Effects of Yoga on Children With Cancer

NCT06651918 | Not Yet Recruiting

• 1 other identifier: ErciyesEKalayci38
• Study Type: interventional
• Target: 20
• Locations: 0 countries
• Sites: N/A

Brief Summary

This study was planned as a randomized controlled experimental study with a pre-test-post-test design to determine the effect of yoga practice accompanied by a specialist yoga instructor on fatigue, quality of life and symptom control in children diagnosed with cancer between the ages of 8-12.The main questions it aims to answer are:

1. 1.Does yoga practice applied to children diagnosed with cancer reduce fatigue in children?
2. 2.Does yoga practice applied to children diagnosed with cancer affect their quality of life?
3. 3.Does yoga practice applied to children diagnosed with cancer affect the symptoms experienced by children?

Conditions

Pediatric Cancer

Keywords

children with cancer; yoga; fatique; quality of life; symptoms of cancer

Outcome Measures

Primary Outcomes (3)

• Quality of Life Inventory for Children (PedsQL)

  The scale, developed by Varni and his colleagues in 2001 and adapted into Turkish by Çakın-Memik et al. (2007), questions the quality of life of children in the areas of physical, emotional, social and school functionality.

  At the beginning yoga and after three weeks ; survey and scale questions will be applied by the researcher. In addition, in the statistical analysis section of the research, correlation and regression analysis will be conducted between the measure

• Memorial Symptom Assessment Scale (7-12 years old)

  The scale, which was developed by Collins et al. in 2002 for use in children with oncology between the ages of 7 and 12, was adapted into Turkish by Şenol and Efe (2022).It is used to evaluate symptoms of pain, numbness, sadness, nausea, pruritus, anxiety, loss of appetite, and insomnia experienced by pediatric oncology patients in the past two days.

  At the beginning yoga and after three weeks ; survey and scale questions will be applied by the researcher. In addition, in the statistical analysis section of the research, correlation and regression analysis will be conducted between the measure

• Fatigue Assessment Scale for Pediatric Oncology Patients Aged 7-12

  The Fatigue Assessment Scale for Pediatric Oncology Patients Aged 7-12, developed by Kudubeş, Bektaş and Uğur in 2019, consists of 27 items and 3 sub-dimensions.

  At the beginning yoga and after three weeks ; survey and scale questions will be applied by the researcher. In addition, in the statistical analysis section of the research, correlation and regression analysis will be conducted between the measure

Study Arms (2)

yoga practise

EXPERIMENTAL

For the experimental study, the researcher will contact the participants to be included in the study and the intervention (yoga group) and control groups will be randomly created. The participants will be informed about the study by the researcher and their voluntary consent will be obtained. The researcher will provide information about the Identifying Characteristics Form for Children Diagnosed with Cancer and Their Families, the Quality of Life Scale for Children (PedsQL) and the Memorial Symptom Assessment Scale to be used in the study. The survey and scales will be applied to each participant individually one day before yoga. Then, the Yoga Group will be applied 3 sessions per week, 3 weeks in a row, each session will be 30 minutes. The researcher will repeat the survey and scale questions that he asked the participants before they started yoga at the end of the 3 weeks.

Behavioral: yoga practise

survey group

NO INTERVENTION

No intervention will be made to the children in this group, only survey and scale questions will be applied.

Interventions

yoga practise BEHAVIORAL

For the experimental study, the researcher will contact the participants to be included in the study and the intervention (yoga group) and control groups will be randomly created. The participants will be informed about the study by the researcher and their voluntary consent will be obtained. The researcher will provide information about the Identifying Characteristics Form for Children Diagnosed with Cancer and Their Families, the Quality of Life Scale for Children (PedsQL) and the Memorial Symptom Assessment Scale to be used in the study. The survey and scales will be applied to each participant individually one day before yoga. Then, the Yoga Group will be applied 3 sessions per week, 3 weeks in a row, each session will be 30 minutes. The researcher will repeat the survey and scale questions that he asked the participants before they started yoga at the end of the 3 weeks.

yoga practise

Eligibility Criteria

• Age: 8 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• The participant must be between the ages of 8-12,
• He/she must not have a chronic or genetic disease other than cancer,
• He/she must not have a physical, mental or neurological disability,
• The participant must have a mother who is at least a primary school graduate,
• The participant must be able to speak and understand Turkish,
• Both the participant and his/her parents must be open to communication and cooperation,
• Participants will be included in the study if both the participant and his/her parents agree to participate in the study voluntarily and give verbal and written consent.

You may not qualify if:

• \- Participants who do not want to participate in the study or who want to leave the study, who have communication difficulties, and who have solid tumors (Osteosarcoma, Ewing sarcoma, etc.) that prevent them from doing yoga will be excluded from the study.

Sponsors & Collaborators

• TC Erciyes University: lead

MeSH Terms

Conditions

Neoplasms

Study Officials

• Emine Erdem, Prof.

  TC Erciyes University

  STUDY DIRECTOR

Central Study Contacts

Eda Kalaycı, phd student

CONTACT

+0905349538932; eda_kalayci937@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: pediatrıc nurse

Study Record Dates

• First Submitted: April 4, 2024
• First Posted: October 22, 2024
• Study Start: January 1, 2025
• Primary Completion: February 1, 2025
• Study Completion: December 1, 2025
• Last Updated: October 22, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share