Clinical trial NCT06512012: Technology-Assisted Yoga and Exercise on Neuropathy and Pain in Children With Leukemia
Official title: Technology-Assisted Yoga and Exercise on Chemotherapy-Induced Peripheral Neuropathy and Pain in Children With Leukemia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Leukemia
Children With Cancer
Yoga Therapy
Excercise
Neuropathy;Peripheral
Pain
Keywords: yoga, excercise, pain, neuropathy, children, leukemia
Lead sponsor: Dokuz Eylul University
Sponsor class: OTHER
First posted: 2024-07-22
Enrollment: 27
Sex: ALL
Minimum age (years): 6
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Pediatric Modified Total Neuropathy Scale and Total Neuropathy Score-Pediatric Vincristine (TNS-PV) for peripheral neuropathy
timeFrame: during 6 months (at the beginning of the study, 3rd month and 6th month)
measure: Adolescent Pediatric Pain Scale for pain
timeFrame: during 6 months (at the beginning of the study, 3rd month and 6th month)
Secondary outcomes:
measure: Pediatric Symptom Screening Scale for chemotherapy related symptoms
timeFrame: during 6 months (at the beginning of the study, 3rd month and 6th month)
Other outcomes:
Locations:
city: İzmir
country: Turkey
facility: Gülçin Özalp Gerçeker
Study officials:
affiliation: Dokuz Eylul University
name: Gülçin Özalp Gerçeker, Assoc. Prof.
role: PRINCIPAL_INVESTIGATOR
References: