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

NCT06512012 | Completed

• 1 other identifier: 2020/26-75
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

yoga, excercise, pain, neuropathy, children, leukemia

Outcome Measures

Primary Outcomes (2)

• 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; 1. 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 2. 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" 3. 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 Outcomes (1)

• Pediatric Symptom Screening Scale for chemotherapy related symptoms

  during 6 months (at the beginning of the study, 3rd month and 6th month)

Study Arms (2)

Yoga and exercise group

EXPERIMENTAL

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

control group

NO INTERVENTION

no yoga or excersize intervention.

Interventions

yoga and exercise BEHAVIORAL

Technology-Assisted Yoga and Exercise Intervention during 6 months

Yoga and exercise group

Eligibility Criteria

• Age: 6 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Dokuz Eylul University: lead

Study Sites (1)

Gülçin Özalp Gerçeker

Izmir, 35100, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Leukemia; Neuritis; Pain

Interventions

Yoga; Exercise

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Mind-Body Therapies; Complementary Therapies; Therapeutics; Spiritual Therapies; Exercise Movement Techniques; Physical Therapy Modalities; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Gülçin Özalp Gerçeker, Assoc. Prof.

  Dokuz Eylul University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assoc. Prof.

Study Record Dates

• First Submitted: August 28, 2023
• First Posted: July 22, 2024
• Study Start: October 30, 2021
• Primary Completion: April 30, 2024
• Study Completion: June 30, 2024
• Last Updated: July 22, 2024

Record last verified: 2024-07

Locations

TU (1)