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LeukemiayogaCIPNNCT06512012

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

A study testing yoga and exercise in people with Leukemia and Children With Cancer, run by Dokuz Eylul University at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 6 to 18 years
Conditions the study is for
Leukemia, Children With Cancer, Yoga Therapy
What is being tested?
yoga and exercise
Could I receive a placebo?
No, everyone receives an active treatment
How many people
27 participants
Where
1 siteTurkey (Türkiye)
Study dates
30 Oct 2021to 30 Jun 2024
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 6 to 18 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Who may be able to join

  • 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,
Show all 11Show fewer
  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site

  • Gülçin Özalp Gerçeker

    Izmir, 35100

Other trials in Turkey (Türkiye)

About this study

Official title: 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.

Read the 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.
Being tested
yoga and exercise
Keywords
yoga, excercise, pain, neuropathy, children, leukemia
Medical subject headings
Leukemia, Neuritis, Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • yoga and exerciseBehavioural

    Technology-Assisted Yoga and Exercise Intervention during 6 months

Study groups in NCT06512012
Study groupRoleWhat they receive
Yoga and exercise groupExperimentalBefore 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.
Receives: Behavioral: yoga and exercise
control groupNo interventionno yoga or excersize intervention.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

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

  2. 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"
    1. word list under 4 dimensions (sensory, emotional, evaluative, time) to indicate the nature of pain.

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

Secondary outcomes (1)

  1. 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.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Jul 2024
  2. Study start30 Oct 2021
  3. Primary completion30 Apr 2024
  4. Study completion30 Jun 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
27 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06512012
Sponsor's protocol ID
2020/26-75
Acronym
yogaCIPN
Status last verified
Jul 2024
First submitted
28 Aug 2023
Last updated
22 Jul 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing yoga and exercise in people with Leukemia and Children With Cancer, run by Dokuz Eylul University at 1 site in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 22 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Pediatric Modified Total Neuropathy Scale and Total Neuropathy Score-Pediatric Vincristine (TNS-PV) for peripheral neuropathy (time frame: during 6 months (at the beginning of the study, 3rd month and 6th month)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06512012.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jul 2024.

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