NCT04932720

Brief Summary

Pediatric oncology patients experience physical and psycho-social symptoms that negatively affect their quality of life during treatment. "Yoga" practices, known as a unique physical activity that combines mind-body awareness and breathing exercises to improve the quality of life of pediatric oncology patients, have recently become popular. The study was conducted experimentally in the form of pre-test and post-test with 30 controls, 30 experimental group children who were treated in the Pediatric Oncology / Hematology service of a university hospital and their parents, in order to investigate the effect of children's yoga program on the quality of life of pediatric oncology patients. Ethics committee, institutional and parental consent was obtained. Data were collected using a questionnaire form and the Pediatric Quality of Life Inventory "PedsQL (4.0)". Participants filled out the Pediatric Quality of Life Inventory "PedsQL (4.0)" Child and Parent Form before the 3-week (6 sessions) yoga program and salivary cortisol samples were taken from the children. These procedures were repeated after the yoga program. Anova test and "Paired sample t" test were used among statistical analysis methods. Statistical significance was accepted as p \<0.05.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2020

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 19, 2020

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 19, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 19, 2021

Completed
20 days until next milestone

First Submitted

Initial submission to the registry

June 8, 2021

Completed
13 days until next milestone

First Posted

Study publicly available on registry

June 21, 2021

Completed
Last Updated

August 13, 2021

Status Verified

June 1, 2021

Enrollment Period

1.3 years

First QC Date

June 8, 2021

Last Update Submit

August 7, 2021

Conditions

Keywords

Child Health and Diseases Nursingcortisolquality of lifestressyoga

Outcome Measures

Primary Outcomes (1)

  • Quality of Life Inventory (PedsQL 4.0) of 8-12 and 13-18 age were used to evaluate the impact of the child yoga program on quality of life of pediatric oncology patients.

    A questionnaire form was used to learn the socio-demographic characteristics of the children and their families. Quality of Life Inventory (PedsQL 4.0) of 8-12 and 13-18 age child and parent form were used to evaluate the impact of the child yoga program on quality of life of pediatric oncology patients.It is a versatile inventory of 23 items covering school functions (5 Items), social functions (5 Items), emotional functions (5 Items), physical functions (8 Items). Saliva samples were taken from the experimental and control groups to measure the stress levels of the children with the cortisol kit.

    3 weeks

Study Arms (2)

experimental group

EXPERIMENTAL

Experimental group consisted of children aged 8-18 years, who did not have a different disease accompanying the oncological disease.

Behavioral: chıld yoga programme

control group

NO INTERVENTION

Also the control group consisted of children aged 8-18 years, who did not have a different disease accompanying the oncological disease.

Interventions

Yoga sessions were in the form of 6 sessions and were held as 2 sessions per week. The program was given by an expert yoga instructor who has an international "Yoga Alliance" approved child and adolescent yoga certificate.Consisting of the components of Hatha Yoga (HY), one of the yoga types known and widely practiced all over the world; Sessions consisting of asanas (yoga postures), pranayamas (breathing techniques), relaxation, relaxation exercises and meditation were prepared. Sessions are 45 minutes; For those who are new to yoga for the first 15 minutes; mental and physical preparation; asanas, pranayamas were taught, drama followed by breathing exercises and asanas in the next 30 minutes, relaxation techniques (imaginary journey) and meditation in the last 15 minutes.

experimental group

Eligibility Criteria

Age8 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Of the participating children, those who did not have any other accompanying disease and did not have developmental disorders were included in the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Çukurova University

Adana, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Neoplasms

Study Officials

  • Şenay Çetinkaya

    Cukurova University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: Children who were treated at Mersin University Medical Faculty Hospital were determined by the "simple random selection" method and formed the experimental and control groups.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

June 8, 2021

First Posted

June 21, 2021

Study Start

January 19, 2020

Primary Completion

May 19, 2021

Study Completion

May 19, 2021

Last Updated

August 13, 2021

Record last verified: 2021-06

Data Sharing

IPD Sharing
Will not share

Locations