TNS-PV) assessment tools will be used. They determine Chemotherapy-induced Peripheral Neuropathy and its severity in children receiving cancer treatment. Each category is scored between 0-4. The highest 32 points are obtained from the scale. The higher the score, the worse the neuropathy. TNS-PV is based on adding constipation and hoarseness to the Pediatric Modified Total Neuropathy Scale.	during 6 months (at the beginning of the study, 3rd month and 6th month)
Adolescent Pediatric Pain Scale for pain	Adolescent Pediatric Pain Scale: This scale consists of three independent parts; body outline diagram where the child/adolescent can mark the location of the pain*Assessment: The child can mark the anterior and posterior sides-upper extremity, lower extremity, head, neck, abdomen, chest, shoulder, back… so that the location and number of the pain area is evaluated; 10 cm long, where the pain can mark the severity as "no pain, mild pain, moderate pain, very pain and worst pain possible" word chart scale* Evaluation: With a scale of 0-10 cm, the pain is evaluated by the child between 0-10 and the pain is defined as "no pain, mild pain, moderate pain, very pain".and defines its intensity by choosing one of the "worst pain possible"; word list under 4 dimensions (sensory, emotional, evaluative, time) to indicate the nature of pain.	during 6 months (at the beginning of the study, 3rd month and 6th month)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pediatric Symptom Screening Scale for chemotherapy related symptoms	Pediatric Symptom Screening Scale: It was developed to evaluate the symptoms experienced by children. The scale consists of a total of 15 items and is Likert type. The scale score ranges from 0 to 60. The overall score increases as the symptoms worsen.	during 6 months (at the beginning of the study, 3rd month and 6th month)

Collaborators and Investigators

• Sponsor: Dokuz Eylul University
• Investigators: Principal Investigator: Gulcin Ozalp Gerçeker, Assoc. Prof., Dokuz Eylul University

Study record dates

Study Major Dates

• Study Start (Actual): October 30, 2021
• Primary Completion (Actual): April 30, 2024
• Study Completion (Actual): June 30, 2024

Study Registration Dates

• First Submitted: August 28, 2023
• First Submitted That Met QC Criteria: July 19, 2024
• First Posted (Actual): July 22, 2024

Study Record Updates

• Last Update Posted (Actual): July 22, 2024
• Last Update Submitted That Met QC Criteria: July 19, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Keywords: yoga, excercise, pain, neuropathy, children, leukemia
• Additional Relevant MeSH Terms: Nervous System Diseases; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Neuromuscular Diseases; Leukemia; Peripheral Nervous System Diseases
• Other Study ID Numbers: 2020/26-75

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No