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

NCT ID: NCT06512012

Last Updated: 2024-07-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 27 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-10-30
• Study Completion Date: 2024-06-30

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.

Conditions

Leukemia; Children With Cancer; Yoga Therapy; Excercise; Neuropathy;Peripheral; Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

yoga and exercise

Intervention Type: BEHAVIORAL

Technology-Assisted Yoga and Exercise Intervention during 6 months

control group

no yoga or excersize intervention.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

yoga and exercise

Technology-Assisted Yoga and Exercise Intervention during 6 months

Intervention Type: BEHAVIORAL

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.

• Minimum Eligible Age: 6 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Dokuz Eylul University

OTHER

Sponsor Role: lead

Responsible Party

Gülçin Özalp Gerçeker

Assoc. Prof.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Gülçin Özalp Gerçeker, Assoc. Prof.

Role: PRINCIPAL_INVESTIGATOR

Dokuz Eylul University

Locations

Gülçin Özalp Gerçeker

Izmir, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

2020/26-75

Identifier Type: -

Identifier Source: org_study_id