NCT06484283

Brief Summary

Childhood cancers have become an important health problem with a rapidly increasing incidence. Although global and national data show that the developmental status of countries has an impact on the success of treatment, there is a significant increase in the incidence of childhood cancers. With the diagnosis of childhood cancer, long-term and exhausting treatments, increased financial and moral burdens and psycho-social difficulties affect children, but it is inevitable that the child's parents are also affected by the situation. Childhood cancer has serious effects on the physical and psychological health of pediatric patients, their families and caregivers. In this process, parents may face psychosocial problems such as depression, anxiety, stress, fatigue, burnout, disruption of family dynamics and inadequacy. Although the treatment process affects the adaptation, coping and family dynamics of all family members, it can be much more tiring and exhausting for mothers, who are often the primary caregivers of the child.Studies point out that parents of a child with oncology need to adapt to the long and strenuous treatment procedures in order to cope and cope with these challenges. Adaptation involves parents more quickly in integrating and taking an active role in the treatment and care processes. This has been linked to people's ability to be resilient. Although resilience is an ability that develops over time, it is very important to support the family of parents of children diagnosed with oncology in this sense. Meditation is a practice with ancient teachings dating back at least 3000 years. In recent years there has been a growing interest in its benefits for psychological and spiritual well-being in many fields including medicine, nursing, psychology, sociology and education. Although it has a wide variety of definitions and contents, it generally consists of practices such as attention and focus training for mindfulness, breathing and relaxation practices for relaxation, and attention practices for mental calming. Studies show that meditation practices are used for purposes such as individual and psychological well-being, anxiety, depression, strengthening spirituality and positive results are obtained. This study aims to determine the effects of meditation on the spiritual well-being and resilience levels of mothers with oncologically diagnosed children aged 6-18 years.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2024

Geographic Reach
1 country

1 active site

Status
not yet recruiting

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

First Submitted

Initial submission to the registry

June 7, 2024

Completed
26 days until next milestone

First Posted

Study publicly available on registry

July 3, 2024

Completed
2 months until next milestone

Study Start

First participant enrolled

September 1, 2024

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2025

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2025

Completed
Last Updated

July 3, 2024

Status Verified

June 1, 2024

Enrollment Period

4 months

First QC Date

June 7, 2024

Last Update Submit

June 25, 2024

Conditions

Keywords

OncologyMeditationResilienceSpiritual Well-Being

Outcome Measures

Primary Outcomes (2)

  • Spiritual well-being level (measured by "Spiritual Well-being Scale".It is a five-point Likert scale comprising 29 items in three sub-dimensions. The score that can be obtained from the scale varies between 29 and 145.)

    The effect of meditation applied to mothers with children with oncological diagnosis in the 6-18 age group on their spiritual well-being level.

    Measurements will be taken at registration, when participants are included in the study, and 3 weeks after the first measurement.

  • Resilience level (measured by the Connor Davidson Resilience Scale Short Form. The scores that can be obtained from the scale vary between 0 and 40. High scores obtained from the scale are considered as high psychological resilience.)

    The effect of meditation applied to mothers with children with oncological diagnosis in the 6-18 age group on their resilience level.

    Measurements will be taken at registration, when participants are included in the study, and 3 weeks after the first measurement.

Study Arms (2)

Experimental Group

EXPERIMENTAL

Researchers will inform mothers who apply to the unit and invite them to participate in the study. The informed consent form will be read to mothers who accept the study, and their written consent will be obtained. A simple randomization method will be used to control selection bias that may arise while determining research groups. All study participants (intervention and control groups) will be asked to complete the Introductory Characteristics Form, Spiritual Well-Being Scale, and Connor Davidson Resilience Scale Short Form. After this stage, mothers in the intervention group will be given a meditation application video, and the details of the application (how long and how to meditate) will be explained. After the implementation period, the mothers will be again administered the Spiritual Well-Being Scale and the Connor Davidson Resilience Scale Short Form

Other: Meditation

Control Group

NO INTERVENTION

No intervention will be made to the control group. To act ethically, after data is collected from the experimental and control groups, participants in the control group will be given the meditation video to practice.

Interventions

Guided meditation will be applied within the scope of the study. A guided meditation video prepared by a Yoga Alliance-certified researcher will be used for this intervention. Guided meditation aims to ensure being in the moment (here and now) with the help of breathing. Meditation practice will take participants 10 minutes.

Experimental Group

Eligibility Criteria

Age6 Years - 18 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsWomen in the 6-18 age group with children diagnosed with oncology will be included in the study.
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Mothers whose children have been diagnosed with oncology,
  • Mothers whose children have received at least one course of chemotherapy
  • Mothers who can speak and understand Turkish
  • Mothers who volunteer to participate in the study will be included.

You may not qualify if:

  • Mothers who have a particular problem that prevents communication (neurodevelopmental delay, verbal speech difficulty, hearing or hearing problems),
  • Mothers who are being treated for relapse or whose children are in the terminal stage will be excluded from the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kocaeli University

Kocaeli, İ̇zmi̇t, 41100, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Psychological Well-BeingNeoplasms

Interventions

Meditation

Condition Hierarchy (Ancestors)

Personal SatisfactionBehavior

Intervention Hierarchy (Ancestors)

Mind-Body TherapiesComplementary TherapiesTherapeuticsSpiritual TherapiesRelaxation TherapyBehavior TherapyPsychotherapyBehavioral Disciplines and Activities

Central Study Contacts

Eda SIMSEK SAHIN, M.Sc

CONTACT

Birgul ERDOGAN, M.Sc

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

June 7, 2024

First Posted

July 3, 2024

Study Start

September 1, 2024

Primary Completion

January 1, 2025

Study Completion

September 1, 2025

Last Updated

July 3, 2024

Record last verified: 2024-06

Data Sharing

IPD Sharing
Will not share

There are no plans to roll out IPD.

Locations